IMMUNE TOLERANCE NETWORK
Clinical Site Qualification Checklist
Complete for Each Clinical Site
Principal Investigator:
Tracking Number:
Site Name:
Yes
A. Recruitment
1. Do you anticipate problems in recruiting the
appropriate patient population?
Describe in the comments section the methods of
recruitment you intend to use in order to meet your
recruitment goals.
2. Do you have any present or future commitments
to other clinical trials which might impact on recruitment
into the proposed clinical trail?
Describe in the comments section what experience you
have in recruiting patients into clinical trials with similar
protocol criteria.
3. Would you be willing to accept assistance from the
ITN network if patient recruitment does not meet
recruitment goals i.e. assistance in communicating your
trial on clinical trial informational websites?
B. Resources
1. Are your site facilities adequate to perform the clinical
assessments outlined in the protocol?
Please comment on your facilities for the preparation
and storage of drug supplies and storage of clinical trial
documents.
2. Do you have up-to-date SOPs for performing the
clinical procedures outlined in the protocol?
3. Has your staff received the training necessary to
perform the clinical procedures outlined in the protocol?
Please comment on any specific training activities.
4. Do you anticipate that you will need additional
resources to conduct the clinical trial? If so, please
comment on what resources you will need.
C. Regulatory
1. Do you anticipatey any difficulty in getting your
regulatory authority to process and approve the clinical
trial protocol and informed consent?
Please comment on your experience in previous trials
on the amount of time it takes to get regulatory approval
at your site.
No
N/A
COMMENTS
Immune Tolerance Network
Site Qualification Checklist
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