PLEASE E-MAIL YOUR COMPLETED APPLICATION (INCLUDING ALL ATTACHMENTS) AND DELIVER HARD COPIES TO:
Ms. Dianne C. Frederick
The original or a copy of your application must be submitted along with the MOST RECENT copies of the following:
- IRB Approval Letter – (if available)
- IRB approved and stamped consent forms (if not available, please include most recent IRB submission)
- Spanish consent (if applicable)
- Protocol Data Sheet from RASCAL
- Investigator’s Brochure (if applicable)
- If study is Industry-sponsored, but investigator-initiated, correspondence between Investigator and Sponsor documenting the role of the Investigator in the initiation and design of the study.
PLEASE DO NOT SUBMIT STAPLED DOCUMENTS
Your application will be sent to key CRR personnel for logistical and financial review, and two members of the CRR Clinical Advisory Committee (ClinAC) for a scientific review. If you have never utilized any CRR services prior to this current submission, Ms. Frederick will contact you within 1-2 weeks to arrange a brief internal review meeting (approx. 30 minutes) with the CRR Program Director or Associate Program Director and nursing staff. Any questions or ambiguities are informally discussed. Investigators who have previously utilized CRR services will be requested to meet for an internal review if specific logistical issues need to be discussed.
Once questions from the internal review meeting and scientific review, if any, are resolved, the protocol application is sent to the ClinAC. The ClinAC reviews protocol applications once a month, generally the 2nd Tuesday of each month. When your protocol is approved, a formal letter will be sent to the Principal Investigator. No research participants may be scheduled until a letter of approval has been issued.
The CRR number assigned to your study will not change from year to year. The IRB numbers may change, however, and you may also wish to amend the study in the future. Please inform Ms. Frederick of any changes in consent forms, IRB numbers or other revisions in the protocol.
Funding for the Irving Institute, which supports the CRR, depends upon continued demonstration that outstanding research is being conducted and published, using CRR services and facilities. Therefore, we ask that you cite the CRR grant, UL1 TR000040, on any publications related to this protocol.
CRR PRICE LISTS:
If you need assistance with the design of your study, please consult the list of Design and Biostatistical References.