Full Committee Review

Materials submitted for full committee review are new studies, all continuing reviews, revision requests that exceed minor changes, SAEs, previously reviewed expedited materials, and any other matters about which the chairperson believes requires consideration by the full committee. The administrator shall review all submitted materials to assure that they are in compliance with the applicable portions of He-M 206.00. If materials are not complete, the administrator will contact the PI to request the missing materials.

Submission Deadline: First Wednesday of each month by noon. Items received after this deadline may or may not be included in that month's review, depending on the lateness of their receipt.

Submission Requirements:

1. Copy of the summary protocol in the NH CPHS format.
2. A copy of any grant application or protocol for the same study submitted to the U. S. Department of Health and Human Services or FDA, if applicable.
3. Completed and signed Human Subjects Review Form.
4. Copy of any applicable investigator's brochures.
5. Copy of the consent form; in NH CPHS format.
6. Letters of support from all sites under jurisdiction of the NH CPHS.
7. Copies of written materials used in the study and to which subjects might be exposed, such as assessment tools that are not standard, scripts, treatment manuals that are not standard, advertisements; or handouts.
8. Data Safety & Monitoring Board Plan (new submission)/Summary (renewals)

Sample Forms & Documents: All necessary documents with instructions can be downloaded from the www.irbnet.org in the "State of New Hampshire DHHS CPHS, Manchester, NH" Library.