Radioactive Drug Research
Committee (RDRC) Program
What are the
Responsibilities of the RDRC?
[21 CFR 361.1(c)]
1. Approval of Research
Studies
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 by the RDRC 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 RDRC?
2. Administrative Functions
Chairperson
A chairperson is selected by the RDRC. The chairperson
signs all applications, minutes, and reports of the RDRC [§
361.1(c)(2)].
Meetings
- Meetings must be held at least once each quarter in which
research activity has been authorized or conducted [§
361.1(c)(2)].
- A quorum consisting of more than 50% of the membership must be
present at the meetings with appropriate representation of the
required fields of specialization
[§ 361.1(c)(2)].
- No RDRC member shall vote on a protocol in which he/she is an
investigator
[§ 361.1(c)(2)].
Minutes
Minutes must be kept and must include the numerical results of
votes on protocols involving human subjects [§ 361.1(c)(2)].
3. Reporting
Annual Report
An annual report must be submitted to
FDA on or before January 31st of each year
[§ 361.1(c)(3)]. The annual report includes:
- the names and qualifications of the members of the RDRC and of
any consultants used by the RDRC (Form FDA 2914) and
- a summary of study information for each study conducted during
the preceding year (Form FDA 2915)
Special Summary
A special summary (Form
FDA 2915) must be submitted to FDA at the time a proposal is
approved that involves more than 30 research subjects (or when a
previously approved protocol is expanded to include more than 30
subjects) or at the time a research proposal is approved that
involves exposure to a research subject under 18 years of age
[§ 361.1(c)(3)].
Studies involving minors are subject to dose limitations as specified in 21 CFR 361.1(b)(3) and must be supported with review by a qualified
pediatric consultant to the RDRC [§ 361.1(d)(5)].
Changes in Membership
Changes in membership and applications for new members (Form
FDA 2914) must be submitted to FDA as soon as, or before,
vacancies occur and new members are appointed to the RDRC [§
361.1(c)(4)].
Adverse Reactions
- The investigator must immediately report to the RDRC
all adverse effects associated with the use of the radioactive
drug in the research study
[§ 361.1(d)(8)].
- The RDRC chairperson must immediately report to FDA all
adverse reactions probably attributable to the use of the
radioactive drug in the research study
[§ 361.1(d)(8)].
All reports
(i.e. annual report, special summary, changes in membership, and
adverse reaction reports) should be sent to the following address:
Food and Drug
Administration
Center for Drug Evaluation and Research
Division of Medical Imaging and Radiopharmaceutical Drug Products
(HFD-160)
5600 Fishers Lane, Room 18B-45
Rockville, MD 20857
Attn: RDRC (CAPT Richard Fejka)
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Date created: September 20, 2004, updated May 25, 2006 |