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Module F: Pre-study Assessment Visit

Module F: Pre-study Assessment Visit. Denise Thwing 14 Apr 2010. Purpose. 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

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Module F: Pre-study Assessment Visit

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  1. Module F: Pre-study Assessment Visit Version: Final 14-Apr-2010 Denise Thwing 14 Apr 2010

  2. Purpose • 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 Version: Final 14-Apr-2010

  3. Preparing 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 Version: Final 14-Apr-2010

  4. Scheduling and Documenting 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 Version: Final 14-Apr-2010

  5. Conducting 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 Version: Final 14-Apr-2010

  6. Conducting 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 Version: Final 14-Apr-2010

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

  8. Site exclusions/Red 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 Version: Final 14-Apr-2010

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