User Manual General Part - MedCODES · GBG MedCODES User Manual V2.5 General Part Page 1 of 25 User...

GBG MedCODES User Manual V2.5 General Part

Page 1 of 25

User Manual

General Part

Revised Version 2.5

Version Datum

0.0 2008-09-19

0.1 2009-02-04

0.2 2009-02-12

0.3 2009-02-13

0.4 2009-03-11

1.0 n.a.

2.0 2011-04-11

2.1 2011-05-16

2.2 2011-09-15

2.3 2012-04-30

2.4 05.07.2013

2.5 20.09.2016


Page 2 of 25

Index Index ............................................................................................................................................. 2

1.0 Introduction ............................................................................................................................ 3

2.0 General ................................................................................................................................... 3

2.1 System requirements .......................................................................................................... 3

2.2 Login .................................................................................................................................... 4

3.0 Homepage ............................................................................................................................... 6

3.1 General News ...................................................................................................................... 8

3.2 Documentation Status ........................................................................................................ 8

3.3. Help .................................................................................................................................... 8

3.4 Message Center (not to use any longer) ............................................................................ 8

3.5 Knowledge Base .................................................................................................................. 9

3.6 User profile (My Profile) ................................................................................................... 10

3.7 Documentation Progress .................................................................................................. 10

3.8 Lab Kits .............................................................................................................................. 11

3.9 GBG Site ............................................................................................................................ 11

3.10 Email ............................................................................................................................... 11

3.11 Field history .................................................................................................................... 13

3.12 Print Function ................................................................................................................. 13

4.0 MedCODES CRF Workflow (except SAEs) ............................................................................. 13

4.1 Colour codes and Buttons................................................................................................. 17

4.2 Icons .................................................................................................................................. 18

4.3 MedCODES Roles .............................................................................................................. 19

4.4 Misc ................................................................................................................................... 20

Do not repeat click .................................................................................................20

Query-Shortcuts .....................................................................................................20

Single – and multiple choice fields and singular fields:.............................................21

Changes in Multiple-choice fields: ...........................................................................22

Delay at “CRF in Correction” ...................................................................................22

List of figures ............................................................................................................................... 23

:: (Changelog): ............................................................................................................................ 24


Page 3 of 25

1.0 Introduction

This user manual will help get an introduction to the user interface and the functionality of

the GBG MedCODES online application for electronic documentation and administration of

clinical trials.

In the following sections the available functions will be described step by step with the help of

the provided workflow.

The user interface of MedCODES is only available in English.

2.0 General

2.1 System requirements

Summary for the optimum usage of MedCODES

Minimum internet connection IE9-(Internet Explorer 9)/DSL access

Minimum screen resolution 1280x960 pixel

Web Browser Internet Explorer 9 (or higher version)

or Firefox v20 (or higher version)

Miscellaneous Cookies and JavaScript have to be activated, Pop-

Ups should be allowed for www.medcodes.de


Page 4 of 25

2.2 Login

To log in go to MedCODES site: https://www.medcodes.de

Login site is presented:

Please enter the user name provided (“Login“ Figure1, No.1), the password („Password“

Figure1, No.2) that you got in the first account-confirmation email, and the letters of the

“Captcha“ field (“Captcha“ Figure 1, No.3).

Click on Login. If all fields are entered correctly access to MedCODES will be granted.

After successful first login, please change your password to a password of your own in the

User Profile, see chapter 3.6.

If a registered MedCODES user has forgotten the password, the user name must be entered

and "New Password"-button must be clicked (Figure1, No. 4).

• The MedCODES system will check if the user name is correct. If the user name is not

correct, no answer will come. In case the user name is forgotten, please contact the

project management team of one of your studies.

• The MedCODES system also checks if the user name is active (a user account will be

de-activated automatically after 6 months without any login to MedCODES). If the user

account is de-activated, the user will get en email about the de-activation, together

with the information that the PM of any of his/her studies should be contacted, to re-

activate the user.

1

2

3

4

Figure 1: Login


Page 5 of 25

• If the user name is correct and active, then MedCODES system will automatically send

you an Email to confirm if a new password is really required:

• Please conform this with an Email containing as text: “yes”.

• Then the MedCODES administrator will send you an email with a new password

(generated automatically), which can be changed to a password of your own again, see

chapter 3.6.

Three login attempts are permitted. The account will be locked if the password is entered

wrongly three times. But you can try again after five minutes. If it still will not work, ask for a

new password with the New password-button, see above.


Page 6 of 25

The demo system (http://demo.medcodes.de) enables all users to access the system through

different roles, to become familiar with MedCODES.

External center or pathologist roles can be used with special accounts for ext.documentalist,

ext.physician and ext.pathologist, see in see MedCODES Usermanual for sites and for

pathologists, with special demo centers activated, please ask the according projectmanager

for special studies.

The role reviewer is for external auditors.

Internal GBG roles can be used with the accounts supervisor, monitor, datamanager, verifier,

pv (pharmacovigilance), trafo and biobank, see MedCODES Usermanual for some of these

roles.

Warning: Do not enter real patient data in the demo system as you would in the live system.

This is not allowed! Please use only test data in the demo system!

3.0 Homepage

On successful login you will enter the Homepage (“Home“) of MedCODES.

The user interface of MedCODES is divided into two superimposed blocks.

In the upper area, the “Navigation-Block“ (Figure 2, No. 1), the “Info-Block“(Figure 2, No. 3) can

be found on the left side. The “Info-Block „shows which user (“User“) with which role (“Role“) is actually logged in as well as the chosen center number (“Center“) and trial (“Trial“). If you

document data for a patient you will also see the patient number “Patient „and the current

treatment period of this patient (“Cycle“). In the “Info-Block”you will also find the countdown

to the next timeout (automatic log out) if no user activity (e.g. click on “Save“ or “Submit“) occurs.


Page 7 of 25

Figure 2: Homepage

To the right of the “Info-Block“ is the main menu and, where applicable, submenus (Figure 2,

No. 4). With these navigation menus you handle MedCODES.

The buttons for the Homepage (“Home“), the Message Center (see also 3.4 Message Center),

the own user profile (“My Profile“) and the button for quit the application (“Logout“) are

always visible in the main menu.

Additional buttons for user specific functions appear when available.

The lower area, the “Content-Block“ (Figure 2, No. 2), is divided into four smaller blocks. These

blocks are (in clockwise order):

• 3.1 Generel News (Figure 2, No. 5)

• 3.2 Documentation Status (Figure 2, No. 6)

• 3.3 Help (Figure 2, No. 8) and 3.5 Knowledge Base (Figure 2, No. 8)

• (3.4 Message Center Preview (Figure 2, No. 7))


Page 8 of 25

3.1 General News

General news for all MedCODES users can be found here. A click on the subject of the

message opens the complete message.

3.2 Documentation Status

On selecting a trial in the “Info-Block“ (Figure 2, No. 3) a summary of the documentation status

of the patients from the selected center will be shown.

Status Explanation

“randomized“ number of patients included in the trial

“Excluded“ number of patients excluded from the trial

“saved“ number of CRFs which are only saved, not yet submitted

“documented“ number of submitted CRFs

“verified“ number of verified CRFs

“monitored“ number of monitored CRFs

“rejected“ number of rejected CRFs

3.3. Help

Links to video clips, amongst other things, and the user manual to help use MedCODES are

found here.

The “Bug-Report-Form” is also found here. All issues with MedCODES can be documented

here and sent to the GBG. We will contact you to help resolve the problem.

When you select a trial on the “Info-Block“ study specific trial material (e.g. CRF Manual) will

also be provided here.

3.4 Message Center (not to use any longer)

Please do not use the Message center any more. Please use the Email-button for Emails via

Outlook instead.


Page 9 of 25

3.5 Knowledge Base

Figure 3: Knowledge Base

On logging into MedCODES click on the Button „Home“ in the main Menu. On the right hand

side the Knowledge Base can be found where you can choose following Manuals:

MedCODES-User Manual ( Figure 3, No 1.) ,

Training Videos (Figure 3, No 2.),

Bug Report form (Figure 3, No 3.),

SAE Manual (Figure 3, No 4.),

CRF Manual (Figure 3, No 5.)

Study specific notes can be found in the CRF Manual

The following Manuals are only available for blinded Trials.

Drug Supply Manual (Figure 3, No 6.)

Unblinding Manual (Figure 3, No 7.)

1

2

4

5

6

3

7


Page 10 of 25

3.6 User profile (My Profile)

The user profile gives an overview of all user data such as name, User ID, mail address, role,

qualification etc. (Figure 4).

The password can also be changed here. This should be the first thing that must be done on

received the Login details by mail.

A password must contain at least 8 digits, among them at least one number, one capital

letter and one special sign.

In “My Profile“a new password in the section “Account Details“ can be entered. Please

confirm the password under “confirm password“. The new password must be used in the next

login.

Figure 4: My Profile

3.7 Documentation Progress

On clicking the button “Doc.Progress“ an excel file will open.

This contains an overview of the CRFs that have been already documented for the patients at

the center chosen in the “Info-Block”.

GBG MedCODES User Manual V2.5 Page 11 of 25

3.8 Lab Kits

In the Info Block, for trials where lab kits can be ordered via MedCODES, click on “Labor Kits“. A window similar to the one shown in Figure 5.

After filling in the order details, click on "bestellen/order"; a mail with your order will be sent

to the GBG.

A pick-up service for serum may also be requested here.

Note: The order form may vary depending on the trial.

3.9 GBG Site

The GBG Homepage is opened in a new browser window.

3.10 Email

After selecting a trial in the “Info-Block“ a mail to the responsible MedCODES user for the

selected trial can be sent directly to their web mail address with a click on “Email".

Figure 5: Example of an order form for lab kits


Figure 6: Email

Select the designated recipient ("Receiver"), for example a Supervisor or a Datamanager, and

enter a Subject. The message can be entered in the field "Body".

The message can be sent with "Submit". If the transmission was successful a confirmation will

be received. With a click on "Cancel" or "X" the window can be closed without sending a mail.

Note: If you have a question regarding a particular documented CRF, please mention the form

and, if applicable, cycle, week, page number etc. For questions concerning GFU please

mention also the trial.


3.11 Field history

In the CRF view a "Field history" is available (Figure 8). To view the field history for a certain

field, click in the CRF view in the corresponding field and then click on "Field history" in the

submenu. A new window will open where you can view:

- the actual value of the field

- older values where applicable

- the person who documented the value

- the reason for the changes

With a click on the red "X" you can close the window.

3.12 Print Function

In the CRF view the actual CRF can be printed out with the "Print" button in the submenu.

A new window opens with the print view of the CRF. At the end of the CRF is a further "Print"

button to start the print. To cancel the print, close the print view window by clicking on "X".

4.0 MedCODES CRF Workflow (except SAEs)

The following illustration shows the CRF workflow in MedCODES. The correctly completed

CRFs show the "ideal case" cycle, or when changes and corrections are required to the

correction circle.

The CRF is processed through the different roles and thereby changes its status accordingly

(view icons).

Figure 7: Field history


ready for DM

Optional: exclude patient

MedCODES-CRF-Workflow: Baseline & Randomization

Physician

Verifier

documentation

DM

in verifying (again)

Ideal case Correction circle

in documentation

again

(1)

(2)

(17)

(16)

not ok � Query

Patient lock = CRF lock

ok

DM

ok (submit)

CRA

not ok � Query

Supervisor =

PM or PMA

of study

if all screening CRF are submitted ready to

randomize

randomization (15)

(13)

ok (submit)

(6) + (7)

(14)

ok (submit)

(5)

Role

ready for DM after

monitoring

save submit

exclusion

not ok � Query

Optional: lock/unlock CRF

(15)

not ok


MedCODES-CRF-Workflow: After randomization

Physician

Verifier

documentation

CRF in correction on demand

DM

in verifying (again)

Ideal case Correction circle

in documentation

again

(1)

(2)

(17)

(16)

(18)

not ok � Query

Patient lock = CRF lock DM

CRF correction reject CRF

ok (submit)

CRA

(6)

(6) + (7)

save submit

Physician

Role

(14)

not ok � Query

ok

ready for DM

not ok � Query

CRF in correction

by query

(5)

ready for DM

after monitoring


Database CRF status

1 New

2 Saved or Rejected 5 In documentation again

6 In verifying

7 In verifying again

13 In supervising 14 Ready for DM 15 Patient excluded 16 Ready for DM after monitoring

17 CRF locked (Self Report Form)

18 In correction on demand (CRF correction Button)

19 SAE rejected

20 SAE closed (resolved)

21 SAE still open (not resolved)

22 SAE reopened

23 Drug-Order submitted

24 Drug-Supply submitted

25 Emergency-Unblinding submitted

26 In coding (for SAE Forms)

27 Baseline locked (from supervisor)

28 SAE

29 GFU- Patient Self Report (submit first time)

GBG MedCODES User Manual V2.5

Page 17 of 25

4.1 Colour codes and Buttons

In MedCODES a traffic lights icon system is used for easier navigation (e.g. for patients, CRFs

and news).

Colour codes and status values for CRFs are:

CRF Icon

CRF-Status CRF-Correction Button Reject Button

new N N

Saved or Rejected N N

in documentation again N N

in verifying Y Y

in verifying again Y Y

in supervising N Y

ready for DM Y Y

patient excluded N N

ready for DM after monitoring N N

CRF locked N N

CRF in correction N N

SAE rejected N N

SAE closed (resolved) N N

SAE still open (not resolved) N N

SAE reopened N N

Drug-Order submitted N N

Drug-Supply submitted N N

Patient Self Report N N


Page 18 of 25

The Colour codes and the meanings for the patient symbol are:

Colour

code

Meaning for the patient

grey patient created but not yet

registered/randomized

grey patient icon with a red

crossed circle patient is excluded from the trial

yellow patient successfully registered/randomized

green patient is locked

green with S Patient is locked, but one or more substudies

ongoing

4.2 Icons

Icon Meaning

Status (general)

In general, the earliest status is shown. If, for example, all CRFs have

been submitted and there are no queries, all CRFs will have a green icon

( ) and the corresponding folders will also be green ( or ).

An undocumented CRF will have been assigned a red ( ) icon, a saved

CRF a yellow ( ) icon and a queried CRF a yellow icon with a red

question mark ( ). The folder containing the CRFs will be marked in

the same colour ( / or / ).

CRF field (without query)

CRF field (with query)

Query open

Query solved by center

Query closed by Verifier or Data Manager

Query delegated from Verifier or Data Manager


Page 19 of 25

List Not ordered

List Ordered descending

List Ordered ascending

4.3 MedCODES Roles

The following roles for the CRFs are in MedCODES; please see the MedCODES User Manuals

for them:

Physician and Documentalist in Sites

Central Pathologist

Supervisor in GBG

Verifyer in GBG

Data Manager in GBG

Monitor in GBG

For SAE see the special SAE MedCODES User manual, including all roles concerning SAEs.

For external reviewer such as auditors a Reviewer role exists, with absolutely restricted read

access rights, namely for one center in one trial and only for a pre-specified time period.


Page 20 of 25

4.4 Misc

Do not repeat click Some tasks are realised in MedCODES by several steps. Due to possible delays in the network,

local computer or communications with external systems (Mail-Systems, IWRS-System etc.) it

may happen that a task needs more time than expected. If you click on other buttons or F5

(for refresh) during this time, the task is interrupted, exceptions may follow, which may cause

errors and incomplete results. These errors must be solved manually and with great effort in

the database. So please wait until the task is finished; at the end the updated MedCODES page

is shown.

Query-Shortcuts

Figure 8: Query short cuts

Short cut meaning:

GC = General Comment

LE = Logical Error

MIS = Missing

You can select different types of “missing” queries for different fields:

- MIS : choice � for missing answer for single choice fields or option box

- MIS : YES/NO text � for missing specifications after a Yes/No answer

- MIS : text � for missing free text

- MIS : date � for missing dates

As a prefix you can see “SLQ” for Second level query (from DM) or “TLQ” for Third-level query

(from statistics), or “Mon” for Monitoring.


Page 21 of 25

Single – and multiple choice fields and singular fields:

Single choice fields, where you can choose only one option of several options, are shown as

circles. See examples:

Multiple choice fields, where you can choose one or more options, are shown as boxes.

See examples:

Some singular fields, where you can tick or not tick, are also shown as box. See Examples:


Page 22 of 25

Changes in Multiple-choice fields:

In order to make a field correction via query-answer or via CRF-correction button in the menu

bar above, the user must click on the option/checkbox he wants to change:

Although all options/checkboxes are shown in the field correction window, only the clicked

checkbox can be changed and saved (the others can only be changed, but not saved here). For

changes to be saved in the other options/checkboxes, you must use the CRF-correction button

again and click the next checkbox to be changed and saved.

Figure 9: Multiple choice field: Field correction

Delay at “CRF in Correction”

If a CRF remains in status “CRF in correction” instead of becoming “in Verifying again” ,

(due to a technical delay for example) you must still finalize the correction. On trying this a

message might appear saying that no changes were done. You should then write a dummy

value in the comment field (a full stop for example) by pressing the “CRF-Correction”-button

again; you can then submit the CRF.


Page 23 of 25

List of figures

Figure 1: Login .............................................................................................................. 4

Figure 2: Homepage ..................................................................................................... 7

Figure 3: Knowledge Base ............................................................................................ 9

Figure 4: My Profile ..................................................................................................... 10

Figure 5: Example of an order form for lab kits ........................................................... 11

Figure 6: Email............................................................................................................ 12

Figure 7: Field history ................................................................................................. 13

Figure 8: Query short cuts .......................................................................................... 20

Figure 9: Multiple choice field: Field correction ........................................................... 22


Page 24 of 25

:: (Changelog):

Date Version

Section

(Page)

Changes

V 0.4 first official version

V 2.0 first revised version

2011-05-16 V 2.1 chapter 3.1.7 new

2011-09-12 V 2.2 in chapter 2.12 color code green:

CRF is "Submitted“

- Baseline and Rando-CRF when Randomization/Registration in process = „in

supervising“

- otherwise

V 2.2 in chapter 3.1 new notes for documentation:

Note: Have you click on a radiobutton (round choicebox e.g. yes/no fields) and you

want to clear your choice completely, make a double-click on these field and the

entry will be removed.

Note: In the "Field Correction" window you can change the complete date (day,

month and year) at once.

V 2.2 in chapter 3.3.1 added:

If a field description is red, the Center changed that field without a query. That

should give a visual hint to the verifier. The old value and the reasons for the

change are shown in the Live help.

Please note: CRF in status "in verifying again" all queries on the CRF have to be

closed, delegated or required before "Submit".

V 2.2 in chapter 3.5.1 added:

If you want to query a field, please change to "Query Workflow" und Select the

corresponding CRF in the "CRF List" (3.5.2 Query Workflow).

V 2.3 Revision of all chapters

New:

Chapter 3.1.8 Drug Supply

Chapter 3.1.9 General Follow-Up

Chapter 3.6 Central Pathologist


Page 25 of 25

2013-07-05 V 2.4 Revision of all chapters

3. MedCODES Roles and their functions

2.12 MedCODES CRF Workflow

2.13 Color codes, Icons and Buttons

2.4.2 (Monitoring) View Support

2.4.2 (Monitoring) Issue tracking

4. SAE MedCODES User Manuel Revision of all chapters

2013-10-02 SAE User Manual separated,

in the meantime there: including new role Medical reviewer (PV/Medicine)

20.09.2016

V 2.5 First time separated into different roles and general part, and updated before:

• Revision of all chapters (delete grammar mistakes)

• New chapter 4.4.Misc

• GFU in MedCODES for all studies now, and patient self register integrated,

see MedCODES User Manual for sites.

• Message center should not be used any longer, but only Email-Button

• New function for Supervisor (un)lock CRF, see MedCODES User manual for

Supervisor

• New function for Supervisor Exclusion without complete baseline, see

MedCODES User manual for Supervisor

• New functions for the Role monitor (see MedCODES User Manual for

Monitors):

--queries and monitoring only possible in Site Support View.

- Button “Patient” on the Monitor Homepage, just useful to

get an overview about monitored CRFs. For submit changes use site

support View)

- Issue tracking module

• New roles in MedCODES: Trial Coordinator and GBG GFU-CRF

documentalist for PSR data, for both see MedCODES User Manual

for Verifyer

• New role in MedCODES: Reviewer (Auditor), see chapter 4.3 MedCODES

Roles

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