Protocol Amendments

Any changes to be made in a protocol, whether initiated by the investigator or a study sponsor, must be submitted with HAC Form 113, Amendment Form, and approved in writing by the HAC prior to its enactment. Conduct of the study under the revised protocol may not proceed until Human Assurance Committee (HAC) approval is granted, with the exception of changes to eliminate an apparent immediate hazard to subjects. Examples of amendments include changes in:

• Procedure
• Drug dose
• Number of participating subjects
• Length of participation
• Principal investigator/sub-investigator
• Administrative issues

The HAC administrative office (CJ-2103) must receive all amendments that require full review by 4:00 pm on the Monday prior to the HAC meeting date unless otherwise notified by the HAC Administration Support Office.  If this Monday falls on a holiday, then the submission must be received by 4:00 pm on the next business day.  The HAC meeting date schedule can be accessed at the following link:  HAC Submission and Meeting Dates   NOTE: If the Chairperson or designee determines that the amendment requires additional review, there may be a delay in amendment approval. Contact the HAC office at 706.721.3110, 706-721-1482 or 706-721.8397  for amendment submission guidance for protocols amendments submitted for this time frame. A full review amendment may include:

• Changes of PI or sub-investigator if the individual will be obtaining consent
• Changes in the dosing regime (i.e., amount, number of times, etc.)
• Any increased risk to subject whether the risks involve physical, psychological, social, economic, confidentiality risks, etc. (I.e., increased number of blood draws, more procedures, adverse events, etc.)
• Protocols involving vulnerable subjects (adding pediatric subjects to an approved protocol is a major change and requires full committee review)

Expedited review by the HAC chairman (or his designee) or full HAC review may be required for approval of protocol amendments, depending on the level of change.  Examples of amendments that may qualify for expedited review include:

• Central lab changes
• Study coordinator changes
• Performance sites
• Advertisements
• Administrative changes such as phone numbers, mailing
  addresses, etc.
• Typographical error corrections
• FDA approval and renaming of a drug

The above lists are by no means all-inclusive and are subject to change and updates.

Although federal regulations do not require HAC review of amendments for studies that meet the criterion for exempt from full review, the HAC does require submission and approval of all amendments for studies that meet the criterion for exempt from full review. This action is taken to provide the maximum protections for the human subjects and/or human derived materials in the study.

Provide either a summary of protocol changes in memo format and/or a copy of the protocol amendment regardless if the protocol was industry or investigator initiated, cooperative or other with all changes highlighted to ensure faster routing and approval of the amendment.  It is highly recommended that investigators date stamp the amendments with the date the amendment was received from the sponsor and submit this stamped copy along with the HAC forms Be certain to maintain an updated protocol in the regulatory files/binder once the amendment is approved. Do not discard old or expired protocols but maintain these in the regulatory files/binder as well.

Amendments and/or revisions to Investigational Drug Brochures (IDB) must be accompanied by a listing or summary of changes from the previously approved version. Be certain to maintain an updated Investigational Drug Brochures (IDB)  in the regulatory files/binder once the amendment is approved. Do not discard old or expired Investigational Drug Brochure (IDB) but maintain these in the regulatory files/binder as well.

A protocol amendment may require a revision to the Informed Consent Document (ICD) and/or Children’s Assent Document (CAD). The revised ICD and/or CAD [or addendum] must be submitted to the HAC with the amendment and the HAC Form 113. The revised ICD and/or CAD must be in compliance with current HAC Policies and Procedures. To ensure faster routing and approval, provide a highlighted copy of the ICD and/or CAD of all changes as well as a “clean” copy. A “clean” copy is required so that it may be stamped on each page with the HAC approval stamp and a copy returned to the investigator. The stamped copy must be used for all informed consent processes.

A protocol amendment may affect the budget for the study. Please contact the Office of Sponsored Program Administration (DSPA) at 706.721.2592 or the Augusta Biomedical Research Council (ABRC) to determine if a revised budget should be completed. If the study will involve the use of MCG Health, Inc., resources (equipment, personnel, patients, space and/or supplies), the amendment 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.

Contact the HAC administrative office for questions or clarifications at 706.721.3110/1482 or 8397.
 

Revised 3/20/06, 3/30/06

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