BioInformatics A Roadmap To Success. Principles of Data Management. Patrick Murphy, Director of Data Management

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1 BioInformatics A Roadmap To Success Principles of Data Management Patrick Murphy, Director of Data Management

2 Elements of Data Management Data Management Plan Training CRF Processing/Filing Data Entry Validation (Query Generation) Query Management Audits

3 Data Management Plan All topics should be included plus: File retention Security Query generation schedule Data export formats/schedule Backing up data Signoff/Distribution Revision/Review plan

4 GCP Connections (d) Maintain a security system that prevents unauthorized access to the data (e) Maintain a list of the individuals who are authorized to make data changes (f) Maintain adequate backup of the data.

5 Training All members of team should have appropriate training Data processing Data entry Programming Coding of medical data

6 GCP Connection The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.

7 CRF Processing Track incoming forms Batch Receipt Tracking Form (next slide) Stamp date and time on forms Reconcile tracking forms with database contents Create folders Label with Study number, Site number, Participant number

8 GCP Connections 2.10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.

9 CRF Processing -Batch Receipt Tracking Form

11 CRF Processing - Database Reconciling Report PROTOCOL: NIH_SPERM_9631 Panel # Forms IHPV 2 SPACCQA 123 SPACCQB 123 SPADCHK 444 SPADMQ 323 SPAE 20

14 Filing Two filing systems (if carbon forms) Original Working Where to file queries With original and working file forms

15 Sample Participant Folder KTM

16 Data Entry (Part 1) Staff should be trained Enter what they see How data entry screens work Practice with test data Also use test data with validations Encourage staff to comment on screens

17 GCP Connection The sponsor should utilize appropriately qualified individuals to supervise the overall conduct of the trial, to handle the data, to verify the data, to conduct the statistical analyses, and to prepare the trial reports.

18 Data Entry (Part 2) Double entry Resolution of differences in first and second entry Accuracy over speed, especially in second entry Save the name of the person entering data

19 Data Entry (Part 3) Enter data in batches Stamp/sign cover sheets to identify date and person who performed 1 st and 2 nd entries

20 Validation (Query Generation) Rules designed to identify errors or conflicting data Run-time, batch processing, embedded Who creates validations? Specification document How much is too little/too much? Revisions during life of project

21 Validation - Specification Document VASMH Rules/Derivations 1. Derive SCREENID from SUB JECT, with sam e attributes. Report Errors W ithin Form Checks 1. If EENT=1 & EENTT is missing. MESSAGE: Item 5 has been coded 1 ; however, no specification has been provided. Please specify diagnosis or condition. 2. If EENT<1 & EENTT is NOT missing. M ESSAGE: A m edical diagnosis or condition has been provided; however, item 5 has not been coded 1. Please code item. 3. If CARDIO=1 & CARDIOT is missing. MESSAGE: Item 6 has been coded 1 ; however, no specification has been provided. Please specify diagnosis or condition. 4. If CARDIO<1 & CARDIOT is NOT missing. M ESSAGE: M ESSAGE: A m edical diagnosis or condition has been provided; however, item 6 has not been coded 1. Please code item.

22 Query Management Reviewing validation output (next 2 slides) Manual queries Confirmation queries Resolving returned queries Updating CRFs Updating the database Tracking

23 Query Management - Review New Query Summary STUDY A Query Frequency Distribution-New Panel Rule Error M essage Frequency EZSIG REPORT11 [Q/H] - COUPLE ENROLLED IN THE STUDY FOR MORE THAN 21 WEEKS, BUT WEEK 22 EZCV IS 1 MISSING FOR THIS COUPLE. EZPDAE REPORT9 [Q/H] - FSN RECORDED IN ITEM 6 DOESN'T MATCH FSN FROM ANY EZAE PREVIOUSLY LOADED 1 FOR THIS COUPLE. EZPDAE REJECT8 [I/H] - D U P LICA TE EZAE FO R M. 1 EZPDAE CONTEXT_REPORT1 [Q /H ] - CEN TER N U M BER IS BLAN K O R IN VALID. 1 EZCM REPORT2 [Q/M] - DATE MEDICATION STARTED IS BLANK OR INVALID. 1 EZCM REPORT11 [Q/H] - FSN RECORDED IN ITEM 11B DOESN'T MATCH FSN FROM ANY PREVIOUSLY LOADED 1 FORM FOR THIS COUPLE. Total 6 Thursday, August 30, 2001 Page 1 of 1

24 Query Management - Review New Query Details Detailed STUDY_A Query Report FSN Form CT_RECID Center = 0691 PN 5205 DISCREP Error Message EZPQF 1,JANELLE.PK?OxE [Q/L] - AT LEAST ONE OF ITEMS 12A-12I IS MISSING. PLEASE CONFIRM THAT THE DATA HAS BEEN TRANSCRIBED FROM THE PARTICIPANT'S QUESTIONNAIRES CORRECTLY. PN EZCV 1,GDAVIS.PCKPK] [I/H] - DUPLICATE EZCV FORM EZEC 1,GDAVIS.PDAIXT [Q/H] - DATE OF INTERCOURSE ACT DOES NOT MATCH ANY DIARY DATE REPORTING VAGINAL SEX. PLEASE CHECK THE DATE OF INTERCOURSE ACT. FOR THIS COUPLE. Tuesday, November 21, 2000 Page 1 of 135

25 Query Management - Query Form Sent to Sites

26 Example of correcting data on CRF

27 GCP Connection Any change or correction to a CRF should be dated, initialed, and explained and should not obscure the original entry. That is, an audit trail should be maintained. This applies to both written and electronic changes or corrections.

28 Query Management - Sample Query Tracking Report Study A - Query Status Report Centers As of: Houston Pittsburgh 08/23/01 Printed Outstanding # Days Printed Outstanding # Days 8/21/01 4 (Conf.) 2 8/21/ /22/01 1 (Faxed) 1 8/22/ Total: 5 Total: 11

29 GCP Connection (c) Ensure that the systems are designed to permit data changes in such a way that the data changes are documented and that there is no deletion of entered data (i.e., maintain an audit trail, data trail, edit trail).

30 Audits Independent Participant folders Comparison with database, tracking forms Database Comparison of data with CRFs Queries Are they all accounted for? Are new values included in database?

31 GCP Connection 1.6 Audit A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor s SOPs, GCP, and the applicable regulatory requirement(s).

32 Audits Participant Folders

34 Data Management Conclusions Data Management Plan is critical Documentation is King Remember your partners Slowly but surely Prepare for glitches Encourage audits Don t panic!

BioInformatics A Roadmap To Success. Data Management Plans. Wes Rountree Associate Director of Data Management Family Health International

BioInformatics A Roadmap To Success Data Management Plans Wes Rountree Associate Director of Data Management Family Health International What is a Data Management Plan? A document that describes how clinical