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.
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.
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.
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.
Cont…. Timing of Institutional Review Board meetings. Contractual and budgetary negotiations. Regulatory history (FDA audits, “blacklist”).
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.
Cont…. Investigator’s selection is based on: Education Training Experience(As per prescription of MCI)
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.
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.
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.
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.
Cont…. The investigator should be aware of and comply with: GCP’s . SOP’s . applicable regulatory requirements.
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.
Cont….CRO project manager fine-tunes the lists & decideswhich center to suggest to the sponsor .Sponsor accepts the proposal? NOYESProceed with the selection