Instructions for Submitting Documents for Pre-Review:
What is “Pre-Review” of investigator-prepared documents for IRB submission?
Pre-review includes a comprehensive review of all draft documents to assure that they are completed correctly, and that the information presented is consistent among the study documents. In addition, the protocol review includes analysis of the research question(s), background information (previous work, literature references), use of a study drug or device, comparison to standard of care, use of a placebo, inclusion and exclusion criteria, recruitment procedures, data collection, risks, safety precautions, protection of confidentiality, potential benefits and biostatistical analysis.
This review is done to assist investigators in presenting complete, accurate, and thorough IRB applications prior to submission to the IRB. We review full board, exempt, and expedited submissions. A Pre-Review usually takes less than 2 business days and typically results in a significant decrease in time required to attain final approval of the protocol.
To obtain a pre-review of your study protocol, submit the following documents via email to CIRC@UTSouthwestern.edu:
- A Pre-Review Request Form or cover letter from the investigator must accompany the submission. (Note: Pre-review requests should be emailed from the Principal Investigator's email address to verify that they have reviewed the documents and have cleared them for submission.)
- Form NR1.
- Investigator’s Brochure (if available in electronic form).
- Protocol (if available in electronic form).
- Project Summary (except for a tissue procurement service or cell/tissue/DNA repository; instead, submit a protocol following the protocol template for tissue procurement services or cell/tissue/DNA repositories).
- Consent Form(s).
- HIPAA Form(s) (HIPAA Authorization form, if applicable / HIPAA Waiver, if applicable).
- We do NOT review documents in languages other than English. It is not necessary to obtain signatures (for those documents that require them) prior to pre-review.
- Forms, and guidance for their completion, are available from the IRB website.
- Pre-Review Checklist (revised 06/12/09) to assist in review of documents before sending to CIRC Services.
Contact the CIRC Services Office for details (214-648-5005) or CIRC@UTSouthwestern.edu.
