Quorum Review IRB has three Boards and conducts up to eight convened Board meetings a week. New U.S. protocols can be submitted to three of these meetings (to Board I (Tuesday and Friday) or Board II (Wednesday)). To be scheduled to a meeting for review, a submission must be received (with all required elements) by 5:00 p.m. Pacific Time one (1) week prior to the meeting. U.S. amendments can be submitted to one of the daily meetings (Board III) and must be submitted by 5:00 p.m. PT 36 hours prior. Canadian research must be submitted (with all required elements) to the Wednesday meeting (Board II) by 5:00 p.m. PT the prior Wednesday.

Quorum posts the Board Roster on our web portal. You can find this by logging on to the web portal and selecting “IRB Roster.” Quorum also posts archived Board Rosters in this location if you need to locate a past Board Roster for your records.

Your Study Manager will be your key point of contact for protocol-related issues. The Study Manager will attend Board meetings where your study will be discussed and will communicate determinations back to you.

Once a complete set of submission elements is submitted for review, Quorum will assign a Study Manager to your study and schedule a review date. Following the Board review, your Study Manager will contact you with the outcome, including any consent form revisions or further information that the Board has requested.

If the Board has requested consent form revisions, you will be asked to review them and submit additional changes as appropriate. Once the consent forms are finalized and any follow-up issues are resolved, your Study Manager will provide you with a Letter of Approval.

Quorum works with sponsors to make sure that studies are started as quickly as possible. However, Quorum cannot issue final approval documents to the sites until they have been approved and the consent form has been finalized. If the timeline is tight it is especially important to respond to your Study Manager with any feedback on the consent form as quickly as possible so that the consent form may be finalized in a timely manner. Once the protocol has been reviewed sites may be scheduled for review while the Board and sponsor negotiate the consent form language. This helps minimize delays. Another item to note, complete site submissions must be received one week prior to a Board meeting to ensure review at or before that meeting; therefore, it would be best that your target site(s) submit as soon as possible.

The Quorum Review IRB OnQ Portal is password-protected and available to study contacts at the site and sponsor level. Please contact Quorum Review IRB to learn more about this service or to request a portal account. Users can view, download, and print all Quorum Review IRB approval documents and most other Board correspondence. The OnQ Portal also offers a status report for tracking site submissions from initial review through the Board’s final decision. Users can submit materials for review electronically and securely through the OnQ Portal provided that the submission is not larger than 30 MB. For items that are larger than 30 MB either use a compression utility such as WinZip or e-mail items that are less than 50 MB to InitialStudySupport@QuorumReview.com. Alternatively you can mail or fax to the attention of Initial Study Support.

The primary contact for a study, as designated on the Central Study Questionnaire, is automatically granted portal access for the study. If the primary contact would like to request to have additional users added or removed there are many ways to accomplish this. Prior to submitting your study the last page of the CSQ allows you to list additional users. Additionally, the primary contact can request additional users via email to their Study Manager or Quorum’s Initial Study Support team. It is also possible to request additional users through the Quorum web portal.

All documents for a study may be submitted via the OnQ Portal. Or, after your initial study submission any protocol-level information may be submitted to your assigned Study Manager via email. Quorum accepts this information via mail as well.

Yes. Log in to Quorum’s OnQ Portal, and click on “Reports.” Then, you can generate a site submission status report for any of the Protocols to which you have access. You will be able to see the status of the site (approved, in progress, not yet active) and whether any information is still needed for the site’s submission to be complete.

Quorum asks that you track any requested changes into the clean, current version of the consent form and that you submit these changes along with the rationale for the changes. This allows the Board to see what changes have been requested to the current approved version of the consent form. Please turn on the “track changes” feature in Microsoft Word, and submit the consent form revisions electronically.

Please start by referencing Quorum’s Guide to Consent Form Development. In the tracked version of the consent form(s), you will see a superscript number (a small number slightly above the rest of the line) after each change or group of changes that correlates to a rationale for change in the document (attached). The superscript numbers do not appear in the “clean” version of the consent form(s). If you have any additional questions regarding the changes that were requested, please contact your Study Manager for more information.

Please contact Quorum Review IRB’s Initial Study Support team; they will provide you with your own account.

Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Initial Study Support at (877) 472-9883 or InitialStudySupport@quorumreview.com if you’d like more information about this process.

Quorum defines a study as single site or central based upon with whom we communicate.

Single site: Quorum communicates directly with the site only. In this case, Quorum is not the central IRB for the study but the site has chosen Quorum as their IRB.

Central: Quorum communicates with the sponsor/CRO, protocol level decisions are made by the sponsor/CRO on behalf of site(s). In this case, Quorum is the designated central IRB for the study.

If the single site option is chosen:

• Information will only be released to the site.
• The site is responsible for safety reporting (please see more information on this below).
• The sponsor is not able to submit on behalf of all sites in a multiple single site study.
• It is more costly to submit multiple single sites under the same protocol then to submit the study as a central study.

At Initial Review, in addition to all site-specific submission materials (Site Information Questionnaire, current CV, and other attachments as applicable) the site is also expected to submit all materials needed for the review of the Protocol including the Protocol, Consent Form, Investigator Brochures and Package Inserts, and any data collection tools. A complete list of the items needed for a single site submission is available on the first page of the Single Site Study Questionnaire. Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions. Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions.

Quorum will issue an acknowledgement letter to the site when a revised Investigator Brochure is received. When all other safety information is received, such as Protocol Deviations, IND safety reports, Serious Adverse Event reports, and reports of Unanticipated Problems, Quorum will issue a standard acknowledgment. In the case of a standard acknowledgement, Quorum will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.