Quorum Review Inc. - Additional Services - prereview

By: Quorum Review  09-12-2011
Keywords: Consent Form, Study Support

Chairperson Study Assessment

Communication between Quorum and our customers can help enhance the research process. In some circumstances, a sponsor or funding agency may want an opinion regarding a protocol or specific elements within the protocol prior to the official Board review.

Quorum can arrange a teleconference that occurs prior to the official Board review of the protocol and consent form. This conference call will involve the following parties: a sponsor representative and other pertinent parties to help give general feedback about the protocol or consent form, the IRB Chairman, and a representative from Quorum's Study Management, Initial Study Support, and Regulatory departments.

Please contact

if you would like to arrange a chairperson study assessment.

Consent Form Consultation/Editing

In some circumstances, a researcher may wish to receive written consent form feedback prior to the official Board review.

Quorum offers consent form consultation/editing, where Quorum's Consent Form Development team will review the consent form and provide written edits and/or feedback prior to Board review. This service may be conducted independently or in conjunction with Quorum's chairperson study assessment process. During consent form consultation, many potential consent form language issues may be resolved prior to Board review.

Please contact the

Team if you would like to arrange a consent form consultation with Quorum's Consent Form Development team.

Q.    What are the advantages of setting up a chairperson study assessment? >>

A chairperson study assessment can expedite the study start-up process because it allows the sponsor and a member of the Board to address possible issues and to answer questions before the study is reviewed by the full Board. Some examples of when a chairperson study assessment may be appropriate are, if the sponsor is proposing a complex trial design, trying to decide if a placebo arm is appropriate within a given population or trying to establish the right age range of participants, or other design or consent form related questions. Obtaining feedback early in the process often helps simplify the post-review negotiations and minimizes Board modifications.

Q.    Is there a charge to conduct a chairperson study assessment of a protocol? >>

No, Quorum offers this service free of charge.

Q.    Who should I contact to arrange a chairperson study assessment? >>

If you would like to schedule a chairperson study assessment, please contact our Initial Study Support team at

.

Q.    What materials do I need to submit prior to the chairperson study assessment? >>

Please submit a draft or final version of your protocol and any supplementary materials such as investigator's brochures, package inserts, or device background literature for all primary and comparator drugs/devices. In addition, if there are specific questions regarding the informed consent document, it may be helpful to provide a copy of the proposed informed consent. It is also helpful to provide a list of questions for discussion ahead of time to help guide the discussion.

Q.    How far in advance should I submit my documents prior to the chairperson study assessment? >>

In order to allow sufficient time for the IRB Chairman to review your materials, please submit all documents one week prior to the scheduled chairperson study assessment, if possible.

Q.    What Quorum representatives attend the chairperson study assessment? >>

Chairperson study assessment teleconferences are led by the IRB Chairman. Representatives from Initial Study Support, Study Management, and Regulatory also attend the meetings.

Q.    What types of documents are eligible for chairperson study assessment teleconferences? >>

Quorum primarily provides chairperson study assessment services for new protocols in order to help guide sponsors as they are writing their protocol or deciding on the specific study design. There also may be times when a sponsor requests a chairperson study assessment of the informed consent document. Quorum can provide this service as well. This service is free of charge if no consent form edits are made. If the consent form is edited by Quorum's consent form team at the request of the sponsor, this service falls under the category of "Consent Form Consultation / Editing."

Q.    Once a chairperson study assessment has occurred, can I expect approval from the fully convened Board? >>

The opinions expressed in the chairperson study assessment are reflective of one individual Board member and may not always represent the opinions of the full Board. While the IRB Chairman cannot speak on behalf of the full Board, he has several years of experience working with Quorum Review IRB and its members and has a good sense of what criteria may be important to the Board.

Q.    Is a chairperson study assessment ever required? >>

If you are a Principal Investigator submitting a PI generated study, the IRB Chair pre-reviews all study-related materials before the study is submitted to the convened Board for review. If necessary, Quorum will contact you if additional information or a chairperson study assessment teleconference is required. You may also request a chairperson study assessment teleconference. For additional guidance see the

.

Q.    What type of feedback will Quorum provide to you during and after the chairperson study assessment? >>

Q.    What are the advantages of setting up consent form consultation/editing prior to the Board meeting? >>

Consent form consultation/editing can expedite the study start-up process because it allows the sponsor and Quorum's Consent Form Development Team to address any consent form language issues before the consent form is reviewed by the full Board. Obtaining feedback early in the process often helps simplify the post-review negotiations and minimizes Board modifications.

Q.    Is there a charge to conduct a consent form consultation/editing? >>

Yes, please see Quorum's price list, located on the OnQ™ portal, for more information.

Q.    Who should I contact to arrange a consent form consultation? >>

Q.    What materials do I need to submit prior to the consent form consultation? >>

Please submit a draft or final version of your protocol and the informed consent document(s).

Q.    Once a consent form consultation has occurred, can I expect approval from the fully convened Board? >>

The opinions expressed in the consent form consultation are reflective of the consent form development group and not Quorum's Board. The Board may request additional changes to the consent form during fully convened Board review.

Keywords: Consent Form, Study Support

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