MTN 003 Data Management Considerations

1. MTN 003 Data Management Considerations SSP Sections 14, 15 & 17

2. Presentation Topics • Contents of SSP section 14 • CRF/label/template supplies • Site data management procedures and considerations (SOPs) • Data Communiqués (SSP section 15) • Overview of reports produced by SCHARP (SSP section 17)

3. SSP Section 14 - Contents • The Data Management section of the 003 SSP contains information on: • The SCHARP MTN 003 team • DataFax overview, including entry/quality control procedures at SCHARP (14.1) • Form completion requirements (14.2) • 003-specific data collection information, including PTIDs, study visit timing, visit windows, visit codes, CRF completion schedule, site review of CRFs, faxing CRFs (14.3) • Form and label supply; form storage (14.4) • Completion of interviewer-administered forms (14.5) • Additional form completion instructions (14.6) • Each MTN 003 case report form (14.7)

4. SSP Section 14 – Contents, cont. • Much of the content of Section 14 is covered in several presentations • Information on SSP Sections 14.1 – 14.2 and 14.3.6-14.3.8 is provided in the “DataFax Overview and CRF Completion” presentation • Information on SSP Section 14.3 can be found in the “Follow-Up Visit Scheduling and Visit Coding” presentation

5. MTN 003 CRF Supplies • SCHARP will provide all CRFs needed for the study • CRFs provided via printed form packets • Bulk “as needed” CRFs are also provided • Site can order more forms using the CRF Request Form

6. MTN 003 CRF Supplies, cont. • Form packets used in MTN 003: • Screening Part 1 • Screening Part 2 • Enrollment • Monthly • Quarterly • Also used for Semi-Annual and Annual visits; sites have to add CRFs to the packet for those two visits • Product Use End Visit (PUEV) • Termination/Study Exit

7. MTN 003 CRF Supplies, cont. • Form packets will only include non-translated forms • Ex. Baseline Behavior Assessment is not included in the Enrollment visit packet • Sites will have to add the appropriate local-language forms to each packet so that all forms needed for the visit are present • this is noted on the visit packet coversheet

8. MTN 003 CRF Supplies, cont. • This is the Enrollment visit packet cover page • Site will need to add appropriate local-language versions of the BBA and Screening Part 2/Enrollment Medical Eligibility forms before the participant’s visit

9. MTN 003 CRF Supplies, cont. • For Semi-annual visits, grab a Quarterly packet, and add these forms • For Annual visits, grab a Quarterly packet and add these forms

10. MTN 003 CRF Request Form • Complete when more MTN 003 CRFs or blank labels are needed • This is a 3-page DataFax form • Always fax all 3 pages when ordering more forms/labels • MTN 003B has it’s own CRF Request Form (1 page)

11. MTN 003 Other Supplies • SCHARP does not provide binders • SCHARP will provide templates that can be used to create 003 binder cover and spine label inserts • SCHARP can provide a template for tab dividers if requested • SCHARP will provide Word templates (macros) that can be used to make specimen labels needed for 003 • SCHARP will provide bulk blank labels (small and large) • Extra CRFs and blank labels can be ordered using the CRF Request Form

12. How well do you know your 003 Data Management SOP? • Your 003 Data Management SOP should explain how you will perform data collection and data management procedures for 003 • Who is responsible for training site staff on the 003 DM SOP? • Who has day-to-day oversight of staff involved in 003 data procedures? • Who has ultimate responsibility for the quality of your site’s 003 study data?

13. Data Management SOP, cont. • What will be contained in participant study files? How will they be organized? Where will they be stored- used and unused? • Who is responsible for assembling participant study files? • Who is responsible for assigning 003 PTIDs? How will PTIDs be assigned?

14. Data Management SOP, cont. • By whom and when will CRFs be reviewed prior to faxing? • Who is responsible for faxing and replacing CRFs in notebooks? • Who is responsible for responding to QC Reports/Clinical QC Reports? • All of this information and more is in your MTN 003 Data Management SOP.

15. Data Communiqués • Data Communiqués are memos issued by SCHARP. • They provide information/instructions to the sites on data collection issues that arise after study start. • Data Communiqués are official study communication, and should be reviewed with site staff. • Communiqués should be printed and placed in SSP section 15

16. Data Communiqués, cont. • First Data Communiqué for VOICE was issued on 09-SEP-09 • Can be downloaded from MTN website

17. SCHARP Study Reports • The Study Reporting Plan section of the SSP (section 17) describes all of the study reports produced by SCHARP • This section also contains information on how reports are distributed (via email attachment or Atlas webpage) • Discuss Data QC Reports, Clinical QC Reports, Site Data Management Quality Reports in this presentation

18. Data Quality Control (QC) Reports • SCHARP staff review data, identify problems such as missing or inconsistent data, and apply Quality Control (QC) notes as necessary • QC notes are compiled into QC Reports • QC Reports may also show missing pages and overdue visits • QC Reports are sent to sites on a regular basis via e-mail (pdf attachment)

19. Anatomy of a DataFax QC Report Study Identifier Site Number and Date of QC Report Cover Letter Name and contact information of Data Coordinator Number of pages of QC Report

20. Anatomy of a DataFax QC Report, cont. Study Identifier Site Number and Date of QC Report Listing of QC notes Number of pages of QC Report

21. Anatomy of a DataFax QC Report, cont.

22. Clinical QC Reports • Are very similar to QC Reports, but are distributed by SCHARP Clinical Affairs Safety Associates (CASAs) and involve safety-related data (AEs, lab values, etc.) • Sent via email (pdf attachment) • Are resolved by making additions or corrections on CRF to the data in question • Clinical queries are not included in your site’s QC rate • Molly Swenson (mollys@scharp.org) is the CASA for VOICE

23. Resolving QC issues • Sites correct or clarify QCs and refax the corrected CRFs to SCHARP DataFax within the time period specified for the study • Timely response to QC reports is essential for data quality • SCHARP staff review the corrections and resolve QC notes • QC note(s) will continue to appear if corrected CRF is not received or processed before next report is generated

24. Common QC Errors to Avoid • Illegible handwriting • Missing initials/date for corrections • Missing data • Skip patterns not followed • Wrong visit code assigned Look for these during site CRF QA/QC review prior to faxing CRFs to SCHARP

25. Data Management Quality Reports • Main tool used to evaluate site’s performance regarding data management • Includes 5 parameters: • Total number of pages faxed • Total number of QCs applied • Percentage of QCs resolved • QC rate/100 pages • Mean days to fax in • Includes data for previous month and cumulatively • Data from all sites included

26. Data Management Quality Reports, cont. • Reports are used to identify data management issues/patterns • Please contact Karen and Laura with any questions about this report (we may be contacting you as well, depending on the situation) • Reports are produced monthly • Will be available via the Atlas webpage

27. Accessing MTN 003 Reports via Atlas • Atlas is a secure web page maintained by SCHARP • It is used to post documents and data for various networks/projects SCHARP is involved with (HVTN, MTN, HPTN, CHAVI, etc.) • To access Atlas, type http://atlas.scharp.org • Click on MTN logo • Click on MTN 003

28. MTN 003 Reports on Atlas • Click on MTN 003 • Under “MTN 003 Open Reports” section, you will see the Site Data Management Quality Report

29. MTN 003 Reports on Atlas, cont. • Some 003 reports will be in the open section, some will be in the secure section (e.g. PSRT Reports) • A login and password is required for secure study reports, and access is maintained by SCHARP • SSP Section 17 details which reports are open and which are secure • Questions about Atlas? Email atlas@scharp.org

30. Questions???