Sites FAQs

Do you require 1572’s?

(7 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 have two facilities, one that is administrative and one that sees patients. Which location should I use for which form?

(5 People have viewed this FAQ)

The location where patients are being seen and research is being conducted should be listed as the primary research facility on the SIQ. The administrative facility can be listed as the contact address. There is no need to fill out an additional form for administrative facilities.

Does Quorum require a CV for each sub investigator?

(4 People have viewed this FAQ)

From time to time, Quorum’s Board will request submission of sub investigator’s CVs. Your sponsor probably will notify you if this request is made. Less frequently, the Board might ask for additional information about your site.

How is safety information acknowledged for a single site study?

(4 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.

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

(4 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.

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

(4 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.

When do I need to complete an Additional Facility Site Information Questionnaire (AFSIQ)?

(2 People have viewed this FAQ)

The AFSIQ needs to be completed and submitted in conjunction with the SIQ if you have more than one facility at which more than minimally invasive procedures are being performed.

What type of information is required on an investigator’s CV?

(2 People have viewed this FAQ)

The CV must describe the principal investigator’s education, licensure (for all states in which the research is being conducted), training, clinical background, and research experience relevant to the study in question. If the principal investigator’s relevant research experience is not included in the CV, please provide additional documentation as necessary.

What are the most common errors Quorum sees on site submissions?

(2 People have viewed this FAQ)

The most common item area of confusion on the Site Information Questionnaire is the question on participant compensation. Please ensure that the per visit amount multiplied by the number of visits equals the total amount you have provided. Also, please ensure that you provide information on whether your site is planning to compensate participants for any substudies, if there are any. 

Additional delays are caused when sites fail to completely and accurately respond to all questions on the SIQ. The best way to prevent this error is to address ALL questions and if you feel the question doesn’t pertain to your site write in "N/A" rather than leaving it blank. 

To ensure that your submission is complete and able to be processed immediately upon receipt by Quorum, please reference the SIQ workbook on the forms tab. If you have any questions regarding your submission, please contact the Site Support Team.

What submission documents are required by Quorum?

(2 People have viewed this FAQ)

Quorum requires the following documents:

  • "Site Information Questionnaire: Primary Research Facility" form
  • Principal investigator’s Curriculum Vitae including clinical research experience with human subjects and education (if applicable,the principal investigator needs to submit a CV to Quorum only once)
  • Canada sites only: Hard copy of principal investigator’s Medical License

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.

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

(2 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 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 you require 1572’s?

(7 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?

(4 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.

Can I make changes to the size of my approved material?

(1 Person has viewed this FAQ)

Changes in size can be made provided that the changes are made to scale relative to the original approved material.

We made modifications to my previously approved material, do I need to submit for review again?

(1 Person has viewed this FAQ)

Yes, changes to previously approved recruitment or participant study materials should be submitted to Quorum Review IRB for approval prior to implementing the change.

Spelling corrections and changes to site specific contact information as indicated with space holders are allowed without additional approval from Quorum Review. If no space holders are present, the advertisement should not be modified. If no space holders are present, the advertisement should not be modified.

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?

(4 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?

(4 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?

(3 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.

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