The responsibility of the Laboratory is to review and approve protocols for the use of radioactive drugs in human subjects in accordance with Food and Drug Administration regulations and policies. Investigators are responsible for obtaining the appropriate approval to use a radioactive drug in a human subject prior to requesting protocol approval from the Human Subjects Committee.
The Laboratory maintains a Radioactive Drug Research Committee (RDRC) in compliance with Food and Drug Administration regulations (21 CFR 363.1.) The LBNL RDRC is identified as RDRC #38. The RDRC meets quarterly or more often as required. In addition to its FDA-mandated responsibilities, the RDRC is required by the Laboratory to review the doses of all radiopharmaceuticals administered to human subjects at the Laboratory.
For approval purposes, a radiopharmaceutical falls into one
of three classifications: experimental, under investigational new drug permit, or commercially available. Basic research involving human use of experimental radiocompounds must
be approved by the Laboratory RDRC. Investigators are responsible for filing an Investigational New Drug
(IND) application with the Food and Drug Administration for qualifying radiopharmaceuticals; such applications are not
reviewed by the RDRC. Human subjects protocols involving the use of IND-covered or commercially available
radiopharmaceuticals are not reviewed by the RDRC but are reviewed
by the LBNL Human Subjects Committee. Protocols calling for the use of an experimental radioactive drug in humans must be submitted at least 90 days in advance
of the required approval date. The RDRC reviews the protocol to ensure that pharmacological and radiation doses lie
within federal guidelines, that the radiation exposure is justified by the benefits of the research, and that the study meets
certain other requirements in investigator expertise and radiation safety.
Protocols approved by the RDRC are automatically forwarded to the LBNL Human Subjects Committee.
Investigators using experimental radioactive drugs must additionally file form FDA 2915 quarterly with the RDRC. These quarterly reports are due on the second Friday after the end of the quarter. For 2011 and 2012 the schedule for filing these quartely reports, and the annual reports, is as follows:
- 1st quarter (January 1 - March 31) - Due April 8, 2011
- 2nd quarter (April 1 - June 30) - Due July 8, 2011
- 3rd quarter (July 1 - September 30) - Due October 7, 2011
- 4th quarter & Annual Summary (October 31 - December 31) - Due January 6, 2011
- 20101st quarter (January 1 - March 31) - Due April 6, 2012
- 2nd quarter (April 1 - June 30) - Due July 6, 2012
- 3rd quarter (July 1 - September 30) - Due October 5, 2012
- 4th quarter & Annual Summary (October 31 - December 31) - Due January 7, 2013
Form 2915 may be submitted electronically to firstname.lastname@example.org or via Lab mail to the HARC office, MS 26RO143. If the report is filed electronically, final copies signed by the investigator will be requested after the RDRC completes their review. If no subject studies were conducted in a given quarter, an e-mail stating this sent to email@example.com by the due date will suffice as a quarterly report.
A signed, hardcopy annual report on Form 2915 must be submitted for each protocol with current approval by the due date even if no subjects have been studied during the year. Protocol principal investigators are responsible for the timely filing of reports. No formal reminder notices will be sent. Failure to submit timely reports may result in suspension of RDRC approval.
Here is a checklist in a .pdf format from the FDA that researchers may find useful in writing their protocols. This is list is used by RDRC members to make sure that all mandated areas have been covered in a given protocol. FDA RDRC Protocol Review Checklist
For further information contact the HARC office at x5399.