Information on the RDRC, review requirements, and application form.
DO YOU NEED AN RDRC REVIEW?
If your study utilizes radiopharmaceuticals to address basic science questions, an IND is not necessary. Instead, your study will be reviewed/approved by the Radioactive Drug Research Committee (RDRC). in this case approval by the Radiation Safety Subcommittee (RSS) is not required..
RADIOACTIVE DRUG RESEARCH COMMITTEE (RDRC)
The RDRC is responsible for the review of basic science research protocols using radioactive drugs in humans that are subject to § 361.1. RDRC approval of a research study is based on assurance that the following requirements are met [§ 361.1(d)(1)-(9)]:
- appropriate limit on the radiation dose
- appropriate limit on the pharmacologic dose
- qualified study investigators
- medical facility properly licensed to possess and handle radioactive materials
- appropriate selection and consent of research subjects
- appropriate quality of radioactive drug administered
- sound research protocol design
- reporting of adverse events by the investigator to the RDRC
- approval by an appropriate Institutional Review Board (IRB)
For more detailed information about each of these requirements, see What Information is Reviewed by the RDRC2?
In order to get a fillable application form, you must save it first. To save it–right click on Review Application. If you just wish to view the application you can just open it. When you have completed the application, upload it to the RDRC Application page, see menu to the left. Once you upload the application you will not be able to view or change it. If you are uploading a revised application, please indicate that in the name of the file. The result of your review will be emailed to you. The next meeting date of the RDRC is July 11, 2016. Currently the RDRC meets quarterly.
If you have not also submitted your IRB protocol for review, please visit the IRB website to get information and submit your application for an IRB review. If you are doing an oncology study, please visit the LCCC Oncology Protocol Review Committee website if you have not submitted your materials for the PRC review.
If you have any questions please contact Trisha Dant in the Office of Research. To email her, click on her name or call her phone number 919-966-4287.
Click here to download a pdf copy of the FDA RDRC Guidance Document.