Research

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Information for CCI Members

IRB Meeting Materials
The complete books from IRB meetings are posted here. This application is available through the CH internal website only.
IRB Meeting Materials

Committee Education Material
Defining, Interpreting, and Applying Concepts of Risk and Benefit in Clinical Research Involving Children

New Protocol Submission, Continuing Renewal and Amendment Reviewer Worksheets
The Committee on Clinical Investigation has posted the criteria the Committee will use to evaluate a protocol. Review of these worksheets prior to submitting an application or continuing review may facilitate the review process.

Full Review

Reviewer Worksheets. Complete Electronically

New/Deferral Protocols

Continuing Renewal

Amendments
REVIEWER REFERENCE: Criteria for Approval Amendments

Subpart B 46.204: Pregnant Women or Fetuses

Subpart C Documentation: Research Involving Prisoners

Short Form Informed Consent

Expedited Review

Reviewer Worksheets. Complete Electronically

New Protocols

Continuing Renewal

Continuing Renewal
DATA ANALYSIS /NO ENROLLMENT/LONGTERM FOLLOW UP ONLY. Expedited Category 8

Amendments

Pre-Review

Analyst Worksheet. Complete Electronically

Comments for PI

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