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

16. Thank you.