Procedures

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The IRB is committed to making the submission process as smooth as possible.   In this section, you will find definitions, explanations and procedures for submitting an application and any other form that may be required during the course of a study.

As of June 16, 2014, the following specific sections of the full protocol may be referenced for all initial submissions for Adult and Pediatric Biomedical applications.  Note: This only applies to studies with a full protocol, not grant applications.

The only sections that can reference the full protocol are:

·      Section II.3 - Background

·      Section II.9 - Inclusion Criteria

·      Section II.10 - Exclusion Criteria

·      Section II.12B – Methods

·      Section II.12F – Statistical methods

·      Section II.16 - Risks

·      Section II.18F – Subject withdrawal criteria

·      Section II.18G – Study Stopping Rules

·      Section II.34 – References

 

When referencing the full protocol, the following information from the protocol must be provided in the appropriate section of the IRB application:

·      Version # of protocol

·      Date of the protocol

·      Section of the protocol

·      Page number(s) being referenced

 

CHANGE REQUESTS

After the new study is approved, if a change is being made to one of the referenced sections of the IRB application, the specific section must be revised to include the following updated protocol information

·      Version # of the protocol

·      Date of the modified protocol

·      Section of the protocol

·      Page number(s) being referenced

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