Sponsor/CROs FAQs

I received a Site Status Report with the packet for Protocol Continuing Review. Do I need to complete the Site Status Report?

(6 People have viewed this FAQ)

No, for central studies Quorum does not require that sponsors or their representatives complete the Site Status Report on behalf of investigators. We include a sample Site Status Update Report and an investigator Periodic Site Review checklist/instruction sheet with the Protocol Continuing Review packet so you are aware of what is expected of sites for periodic review.

Does the sponsor or sponsor representative need to send Site Status Reports to the investigators to complete?

(4 People have viewed this FAQ)

No, Quorum will provide investigators with Site Status Reports and a letter requesting that the report be completed for periodic site review or site closure. These materials are issued to investigators approximately four weeks prior to the Site Status Report due date as cited on the original Notice of Approval or Notice of Re-Approval issued. Additionally, Quorum staff will contact the sponsor or sponsor representative if investigators are unresponsive to our attempts at obtaining a Site Status Report.

Where can I obtain an electronic copy of my Continuing Review Report for Protocols?

(2 People have viewed this FAQ)

An electronic copy of the Continuing Review Report for Protocols that includes pre-populated study information can be found on the OnQ Portal.

How do I obtain help completing the Continuing Review Report for Protocols?

(2 People have viewed this FAQ)

Please feel free to contact your Quorum Study Manager if you need assistance in completing specific questions on the Continuing Review Report for Protocols.

You can also reference Quorum's Continuing Review Report for Protocols - Client Guidance for additional information.

Do you require 1572’s?

(6 People have viewed this FAQ)

No, Quorum does not review or acknowledge the FDA Form 1572. Quorum’s SIQ collects all the information that Quorum needs from the 1572.

I am interested in transferring jurisdiction of my site from another IRB to Quorum, what should I do?

(3 People have viewed this FAQ)

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

What differences can I expect when submitting as a single study?

(3 People have viewed this FAQ)

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.

How is safety information acknowledged for a single site study?

(3 People have viewed this FAQ)

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.

Where can I find the Board Roster?

(3 People have viewed this FAQ)

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.

What are single sites expected to submit to Quorum?

(2 People have viewed this FAQ)

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 Single Site Studies page. 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.

How is safety information acknowledged for a Principal Investigator Generated Study?

(2 People have viewed this FAQ)

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.

I am interested in transferring jurisdiction of my site from another IRB to Quorum, what should I do?

(1 Person has viewed this FAQ)

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

What are the consequences of submitting as a single site study?

(1 Person has viewed this FAQ)

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.

Do you require 1572’s?

(6 People have viewed this FAQ)

No, Quorum does not review or acknowledge the FDA Form 1572. Quorum’s SIQ collects all the information that Quorum needs from the 1572.

I am interested in transferring jurisdiction of my site from another IRB to Quorum, what should I do?

(3 People have viewed this FAQ)

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

How is safety information acknowledged for a Principal Investigator Generated Study?

(2 People have viewed this FAQ)

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.

I am interested in transferring jurisdiction of my site from another IRB to Quorum, what should I do?

(1 Person has viewed this FAQ)

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

Do Sponsors receive a copy of approved model recruitment and participant study material?

(1 Person has viewed this FAQ)

As of March 1, 2010, Sponsors will receive an approval letter for approved model recruitment and participant study material reviewed after study start up. The approval letter will contain a "Quorum Approved" stamped copy of approved material.

Model recruitment and participant study material approved during study start up will be cited on the Sponsor’s Letter of Approvability. A "Quorum Approved" stamped copy of the material will not be provided to the Sponsor at this time.

Do I need to submit participant gifts for review?

Yes, any gifts that will be given to participants should be submitted to Quorum for review.

How is safety information acknowledged for a single site study?

(3 People have viewed this FAQ)

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.

How do I submit safety information and unanticipated problems (e.g. Major Protocol Deviations/Violations, SAEs, IND safety reports) to Quorum?

(3 People have viewed this FAQ)

Quorum requires prompt reporting of all Major Protocol Deviations/Violations and Serious Adverse Events and Unanticipated Problems that occur at the investigator's site. Notification of IND safety reports, Investigator Brochures, Device Manuals, Package Inserts, FDA Safety Alerts and other protocol level safety documents is required as arranged previously with the study sponsor. Quorum requires the use of its forms when submitting safety information.

For detailed guidance on submitting safety information refer to the Reporting Safety Information and Unanticipated Problems guidance document. Please do not hesitate to contact us with any questions.

How should I submit safety information and potential unanticipated problems to Quorum Review IRB?

(2 People have viewed this FAQ)

Safety information and other reportable events can be submitted to Quorum Review IRB using the OnQ portal, fax or mail. All safety information should be submitted using the appropriate report forms found on the Quorum website. Quorum expects investigators to report safety information and other reportable events to Quorum Review IRB within ten (10) business days of becoming aware of the event’s occurrence.

What do I need to include if I want to submit an amendment?

(1 Person has viewed this FAQ)

When submitting an amendment to Quorum you must include:

  • Amendment Submission Coverpage
  • Protocol Amendment
  • Summary of changes per the Amendment (including rationale)
  • Revised consent form(s), if applicable. Modifications must be incorporated into the current IRB approved consent form, using the ‘Tracking’ feature in Microsoft Word.
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