MODULE G INITIATION VISIT

1. MODULE GINITIATION VISIT Jane Fendl April 14, 2010 Version: Final 14-Apr-2010

2. AGENDA • Purpose of the visit • Preparing for the visit • Conducting the visit • Source documents • Contact information • Writing the report • Follow-up procedures & action items Version: Final 14-Apr-2010

3. Purpose of an Site Initiation Visit (SIV) • To review/train the Investigator and staff on the protocol • To review/train the Investigator and staff on all required protocol procedures • To review the roles and responsibilities of all involved parties • To confirm that the Investigator, facilities and staff are prepared to begin the study • Communicate sponsor standards and expectations in regards to GCP • Final step before conducting the actual study Version: Final 14-Apr-2010

4. Preparing for the SIV • Review and confirm that all regulatory documents are acceptable and in the sponsor file • Schedule a date with the site to perform the SIV • Call to determine a date when the entire staff can be present • Investigator, Sub-Investigators, Research fellows, Specialists, Study coordinator, Study nurse, Pharmacist, Laboratory Tech, Administrator • Inform the Project Manager of date Version: Final 14-Apr-2010

5. Preparing for the SIV • Send a confirmation letter with agenda to the Investigator • A few days before call the site to: • Confirm that the site has received all documents, study supplies • Confirm that all administrative and logistical arrangements are completed Version: Final 14-Apr-2010

6. Preparing for the SIV • Gather documents and materials for the visit • Protocol and slide presentation • Samples of drug packaging • Samples of laboratory kits • Blank CRF • Annotated CRF • CRF completion guidelines • Logs • Ship any necessary documents or materials so that they arrive at the site on time Version: Final 14-Apr-2010

7. Conducting the Visit • Be prepared to document the visit by taking notes or using SIV report form • Introduce your self, other sponsor staff and have site staff introduce themselves • Attendance – have all the attendees sign a training form • Be flexible with agenda – ask about staff schedules and adjust if necessary Version: Final 14-Apr-2010

8. Conducting the Visit See separate SIV presentation slides Version: Final 14-Apr-2010

9. Source Documents • The first place that study documentation is recorded • Lab reports, x-rays, ECG tracings, Progress notes, electronic records • Review the Source Documents with the Study Coordinator • Complete the Source Document log Version: Final 14-Apr-2010

10. Individual Contacts • Meet with anyone who could not be present at the SIV meeting • Inspect facilities to assure no changes occurred from the PSSV to the SIV • Inspect the Clinical Drug Supplies • Complete • Damage • Receipt documentation is present • Blinding preserved • Meet with the Investigator to review any outstanding issues and state if enrollment can begin Version: Final 14-Apr-2010

11. Writing the Report Refer to SIV Report Template Handout Version: Final 14-Apr-2010

12. Follow up Procedures & Action Items Complete visit by writing a “Follow-up Visit” letter to the Investigator • Items to include: • Thank the Investigator and staff for their attendance • Confirm they can begin enrolling if applicable • List outstanding items • Offer resolutions to outstanding items • Provide a possible date of next visit Version: Final 14-Apr-2010