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Informed Consent Document Templates

SECTION 15

Addendum to ICD and/or CAD

A protocol amendment, investigator change or any other item of information that may be provided to the subject may require an Informed Consent Document (ICD) and/or Children’s Assent Document (CAD) addendum and must be labeled as such.  All revisions must be in compliance with current Human Assurance Committee (HAC) Policies and Procedures. All addenda are to follow the same formatting procedures as the original ICD and /or CAD.

If an amendment, adverse event, or other change requires a change in the HAC approved ICD or CAD, provide a copy of each with all changes highlighted as well as a “clean” copy to be stamped approved to ensure faster routing and approval.

Note: All ICD addenda and/or CAD addenda must be signed and dated in blue or black ink.  Originals and copies are to be distributed the same as original ICD and/or CAD documents.  Addenda must be stamped approved by the HAC.  Please refer to Section 10 for further information.

If the study will involve the use of MCG Health, Inc., resources (equipment, personnel, patients, space and/or supplies), the amendment regarding the addenda must be submitted to the President and CEO of MCG Health, Inc., for their review.  For more information on their submission requirements, contact MCGHI at 706-721-6569.
 

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February 20, 2007