Download SOP 006 Reporting Procedures - University of Kansas Medical Center

Standard Operating Procedures, Radioactive Drug
Research Committee
SOP Title: Reporting Procedures, Radioactive Drug Research
Committee
SOP Version: 1
SOP#XXX
PURPOSE:
To describe the RDRC review procedures required by the Food and Drug Administration
(FDA) regulations at 21 CFR 361.1.
RESPONSIBLE PERSONNEL:
RDRC, IRB, Human Research Protection Program, Office of Compliance, Principal
Investigators (“PI”) , Study Coordinators and other Study Team members.
BACKGROUND:
Food and Drug Administration (FDA) regulations entitled “Prescription Drugs for
Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs
Used In Research” provide for a mechanism that allows the use of radioactive drugs in
human research under certain specific conditions. The human research use of radioactive
drugs that meet these specific conditions can be performed without the need for an FDAapproved New Drug Application or an FDA-accepted Investigational New Drug (IND)
exemption. 21 CFR 361.1. Among the conditions specified at 21 CFR 361.1 is the
requirement that each research project be approved and monitored by a Radioactive Drug
Research Committee (RDRC) that is itself approved by the FDA.
REGULATION AND GUIDELINE REFERENCE(S):
21 CFR Part 361
KUMC REFERENCES:
None
ATTACHMENT(S):
Application to Involve Human Subjects in Biomedical Research that includes use of
Radioactive Drugs not covered under an IND.
FDA Form 2915, Radioactive Drug Research Committee (RDRC) Report on Research
Use of Radioactive Drugs Study Summary
Biannual Progress Report for RDRC-Approved Research Protocol Subject to
Requirements of 21 CFR 361.1
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University of Kansas Medical Center
Standard Operating Procedures, Radioactive Drug
Research Committee
SOP Title: Reporting Procedures, Radioactive Drug Research
Committee
SOP Version: 1
SOP#XXX
DEFINITIONS:
Institutional Review Board (IRB): An independent body constituted of medical, scientific, and
nonscientific members, whose responsibility it is to ensure the protection of the rights, safety,
and well-being of human subjects involved in a trial by, among other things, reviewing,
approving, and providing continuing review of trials, of protocols and amendments, and of the
methods and material to be used in obtaining and documenting informed consent of the trial
subjects. KUMC has several IRB’s.
Radioactive Drug Research Committee (RDRC): the duly constituted governing body at
KUMC authorized and approved by the U.S. Food and Drug Administration to review and
approve or disapprove certain uses of radioactive drugs in the conduct of basic research in
humans. 21 CFR Part 361.
PROCEDURE:
1. Adverse Reaction Reporting: The investigator must immediately (but no later than 7
calendar days), report to the KUMC RDRC all adverse effects associated with the use of
the radioactive drug in the research study In accordance with 21 CFR 361.1. The KUMC
RDRC Chair must immediately, but no later than 7 calendar days, report to FDA all
adverse reactions determined to be probably attributable to the use of the radioactive drug
in the research study. Any adverse reactions reported by the KUMC RDRC to the FDA
will also be reported to the IRB. All adverse reactions will be reviewed by the RDRC at
the next meeting.
2. Biannual Reporting: For al protocols subject to the requirements of 21 CFR 361.1,
effective January 2016, in addition to annual reporting, the PI must report on the progress
of the research before July 15 (Reporting Period January 1-June 30) and January 15
(Reporting Period July 1-December 31) of each year to the RDRC. This is performed by
submission of a form entitled “Biannual Progress Report for RDRC-Approved Research
Protocol Subject to Requirements of 21 CFR 361.1. This interim document will need to
include:
a. A summary of all patients recruited into each protocol and subgroup.
b. The number of extra doses of radiopharmaceuticals administered due to the
technical failures as part of proposed protocol contingencies.
c. Any issues related to radiochemistry production and quality assurance; and
d. Any adverse events. An Adverse Event is defined as all events associated with
the radiotracer that are not clearly defined in the IRB protocol as expected side
effect of other drugs, which may be used in the protocol.
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University of Kansas Medical Center
Standard Operating Procedures, Radioactive Drug
Research Committee
SOP Title: Reporting Procedures, Radioactive Drug Research
Committee
SOP Version: 1
SOP#XXX
3. Reporting IRB Renewal and Study Closure: The RDRC should receive a copy of the
annual renewal form that is provided to the IRB at the time of annual expiration of the
IRB protocol, the IRB renewal approval letter, and a copy of the reapproved consent
forms. It is the responsibility of the PI to provide the information to the KUMC RDRC
within 1 week of receipt of the IRB annual re-approval letter. The PI should also provide
the KUMC RDRC notification of the close of any research study, providing a copy of the
IRB form requesting closure, at the time of submission to the IRB.
4. FDA Reporting Requirements:
a. Annual Report: FDA regulations require that the responsible investigator submit
an annual report to an RDRC using Form FDA 2915, “Report on Research Use of
Radioactive Drug”. Completed annual reports must be submitted to the KUMC
RDRC by the 15th of January each year, so that these forms can be reviewed by
the Chair, and other committee members as necessary and forwarded by the
RDRC to the Food and Drug Administration by 31st of January. The KUMC
RDRC will add the names and qualifications of members of the committee and
any consultants used by the KUMC RDRC during the review of studies over the
past year to the annual report submitted to the FDA.
b. Special Summary Report: for any protocol subject to the requirements of 21
CFR 3611 that involves either more than 30 subjects or subjects under 18 years of
age, a special summary must be submitted to the FDA no later than 7 calendar
days post RDRC approval, using FDA Form 2915 as outlined above. The
responsible physician must provide the KUMC RDRC with a completed FDA
Form 2915 for each such protocol as a condition for final approval by the KUMC
RDRC.
HISTORY:
Written/Revised
by:
Approved by:
Approval Date
Version
Number
Notes:
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University of Kansas Medical Center