SECTION 16

Continuation Requests/Reports

CLINICAL STUDY STATUS REPORT (HAC FORM 107)

The Human Assurance Committee (HAC) must review all research studies that use  human subjects and /or human derived materials at least annually in compliance with federal regulations (21CFR56.109f).  These regulations do not allow approval for periods of more than one year.

The HAC administrative office will send the HAC Form 107, "Clinical Study Status Report" to the principal investigator (PI) or the designated study coordinator (SC) via campus or regular mail. It is the principal investigator's responsibility to file this report on time, including obtaining the HAC Form 107 if one was not received.  Print or type all information and do not use correction fluid on this form.

This form must be completed, in its entirety, including a progress report on activity and returned to the HAC by the stated due date. In the case of multi-center studies, progress at MCG/VAMC only must be described. If a progress report is submitted to the granting agency, a copy of that report should be submitted with the continuation request.

If a research study has not commenced (i.e., no subjects enrolled, no samples received, no data collected, etc.) and it has been three years since the original study approval date, the PI should submit a completed HAC Form 107 or HAC Form 111 to officially close the study.

A “clean” version of the informed consent document and/or children’s assent document must be attached and submitted to the HAC with the HAC Form 107 for those studies that are still actively enrolling subjects.  A “clean” version means without the HAC approval stamp.  This clean copy is required so that the HAC can stamp it approved.  The HAC administrative office will maintain the original and a copy will be returned to the PI or designee if approved for continuation.  In compliance with federal regulations, each ICD and/or CAD will be reviewed and stamped approved as necessary.

If a study has an approved advertisement and will continue to recruit, a “clean” copy of the advertisement must also be submitted for review.  A “clean” version means without the HAC approval stamp.  This clean copy is required so that the HAC can stamp it approved.  The HAC administrative office will maintain the original and a copy will be returned to the PI or designee if approved for continuation.  In compliance with federal regulations, each advertisement will be reviewed and stamped approved as necessary. This includes brochures and pamphlets that may be given to the study subjects.  These requests for continuing review apply to all studies regardless of the level of initial review including medical record reviews, sample processing or other.  It should be a cumulative report from the original approval date of the activity in the study.   Directions for the proper completion of the form are outlined below.

Please note studies that initially met the criteria for exempt and expedited review are eligible for expedited review for their continuation request. Although federal regulations do not require that the HAC provide continuing review for those studies that were initially approved as exempt from full review, the HAC does require review to provide the maximum protection for human subjects and/or human derived materials as defined in the General Information Section.

Page One 

If the study was not funded and therefore not initiated, check the space next to “Completed” and note that information on page two under “Study Progress.”  If the study is finished, check “Completed”.  If a study terminates before the HAC Form 107 is received, the research team may submit a completed HAC Form 111 to terminate the study.  NOTE: The form must still be completed, especially the report section on page two (2).  If the data is still being analyzed, the study must remain active.  If all data has been analyzed and a publication is in process, the study may be completed and terminated.  The columns, on the bottom of page one, are for the cumulative number of subjects from the original approval date of the study.

Specified by protocol/contract:  the number of subjects that the site intends to enroll in the study.  This number may be available from the contract, if applicable.

Screened:  the number of subjects screened for
            inclusion/exclusion criteria

Consented:  the number of signed informed consent documents (ICD) and/or children assent documents (CAD)

Dropped/Withdrawn/Screen Failures:  the number of subjects who were dropped from the study by the PI, the number of subjects who withdrew from the study and the number of subjects that were screening failures after signing the informed consent document.  NOTE: these must be explained in the brief report section on page two.

Completed:  The number of subjects who fulfilled their obligation as study participants and have completed all required visits.

Continuing:  the number of subjects who are continuing their participation in the study because they have not completed all required visits.

Only complete the extension column if the HAC approved a protocol extension.  Continuing review of the protocol is not an extension.

Page Two 

A listing of all received reports will be included with the HAC Form 107 if adverse events (AE), serious adverse events (SAE) or investigational new drug (IND) safety reports were submitted.  Please review the listing carefully to determine if all reports were submitted to the HAC.  It is the investigator’s responsibility to compare this listing with all documents located at the study site.  If a discrepancy is found, it must be promptly addressed with the HAC. 

A listing of all received amendments will be included with the HAC Form 107 if amendments were requested.  Please review the listing carefully to determine if all amendments were submitted to the HAC.  It is the investigator’s responsibility to compare this listing with all documents located at the study site.  If a discrepancy is found, it must be promptly addressed with the HAC. 

A listing of protocol deviations/violations will be included with the HAC Form 107 if protocol deviations/violations were reported.  Please review the listing carefully to determine if all protocol deviations/violations were submitted to the HAC.  It is the investigator’s responsibility to compare this listing with all documents located at the study site.  If a discrepancy is found, it must be promptly addressed with the HAC.

Brief Report on Study Progress

Please note that the statement “Study is proceeding as planned” is not an adequate report regarding the study progress.  If there were any unanticipated problems with recruitment, retention, lab tests, supplies, the protocol itself or if there were unanticipated benefits, this information must be provided.   If a progress report was made to the sponsoring agency, a copy should be submitted with this form.  If an article was published on data collected, a copy should be submitted with this form.  Reasons for subject withdrawal and/or termination should be stated.  The Clinical Study Status Report will be returned to the PI and may be allowed to expire if a brief study report is not completed as requested.

Some Guidance Statements for the Brief Report Section

"The study was not begun at the desired start date.  Therefore, our enrollment goals were not met.  We enrolled 12 of the projected 50.  One subject was dropped from the study since the subject relocated to another area.  Ten subjects have completed the study and one subject is nearing completion.  There have been no unexpected adverse events or problems with this study." 

Or:

"Twelve medical records were reviewed.  The data was gathered and protected as per the Description of Research Proposal.  The poster presentation was made at the July meeting of National Principal Investigators.  The study is now complete."  

NOTE:  These are suggestions to assist the investigators.  Please be as informative as possible.  Use of these guides does not guarantee that the HAC will approve the continuation request.  These are guides only.  If there are any questions, please contact the HAC Administrative Office at 706-721-3110 or 706-721-1482 or 706-721-8397.If the study will involve the use of MCG Health, Inc., resources (equipment, personnel, patients, space and/or supplies), the HAC Form 107 and all supporting documentation 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.

Any members of the research team who have not successfully completed the appropriate tiers of the required web-based education program or the recertification program must complete the program or the continuation request will not be processed.  A current signed and dated CV must also be on file with the HAC and the regulatory binder for all approved members of the research team.

If the study has not been approved for continuation by the approval expiration date, all research activity must cease immediately. Subject accrual and data collection must be suspended pending re-approval of the research by the HAC.  The protocol must be re-submitted as a new review.  Subjects on study medication should be withdrawn in an orderly manner appropriate to the research medication.  These are requirements of the Food and Drug Administration. 

Enrollment of new subjects cannot occur after the expiration of HAC approval.  If subjects are entered after the expiration date, then their data must not be included in the research analysis.  If subjects are enrolled after the HAC approval expiration date, then this is a protocol violation and must be submitted via a completed HAC Form 120PDV.

NOTE:  Retain a copy of this completed form and any support documentation (such as informed consent documents, children’s assent documents, publications, study reports to funding agency, etc.) with the regulatory files or binders as maintained by the Principal Investigator.

Revised 01/10/2007

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