QualityControlReports.ppt

MTN 003 Data Management Considerations SSP Sections 14, 15 17 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) 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) 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 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 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 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