Please see the Study Start-Up Process section of the site for forms and information about getting started. To ensure that the review process goes smoothly, please coordinate your submission with the sponsor for the study. Feel free to contact the Site Support Team with any questions about the submission process.

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

The SIQ instructions will alert you if any of the following elements are needed.

• "Site Information Questionnaire: Additional Research Facility" form
• Proposed site-specific advertisements and recruitment materials. These materials should be accompanied by written sponsor approval if this is required by the sponsor
• Proposed site-specific participant study materials (diaries, questionnaires, written study instructions, etc.)
• Supplemental material as appropriate based on "Site Information Questionnaire" responses (for example, FDA Audit information, letters of explanation, etc.)

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.

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.

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

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.

If you aren’t certain if your site has submitted to Quorum before you can contact Site Support, the protocol Study Manager or the Initial Study Support team.

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.

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.

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.

By insuring that your site’s compensation schedule is accurate and reflective of the consent form language determined by Quorum and the sponsor. 

Throughout the past year, Quorum has been analyzing data we collect on the reasons for held submissions. Our #1 hold reason is compensation issues. To better assist our clients, we have assembled a list of items you should review before sending your submission documents to Quorum. By going through this list, you can save yourself the delay of having us contact you to resolve issues which may arise from your payment plans. 

1. Did you add up the amount per visit and does it match the total you have listed on the SIQ (or compensation attachment)? Something as simple as making sure the ‘per visit’ amount adds up to the total you provide is a common error that is often overlooked.
2. Ask your sponsor if there are any special compensation parameters for this study when they send you your enrollment forms. Some studies have very specific arrangements for payment. Find out before-hand if your study has any of these requirements.
3. Feel free to use the Compensation Template available in the forms section of our website. The template provides you with a table format to easily list your visit payments and the combined total for the visits.
4. Unless the study specifically states otherwise, please remember that a total for all visits is required for review by Quorum. While you may request that the total not be included in the consent form verbiage (which we typically allow unless the sponsor has locked the model language), we must always know the total possible for a participant to receive – it must be listed on the SIQ or the compensation attachment you provide. If you do not want the total listed on the consent form, and the language is allowed to be modified per the sponsor, please write a note on your SIQ’s compensation section indicating your choice to do so. Again, you must still list the total on the SIQ for your submission to be reviewed.
5. If the study you are conducting has a sub-study associated with it or a study that may involve a caregiver consent form, be sure to find out if compensation plans are required for those as well. Contact your sponsor prior to submission to find out if there are special compensation worksheets or attachments that your study will use. This can include – but is not limited to - genetics, biomarker, or Caregiver consent forms. If you are not compensating for these things, please be sure to indicate that as well. Do not assume Quorum will automatically know your plans not to compensate.

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.