Request Forms for Revised/New study documents for previously approved study
Please submit the forms below to either your assigned IRB Coordinator or to integreview@integreview.com.
Criteria for Determining Type of Review (revised 04/26/10)
Criteria to determine whether subsequent protocol amendments and/or informed consent document revisions are reviewed via full board or expedited review.
1. Protocol and Informed Consent Request Form (revised 04/16/12)
This form is to be used to submit requests for review and approval of the following study documents for previously-approved studies:
- Protocol
- Informed Consent revisions (if due to change in Principal Investigator or site address(es), submit Investigational Site Revision Request Form listed below)
- New Informed Consent documents
2. Request for Translation Form (revised 02/07/12)
This form is to be used to submit all requests relating to the translation of study documents.
3. Request for Review of IB-Package Inserts Form (revised 02/01/12)
This form is to be used to submit requests for review and approval of the following study documents for previously-approved studies:
- Investigator’s Brochure(s)
- Package Insert(s)/PDR reprint/Ingredient list
4. Request for Review of Recruiting Materials/Other Materials Form (revised 02/01/12)
This form is to be used to submit requests for review and approval of the following study documents for previously-approved studies:
- New recruiting materials/other materials to be seen or heard by participants
- Revised recruiting materials/other materials to be seen or heard by participants
- Translated documents or translation requests (appropriate for use with this form)
- Recruiting Materials Guidelines (revised 04/16/12) (select to view guidelines to assist with IRB approval of recruiting materials to include generic materials).
5. Investigational Site Revision Request Form (revised 02/01/12)
This form is to be used by an Investigator participating in a previously-approved study who is requesting a change in a research site, PI, and other site revisions.