Pre-Review
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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 pre-review 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 Initial Study Support if you would like to arrange a pre-review teleconference.
Quorum can arrange a pre-review 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 Initial Study Support if you would like to arrange a pre-review teleconference.
Q. What are the advantages of setting up a protocol pre-review teleconference? >>
A pre-review meeting 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 pre-review teleconference 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 pre-review of a protocol? >>
No, Quorum offers this service free of charge.
Q. Who should I contact to arrange a protocol pre-review teleconference? >>
If you would like to schedule a protocol pre-review, please contact our Initial Study Support team at InitialStudySupport@quorumreview.com.
Q. What materials do I need to submit prior to the pre-review teleconference? >>
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 pre-review teleconference? >>
In order to allow sufficient time for the IRB Chairman to review your materials, please submit all documents one week prior to the scheduled pre-review teleconference, if possible.
Q. What Quorum representatives attend the pre-review teleconference? >>
Protocol pre-review 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 pre-review? >>
Quorum primarily provides pre-review 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 pre-review of the informed consent document. Quorum can provide this service as well. Please contact our Initial Study Support team for more information.
Q. Once a pre-review of my protocol has occurred, can I expect approval from the fully convened Board? >>
The opinions expressed in the pre-review meeting 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 protocol pre-review 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 pre-review teleconference is required. You may also request a pre-review teleconference. For additional guidance see the Investigator Generated Studies page.
Q. What type of feedback will Quorum provide to you during and after the pre-review teleconference? >>
The IRB Chair and members of Quorum staff will answer questions and provide feedback during the teleconference regarding your study. Members of Quorum’s staff may also follow up with you by phone or email after the teleconference in order to answer questions or to resolve any outstanding issues.