Email this pageFor Health Research Participants:
For information about Health Research at the University of Rochester, including opportunities to volunteer, please visit the
If you have general questions about what it means to participate in clinical research, contact Nancy Needler with your questions. Nancy is our Research Subject Advocate (RSA). For more information visit the Research Subject Advocacy Program website.
For Health Research Personnel:
The Research Subject Advocacy (RSA) Program provides assistance in the following areas:
- Creating a compliant data and safety monitoring plan
- Establishing an informed consent process
- Discussing human subject protection concerns
To learn more about the RSA Program and how it may assist your research, visit the Research Subject Advocacy Program website.
Data & Safety Monitoring
Protocols should reflect the Guidelines for Writing a Research Protocol as outlined by the Research Subject Review Board.
Every protocol evaluated by the CRC Advisory Committee must have a Data & Safety Monitoring Plan (DSMP). To assist the Committee in completing their evaluations, please include all of the required elements outlined in the CRC Safety Monitoring Requirement Policy. Please note that studies conducted on the CRC must have a physician on the study team who monitors for safety.
Every DSMP must include:
1. The mechanism by which the PI will monitor for participant safety and adherence to the study protocol
- Specific details of the PI's involvement are required, as are process details of any other entities involved in monitoring.
2. The system used to report adverse events
- Specific details of the timeline of reporting to the IRB, the study sponsor, and any other agency.
3. The steps taken to ensure quality control and management of data
- A data management plan must include a description of the study procedures for maintaining confidentiality and securing of participants' Protected Health Information (PHI).
If you would like assistance with DSMP development, submit a request for consultation to Nancy Needler.
Nancy_Needler@urmc.rochester.edu
Here is a useful tool which will guide you with questions to prompt your data safety monitoring plan development.
If your DSMP does not meet the requirements of the CRC policy, you may submit a waiver application.
This application and the waiver policy are located towards the bottom of the CRC Forms/Application Page.
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