POST-TEST EVALUATION FORM
****SEMINAR PARTICIPANTS MUST COMPLETE ALL SECTIONS OF THIS FORM IN ORDER TO RECEIVE CREDIT FOR ATTENDANCE AND PARTICIPATION. PARTICIPANTS MUST ATTEND ALL FOUR PROGRAMS TO RECEIVE CE VERIFICATION. PLEASE RETURN FORM TO CINDY NELSON AT BOX 817****
NEW ENGLAND MEDICAL CENTER
EDUCATIONAL SEMINAR SERIES
RECOGNIZING AND REPORTING ADVERSE EVENTS DURING A CLINICAL TRIAL
Presented by Mark Barnes, October 18, 2002
Seminar Participant Information
Name: ______Degree: ______
Department: ______Phone Number: ______
E-mail Address: ______
Check the one that best describes your position:
1. Principal Investigator ___ 2. Co-Investigator ___
3. Study Coordinator ___ 4. Data Manager ___ 5. Admin. Manager ___
6. Other____
If you checked 2-6, please indicate the principal investigator or supervisor for whom you work: ______
If you are a physician, do you want to receive CME credit? Yes_____ No_____
If you are a nurse, do you want to receive contact hours? Yes_____ No______
Goals of Presentation
This presentation is intended to orient and educate principal investigators and others involved in the conduct of clinical research to the main compliance issues surrounding documenting and reporting adverse and serious adverse events.
Objectives of Presentation
1. Government Enforcement Focus on the Reporting of Adverse Events: Give seminar participants general background information on the enhanced regulatory scrutiny and enforcement by government agencies regarding adverse event reporting and describe recent cases where this issue has been the focus of government investigation.
2. Regulatory Reporting Obligations: Give seminar participants an overview of the various regulatory obligations for collecting and reporting the occurrence of adverse and serious adverse events, and how an IRB's own policies and approval terms interact with this regulatory backdrop.
3. Impact on Protocol Design and IRB Approval Process: Examine the way in which investigators and research staff can design protocols and work with the IRB to facilitate compliance with adverse event reporting obligations, and the process by which investigators and research staff should report adverse and serious adverse events to the IRB.
4. Multi-Site Trials: Special Considerations: Explore the special issues for adverse event reporting that arise in the context of industry sponsored research, specifically those that arise for investigators participating in a multi-site trial.
Substantive Questions on Seminar’s Objectives: Please answer the following questions on the content of today’s educational seminar.
1. Government Enforcement Focus on the Reporting of Adverse Events.
Failure to adequately report adverse events is seen as evidence of an investigator's failure to minimize ______.
OHRP has expressed particular concern with investigators failing to report adverse events during subsequent submissions to the _____, and investigators continuing to ______subjects before reporting the occurrence of a serious adverse event.
2. Regulatory Reporting Obligations.
Regulatory reporting obligations are found both in the ______(HHS Regulations) and ______Regulations.
The following four factors are relevant to whether an event is an "adverse event" and whether it must be reported: ______, ______, ______, ______.
3. Impact on Protocol Design and IRB Approval Process.
It is important to clearly define ______in the context of each protocol.
The ______may need to be modified to give subjects current information about occurrence of a new adverse event.
4. Multi-Site Trials: Special Considerations.
In light of IRB overload, many commentators suggest using a ______to review and aggregate data from other sites and report a summary back to each individual IRB.
OHRP has indicated in its July 11, 2002 Guidance that IRBs may rely on a statement from a DSMB in performing ______.
Evaluation of Program
Content _____ Good _____ Fair _____ Poor
Presentation _____ Good _____ Fair _____ Poor
Speaker: Mark Barnes _____ Good _____ Fair _____ Poor
Was the content non-biased and balanced? _____ Yes _____ No
Was the Conflict of Interest information made available? _____ Yes ______No
Were the educational objectives listed below identified and met?
1. Government Enforcement Focus on the Reporting of
Adverse Events ____Yes ____No
2. Regulatory Reporting Obligations ____Yes ____No
3. Impact on Protocol Design and IRB Approval Process ____Yes ____No
4. Multi-Site Trials: Special Considerations ____Yes ____No
The following topics are scheduled to be covered in future sessions of the Educational Seminar Series: (1) Continuing Review (November 2002); and (2) The Impact of the Health Insurance Portability and Accountability Act on Clinical Research (December 2002). The educational seminar on IND and IDE Applications, previously scheduled for December 2002, will be given in early 2003. Please list any other topics that you would like to see covered in future presentations: ______
______.
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