As of December 15, 2017, all documents posted to the CSTU website will be posted only once for ease of access and simplification of posting. All documents reviewed by the CIRB will continue to be listed in the outcome letter but those documents provided to the CIRB for reference and posted in other locations on the CTSU website will not be duplicated.
Below is a summary of documents which will be made available via the CIRB Documents tab.
CIRB Documents Posted per Review Type
Initial Review:
- CIRB Application for Initial Review
- CIRB Outcome Letter(s)
- Protocol
- Consent Form
- Patient facing documents (i.e. Quality of Life Questionnaires, Surveys, etc.)
- CIRB Meeting Minutes or Expedited Reviewer Worksheets (as applicable)
Continuing Review:
- CIRB Application
- CIRB Outcome Letter(s)
- CIRB Meeting Minutes or Expedited Reviewer Worksheets (as applicable)
*Note: The currently approved Protocol and Consent Form are available in the CIRB Details section of the CTSU website and are not reposted.
Amendment Review:
CIRB Amendment Review Application:
- CIRB Outcome Letter(s)
- Protocol
- Consent Form
- Change Memo(s) for Protocol and Consent Form as appropriate
- Patient facing documents (i.e. Quality of Life Questionnaires, Surveys, etc.)
- CIRB Meeting Minutes or Expedited Reviewer Worksheets (as applicable)
Recruitment Review:
- CIRB Recruitment Material Application
- CIRB Outcome Letter(s)
- Recruitment Material
- CIRB Meeting Minutes or Expedited Reviewer Worksheets (as applicable)
Acknowledgements:
- CIRB Outcome Letter
Examples of documents posted to the Supplemental Documents Tab which will not be duplicated:
- Data Safety Monitoring Reports
- Toxicity Summaries
- Dear Patient Letters/Dear Investigator Letters containing emergent issues which must be communicated immediately to participants
- Action Letters
Updated: August 27, 2018