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Information on the RDRC, review requirements, and application form.<\/p>\n
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.<\/p>\n
The RDRC is responsible for the review of basic science research protocols using radioactive drugs in humans that are subject to \u00a7 361.1. RDRC approval of a research study is based on assurance that the following requirements are met [\u00a7 361.1(d)(1)-(9)]:<\/p>\n
For more detailed information about each of these requirements, see What Information is Reviewed by the RDRC<\/a>2<\/sup>?<\/p>\n In order to get a fillable application form, you must save it first<\/strong><\/em>. To save it–right click<\/strong> on<\/strong><\/em> Review Application<\/a>. 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<\/a>, see menu to the left. Once you upload the application you will not be able to view or change it<\/strong>. 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. Currently the RDRC meets quarterly.<\/p>\n If you have not also submitted your IRB protocol for review, please visit the IRB website<\/a> 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<\/a> if you have not submitted your materials for the PRC review.<\/p>\n If you have any questions please contact Janelle Cross<\/a>\u00a0in the Office of Research. To email her, click on her name or call her phone number 919-966-4287.<\/p>\n Click here to download a pdf copy of the FDA RDRC Guidance <\/a>Document.<\/p>\n","protected":false},"excerpt":{"rendered":"