Preparing for the Annual Visit

1. Preparing for the Annual Visit SCORE Workshop March 17, 2003 Detra K. Robinson, MA

2. Objectives • Introduce Audit Task Team at Westat • Explain ‘auditing’ vs. ‘monitoring’ • Outline focus of annual monitoring visit • Explain monitoring templates used • Highlight education tools available

3. Westat CRAs • Experienced monitors with backgrounds in • Oncology nursing • Public health • Pharmacy • Clinical trials management • Medical anthropology • Laboratory technology

4. Monitoring Frequency • Initiation, at lead site • Timing as decided by the site and PIO • Annual, once per year at lead site • Continues until study closure • Interim visit, if indicated • Close-out, at lead site • After draft of final report

5. Defining an Audit • “A systematic examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded and analyzed, and accurately reported according to the protocol, sponsor’s SOPs, good clinical practice, and the applicable regulatory requirements” (Source, Code of Federal Regulations, ICH Guidelines)

6. Defining Monitoring • “The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, SOPs, GCP, and the applicable regulatory requirements” (Source, Code of Federal Regulations, ICH Guidelines)

7. Cooperative Group Audit vs. DCP Audit • A comparison of features:

8. Focus of an Annual Site Visit • Regulatory • Informed consent • IRB documentation • Pharmacy operations • Review of participant study records • CRF entries against source documentation

9. stamped approval of consent consent version date(s) date participant signed date signed by PI presence of initial approved protocol approved protocol versions and amendments approvals of changes to consent form(s) approved advertisements laboratory certification(s) lab normals IRB roster current Form 1572 annual reapproval of study whether regulatory documents have been submitted to CCSA reported/submitted SAEs Investigator Brochures submitted safety reports Regulatory Review

10. maintenance of records use of Drug Accountability Record Form (DARF) as primary transaction record security of study drug drug storage shelf supply against DARF drug shipment receipts against DARF drug return receipts dispensation procedures Pharmacy Operations

11. presence of consent form(s) eligibility evaluations done according to protocol timeliness of evaluations reported deviations security of records adverse events lab samples correctly collected and stored recorded toxicities adequacy of source documentation completeness of CRFs based on source docs participant ID list Chart Review

12. Source Documents • The original record of subject participation • Contains all information related to a participant’s protocol treatment • Used to verify • The integrity of the study data • That participant met all requirements for eligibility • Procedures were followed per protocol

13. progress notes pathology reports in/out patient medical record radiology reports nursing notes surgical reports appointment books study-specific data sheets signed/dated flow sheets participant calendars progress notes admission forms discharge summaries faxes, email, phone calls with participant relevant communication from non-study providers Source Documentation

14. Additional Assessments • Data management • Assess that forms are keyed • Review CRF entries against keyed data • Monitoring at participating sites • Discuss with study coordinator accomplishments/plans for monitoring at participating sites • Discuss outcome of monitoring by staff at lead site

15. Monitoring by Lead Site • Coordinator or other designee (at the site contracted with DCP to conduct the protocol) will monitor participating sites • Coordinator or designee will also • Assure that regulatory documents at participating sites are sent to CCSA • Record monitoring plan [to be] used • Communicate with coordinators at participating sites to obtain their plans for quality assurance

16. Westat CRA Preparation • Makes contact with study coordinator • Requests time with the site pharmacist • Requests time with PI for summary session • Confirms visit by letter • Provides list of charts to review • Reviews previous site visit reports

17. Study Coordinator Preparation • Makes available the requested study records • Makes available 100% of consent forms • Prepare to orient CRA to record keeping • Identifies a quiet space for the CRA • Reviews Westat templates to be used by site monitor in advance of the visit

18. Tools Used to Conduct Visit • Preliminary Report of Audit Findings • Annual Visit Report • Reporting Deviations • Pharmacy Audit Report • Available at www3.cancer.gov/prevention • Click “Information for Researchers” • Click “Resources” • Click “Study Site Monitoring Manual”

19. Availability of Monitoring Tools • Located in DCP Study Site Monitoring Manual (www3.cancer.gov/prevention/sitemonitoring.pdf) • In advance of the annual visit, review • Appendix G - Annual Visit Report Form • Appendix I - Pharmacy Audit Form • Appendix J - Essential Documents for the Conduct of a Clinical Trial

23. Questions? Comments? Join us at the ‘Roundtable’