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Submitted by:-
Mukesh Kumar Jaiswal
PGDACR
ICRI, Dehradun.
Site selection
 Site selection is a rigorous process in conducting
clinical trials successfully, efficiently and in
compliance with the regulatory guidelines.
 While choosing clinical trial sites, there are a number
of factors that require careful consideration , but first
and foremost should always be the sites ability to
gather high quality data.
Cont….
 This broad statement encompasses:
 the experience and qualifications of the site staff.
 the availability of suitable patients who meet the
protocol entry criteria.
 the ability to perform the required clinical
assessments.
Cont….
 Site selection requires due effort on the part of the
sponsor to ensure that the proposed clinical trial site
meets all the considerations for a successful clinical
trail to be conducted.
Consideration in site selection
 Experience and qualifications of the investigator along
with monitor.
 Experience and qualifications of study coordinator and
other staff.
 Availability of suitable patient population.
 Availability of specialized diagnostic or therapeutic
equipment.
 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 an
investigator to play a key role in recruiting
patients, analyzing data, publishing the results and
speaking at conferences.
 Therefore the PI selection is a matter of consideration
for 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 relevant
documents requested by the sponsor, the ethics
committee, the CRO or the regulatory
authorities.
Cont….
 He / she should clearly understand the time and other
resource demands the study is likely to make and
ensure they can be made available throughout the
duration of the study.
Cont….
 The Investigator should be able to demonstrate
potential for recruiting the required number of
suitable subjects within the agreed recruitment
period.
 The investigator should have sufficient time to
properly conduct and complete the trial within the
agreed trial period .
 The investigator should have available an adequate
number of qualified staff and adequate facilities for
the foreseen duration of the trial to conduct the trial
properly and safely.
Cont….
 The investigator should be thoroughly familiar with
the :
 Safety .
 Efficacy .
 Appropriate use of the investigational product as
described 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 investigator
selection
Sponsor ask CRO to conduct a feasible trial.
Sponsor suggests the Principle Investigator.
CRO appoints monitors to collect information about
potential sites & investigators.
Monitor uses sponsors list of suggested sites &
investigator along with other resources & conduct
feasibility interviews.
Cont….
CRO project manager fine-tunes the lists & decides
which center to suggest to the sponsor .
Sponsor accepts the proposal? NO
YES
Proceed with the selection
Thank you.

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Site & investigator selection

  • 1. Submitted by:- Mukesh Kumar Jaiswal PGDACR ICRI, Dehradun.
  • 2. Site selection  Site selection is a rigorous process in conducting clinical trials successfully, efficiently and in compliance with the regulatory guidelines.  While choosing clinical trial sites, there are a number of factors that require careful consideration , but first and foremost should always be the sites ability to gather high quality data.
  • 3. Cont….  This broad statement encompasses:  the experience and qualifications of the site staff.  the availability of suitable patients who meet the protocol entry criteria.  the ability to perform the required clinical assessments.
  • 4. Cont….  Site selection requires due effort on the part of the sponsor to ensure that the proposed clinical trial site meets all the considerations for a successful clinical trail to be conducted.
  • 5. Consideration in site selection  Experience and qualifications of the investigator along with monitor.  Experience and qualifications of study coordinator and other staff.  Availability of suitable patient population.  Availability of specialized diagnostic or therapeutic equipment.  Track record with previous, similar trials.  Geographic location (including international)  Anticipated rate of patient recruitment.
  • 6. Cont….  Timing of Institutional Review Board meetings.  Contractual and budgetary negotiations.  Regulatory history (FDA audits, “blacklist”).
  • 7. Investigator selection  It is important for the principal investigator(PI) or an investigator to play a key role in recruiting patients, analyzing data, publishing the results and speaking at conferences.  Therefore the PI selection is a matter of consideration for a sponsor.
  • 8. Cont….  Investigator’s selection is based on:  Education  Training  Experience (As per prescription of MCI)
  • 9. Cont….  The investigator should provide a copy of: the curriculum vitae and / or other relevant documents requested by the sponsor, the ethics committee, the CRO or the regulatory authorities.
  • 10. Cont….  He / she should clearly understand the time and other resource demands the study is likely to make and ensure they can be made available throughout the duration of the study.
  • 11. Cont….  The Investigator should be able to demonstrate potential for recruiting the required number of suitable subjects within the agreed recruitment period.  The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period .  The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.
  • 12. Cont….  The investigator should be thoroughly familiar with the :  Safety .  Efficacy .  Appropriate use of the investigational product as described in the protocol .  Investigator’s brochure .  Other information sources provided by the sponsor.
  • 13. Cont….  The investigator should be aware of and comply with:  GCP’s .  SOP’s .  applicable regulatory requirements.
  • 14. Process of Site and investigator selection Sponsor ask CRO to conduct a feasible trial. Sponsor suggests the Principle Investigator. CRO appoints monitors to collect information about potential sites & investigators. Monitor uses sponsors list of suggested sites & investigator along with other resources & conduct feasibility interviews.
  • 15. Cont…. CRO project manager fine-tunes the lists & decides which center to suggest to the sponsor . Sponsor accepts the proposal? NO YES Proceed with the selection