gcrc advisory committee evaluating projects for gcrc use dr. jules l. dienstag, chair evaluating...

GCRC Advisory GCRC Advisory CommitteeCommittee

GCRC Advisory GCRC Advisory CommitteeCommittee

Evaluating Projects for GCRC Use

Dr. Jules L. Dienstag, Chair

Evaluating Projects for GCRC Use


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OrganizationOrganizationOrganizationOrganizationThe Committee is responsible to the GCRC Principal Investigator, Dr. James J. Mongan, President, Massachusetts General Hospital

The Committee is responsible to the GCRC Principal Investigator, Dr. James J. Mongan, President, Massachusetts General Hospital

Dr. Jules L. Dienstag, ChairDr. Jules L. Dienstag, Chair

Principal Investigator

Dr. Peter Slavin

GCRC Advisory Committee


Program Director

Dr. David M. Nathan

Co-Director

Dr. Anne Klibanski

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PurposePurposePurposePurpose Supervise and reviews the operations of the

GCRC Sets general policies Evaluates projects for GCRC use Responsible for assuring implementation of

existing NIH policies Periodically reviews GCRC operations to

ensure optimal resource allocation

Supervise and reviews the operations of the GCRC

Sets general policies Evaluates projects for GCRC use Responsible for assuring implementation of

existing NIH policies Periodically reviews GCRC operations to

ensure optimal resource allocation

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The Protocol Review Process

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Understanding the Protocol Understanding the Protocol Review ProcessReview Process


Protocol is Received from Study Team

At the same time the Investigators protocol is being reviewed by the HRC, the GCRC Advisory Committee reviews the protocol as well.

Or

HRC approval may already have been granted when the GCRC reviews the protocol.

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Protocol is distributed by the GCRC

Administrative Office to all appropriate reviewers

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THE CLOCK STARTS

A template (Critique Sheet) for each evaluator to access and place their comments on is placed on the network drive

X:\GCRCM_PU\SPIDS FOR REVIEW - DRAFT

Review of proposal is to be completed within 10 “working” days from day of distribution

Efforts are made to identify two scientific reviewers from the GCRC Advisory Committee

A protocol nurse and bionutritionist are assigned to the study.


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Reviews are returned to Committee within the required 10 business days

– If you have completed the review and are satisfied with the protocol, type “NO “NO CONCERNS”CONCERNS” by your discipline.

– After the designated review period, the file is moved to a read-only area of the network and no additional changes are permitted X:\GCRCM_PL\PROTOCOLS - FINAL VERSION.

– If no safety-related concerns are identified, the investigator may challenge any concerns addressed after the appropriate review period.

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When Reviewing ProjectsWhen Reviewing Projects


Please respect the Committee’s commitment to the investigator to

complete the review in the established timeframe

Please respect the Committee’s commitment to the investigator to

complete the review in the established timeframe

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– The GAC Editor will review the comments with 24 hours * Dr. David Nathan * Dr. Anne Klibanski

– The purpose of the Editor is to ensure that comments are listed in the appropriate areas on the Critique Sheet, and for completeness of the review.

– The GAC Editor reserves the right to alter, move or delete comments

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Critique Sheet is Submitted to the Critique Sheet is Submitted to the GAC EditorGAC Editor

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– The investigator will review and respond at their earliest convenience.

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The Critique Sheet is Submitted to The Critique Sheet is Submitted to the Principal Investigatorthe Principal Investigator

(RESPONSE (RESPONSE MEMO)MEMO)

(RESPONSE (RESPONSE MEMO)MEMO)

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– If you have completed the review and are satisfied with the investigators response, promptly notify the Committee by calling (617) 726-6886 or by emailing [email protected] (A response must be received)

– If your initial concerns are not addressed in the investigators response, the reviewer may notify the Committee in writing (email [email protected]) or direct your additional concerns to the PI directly for clarification before giving final approval.

– Extensions are granted by the Chair to address concerns involving research volunteer safety.

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The response from the Principal The response from the Principal Investigator is distributed to the initial Investigator is distributed to the initial

reviewersreviewers(QUERY LETTER)(QUERY LETTER)(QUERY LETTER)(QUERY LETTER)

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Understanding the Protocol Review Understanding the Protocol Review ProcessProcess

Understanding the Protocol Review Understanding the Protocol Review ProcessProcess

– Barring evaluator objections, the protocol is conditionally approved subject to final approval at the next meeting of the GCRC Advisory Committee.

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Protocol is conditionally approved within 7 business days once all

information has been collected and addressed satisfactorily

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Investigator is required to introduce their study at an in-service (Protocol Meeting)

to the GCRC Staff. The protocol nurse assigned to the study

will set up a protocol meeting with the study team.

The study may enroll patients after the in-service.

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Protocol is submitted to the GCRC Advisory Committee

for final approvalat the next scheduled meeting

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Communicating with the Communicating with the CommitteeCommittee

Communicating with the Communicating with the CommitteeCommittee

(617) 726-6886 (phone)

(617) 724-3299 (fax)

E-Mail:E-Mail: [email protected]

Web SiteWeb Site

http://www.mgh.harvard.edu/GCRC

Network DriveNetwork Drive

Protocols Pending Evaluation– X:\GCRCM_PU\SPIDS for Review - Draft

Evaluated Protocols– X:\GCRCM_PL\Protocols - Final Version

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Evaluating Projects for GCRC Evaluating Projects for GCRC UseUse

Responsibility of Each ReviewerResponsibility of Each Reviewer

Evaluating Projects for GCRC Evaluating Projects for GCRC UseUse

Responsibility of Each ReviewerResponsibility of Each Reviewer

To provide constructive feedback within their purview that reflect the

–Rights & Responsibilities

–Values

of the GCRC program.

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Remember who the readers are– First-time users of the GCRC program– New investigators– Seasoned investigators– Your colleagues– GCRC Leadership– Committee’s Chair– Principal Investigator– National Institutes of Health

Your comments should reflect this large diversity

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Present the comment as a questionPresent the comment as a question

Example:

“Some provision should be made for blinding the investigators to the DEXA results until the study is complete”.

The question should have been presented to the investigator as:

Does the investigator believe that a provision should be made for blinding themselves and their study team to the DEXA results until the study is complete?

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Add Your Question to the Appropriate AreaAdd Your Question to the Appropriate Area

The following question added to the scientific section, should have been added to the core laboratory section:

The reason for measurement of IGF-1 in both the core lab and in chemistry should be stated in the protocol

(Notice the concern was not presented as a question . . .)

The following question added to the scientific section, should have been added to the core laboratory section:

The reason for measurement of IGF-1 in both the core lab and in chemistry should be stated in the protocol

(Notice the concern was not presented as a question . . .)

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When Reviewing ProjectsWhen Reviewing ProjectsWhen Reviewing ProjectsWhen Reviewing ProjectsNumber Your Questions

Example“Is the primary endpoint percent change in bone density form baseline at 6 months or 12 months? In either case how will the other time point and the 9 month time point be analyzed? Is the comparison of rhIGF-1 plus Actonel and Actonel at 6 or 12 months?”

The questions should have been presented to the investigator as:1. Is the primary endpoint percent change in bone density form

baseline at 6 months or 12 months? 2. Referring to the question above, how will the other time point and

the 9 month time point be analyzed? 3. Is the comparison of rhIGF-1 plus Actonel and Actonel at 6 or 12

months?”

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Provide the reader with clarity

In the following example the principal investigator was not sure if the comment is a suggestion or a request:

“Since the 4-day food record requires active participant compliance, it is recommended that the consent include a phase such as “the participant will agree to document food intake for 4 days and bring completed food records to the baseline, 3m, 6m, 9m, and 12m visits”. Please change consent accordingly.”

Again, notice the concern was not presented as a question…

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Avoid Pronouns

Because many people review each protocol, make comments and add responses, evaluators and investigators must use clear identifiers when commenting.

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Ensure the Review is Complete

A common mistake is to not review the Physician’s Orders that accompany the protocol but rather wait until the in-service.

The Committee asks that all documentsall documents (e.g., Physician’s Orders, Consent forms, drug labels) are reviewed when submitted to the reviewers and that all concerns are stated at that time before they give final approval to Faith Fortune.

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Frequently Asked QuestionsFrequently Asked Questions

Frequently Asked QuestionsFrequently Asked Questions It states that the evaluator is to “provide constructive feedback within their

purview”. What is my purview?– For scientific reviewers, the Committee has developed a brief and helpful guide– For GCRC staff, please contact your immediate supervisor.

What if I have a concern but it is considered outside of my purview?– Contact your immediate supervisor who can direct you to speak to the evaluator

responsible for that area. The protocol was distributed while I was on vacation/out of the office. I don’t

believe I have time to evaluate the protocol. What do I do?– You need to obtain an extension from the Chair. Typically extensions are granted to

address a research volunteer safety-related concerns. Does the Committee allow expedited reviews?

– Provisions are made for urgent studies with an unexpected opportunity to study unusual research patients. In these instances, the Committee will provide information for an ad hoc review process.

Where are the evaluations maintained?– The evaluations are maintained on the GCRC network drive. For assistance accessing

files please contact Faith Fortune

gcrc advisory committee evaluating projects for gcrc use dr. jules l. dienstag, chair evaluating...

Documents

protocol review process

gcrc operations

gcrc use

appropriate reviewers

protocol review process

investigators protocol

protocol nurse

gcrc principal investigator