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

2. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 16 Data Communiqués, cont. First Data Communiqué for VOICE was issued on 09-SEP-09 Can be downloaded from MTN website

17. 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. 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. 19 Anatomy of a DataFax QC Report Site Number and Date of QC Report Name and contact information of Data Coordinator Number of pages of QC Report Cover Letter Study Identifier

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

21. 21 Anatomy of a DataFax QC Report, cont.

22. 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 VOICEmollys@scharp.org

23. 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. 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. 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. 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. 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 http://atlas.scharp.org Click on MTN logo Click on MTN 003

28. 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. 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. 30 Questions???