MedidataRWSNET DocumentationRelease 10

Matthew Koch MSKCC

Jul 18 2018

Contents

1 Introduction 311 Assumptions 312 Acknowledgments 3

2 Getting Started 521 Installation 522 Basic Example 523 Miscellaneous Configuration 6

3 Topics 931 Authentication 932 Errors 9

4 Basic Requests 1141 VersionRequest() 1142 BuildVersionRequest() 1143 TwoHundredRequest() 1244 CacheFlushRequest() 12

5 Core Resources 1351 Clinical Data 1352 Clinical View Datasets 14

6 Using Builders 1961 Basic Example - Register a Subject 19

7 Indices and tables 21

i

ii

MedidataRWSNET Documentation Release 10

MedidataRWSNET is a comprehensive fluent NET API library for Medidata RAVE Web Services (RWS) It handlesa large portion of the boilerplate C code yoursquod normally have to write in order to communicate with RWS allowingyou to get up and running faster

Contents 1

Contents

1 Introduction 311 Assumptions 312 Acknowledgments 3

2 Getting Started 521 Installation 522 Basic Example 523 Miscellaneous Configuration 6

3 Topics 931 Authentication 932 Errors 9

4 Basic Requests 1141 VersionRequest() 1142 BuildVersionRequest() 1143 TwoHundredRequest() 1244 CacheFlushRequest() 12

5 Core Resources 1351 Clinical Data 1352 Clinical View Datasets 14

6 Using Builders 1961 Basic Example - Register a Subject 19

7 Indices and tables 21

i

ii

MedidataRWSNET Documentation Release 10

MedidataRWSNET is a comprehensive fluent NET API library for Medidata RAVE Web Services (RWS) It handlesa large portion of the boilerplate C code yoursquod normally have to write in order to communicate with RWS allowingyou to get up and running faster

Contents 1

ii

MedidataRWSNET Documentation Release 10

MedidataRWSNET is a comprehensive fluent NET API library for Medidata RAVE Web Services (RWS) It handlesa large portion of the boilerplate C code yoursquod normally have to write in order to communicate with RWS allowingyou to get up and running faster

Contents 1

MedidataRWSNET Documentation Release 10

MedidataRWSNET is a comprehensive fluent NET API library for Medidata RAVE Web Services (RWS) It handlesa large portion of the boilerplate C code yoursquod normally have to write in order to communicate with RWS allowingyou to get up and running faster

Contents 1

MedidataRWSNET Documentation Release 10

2 Contents

CHAPTER 1

Introduction

11 Assumptions

This documentation assumes that the reader has a familiarity with the Medidata RAVE platform as well as a basic un-derstanding of RESTful Web Service concepts While the MedidataRWSNET library attempts to abstract away someof the typical HTTP communication mechanisms required when making typical web service requests the underlyingHTTP codes and raw request response data is still available to developers

12 Acknowledgments

The creation of this library wouldnrsquot have been possible without inspiration and examples from some fine folks atMedidata Solutions specifically Ian Sparks and Geoff Low In many ways the library has taken some inspirationfrom the Python flavored ldquorwslibrdquo available on Github httpsgithubcommdsolrwslib

3

CHAPTER 1

Introduction

11 Assumptions

This documentation assumes that the reader has a familiarity with the Medidata RAVE platform as well as a basic un-derstanding of RESTful Web Service concepts While the MedidataRWSNET library attempts to abstract away someof the typical HTTP communication mechanisms required when making typical web service requests the underlyingHTTP codes and raw request response data is still available to developers

12 Acknowledgments

The creation of this library wouldnrsquot have been possible without inspiration and examples from some fine folks atMedidata Solutions specifically Ian Sparks and Geoff Low In many ways the library has taken some inspirationfrom the Python flavored ldquorwslibrdquo available on Github httpsgithubcommdsolrwslib

3

MedidataRWSNET Documentation Release 10

4 Chapter 1 Introduction

CHAPTER 2

Getting Started

21 Installation

Install MedidataRWSNET via NuGet nuget install MedidataRWSNET

or via the Package Manager Console Install-Package MedidataRWSNET

22 Basic Example

At the most basic level communicating with Medidata RAVE using MedidataRWSNET involves

1 Creating a connection

using MedidataRWSCoreRequestsvar connection = new RwsConnection(innovate RAVE username RAVE password)

The above code will create a RwsConnection object to the ldquoinnovaterdquo RAVE instance (subdomain) - httpsinnovatemdsolcom Yoursquod substitute your RAVE instance subdomain here The RAVE username and RAVE password param-eters should reference a dedicated RAVE account you intend to use for web service activities

2 Creating a request

using MedidataRWSCoreRequestsDatasetsvar datasetRequest = new SubjectDatasetRequest(MediFlex PROD subject_keyrarr˓SUBJECT001 formOid HEM)

3 Sending the request

var response = connectionSendRequest(datasetRequest) as RWSResponse

4 Dealing with the responseexception

5

CHAPTER 2

Getting Started

21 Installation

Install MedidataRWSNET via NuGet nuget install MedidataRWSNET

or via the Package Manager Console Install-Package MedidataRWSNET

22 Basic Example

At the most basic level communicating with Medidata RAVE using MedidataRWSNET involves

1 Creating a connection

using MedidataRWSCoreRequestsvar connection = new RwsConnection(innovate RAVE username RAVE password)

The above code will create a RwsConnection object to the ldquoinnovaterdquo RAVE instance (subdomain) - httpsinnovatemdsolcom Yoursquod substitute your RAVE instance subdomain here The RAVE username and RAVE password param-eters should reference a dedicated RAVE account you intend to use for web service activities

2 Creating a request

using MedidataRWSCoreRequestsDatasetsvar datasetRequest = new SubjectDatasetRequest(MediFlex PROD subject_keyrarr˓SUBJECT001 formOid HEM)

3 Sending the request

var response = connectionSendRequest(datasetRequest) as RWSResponse

4 Dealing with the responseexception

5

MedidataRWSNET Documentation Release 10

ConsoleWrite(responseRawXMLString())

5 Putting this all together we have the following

using MedidataRWSCoreRequestsDatasetsusing MedidataRWSCoreRequests

Create a connectionvar connection = new RwsConnection(innovate RAVE username RAVE password)

Create a requestvar datasetRequest = new SubjectDatasetRequest(MediFlex PROD subject_keyrarr˓SUBJECT001 formOid HEM)

Send the request get a responsevar response = connectionSendRequest(datasetRequest) as RWSResponse

Write the response XML string to the consoleConsoleWrite(responseRawXMLString())

The above steps outline how to retrieve data for SUBJECT001rsquos HEM form in the MediFlex study (specifically thePROD environment)

23 Miscellaneous Configuration

When working with MedidataRWSNET you may wish to configure the connection to RWS beyond the defaultsettings Options for doing so are described below

231 Virtual Directory

When you make requests to RAVE Web services the URL you communicate with follows a specific pattern Thedomain name will always be ldquomdsolcomrdquo and the protocol will always be ldquohttpsrdquo The sub-domain amp virtualdirectory are configurable The default virtual directory is ldquoRaveWebServicesrdquo This means that when you create anew connection to innovate using the default virtual directory yoursquoll get the following

using MedidataRWSCoreRequests

Create a connectionvar connection = new RwsConnection(innovate RAVE username RAVE password)connectionbase_url httpsinnovatemdsolcomRaveWebServices

If instead yoursquod like to change the virtual directory to a custom one you can pass an additional parameter through theRwsConnection constructor

using MedidataRWSCoreRequests

Create a connectionvar connection = new RwsConnection(innovate RAVE username RAVE passwordrarr˓CustomVirtualDirectory)connectionbase_url httpsinnovatemdsolcomCustomVirtualDirectory

Note that this is provided as a convenience and the default virtual directory will be preferable in most scenarios

6 Chapter 2 Getting Started

MedidataRWSNET Documentation Release 10

232 Timeouts

If supplied the timeout of the request in milliseconds If the request takes longer than the timeout value an exceptionwill be thrown

using MedidataRWSCoreRequests

Create a connectionvar connection = new RwsConnection(innovate RAVE username timeout 1000)

23 Miscellaneous Configuration 7

MedidataRWSNET Documentation Release 10

8 Chapter 2 Getting Started

CHAPTER 3

Topics

31 Authentication

In order to use Medidata RAVE web services you must authenticate your web service requests You can do this bysupplying both a RAVE username and RAVE password parameter when you establish a RwsConnection objectThis usernamepassword should reference a dedicated RAVE account you intend to use for web service activities

For example

using MedidataRWSCoreRequestsvar connection = new RwsConnection(innovate rwsUser1 password1)

The above code will create a RwsConnection object and point it to the innovate RAVE instance (subdomain) -httpsinnovatemdsolcom The username and password you provide are concatenated base64-encodedand passed in the Authorization HTTP header each time you make a request using the connection object as follows

Authorization Basic cndzVXNlcjE6cGFzc3dvcmQx

Do not share your username password in publicly accessible areas such GitHub client-side code and so forthAuthentication is only required when establishing a new RwsConnection object The MedidataRWSNET librarywill then automatically send the appropriate Authorization header for each request made with this connection objectAPI requests without authentication will fail

32 Errors

Medidata RAVE web services uses HTTP response codes to indicate success or failure of an API request Generallyspeaking HTTP codes in the ranges below mean the following

bull 2xx - success

bull 4xx - an error that failed given the information provided

bull 5xx - an error with Medidatarsquos servers

9

MedidataRWSNET Documentation Release 10

Not all errors map cleanly onto HTTP response codes however Medidata usually attempts to return a ldquoRWS ReasonCoderdquo in addition to the conventional HTTP code to explain in more detail about what went wrong To see a fulllisting of these codes refer to Rave Web Services Error Responses - Complete List

321 Handling errors

The MedidataRWSNET library can raise an exception for a variety reasons such as invalid parameters authenticationerrors and network unavailability We recommend writing code that gracefully handles all possible API exceptions

10 Chapter 3 Topics

MedidataRWSNET Documentation Release 10

8 Chapter 2 Getting Started

CHAPTER 3

Topics

31 Authentication

In order to use Medidata RAVE web services you must authenticate your web service requests You can do this bysupplying both a RAVE username and RAVE password parameter when you establish a RwsConnection objectThis usernamepassword should reference a dedicated RAVE account you intend to use for web service activities

For example

using MedidataRWSCoreRequestsvar connection = new RwsConnection(innovate rwsUser1 password1)

The above code will create a RwsConnection object and point it to the innovate RAVE instance (subdomain) -httpsinnovatemdsolcom The username and password you provide are concatenated base64-encodedand passed in the Authorization HTTP header each time you make a request using the connection object as follows

Authorization Basic cndzVXNlcjE6cGFzc3dvcmQx

Do not share your username password in publicly accessible areas such GitHub client-side code and so forthAuthentication is only required when establishing a new RwsConnection object The MedidataRWSNET librarywill then automatically send the appropriate Authorization header for each request made with this connection objectAPI requests without authentication will fail

32 Errors

Medidata RAVE web services uses HTTP response codes to indicate success or failure of an API request Generallyspeaking HTTP codes in the ranges below mean the following

bull 2xx - success

bull 4xx - an error that failed given the information provided

bull 5xx - an error with Medidatarsquos servers

9

MedidataRWSNET Documentation Release 10

Not all errors map cleanly onto HTTP response codes however Medidata usually attempts to return a ldquoRWS ReasonCoderdquo in addition to the conventional HTTP code to explain in more detail about what went wrong To see a fulllisting of these codes refer to Rave Web Services Error Responses - Complete List

321 Handling errors

The MedidataRWSNET library can raise an exception for a variety reasons such as invalid parameters authenticationerrors and network unavailability We recommend writing code that gracefully handles all possible API exceptions

10 Chapter 3 Topics

CHAPTER 3

Topics

31 Authentication

In order to use Medidata RAVE web services you must authenticate your web service requests You can do this bysupplying both a RAVE username and RAVE password parameter when you establish a RwsConnection objectThis usernamepassword should reference a dedicated RAVE account you intend to use for web service activities

For example

using MedidataRWSCoreRequestsvar connection = new RwsConnection(innovate rwsUser1 password1)

The above code will create a RwsConnection object and point it to the innovate RAVE instance (subdomain) -httpsinnovatemdsolcom The username and password you provide are concatenated base64-encodedand passed in the Authorization HTTP header each time you make a request using the connection object as follows

Authorization Basic cndzVXNlcjE6cGFzc3dvcmQx

Do not share your username password in publicly accessible areas such GitHub client-side code and so forthAuthentication is only required when establishing a new RwsConnection object The MedidataRWSNET librarywill then automatically send the appropriate Authorization header for each request made with this connection objectAPI requests without authentication will fail

32 Errors

Medidata RAVE web services uses HTTP response codes to indicate success or failure of an API request Generallyspeaking HTTP codes in the ranges below mean the following

bull 2xx - success

bull 4xx - an error that failed given the information provided

bull 5xx - an error with Medidatarsquos servers

9

MedidataRWSNET Documentation Release 10

Not all errors map cleanly onto HTTP response codes however Medidata usually attempts to return a ldquoRWS ReasonCoderdquo in addition to the conventional HTTP code to explain in more detail about what went wrong To see a fulllisting of these codes refer to Rave Web Services Error Responses - Complete List

321 Handling errors

The MedidataRWSNET library can raise an exception for a variety reasons such as invalid parameters authenticationerrors and network unavailability We recommend writing code that gracefully handles all possible API exceptions

10 Chapter 3 Topics

MedidataRWSNET Documentation Release 10

Not all errors map cleanly onto HTTP response codes however Medidata usually attempts to return a ldquoRWS ReasonCoderdquo in addition to the conventional HTTP code to explain in more detail about what went wrong To see a fulllisting of these codes refer to Rave Web Services Error Responses - Complete List

321 Handling errors

The MedidataRWSNET library can raise an exception for a variety reasons such as invalid parameters authenticationerrors and network unavailability We recommend writing code that gracefully handles all possible API exceptions

10 Chapter 3 Topics

CHAPTER 4

Basic Requests

MedidataRWSNET provides some basic diagnostic health check API requests out of the box

41 VersionRequest()

Returns the RWS version number Specifically this is the textual response returned when calling httpssubdomain mdsolcomRaveWebServicesversion

using MedidataRWSCoreRequests

Create a connectionvar connection = new RwsConnection(innovate) no authentication required

Send the request get a responsevar response = connectionSendRequest(new VersionRequest()) as RWSTextResponse

Write the response text to the consoleConsoleWrite(responseResponseText)1150

42 BuildVersionRequest()

Returns the internal RWS build number Specifically this is the textual response returned when calling httpssubdomain mdsolcomRaveWebServicesversionbuild

using MedidataRWSCoreRequests

Create a connectionvar connection = new RwsConnection(innovate) no authentication required

(continues on next page)

11

MedidataRWSNET Documentation Release 10

(continued from previous page)

Send the request get a responsevar response = connectionSendRequest(new BuildVersionRequest()) as RWSTextResponse

Write the response text to the consoleConsoleWrite(responseResponseText)565335

43 TwoHundredRequest()

Returns the html document (along with a 200 HTTP response code) that contains information about the MAuth con-figuration of Rave Web Services with the given configuration Specifically this is the html response returned whencalling https subdomain mdsolcomRaveWebServicestwohundred

using MedidataRWSCoreRequests

Create a connectionvar connection = new RwsConnection(innovate) no authentication required

Send the request get a responsevar response = connectionSendRequest(new TwoHundredRequest()) as RWSTextResponse

Write the response text to the consoleConsoleWrite(responseResponseText)ltDOCTYPE htmlgtrnlthtmlgtrnltheadgtltscript

44 CacheFlushRequest()

Send a request to flush the RWS cache Typically this is used to immediately implement configuration changesin RWS Under normal circumstances this request is unnecessary as RAVE and RWS manage their own cachingmechanisms automatically Specifically this is the equivalent of calling https subdomain mdsolcomRaveWebServiceswebserviceaspxCacheFlush

using MedidataRWSCoreRequests

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication is required

Send the request get a responsevar response = connectionSendRequest(new CacheFlushRequest()) as RWSResponse

Write the response text to the consoleConsoleWrite(responseIsTransactionSuccessful)true

12 Chapter 4 Basic Requests

CHAPTER 5

Core Resources

51 Clinical Data

Often times yoursquoll want to work with the clinical data of your studies The MedidataRWSNET library provides sev-eral requests for extracting clinical data (via RAVE ldquoClinical Viewsrdquo) or POSTing clinical data to the RAVE platform

511 ClinicalStudiesRequest

Returns a list of EDC studies (as a RWSStudies object) Excludes studies that you (the authenticated user) are notassociated with

Example

using MedidataRWSCoreRequestsImplementations

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new ClinicalStudiesRequest()) as RWSStudies

Write the study list to the consoleforeach (var s in response)

ConsoleWrite(sOID + rn)Mediflex(Prod)Mediflex(Dev)PlaceboTest(Prod)

13

MedidataRWSNET Documentation Release 10

512 StudySubjectsRequest

Returns a listing of all the subjects in a study (as a RWSSubjects object) optionally including those currentlyinactive or deleted Clinical data for the subjects is not included in the response

This is the equivalent of calling httpssubdomainmdsolcomstudiesstudy-oidSubjects[status=allampinclude=inactive|inactiveAndDeleted]

Parameters

Parameter Description Manda-tory

study-oid The study name Yesstatus=true | false If true add subject level workflow status to the response (if

present)No

include= inactive | deleted | inac-tiveAndDeleted

Will include active inactive andor deleted subjects in the re-sponse

No

subjectKeyType= SubjectName |SubjectUUID

Whether RWS should return the unique identifier (UUID) orthe subject name

No

links=true | false If true includes ldquodeep linkrdquo(s) (eg URLs) to the subject pagein Rave in the response

No

Example

using MedidataRWSCoreRequestsImplementations

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new StudySubjectsRequest(Mediflex Prod))rarr˓as RWSSubjects

Write each subject key to the consoleforeach (var s in response)

ConsoleWrite(sSubjectKey + rn) SUBJECT001 SUBJECT002 SUBJECT003

52 Clinical View Datasets

In addition to the above requests Medidata RAVE Web Services allows for the extraction of clinical data in the formof ldquoClinical Viewsrdquo - that is RAVE database views There are 3 ldquoDatasetsrdquo available that represent different subsetsof clinical data for your studies

14 Chapter 5 Core Resources

MedidataRWSNET Documentation Release 10

521 StudyDatasetRequest

Clinical data in ODM format for the given study environment This data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)datasets regular|raw formoid options

Example

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new StudyDatasetRequest(Mediflex Prodrarr˓dataset_type regular)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=92747321-c8b3-4a07-a874-0ecb53153f20rarr˓CreationDateTime=2017-06-05T130933202-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gt

ltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gtltSubjectData SubjectKey=1gt

ltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T140900rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-13T163400rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

(continues on next page)

52 Clinical View Datasets 15

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-05-09T185200rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagt

ltODMgt

522 SubjectDatasetRequest

Clinical data in ODM format for the given study environment for a single subject Similar toStudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new SubjectDatasetRequest(Mediflex Prodrarr˓subject_key 1 dataset_type regular)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

(continues on next page)

16 Chapter 5 Core Resources

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=ABX FormRepeatKey=1gtltItemGroupData ItemGroupOID=ABX_LOG_LINEgt

ltItemData ItemOID=ABXABXDATE Value=2017-04-25 gtltItemData ItemOID=ABXMODALITY Value=2 gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=BONEMARROW FormRepeatKey=1gtltItemGroupData ItemGroupOID=BONEMARROW_LOG_LINEgt

ltItemData ItemOID=BONEMARROWVISITDAT Value=2015-04-24 gtltItemData ItemOID=BONEMARROWCHEMSAMPLE Value=1 gtltItemData ItemOID=BONEMARROWBMPB_COLLECT Value=1 gt

ltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

523 VersionDatasetRequest

Clinical data in ODM format for the given study environment for a single RAVE study version for all subjectsSimilar to StudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

(continues on next page)

52 Clinical View Datasets 17

MedidataRWSNET Documentation Release 10

(continued from previous page)

Send the request get a responsevar response = connectionSendRequest(new VersionDatasetRequest(project_namerarr˓Mediflex environment_name Dev version_oid 999)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

Note the MetaDataVersionOID value in the XML response

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2016-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2017-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

18 Chapter 5 Core Resources

CHAPTER 6

Using Builders

When communicating with Medidata RAVE Web Services your data payloads will take the form of ODM XML - orOperational Data Model XML documents

Itrsquos important to understand that RWS expects the XML data you send to conform to the ODM format - malformed orotherwise improperly formatted XML wonrsquot be processed Since creating these data structures manually can be timeconsuming and tedious MedidataRWSNET provides several ldquoBuilderrdquo classes to help

61 Basic Example - Register a Subject

By way of example letrsquos say you want to register a subject onto a RAVE study using RWS In order to do this yoursquollneed

1 An authenticated connection to RWS

2 An XML document that represents the POST request you intend to make which will include

bull A Study OID (study)

bull A LocationOID (site)

bull A SubjectKey (subject)

3 A way to deal with the response after the request is sent

The ODMBuilder class allows developers to build out the ODM XML documents required for transmission usinga simple to use fluent interface Using the above example letrsquos create a new ODMBuilder instance to register asubject

var odmObject = new ODMBuilder()WithClinicalData(MediFlex cd =gtcdWithSubjectData(SUBJECT001 SITE01 sd =gt

sdWithTransactionType(TransactionTypeInsert)))

After instantiating the ODMBuilder class yoursquoll notice that you have access to chain-able methods which allow youto construct the object appropriate for your use case Since we are registering a subject we supplied a Study OID(Mediflex) Subject Key (SUBJECT001) and Site (SITE01)

19

MedidataRWSNET Documentation Release 10

(continued from previous page)

Send the request get a responsevar response = connectionSendRequest(new BuildVersionRequest()) as RWSTextResponse

Write the response text to the consoleConsoleWrite(responseResponseText)565335

43 TwoHundredRequest()

Returns the html document (along with a 200 HTTP response code) that contains information about the MAuth con-figuration of Rave Web Services with the given configuration Specifically this is the html response returned whencalling https subdomain mdsolcomRaveWebServicestwohundred

using MedidataRWSCoreRequests

Create a connectionvar connection = new RwsConnection(innovate) no authentication required

Send the request get a responsevar response = connectionSendRequest(new TwoHundredRequest()) as RWSTextResponse

Write the response text to the consoleConsoleWrite(responseResponseText)ltDOCTYPE htmlgtrnlthtmlgtrnltheadgtltscript

44 CacheFlushRequest()

Send a request to flush the RWS cache Typically this is used to immediately implement configuration changesin RWS Under normal circumstances this request is unnecessary as RAVE and RWS manage their own cachingmechanisms automatically Specifically this is the equivalent of calling https subdomain mdsolcomRaveWebServiceswebserviceaspxCacheFlush

using MedidataRWSCoreRequests

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication is required

Send the request get a responsevar response = connectionSendRequest(new CacheFlushRequest()) as RWSResponse

Write the response text to the consoleConsoleWrite(responseIsTransactionSuccessful)true

12 Chapter 4 Basic Requests

CHAPTER 5

Core Resources

51 Clinical Data

Often times yoursquoll want to work with the clinical data of your studies The MedidataRWSNET library provides sev-eral requests for extracting clinical data (via RAVE ldquoClinical Viewsrdquo) or POSTing clinical data to the RAVE platform

511 ClinicalStudiesRequest

Returns a list of EDC studies (as a RWSStudies object) Excludes studies that you (the authenticated user) are notassociated with

Example

using MedidataRWSCoreRequestsImplementations

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new ClinicalStudiesRequest()) as RWSStudies

Write the study list to the consoleforeach (var s in response)

ConsoleWrite(sOID + rn)Mediflex(Prod)Mediflex(Dev)PlaceboTest(Prod)

13

MedidataRWSNET Documentation Release 10

512 StudySubjectsRequest

Returns a listing of all the subjects in a study (as a RWSSubjects object) optionally including those currentlyinactive or deleted Clinical data for the subjects is not included in the response

This is the equivalent of calling httpssubdomainmdsolcomstudiesstudy-oidSubjects[status=allampinclude=inactive|inactiveAndDeleted]

Parameters

Parameter Description Manda-tory

study-oid The study name Yesstatus=true | false If true add subject level workflow status to the response (if

present)No

include= inactive | deleted | inac-tiveAndDeleted

Will include active inactive andor deleted subjects in the re-sponse

No

subjectKeyType= SubjectName |SubjectUUID

Whether RWS should return the unique identifier (UUID) orthe subject name

No

links=true | false If true includes ldquodeep linkrdquo(s) (eg URLs) to the subject pagein Rave in the response

No

Example

using MedidataRWSCoreRequestsImplementations

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new StudySubjectsRequest(Mediflex Prod))rarr˓as RWSSubjects

Write each subject key to the consoleforeach (var s in response)

ConsoleWrite(sSubjectKey + rn) SUBJECT001 SUBJECT002 SUBJECT003

52 Clinical View Datasets

In addition to the above requests Medidata RAVE Web Services allows for the extraction of clinical data in the formof ldquoClinical Viewsrdquo - that is RAVE database views There are 3 ldquoDatasetsrdquo available that represent different subsetsof clinical data for your studies

14 Chapter 5 Core Resources

MedidataRWSNET Documentation Release 10

521 StudyDatasetRequest

Clinical data in ODM format for the given study environment This data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)datasets regular|raw formoid options

Example

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new StudyDatasetRequest(Mediflex Prodrarr˓dataset_type regular)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=92747321-c8b3-4a07-a874-0ecb53153f20rarr˓CreationDateTime=2017-06-05T130933202-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gt

ltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gtltSubjectData SubjectKey=1gt

ltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T140900rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-13T163400rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

(continues on next page)

52 Clinical View Datasets 15

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-05-09T185200rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagt

ltODMgt

522 SubjectDatasetRequest

Clinical data in ODM format for the given study environment for a single subject Similar toStudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new SubjectDatasetRequest(Mediflex Prodrarr˓subject_key 1 dataset_type regular)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

(continues on next page)

16 Chapter 5 Core Resources

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=ABX FormRepeatKey=1gtltItemGroupData ItemGroupOID=ABX_LOG_LINEgt

ltItemData ItemOID=ABXABXDATE Value=2017-04-25 gtltItemData ItemOID=ABXMODALITY Value=2 gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=BONEMARROW FormRepeatKey=1gtltItemGroupData ItemGroupOID=BONEMARROW_LOG_LINEgt

ltItemData ItemOID=BONEMARROWVISITDAT Value=2015-04-24 gtltItemData ItemOID=BONEMARROWCHEMSAMPLE Value=1 gtltItemData ItemOID=BONEMARROWBMPB_COLLECT Value=1 gt

ltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

523 VersionDatasetRequest

Clinical data in ODM format for the given study environment for a single RAVE study version for all subjectsSimilar to StudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

(continues on next page)

52 Clinical View Datasets 17

MedidataRWSNET Documentation Release 10

(continued from previous page)

Send the request get a responsevar response = connectionSendRequest(new VersionDatasetRequest(project_namerarr˓Mediflex environment_name Dev version_oid 999)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

Note the MetaDataVersionOID value in the XML response

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2016-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2017-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

18 Chapter 5 Core Resources

CHAPTER 6

Using Builders

When communicating with Medidata RAVE Web Services your data payloads will take the form of ODM XML - orOperational Data Model XML documents

Itrsquos important to understand that RWS expects the XML data you send to conform to the ODM format - malformed orotherwise improperly formatted XML wonrsquot be processed Since creating these data structures manually can be timeconsuming and tedious MedidataRWSNET provides several ldquoBuilderrdquo classes to help

61 Basic Example - Register a Subject

By way of example letrsquos say you want to register a subject onto a RAVE study using RWS In order to do this yoursquollneed

1 An authenticated connection to RWS

2 An XML document that represents the POST request you intend to make which will include

bull A Study OID (study)

bull A LocationOID (site)

bull A SubjectKey (subject)

3 A way to deal with the response after the request is sent

The ODMBuilder class allows developers to build out the ODM XML documents required for transmission usinga simple to use fluent interface Using the above example letrsquos create a new ODMBuilder instance to register asubject

var odmObject = new ODMBuilder()WithClinicalData(MediFlex cd =gtcdWithSubjectData(SUBJECT001 SITE01 sd =gt

sdWithTransactionType(TransactionTypeInsert)))

After instantiating the ODMBuilder class yoursquoll notice that you have access to chain-able methods which allow youto construct the object appropriate for your use case Since we are registering a subject we supplied a Study OID(Mediflex) Subject Key (SUBJECT001) and Site (SITE01)

19

CHAPTER 5

Core Resources

51 Clinical Data

Often times yoursquoll want to work with the clinical data of your studies The MedidataRWSNET library provides sev-eral requests for extracting clinical data (via RAVE ldquoClinical Viewsrdquo) or POSTing clinical data to the RAVE platform

511 ClinicalStudiesRequest

Returns a list of EDC studies (as a RWSStudies object) Excludes studies that you (the authenticated user) are notassociated with

Example

using MedidataRWSCoreRequestsImplementations

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new ClinicalStudiesRequest()) as RWSStudies

Write the study list to the consoleforeach (var s in response)

ConsoleWrite(sOID + rn)Mediflex(Prod)Mediflex(Dev)PlaceboTest(Prod)

13

MedidataRWSNET Documentation Release 10

512 StudySubjectsRequest

Returns a listing of all the subjects in a study (as a RWSSubjects object) optionally including those currentlyinactive or deleted Clinical data for the subjects is not included in the response

This is the equivalent of calling httpssubdomainmdsolcomstudiesstudy-oidSubjects[status=allampinclude=inactive|inactiveAndDeleted]

Parameters

Parameter Description Manda-tory

study-oid The study name Yesstatus=true | false If true add subject level workflow status to the response (if

present)No

include= inactive | deleted | inac-tiveAndDeleted

Will include active inactive andor deleted subjects in the re-sponse

No

subjectKeyType= SubjectName |SubjectUUID

Whether RWS should return the unique identifier (UUID) orthe subject name

No

links=true | false If true includes ldquodeep linkrdquo(s) (eg URLs) to the subject pagein Rave in the response

No

Example

using MedidataRWSCoreRequestsImplementations

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new StudySubjectsRequest(Mediflex Prod))rarr˓as RWSSubjects

Write each subject key to the consoleforeach (var s in response)

ConsoleWrite(sSubjectKey + rn) SUBJECT001 SUBJECT002 SUBJECT003

52 Clinical View Datasets

In addition to the above requests Medidata RAVE Web Services allows for the extraction of clinical data in the formof ldquoClinical Viewsrdquo - that is RAVE database views There are 3 ldquoDatasetsrdquo available that represent different subsetsof clinical data for your studies

14 Chapter 5 Core Resources

MedidataRWSNET Documentation Release 10

521 StudyDatasetRequest

Clinical data in ODM format for the given study environment This data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)datasets regular|raw formoid options

Example

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new StudyDatasetRequest(Mediflex Prodrarr˓dataset_type regular)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=92747321-c8b3-4a07-a874-0ecb53153f20rarr˓CreationDateTime=2017-06-05T130933202-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gt

ltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gtltSubjectData SubjectKey=1gt

ltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T140900rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-13T163400rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

(continues on next page)

52 Clinical View Datasets 15

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-05-09T185200rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagt

ltODMgt

522 SubjectDatasetRequest

Clinical data in ODM format for the given study environment for a single subject Similar toStudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new SubjectDatasetRequest(Mediflex Prodrarr˓subject_key 1 dataset_type regular)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

(continues on next page)

16 Chapter 5 Core Resources

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=ABX FormRepeatKey=1gtltItemGroupData ItemGroupOID=ABX_LOG_LINEgt

ltItemData ItemOID=ABXABXDATE Value=2017-04-25 gtltItemData ItemOID=ABXMODALITY Value=2 gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=BONEMARROW FormRepeatKey=1gtltItemGroupData ItemGroupOID=BONEMARROW_LOG_LINEgt

ltItemData ItemOID=BONEMARROWVISITDAT Value=2015-04-24 gtltItemData ItemOID=BONEMARROWCHEMSAMPLE Value=1 gtltItemData ItemOID=BONEMARROWBMPB_COLLECT Value=1 gt

ltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

523 VersionDatasetRequest

Clinical data in ODM format for the given study environment for a single RAVE study version for all subjectsSimilar to StudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

(continues on next page)

52 Clinical View Datasets 17

MedidataRWSNET Documentation Release 10

(continued from previous page)

Send the request get a responsevar response = connectionSendRequest(new VersionDatasetRequest(project_namerarr˓Mediflex environment_name Dev version_oid 999)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

Note the MetaDataVersionOID value in the XML response

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2016-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2017-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

18 Chapter 5 Core Resources

CHAPTER 6

Using Builders

When communicating with Medidata RAVE Web Services your data payloads will take the form of ODM XML - orOperational Data Model XML documents

Itrsquos important to understand that RWS expects the XML data you send to conform to the ODM format - malformed orotherwise improperly formatted XML wonrsquot be processed Since creating these data structures manually can be timeconsuming and tedious MedidataRWSNET provides several ldquoBuilderrdquo classes to help

61 Basic Example - Register a Subject

By way of example letrsquos say you want to register a subject onto a RAVE study using RWS In order to do this yoursquollneed

1 An authenticated connection to RWS

2 An XML document that represents the POST request you intend to make which will include

bull A Study OID (study)

bull A LocationOID (site)

bull A SubjectKey (subject)

3 A way to deal with the response after the request is sent

The ODMBuilder class allows developers to build out the ODM XML documents required for transmission usinga simple to use fluent interface Using the above example letrsquos create a new ODMBuilder instance to register asubject

var odmObject = new ODMBuilder()WithClinicalData(MediFlex cd =gtcdWithSubjectData(SUBJECT001 SITE01 sd =gt

sdWithTransactionType(TransactionTypeInsert)))

After instantiating the ODMBuilder class yoursquoll notice that you have access to chain-able methods which allow youto construct the object appropriate for your use case Since we are registering a subject we supplied a Study OID(Mediflex) Subject Key (SUBJECT001) and Site (SITE01)

19

MedidataRWSNET Documentation Release 10

512 StudySubjectsRequest

Returns a listing of all the subjects in a study (as a RWSSubjects object) optionally including those currentlyinactive or deleted Clinical data for the subjects is not included in the response

This is the equivalent of calling httpssubdomainmdsolcomstudiesstudy-oidSubjects[status=allampinclude=inactive|inactiveAndDeleted]

Parameters

Parameter Description Manda-tory

study-oid The study name Yesstatus=true | false If true add subject level workflow status to the response (if

present)No

include= inactive | deleted | inac-tiveAndDeleted

Will include active inactive andor deleted subjects in the re-sponse

No

subjectKeyType= SubjectName |SubjectUUID

Whether RWS should return the unique identifier (UUID) orthe subject name

No

links=true | false If true includes ldquodeep linkrdquo(s) (eg URLs) to the subject pagein Rave in the response

No

Example

using MedidataRWSCoreRequestsImplementations

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new StudySubjectsRequest(Mediflex Prod))rarr˓as RWSSubjects

Write each subject key to the consoleforeach (var s in response)

ConsoleWrite(sSubjectKey + rn) SUBJECT001 SUBJECT002 SUBJECT003

52 Clinical View Datasets

In addition to the above requests Medidata RAVE Web Services allows for the extraction of clinical data in the formof ldquoClinical Viewsrdquo - that is RAVE database views There are 3 ldquoDatasetsrdquo available that represent different subsetsof clinical data for your studies

14 Chapter 5 Core Resources

MedidataRWSNET Documentation Release 10

521 StudyDatasetRequest

Clinical data in ODM format for the given study environment This data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)datasets regular|raw formoid options

Example

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new StudyDatasetRequest(Mediflex Prodrarr˓dataset_type regular)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=92747321-c8b3-4a07-a874-0ecb53153f20rarr˓CreationDateTime=2017-06-05T130933202-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gt

ltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gtltSubjectData SubjectKey=1gt

ltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T140900rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-13T163400rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

(continues on next page)

52 Clinical View Datasets 15

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-05-09T185200rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagt

ltODMgt

522 SubjectDatasetRequest

Clinical data in ODM format for the given study environment for a single subject Similar toStudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new SubjectDatasetRequest(Mediflex Prodrarr˓subject_key 1 dataset_type regular)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

(continues on next page)

16 Chapter 5 Core Resources

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=ABX FormRepeatKey=1gtltItemGroupData ItemGroupOID=ABX_LOG_LINEgt

ltItemData ItemOID=ABXABXDATE Value=2017-04-25 gtltItemData ItemOID=ABXMODALITY Value=2 gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=BONEMARROW FormRepeatKey=1gtltItemGroupData ItemGroupOID=BONEMARROW_LOG_LINEgt

ltItemData ItemOID=BONEMARROWVISITDAT Value=2015-04-24 gtltItemData ItemOID=BONEMARROWCHEMSAMPLE Value=1 gtltItemData ItemOID=BONEMARROWBMPB_COLLECT Value=1 gt

ltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

523 VersionDatasetRequest

Clinical data in ODM format for the given study environment for a single RAVE study version for all subjectsSimilar to StudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

(continues on next page)

52 Clinical View Datasets 17

MedidataRWSNET Documentation Release 10

(continued from previous page)

Send the request get a responsevar response = connectionSendRequest(new VersionDatasetRequest(project_namerarr˓Mediflex environment_name Dev version_oid 999)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

Note the MetaDataVersionOID value in the XML response

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2016-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2017-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

18 Chapter 5 Core Resources

CHAPTER 6

Using Builders

When communicating with Medidata RAVE Web Services your data payloads will take the form of ODM XML - orOperational Data Model XML documents

Itrsquos important to understand that RWS expects the XML data you send to conform to the ODM format - malformed orotherwise improperly formatted XML wonrsquot be processed Since creating these data structures manually can be timeconsuming and tedious MedidataRWSNET provides several ldquoBuilderrdquo classes to help

61 Basic Example - Register a Subject

By way of example letrsquos say you want to register a subject onto a RAVE study using RWS In order to do this yoursquollneed

1 An authenticated connection to RWS

2 An XML document that represents the POST request you intend to make which will include

bull A Study OID (study)

bull A LocationOID (site)

bull A SubjectKey (subject)

3 A way to deal with the response after the request is sent

The ODMBuilder class allows developers to build out the ODM XML documents required for transmission usinga simple to use fluent interface Using the above example letrsquos create a new ODMBuilder instance to register asubject

var odmObject = new ODMBuilder()WithClinicalData(MediFlex cd =gtcdWithSubjectData(SUBJECT001 SITE01 sd =gt

sdWithTransactionType(TransactionTypeInsert)))

After instantiating the ODMBuilder class yoursquoll notice that you have access to chain-able methods which allow youto construct the object appropriate for your use case Since we are registering a subject we supplied a Study OID(Mediflex) Subject Key (SUBJECT001) and Site (SITE01)

19

MedidataRWSNET Documentation Release 10

521 StudyDatasetRequest

Clinical data in ODM format for the given study environment This data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)datasets regular|raw formoid options

Example

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new StudyDatasetRequest(Mediflex Prodrarr˓dataset_type regular)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=92747321-c8b3-4a07-a874-0ecb53153f20rarr˓CreationDateTime=2017-06-05T130933202-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gt

ltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gtltSubjectData SubjectKey=1gt

ltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T140900rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-13T163400rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

(continues on next page)

52 Clinical View Datasets 15

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-05-09T185200rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagt

ltODMgt

522 SubjectDatasetRequest

Clinical data in ODM format for the given study environment for a single subject Similar toStudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new SubjectDatasetRequest(Mediflex Prodrarr˓subject_key 1 dataset_type regular)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

(continues on next page)

16 Chapter 5 Core Resources

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=ABX FormRepeatKey=1gtltItemGroupData ItemGroupOID=ABX_LOG_LINEgt

ltItemData ItemOID=ABXABXDATE Value=2017-04-25 gtltItemData ItemOID=ABXMODALITY Value=2 gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=BONEMARROW FormRepeatKey=1gtltItemGroupData ItemGroupOID=BONEMARROW_LOG_LINEgt

ltItemData ItemOID=BONEMARROWVISITDAT Value=2015-04-24 gtltItemData ItemOID=BONEMARROWCHEMSAMPLE Value=1 gtltItemData ItemOID=BONEMARROWBMPB_COLLECT Value=1 gt

ltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

523 VersionDatasetRequest

Clinical data in ODM format for the given study environment for a single RAVE study version for all subjectsSimilar to StudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

(continues on next page)

52 Clinical View Datasets 17

MedidataRWSNET Documentation Release 10

(continued from previous page)

Send the request get a responsevar response = connectionSendRequest(new VersionDatasetRequest(project_namerarr˓Mediflex environment_name Dev version_oid 999)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

Note the MetaDataVersionOID value in the XML response

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2016-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2017-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

18 Chapter 5 Core Resources

CHAPTER 6

Using Builders

When communicating with Medidata RAVE Web Services your data payloads will take the form of ODM XML - orOperational Data Model XML documents

Itrsquos important to understand that RWS expects the XML data you send to conform to the ODM format - malformed orotherwise improperly formatted XML wonrsquot be processed Since creating these data structures manually can be timeconsuming and tedious MedidataRWSNET provides several ldquoBuilderrdquo classes to help

61 Basic Example - Register a Subject

By way of example letrsquos say you want to register a subject onto a RAVE study using RWS In order to do this yoursquollneed

1 An authenticated connection to RWS

2 An XML document that represents the POST request you intend to make which will include

bull A Study OID (study)

bull A LocationOID (site)

bull A SubjectKey (subject)

3 A way to deal with the response after the request is sent

The ODMBuilder class allows developers to build out the ODM XML documents required for transmission usinga simple to use fluent interface Using the above example letrsquos create a new ODMBuilder instance to register asubject

var odmObject = new ODMBuilder()WithClinicalData(MediFlex cd =gtcdWithSubjectData(SUBJECT001 SITE01 sd =gt

sdWithTransactionType(TransactionTypeInsert)))

After instantiating the ODMBuilder class yoursquoll notice that you have access to chain-able methods which allow youto construct the object appropriate for your use case Since we are registering a subject we supplied a Study OID(Mediflex) Subject Key (SUBJECT001) and Site (SITE01)

19

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-05-09T185200rarr˓gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagt

ltODMgt

522 SubjectDatasetRequest

Clinical data in ODM format for the given study environment for a single subject Similar toStudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)subjects subjectkey datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

Send the request get a responsevar response = connectionSendRequest(new SubjectDatasetRequest(Mediflex Prodrarr˓subject_key 1 dataset_type regular)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

(continues on next page)

16 Chapter 5 Core Resources

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=ABX FormRepeatKey=1gtltItemGroupData ItemGroupOID=ABX_LOG_LINEgt

ltItemData ItemOID=ABXABXDATE Value=2017-04-25 gtltItemData ItemOID=ABXMODALITY Value=2 gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=BONEMARROW FormRepeatKey=1gtltItemGroupData ItemGroupOID=BONEMARROW_LOG_LINEgt

ltItemData ItemOID=BONEMARROWVISITDAT Value=2015-04-24 gtltItemData ItemOID=BONEMARROWCHEMSAMPLE Value=1 gtltItemData ItemOID=BONEMARROWBMPB_COLLECT Value=1 gt

ltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

523 VersionDatasetRequest

Clinical data in ODM format for the given study environment for a single RAVE study version for all subjectsSimilar to StudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

(continues on next page)

52 Clinical View Datasets 17

MedidataRWSNET Documentation Release 10

(continued from previous page)

Send the request get a responsevar response = connectionSendRequest(new VersionDatasetRequest(project_namerarr˓Mediflex environment_name Dev version_oid 999)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

Note the MetaDataVersionOID value in the XML response

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2016-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2017-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

18 Chapter 5 Core Resources

CHAPTER 6

Using Builders

When communicating with Medidata RAVE Web Services your data payloads will take the form of ODM XML - orOperational Data Model XML documents

Itrsquos important to understand that RWS expects the XML data you send to conform to the ODM format - malformed orotherwise improperly formatted XML wonrsquot be processed Since creating these data structures manually can be timeconsuming and tedious MedidataRWSNET provides several ldquoBuilderrdquo classes to help

61 Basic Example - Register a Subject

By way of example letrsquos say you want to register a subject onto a RAVE study using RWS In order to do this yoursquollneed

1 An authenticated connection to RWS

2 An XML document that represents the POST request you intend to make which will include

bull A Study OID (study)

bull A LocationOID (site)

bull A SubjectKey (subject)

3 A way to deal with the response after the request is sent

The ODMBuilder class allows developers to build out the ODM XML documents required for transmission usinga simple to use fluent interface Using the above example letrsquos create a new ODMBuilder instance to register asubject

var odmObject = new ODMBuilder()WithClinicalData(MediFlex cd =gtcdWithSubjectData(SUBJECT001 SITE01 sd =gt

sdWithTransactionType(TransactionTypeInsert)))

After instantiating the ODMBuilder class yoursquoll notice that you have access to chain-able methods which allow youto construct the object appropriate for your use case Since we are registering a subject we supplied a Study OID(Mediflex) Subject Key (SUBJECT001) and Site (SITE01)

19

MedidataRWSNET Documentation Release 10

(continued from previous page)

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=ABX FormRepeatKey=1gtltItemGroupData ItemGroupOID=ABX_LOG_LINEgt

ltItemData ItemOID=ABXABXDATE Value=2017-04-25 gtltItemData ItemOID=ABXMODALITY Value=2 gt

ltItemGroupDatagtltFormDatagt

ltStudyEventDatagtltSubjectDatagt

ltClinicalDatagtltClinicalData StudyOID=Mediflex(Prod) MetaDataVersionOID=1gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=BONEMARROW FormRepeatKey=1gtltItemGroupData ItemGroupOID=BONEMARROW_LOG_LINEgt

ltItemData ItemOID=BONEMARROWVISITDAT Value=2015-04-24 gtltItemData ItemOID=BONEMARROWCHEMSAMPLE Value=1 gtltItemData ItemOID=BONEMARROWBMPB_COLLECT Value=1 gt

ltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

523 VersionDatasetRequest

Clinical data in ODM format for the given study environment for a single RAVE study version for all subjectsSimilar to StudyDatasetRequest this data can be optionally filtered by a specific Form

This is the equivalent of calling httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw options

or to filter the data by form httpssubdomainmdsolcomstudiesproject(environment)versions version_id datasets regular|raw formoid options

using MedidataRWSCoreRequestsusing MedidataRWSCoreRequestsDatasets

Create a connectionvar connection = new RwsConnection(innovate username password) rarr˓authentication required

(continues on next page)

52 Clinical View Datasets 17

MedidataRWSNET Documentation Release 10

(continued from previous page)

Send the request get a responsevar response = connectionSendRequest(new VersionDatasetRequest(project_namerarr˓Mediflex environment_name Dev version_oid 999)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

Note the MetaDataVersionOID value in the XML response

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2016-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2017-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

18 Chapter 5 Core Resources

CHAPTER 6

Using Builders

When communicating with Medidata RAVE Web Services your data payloads will take the form of ODM XML - orOperational Data Model XML documents

Itrsquos important to understand that RWS expects the XML data you send to conform to the ODM format - malformed orotherwise improperly formatted XML wonrsquot be processed Since creating these data structures manually can be timeconsuming and tedious MedidataRWSNET provides several ldquoBuilderrdquo classes to help

61 Basic Example - Register a Subject

By way of example letrsquos say you want to register a subject onto a RAVE study using RWS In order to do this yoursquollneed

1 An authenticated connection to RWS

2 An XML document that represents the POST request you intend to make which will include

bull A Study OID (study)

bull A LocationOID (site)

bull A SubjectKey (subject)

3 A way to deal with the response after the request is sent

The ODMBuilder class allows developers to build out the ODM XML documents required for transmission usinga simple to use fluent interface Using the above example letrsquos create a new ODMBuilder instance to register asubject

var odmObject = new ODMBuilder()WithClinicalData(MediFlex cd =gtcdWithSubjectData(SUBJECT001 SITE01 sd =gt

sdWithTransactionType(TransactionTypeInsert)))

After instantiating the ODMBuilder class yoursquoll notice that you have access to chain-able methods which allow youto construct the object appropriate for your use case Since we are registering a subject we supplied a Study OID(Mediflex) Subject Key (SUBJECT001) and Site (SITE01)

19

MedidataRWSNET Documentation Release 10

(continued from previous page)

Send the request get a responsevar response = connectionSendRequest(new VersionDatasetRequest(project_namerarr˓Mediflex environment_name Dev version_oid 999)) as RWSResponse

Write the XML response to the console (see XML below)ConsoleWrite(responseRawXMLString())

Note the MetaDataVersionOID value in the XML response

ltxml version=10 encoding=utf-8gtltODM FileType=Snapshot FileOID=9035596c-f090-4030-860a-0ed27a4e3d03rarr˓CreationDateTime=2017-06-05T132839325-0000 ODMVersion=13 xmlnsmdsol=rarr˓httpwwwmdsolcomnsodmmetadata xmlnsxlink=httpwwww3org1999xlinkrarr˓xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=1gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2015-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=2gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2016-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagtltClinicalData StudyOID=Mediflex(Dev) MetaDataVersionOID=999gt

ltSubjectData SubjectKey=3gtltSiteRef LocationOID=1 gtltStudyEventData StudyEventOID=SCREENING StudyEventRepeatKey=1gt

ltFormData FormOID=CHEM FormRepeatKey=1gtltItemGroupData ItemGroupOID=CHEM_LOG_LINEgt

ltItemData ItemOID=CHEMDATECOLL Value=2017-04-25T160900 gtltItemGroupDatagt

ltFormDatagtltStudyEventDatagt

ltSubjectDatagtltClinicalDatagt

ltODMgt

18 Chapter 5 Core Resources

CHAPTER 6

Using Builders

When communicating with Medidata RAVE Web Services your data payloads will take the form of ODM XML - orOperational Data Model XML documents

Itrsquos important to understand that RWS expects the XML data you send to conform to the ODM format - malformed orotherwise improperly formatted XML wonrsquot be processed Since creating these data structures manually can be timeconsuming and tedious MedidataRWSNET provides several ldquoBuilderrdquo classes to help

61 Basic Example - Register a Subject

By way of example letrsquos say you want to register a subject onto a RAVE study using RWS In order to do this yoursquollneed

1 An authenticated connection to RWS

2 An XML document that represents the POST request you intend to make which will include

bull A Study OID (study)

bull A LocationOID (site)

bull A SubjectKey (subject)

3 A way to deal with the response after the request is sent

The ODMBuilder class allows developers to build out the ODM XML documents required for transmission usinga simple to use fluent interface Using the above example letrsquos create a new ODMBuilder instance to register asubject

var odmObject = new ODMBuilder()WithClinicalData(MediFlex cd =gtcdWithSubjectData(SUBJECT001 SITE01 sd =gt

sdWithTransactionType(TransactionTypeInsert)))

After instantiating the ODMBuilder class yoursquoll notice that you have access to chain-able methods which allow youto construct the object appropriate for your use case Since we are registering a subject we supplied a Study OID(Mediflex) Subject Key (SUBJECT001) and Site (SITE01)

19

CHAPTER 6

Using Builders

When communicating with Medidata RAVE Web Services your data payloads will take the form of ODM XML - orOperational Data Model XML documents

Itrsquos important to understand that RWS expects the XML data you send to conform to the ODM format - malformed orotherwise improperly formatted XML wonrsquot be processed Since creating these data structures manually can be timeconsuming and tedious MedidataRWSNET provides several ldquoBuilderrdquo classes to help

61 Basic Example - Register a Subject

By way of example letrsquos say you want to register a subject onto a RAVE study using RWS In order to do this yoursquollneed

1 An authenticated connection to RWS

2 An XML document that represents the POST request you intend to make which will include

bull A Study OID (study)

bull A LocationOID (site)

bull A SubjectKey (subject)

3 A way to deal with the response after the request is sent

The ODMBuilder class allows developers to build out the ODM XML documents required for transmission usinga simple to use fluent interface Using the above example letrsquos create a new ODMBuilder instance to register asubject

var odmObject = new ODMBuilder()WithClinicalData(MediFlex cd =gtcdWithSubjectData(SUBJECT001 SITE01 sd =gt

sdWithTransactionType(TransactionTypeInsert)))

After instantiating the ODMBuilder class yoursquoll notice that you have access to chain-able methods which allow youto construct the object appropriate for your use case Since we are registering a subject we supplied a Study OID(Mediflex) Subject Key (SUBJECT001) and Site (SITE01)

19

MedidataRWSNET Documentation Release 10

Each of the nested methods used (eg WithClinicalData WithSubjectData andWithTransactionType) map to the specific XML node we want to construct

To see the XML string representation of what wersquove got so far you can use the AsXMLString() method whichwill convert the ODM object you constructed into an XML string

For example

string registrationXml = new ODMBuilder()WithClinicalData(MediFlex cd =gtcdWithSubjectData(SUBJECT001 SITE01 sd =gt

sdWithTransactionType(TransactionTypeInsert)))AsXMLString()

would produce

ltxml version=10 encoding=utf-16gtltODM xmlnsmdsol=httpwwwmdsolcomnsodmmetadata FileType=Transactionalrarr˓Granularity=All FileOID=1d84fb20-1959-45bf-b9c4-cf2ad7a4273d CreationDateTime=rarr˓2017-09-14T1501508441121-0400 AsOfDateTime=0001-01-01T000000 ODMVersion=rarr˓13 xmlns=httpwwwcdiscorgnsodmv13gtltClinicalData StudyOID=MediFlex MetaDataVersionOID=1gt

ltSubjectData SubjectKey=SUBJECT001 TransactionType=InsertgtltSiteRef LocationOID=SITE01 gt

ltSubjectDatagtltAuditRecords gtltSignatures gtltAnnotations gt

ltClinicalDatagtltODMgt

Using this ODM conformant XML you could now POST it to RAVE by wrapping it in a PostDataRequest object

RwsConnection conn = new RwsConnection(innovate username password)var registrationRequest = new PostDataRequest(registrationXml)var response = connSendRequest(registrationRequest) as RWSPostResponse

If successful SUBJECT001 should be registered in SITE01 for the Mediflex study

20 Chapter 6 Using Builders

CHAPTER 7

Indices and tables

bull genindex

bull modindex

bull search

21

• Introduction
• • Assumptions
  • Acknowledgments
  • • Getting Started
    • • Installation
      • Basic Example
      • Miscellaneous Configuration
      • • Topics
        • • Authentication
          • Errors
          • • Basic Requests
            • • VersionRequest()
              • BuildVersionRequest()
              • TwoHundredRequest()
              • CacheFlushRequest()
              • • Core Resources
                • • Clinical Data
                  • Clinical View Datasets
                  • • Using Builders
                    • • Basic Example - Register a Subject
                      • • Indices and tables

CHAPTER 7

Indices and tables

bull genindex

bull modindex

bull search

21

• Introduction
• • Assumptions
  • Acknowledgments
  • • Getting Started
    • • Installation
      • Basic Example
      • Miscellaneous Configuration
      • • Topics
        • • Authentication
          • Errors
          • • Basic Requests
            • • VersionRequest()
              • BuildVersionRequest()
              • TwoHundredRequest()
              • CacheFlushRequest()
              • • Core Resources
                • • Clinical Data
                  • Clinical View Datasets
                  • • Using Builders
                    • • Basic Example - Register a Subject
                      • • Indices and tables