<\/p>\n
<\/p>\n
<\/p>\n
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":" 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 … Read more<\/a><\/p>\n","protected":false},"author":14916,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-2238","page","type-page","status-publish","hentry","odd"],"acf":[],"_links_to":[],"_links_to_target":[],"_links":{"self":[{"href":"https:\/\/www.med.unc.edu\/oor\/wp-json\/wp\/v2\/pages\/2238","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.med.unc.edu\/oor\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.med.unc.edu\/oor\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/oor\/wp-json\/wp\/v2\/users\/14916"}],"replies":[{"embeddable":true,"href":"https:\/\/www.med.unc.edu\/oor\/wp-json\/wp\/v2\/comments?post=2238"}],"version-history":[{"count":12,"href":"https:\/\/www.med.unc.edu\/oor\/wp-json\/wp\/v2\/pages\/2238\/revisions"}],"predecessor-version":[{"id":5890,"href":"https:\/\/www.med.unc.edu\/oor\/wp-json\/wp\/v2\/pages\/2238\/revisions\/5890"}],"wp:attachment":[{"href":"https:\/\/www.med.unc.edu\/oor\/wp-json\/wp\/v2\/media?parent=2238"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}