Adventist Healthcare Institutional Review Board

Adventist HealthCare Institutional Review Board

Investigational Drug Form

IRB Study #: Organizational Entity:

Study Name:

Principal Investigator (PI):

Form Completed by:

Researchers planning to use investigational drugs in research projects must complete this form and include it with the complete protocol package for review.

Please answer the questions that follow in as much detail as possible to allow the IRB to evaluate your research proposal; use as much space as you need to answer each question. You may add additional pages if you prefer to submit your answers on separate pages.

Answer the following questions for each investigational drug used as part of the proposed research. Submit a separate form for each investigational drug.
Trade Name of Drug:
Generic Name of Drug:
Description of Drug:
Drug Form(s) and Strength:
Drug Manufacturer:
Indications for Use of Drug:
FDA IND Number:
Holder of the IND:
Drug Trial Phase: Phase I Phase II Phase III Phase IV
1. Has the IND been approved by the FDA?
Yes – clean approval Yes – conditional approval No
2. If “yes,” please attach a copy of the FDA correspondence. If applicable, correspondence noting any restrictions placed on the IND/IDE during the conduct of the study must also be distributed to the IRB in a timely fashion.
3. Is this an FDA-approved drug being used for an unapproved purpose (new indication) or in an unapproved way (e.g., different dosage, new route of administration)?
Yes No
4. Identify the study design (as applicable):
Single-blind Double-blind Randomized Non-randomized
Placebo control Open trial Other (describe below)
5. Please identify any special storage requirements for the drug.
6. Please identify any precautions, warnings, and contraindications relating to this drug.
7. Please identify all the other drugs that you expect will be utilized as part of this study (including both investigational and approved drugs).
8. Is this investigational drug being provided without charge (free) to the hospital for purposes of this study?
Yes No If “no,” how much will the drug cost the hospital?
Will the patient (or his/her insurer) be billed for this drug?
Yes No
9. Please provide the IRB with any additional information or comments regarding the drug that you believe would be helpful its review of this application.

SIGNATURE

______

Signature of the Principal Investigator Date

Investigational Drug Form Page 2 of 2

Version 9, August 25, 2017