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Adverse Event Reporting Work Group
The Adverse Events Reporting Work Group is developing requirements and providing input towards the development of a nationally scalable, comprehensive, modular, automated solution for monitoring and managing adverse events (AEs). This system will manage AEs that emerge during the conduct of NCI-supported clinical trials and is intended for generating AE reports for submission to internal and external regulatory organizations. Requirements are being defined in the order of priority based on the requirements defined by the NCI cancer community with the ultimate goal of improving patient safety, increasing productivity, streamlining processes, and facilitating the sharing of adverse events information for research purposes. The Adverse Events Reporting Work Group is part of the Reporting / Sharing Special Interest Group within the Clinical Trials Management Systems (CTMS) Workspace.
Who should get involved?The Adverse Events Reporting Work Group encourages anyone who is interested and/or involved in the conduct, administration, and regulation of clinical trials. These include, clinical trialists, clinical investigators, research nurses, informaticists, clinical trial sponsors, IRB and FDA representatives. These and others are key stakeholders whose input, review and feedback is imperative to the successful development and deployment of applications to support clinical trials and enable improved exchange of clinical trial information. Individuals interested in participating are invited to join the Adverse Events Reporting Work Group Listserv. The Listserv serves as the primary means of communication for the Work Group. Meeting announcements are posted to the Listserv prior to the meeting.
Contact InformationAdverse Events Reporting Work Group Lead - Joyce Niland
Meeting ScheduleThis Working Group is no longer meeting Review past meeting notes: Meeting Notes
Adverse Events Reporting DocumentsDocuments - internal working documents used by this group. | Adverse Events Reporting Work Group Participant ShortcutsRelated Products
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