1. M ODULE F: P RE - STUDY A SSESSMENT V ISIT Denise Thwing 14 Apr 2010 1 Version: Final 14-Apr-2010

2. P URPOSE 21 CRF 312.53 To select a qualified research site Actual visit takes place After PI and site meet criteria for selection agreed by the sponsor After verification PI indicated interest in study Telephone PSSV may be allowed if site has been used in the last 12 months 2 Version: Final 14-Apr-2010

3. P REPARING FOR THE VISIT Copies of the protocol Site correspondence Qualification visit template Regulatory document review checklist ICF template Advertising text, if available Practice your presentation Make your appt and send confirmation letter Confirm visit and attendees 24-48 hrs in advance 3 Version: Final 14-Apr-2010

4. S CHEDULING AND D OCUMENTING SITE CONTACT Procedure Contact PI to arrange mutual time and date, letter with expectations Meet with all staff for an interview Document findings Follow-up letter 4 Version: Final 14-Apr-2010

5. C ONDUCTING THE VISIT Objectives Informing the PI about the study and the study drug Review overall study design/brief review CRF Review enrollment criteria Review any special procedures SAE/AE documentation Evaluate PI capability to conduct the trial Staff - interview Time - competing studies/obligations Population - review recent historical data Recruitment methods Personality- cooperative Financial requirements 5 Version: Final 14-Apr-2010

6. C ONDUCTING THE VISIT Inspect Facility Clean/organized Equipment serviced annually or per maintenance agreement elevator open access doorways Lab exam rooms/CRA work area other specialty areas Verify all staff at the site are qualified by experience, education and training to perform the study Both parties commit and agree with contract terms Review regulatory documents required Review /agree timelines and goals 6 Version: Final 14-Apr-2010

7. R EVIEWING DOCUMENTS 1572 CVs, licenses Investigator protocol agreement IB receipt Clinical study signature list ICF template Advertising text 7 Version: Final 14-Apr-2010

8. S ITE EXCLUSIONS /R ED FLAGS PI unprepared for your visit PI makes unrealistic promises PI and SC do not interact well Inadequate PI training High staff turnover Excessive high fees requested Inadequate facility Long IRB approval time 8 Version: Final 14-Apr-2010