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lnfoCard#: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019 PEbIATRIC BLOOD AND MARROW TRANSPLANT PROGRAM DOCUMENT NUMBER: PBMT-GEN-067 DOCUMENT TITLE: Data Management DOCUMENT NOTES: Document Information Revision: 03 Vault: PBMT-General-rel Status: Release Document Type: General Date Information Creation Date: 17 jan 2019 Release Date: 15 Feb 2019 Effective Date: 15 Feb 2019 Expiration Date: Control Author: Previous Information MOORE171 Number: PBMT-GEN-067 Rev 02 Owner: Change MOORE171 Number: PBMT-CCR-232 CONFIDENTIAL - Printed by: ACM93on 15 Feb 2019 08:10:16 am
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Page 1: PEbIATRIC BLOOD AND MARROW - spitfire.emmes.comspitfire.emmes.com/study/duke/SOP/Common Quality/PBMT-GEN-067 Data... · InfoCardff: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

lnfoCard#: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

PEbIATRIC BLOOD AND MARROWTRANSPLANT PROGRAM

DOCUMENT NUMBER: PBMT-GEN-067

DOCUMENT TITLE:Data Management

DOCUMENT NOTES:

Document Information

Revision: 03 Vault: PBMT-General-rel

Status: Release Document Type: General

Date Information

Creation Date: 17 jan 2019 Release Date: 15 Feb 2019

Effective Date: 15 Feb 2019 Expiration Date:

Control

Author:

Previous

Information

MOORE171

Number: PBMT-GEN-067 Rev 02

Owner:

Change

MOORE171

Number: PBMT-CCR-232

CONFIDENTIAL - Printed by: ACM93on 15 Feb 2019 08:10:16 am

Page 2: PEbIATRIC BLOOD AND MARROW - spitfire.emmes.comspitfire.emmes.com/study/duke/SOP/Common Quality/PBMT-GEN-067 Data... · InfoCardff: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

InfoCardff: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

PBMT-GEN-067DATA MANAGEMENT

1 PURPOSE

1.1 The Pediatric Blood and Marrow Transplant (PBMT) Database is a MicrosoftWindows-based desktop application used by members of the Duke PediatricBlood and Marrow Transplant Program for data management of patients anddonors. The data contained includes patient/donor demographics, transplantinformation, referring physicians, scheduling of upcoming admissions,reinfusions, procedures, and history/physicals, and incoming patient management.The application is a supplementary data management tool and does not functionas the patient electronic medical record.

2 INTRODUCTION

2. 1 PBMT Database

2. 1. 1 The application contains built-in report functionality, including weeklyconference reports (patient scheduling and current outpatient review).An ad-hoc querying tool is available to create datasets of patients.

3 SCOPE AND RESPONSIBILITES

3. 1 Access to the application is restricted to authorized personnel who are listed in theActive Directory group of the server on which the application resides. There is a15 minute inactivity timeout enforced at the Operating System (OS) level. Anaudit trail is maintained for data that is created and modified, containing the actualdata, user Identification (ID), and the date and time of modification.

4 DEFINITIONS/ACRONYMS

4. 1 ID Identification

4.2 OS Operating System

4. 3 PBMT Pediatric Blood and Marrow Transplant

5 MATERIALS

5. 1 NA

6 EQUIPMENT

6. 1 Computer

7 SAFETY

7. 1 N/A

8 PROCEDURE

All donor and patient identifiers are uniquely identified and automatically created by theapplication. Back-ups are performed on a nightly basis.

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InfoCardff: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

8. 1 Screen Shots

g']]^la«n Menu aid I

Patient Information

feReferring Physicians

Patient Visit

Clinic List

PBMT Conference Inpatient Census

Long Term Follow Up New Referral

Database Query Incoming Patients

Reports

Exrr

Main Control Board

PBMT-GEN-067 Data ManagementPBMT, DUMCDurham, NC

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Page 2 of 14

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InfoCardff: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

patient Data ^isl^ll

Last Name

First Name

Middle Name

MRN

Date of Birth

Date of Death

Sex

Race

Ethnldty

Age ICause |CMV(+;-)|

»J ABO/Rh~3

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r

Duke Physician

Nurse Coordinator

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Kurtzberg, Joanne

Allison-Thacter. June "

McLaughlin, Colleen »

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Transplant

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InfoCardff: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

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PBMT-GEN-067 Data ManagementPBMT, DUMCDurham, NC Page 4 of 14

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InfoCardff: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

1 Status

Company

Phones

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2 Status

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PBMT-GEN-067 Data ManagementPBMT, DUMCDurham, NC Page 5 of 14

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lnfoCard#: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

... :..y. ^

Patient

Date of Transplant 08/15/97

Available donors (BF.1, UCB, Granulacyte, etc.) Donor(s) for 08/15/97 transplant

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PBMT-GEN-067 Data ManagementPBMT, DUMCDurham, NC

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Page 6 of 14

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lnfoCard#: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

; Referring Phys'ician(s) for

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PBMT-GEN-067 Data ManagementPBMT, DUMCDurham, NC

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Page 7 of 14

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lnfoCard#: PBMT-GEN-067 Rev. 03 Effective Date-15 Feb 2019

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PBMT-GEN-067 Data ManagementPBMT, DUMCDurham, NC

CONFIDENTIAL - Printed by: ACM93 on 15 Feb 2019 08:10:16 am

Page 8 of 14

Page 10: PEbIATRIC BLOOD AND MARROW - spitfire.emmes.comspitfire.emmes.com/study/duke/SOP/Common Quality/PBMT-GEN-067 Data... · InfoCardff: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

lnfoCard#: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

Last Name

First Name

Middle Name

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PBMT-GEN-067 Data ManagementPBMT, DUMCDurham, NC

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Page 9 of 14

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InfoCardff: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

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PBMT-GEN-067 Data ManagementPBMT, DUMCDurham, NC Page 10 of 14

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InfoCardff: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

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PBMT-GEN-067 Data ManagementPBMT, DUMCDurham, NC

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Page 11 of 14

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lnfoCard#: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

». ; iPBHT Patient Reports ^JBJ2<1|

Query Type

Transplanted Patients

Transplant Type

(F

r

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InfoCardff: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

.JBI^J

Qick on a column header tn sort

Name Mm Transplant Upn Dot) Dod Age_dot Diagnosis Lt

WLLSickle Cell Anemia

]' ~JT

Save to Excel |L^CIose^]|

Database Query Output

9 RELATED DOCUMENTS/FORMS

9. 1 N/A

10 REFERENCES

10. 1 N/A

11 REVISION HISTORY

Revision No.

03

Author

SallyMcCollum

Description of Change(s)

Acronyms defined

PBMT-GEN-067 Data ManagementPBMT, DUMCDurham, NC Page 13 of 14

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lnfoCard#: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

Example of Database Application Revision:

Patient Visit Screen (Modify Age at Visit label)COMPLETED

Authorization: Joanne Kurtzberg email on 12/21/16 Date:

Task/Purpose

Plan

Don't display Age at Visit if patient is deceased and note was created afterdate of death

Date initiated

Date Testing CompletedDate Live

Version #

Files created, modified

Project Backup (initial and post)\\cancerlan6\vines003\PBMTDBProject Backup folderBuild/exe name

Test Data

12/28/1612/30/1612/30/162. 1.23Patientvisit.scx

pbmtdbview_prod 2016_12_13 (v2. 1.22). zip (initial)pbmtdbview_prod 2016_12_30 (v2. 1.23). zip (post)

Pbmtdb4. exe

12/08/16 backup

Data Entry ScreensGeneral Requirements

Label IblAgeVisit - code a method, age_display(), to be called to update the labelCall age_display at:

Init

cboVisit valid

cmdUp buttoncmdDown button

Test display of IblAgeVisit for deceased/alive patientsInk

cboVisit valid

cmdUp buttoncmdDown button

Update launchdb.dbf (production version/exe)Backup code

Done

Done

Done

Done

Done

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lnfoCard#: PBMT-GEN-067 Rev. 03 Effective Date: 15 Feb 2019

Signature Manifest

Document Number: PBMT-GEN-067

Title: Data Management

Revision: 03

All dates and times are in Eastern Time.

PBMT-GEN-067 Data Management

Author

NamelSignatwe ^

^ijnfe ^ ^_^ _ ". ^, _ _.

_LD ate_. _»«.. _.. _. _., «^..«...

I ..Mean !,ng./Reas. on.Sally McCollum(MOORE171) 30 Jan 2019, 10:04:02 AM Approved

Medical Director

I Name/Signature lj^e_ ".,. __" ,." _ _. _ LJ?£lS_- _"_". _.... ._........... -..E..!^?!l!rI3{?easonJ,oannTe^rtzber9 30 Jan 2019, 10:21:03 AM Approved

Quality

I Name/Signature | Title | Date I Meaning/ReasonBing Shen (BS76) 31 Jan 2019, 10:32:32 AM Approved

Document Release

[^a^!S^St^. ^^. ^-:..^AJ}^^»^.. ^.».^-^^^-^--^Betsy Jordan (BJ42) 01 Feb 2019, 10:03:22 AM Approved

CONFIDENTIAL - Printed by: ACM93 on 15 Feb 2019 08:10:16 am


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