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Medical Research
Forms
The eProtocol System is used for:
- New Protocol applications - see Sample
Medical Application Questions.
For VA research also complete and attach Required Questions-VA Research. - Modifications to approved protocols; need prior IRB approval to implement.
- Continuing Review applications.
- Reports - unanticipated problems, events/information requiring prompt reporting.
- Final Reports - to close a protocol; not required for Exempt research.
Click here for eProtocol
Questions about eProtocol? See eProtocol Help.
Forms and Templates
- Medical Consent - Consent Form Templates and Consent Process Information
- Determination of Human Subject Research application
Federal regulations require IRB review of all human subject research. Some categories of research are difficult to discern as to whether they qualify as human subject research. The IRB has established policies and procedures to assist in this determination. Complete this form and return it to the IRB Coordinator if you want the IRB to determine whether your activity constitutes human subject research. For help, contact the Research Compliance Office.
- Scientific Review:
- Review of Scientific and Scholarly Validity, and Oversight (by Faculty Sponsor)
- Review of Scientific and Scholarly Validity (Dept Chair or School Dean)
- Letter of Agreement
Use for STANFORD sponsored research in cooperation with other organizations or agencies.
Protocols using Biological Agents or Recombinant DNA Vectors
All submissions for these protocols must be done via eProtocol - contact the IRB 1 Manager (650-724-8943) before preparing a new protocol or a modification application, or with any other questions about these protocols.
- New Protocol application -
In the eProtocol application:
a) complete the personnel section and all checklists
b) insert "gene transfer protocol" in all required text fields.
Complete the Gene Transfer Form and the Required Questions and "attach" both to the eProtocol application. This is a combined application for studies which include human participants and the use of biological agents or recombinant DNA vectors. It will be reviewed by both the IRB and the Biosafety Panel.
- Modifications - to approved protocols.
Use for changing protocol procedure for studies which include human participants and the use of biological agents or recombinant DNA vectors.
You may not implement a protocol modification without Panel approval.
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Report Form - this also contains the NIH report template. It is used to report all serious adverse events to the IRB and to the IBC (Biosafety). Complete this form, and "attach" it to the eProtocol Report Form.
Contact the IRB 1 Manager (650-724-8943) with any questions.
© 2008 Stanford University. All rights reserved.
Last modified: Monday, 05-May-2008 13:27:12 PDT