Types of Reports Associated with RDRC/SHUR Approved Research Studies
- RDRC Adverse Events
As a PI of an RDRC-approved research study involving the use of a radioactive drug or tracer, please be aware of your requirement to immediately notify the University of Michigan - Radioactive Drug Research Drug Committee (RDRC) of all adverse effects or adverse reactions (mild or severe) that are probably attributable to the use of the radioactive drug or tracer in your research study.
You need not confirm a causal relationship between the drug and the event, but the likelihood that the event and the use of the drug were related.
The U-M RDRC/SHUR must be notified no later than 3 calendar days after the identification of an adverse effect or adverse reaction that was probably attributable to a radioactive drug or radioactive tracer. Notification should be made by contacting Radiation Safety Service (RSS) / OSEH (764-6200) or e-mailing the Radiation Safety Officer (Mark Driscoll / firstname.lastname@example.org) or RSS secretary (Jenniffer Neault / email@example.com).
This requirement to report adverse effects or adverse reactions to the U-M RDRC is in addition to the formal reporting requirement using the eResearch system. In accordance with FDA regulations, the U-M RDRC only has 7 days to assess and report adverse effects or reactions to the FDA.
FDA Warning Letter – Columbia University Medical Center
In a letter dated September 20, 2011, the Food and Drug Administration (FDA) issued a warning letter to Columbia University Medical Center (CUMC) noting that the CUMC Radioactive Drug Research Committee failed to adhere to the applicable statutory requirements and FDA regulations governing the use of radioactive drugs for human research. Refer to the FDA Warning Letter issued to CUMC in the link below:
Specifically, refer to non-compliance item #2 in the warning letter: ‘The RDRC failed to assure that investigators immediately report all adverse events (effects) associated with the use of the radioactive drug in a research study [21 CFR 361.1(d)(8)].’
Thank you for your time, consideration, and cooperation with respect to this FDA reporting requirement. Please do not hesitate to contact Radiation Safety Service / OSEH (764-6200) should you have any question, comments, or concerns regarding this notification.
- RDRC Quarterly Reporting
The RDRC requires completion and submission of Quarterly reports. These reports are generated by the RDRC and posted to the eResearch "Ancillary Manage Documents" tab of the main study within eResearch. These reports are used for tracking the number of approved "Unique Subjects" as they are studied each quarter. This means that the subject is counted only one time when they receive the first administration of the radiopharmaceutical. The study team is encouraged to keep an excel spreadsheet to track when each subject is studied and what the organ doses were for each administration of radiopharmaceutical. Please see template for suggested format which makes it easy to keep track of each subject as they progress thru the protocol.
- RDRC "Annual Reporting" (2915)
The FDA requires that an "Annual Report" be submitted by January 31 of each year in which a research study is active. The UM-RDRC is one of the only RDRC’s in the US which submits an all- inclusive FDA Form 2915 "Annual Report" packet. This means that each PI must submit the FDA Form 2915 Annual Report for each of their RDRC approved research projects to the UM- RDRC. These reports are then reviewed, revisions requested from the PI if necessary, and then sent by the UM- RDRC to the FDA. Again these reports show the number of “Unique Subjects” who are studied during the calendar year. Please note that the Sum of the Quarterly reports and the Annual report totals of “Unique Subjects” studied for each calendar year must match.
The FDA posts the current version of the FDA Form 2915 "Annual Report/Special Summary" on it’s website. They will not accept an outdated version of this form, so check each time before filling the form out! See "Links" section for the website.
- FDA Form 2915 "Special Summary"
This is the same form used for the Annual Reporting except that box is completed to indicate it is a Special Summary. This is the request to study more than 30 subjects. It is initially completed when more than 30 subjects are requested to be studied for an RDRC research project. Then if additional numbers of subjects are needed to be studied for scientific reasons, additional "Special Summaries" must be completed by the study team and submitted to the UM-RDRC for approval signature and sending to the FDA.
- RDRC Termination Reporting (2915)
The FDA uses the same form for a third purpose. When an RDRC approved study closes enrollment, and ceases administration of radiopharmaceuticals, the study team must complete the FDA Form 2915 "Special Summary" one last time being sure to enter the date of "Termination" in section 1 d. This indicates to the FDA that the study is no longer active. The study can however be in Data Analysis, and be considered "Terminated" from RDRC review. This form must also be submitted by the study team to the UM-RDRC for review, any necessary revision, approval and finally submission by the UM-RDRC to the FDA.
- SHUR Annual Reporting
The SHUR requires that the PI/Study team submit an annual report to show the number of "Unique Subjects" which are studied each calendar year. The SHUR generates the reports and posts them in the “Manage Ancillary Documents” tab of the main/parent study in eResearch.
- SHUR Termination Reporting
While there is no formal reporting needed to "Terminate" approval for a previously approved SHUR study here at UM, the study team is requested to notify the SHUR committee when the study is terminated within eResearch. At this time, it is suggested that a "Correspondence" be posted within eReasearch to advise the SHUR committee of the impending termination of a research study. This could be done at the same time that the IRBMed is given notice of the intent to terminate.