Site & investigator selection


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Site & investigator selection

  1. 1. Submitted by:-Mukesh Kumar JaiswalPGDACRICRI, Dehradun.
  2. 2. Site selection Site selection is a rigorous process in conductingclinical trials successfully, efficiently and incompliance with the regulatory guidelines. While choosing clinical trial sites, there are a numberof factors that require careful consideration , but firstand foremost should always be the sites ability togather high quality data.
  3. 3. Cont…. This broad statement encompasses: the experience and qualifications of the site staff. the availability of suitable patients who meet theprotocol entry criteria. the ability to perform the required clinicalassessments.
  4. 4. Cont…. Site selection requires due effort on the part of thesponsor to ensure that the proposed clinical trial sitemeets all the considerations for a successful clinicaltrail to be conducted.
  5. 5. Consideration in site selection Experience and qualifications of the investigator alongwith monitor. Experience and qualifications of study coordinator andother staff. Availability of suitable patient population. Availability of specialized diagnostic or therapeuticequipment. Track record with previous, similar trials. Geographic location (including international) Anticipated rate of patient recruitment.
  6. 6. Cont…. Timing of Institutional Review Board meetings. Contractual and budgetary negotiations. Regulatory history (FDA audits, “blacklist”).
  7. 7. Investigator selection It is important for the principal investigator(PI) or aninvestigator to play a key role in recruitingpatients, analyzing data, publishing the results andspeaking at conferences. Therefore the PI selection is a matter of considerationfor a sponsor.
  8. 8. Cont…. Investigator’s selection is based on: Education Training Experience(As per prescription of MCI)
  9. 9. Cont…. The investigator should provide a copy of:the curriculum vitae and / or other relevantdocuments requested by the sponsor, the ethicscommittee, the CRO or the regulatoryauthorities.
  10. 10. Cont…. He / she should clearly understand the time and otherresource demands the study is likely to make andensure they can be made available throughout theduration of the study.
  11. 11. Cont…. The Investigator should be able to demonstratepotential for recruiting the required number ofsuitable subjects within the agreed recruitmentperiod. The investigator should have sufficient time toproperly conduct and complete the trial within theagreed trial period . The investigator should have available an adequatenumber of qualified staff and adequate facilities forthe foreseen duration of the trial to conduct the trialproperly and safely.
  12. 12. Cont…. The investigator should be thoroughly familiar withthe : Safety . Efficacy . Appropriate use of the investigational product asdescribed in the protocol . Investigator’s brochure . Other information sources provided by the sponsor.
  13. 13. Cont…. The investigator should be aware of and comply with: GCP’s . SOP’s . applicable regulatory requirements.
  14. 14. Process of Site and investigatorselectionSponsor ask CRO to conduct a feasible trial.Sponsor suggests the Principle Investigator.CRO appoints monitors to collect information aboutpotential sites & investigators.Monitor uses sponsors list of suggested sites &investigator along with other resources & conductfeasibility interviews.
  15. 15. Cont….CRO project manager fine-tunes the lists & decideswhich center to suggest to the sponsor .Sponsor accepts the proposal? NOYESProceed with the selection
  16. 16. Thank you.