Quorum Review: Site Submission Simplified
Background Information
Throughout the past year, Quorum has been analyzing the data we collect on site submissions. Specifically, we wanted to track the reasons for held site submissions and any delay in approval notices being posted. We learned in this targeted examination that the majority of our delayed sites were the result of a few key areas on the SIQ form. By providing additional SIQ guidance to our clients we believe that we can significantly improve the number of sites qualifying for 24 hour approval. Assembled below is a list of items that you should review before sending your submission documents to Quorum. By going through this list, you can reduce the delays of having us contact you to gather additional information. The sections below follow the SIQ form in order.
Section I – All Sites must complete this section
#1Principal Investigator
Clinical Trial Budget for Canadian Sites:
Quorum Review recognizes that it may be difficult to provide this information upfront during study start up. For this reason, we will not hold a site approval based on the clinical trial budget. We do however need to have a copy of the information within 1 month of the start up. The clinical trial budget does not need to be submitted to Quorum on a special form.
TCPSfor Canadian Sites:
The main reason for TCPS regulations not being applied would be if a facility has never accepted public funding for any research.
#2Primary Research Facility
This section of the SIQ does not present any significant issues with regards to site holdswhen completed in full.
#3Communication with Quorum Review
This section of the SIQ does not present any significant issues with regards to site holds when completed in full. Should the fax # provided in response to this question be the same as the emergency after hours # or the primary contact # provided in question #2 the site will be held. To preempt this hold reason, please indicate on the SIQ if these numbers should be the same.
#4Information about the Principal Investigator
Clinical Research Experience:
Quorum defines clinical research experience as research involving human subjects in a Phase I-IV environment. In question 4a, having only scientific or basic research experience requires an answer of No. If “No” you would need to provide the CV’s of support staff with previous phase I-IV experience listed, including Dates, Phases, Study titles and role as PI or Sub-I
Audit Information (483’s, warning letters, etc.): When noting audits in regard to this question be sure to put very specific dates, they will be listed on any audit correspondence.
When submitting copies of audit information to Quorum, we also need to have you include the investigator’s responses. Often we receive the audit information without the investigator’s response which causes a hold.
#5Potential Conflict of Interest
Conflict of Interest:
If a site responds “yes” to the potential conflict of interest, the Conflict of Interest Statement Form should be included with the Site Information Questionnaire. Quorum also accepts the FDA form 3455 in place of Quorum’s Conflict of Interest Form. The FDA form 3455 can be used if the investigator is the only one at the site with a conflict of interest and if the investigator has not disclosed other relationships than those listed on the FDA form 3455. Quorum’s conflict of interest statement form may be located on our website, It is form number F-031.
Special Note: When conflict of interest is found with a site, Quorum sends the site to the full Board for review. Expect up to 1 week for site approval if this occurs. There will be comments in the Site Start up report that indicates if a site is scheduled for full Board review.
#6Human Research Participant Protection Training
Other Self Study Training
If the investigator selects “Other self study training”, please make sure to include an explanation. Please note the first check box indicates the PI has not completed “any” training, if checked or the sub groups below are checked in addition to “yes” the site will be held for conflicting information.
#7Information about the Primary Research Facility
This section of the SIQ does not present any significant issues with regards to site holds when completed in full.
#8Research Resources
Number of research staff and number of research studies:
Often the answers to these particular sub-sections are zero. In this case, please place a zero in each box. A blank section will indicate missing information and cause an unnecessary hold.
#9Local Jurisdiction Issues
Quorum Review Institutional Jurisdiction
When a local IRB (hospital or university) allows Quorum to provide oversight on a study, a common oversight is not including a Waiver of Jurisdiction from the local IRB. The Waiver of Jurisdiction form can be found on our website at and is form # F-016.
State/Provincial/Local Laws
Question 9g on the SIQ is where you can note any state or local laws that need to be brought to Quorum’s attention. Although we will not hold a site for this information, our regulatory team does review these elements. Please include a description or a copy of the local law(s) where applicable in order to aid in this evaluation.
#10Privacy of Study Participants
This section of the SIQ does not present any significant issues with regards to site holds.
#11Confidentiality of Study Data
This section of the SIQ does not present any significant issues with regards to site holds when completed in full.
Section II – Must be completed site will interact with participants
#12Recruitment of Study Participants
This section of the SIQ does not present any significant issues with regards to site holds when completed in full.
#13Compensation of Study Participants
Background Information on Compensation:
The #1 reason for site delays stems from compensation related issues. There is acompensation template available on our website: This template provides an easy format for calculating per visit payments and corresponding totals. Ensuring that site’s compensation schedules arereflective of the consent form language is highly important.
Additionally, here are some further insights into the elements that Quorum needs to see regarding compensation.
Special Compensation Parameters:
Some studies have very special arrangements for payment. When the compensation for the study is complex, including a copy of the compensation schedule with the SIQ can help to alleviate confusion.
Total compensation for the study (Question 13a):
If visit amounts vary a possible total is required, if participants will compensated the same at each visit a total is not required. Please note this on the SIQ form in question 13a or on the compensation attachment that you provide if compensation varies per visit.
You may request that the total compensation for a study not be included in the consent form language. We typically allow this unless the sponsor has locked the model language.
If you do not want the total compensation listed on the consent form and the language is allowed to be modified per the sponsor, please write a note in the SIQ compensation section (anywhere is fine) indicating your choice to do so. This could also be noted on the compensation attachment that you include.
(The $ Amount / Visit) X(# of Visits) = Total Compensation:
The $ amount per visit multiplied by the number of visits needs toexactly match the total that is listed on the SIQ or the 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 and causes delays.
Sub-Studies or Caregiver Consent Forms:
If the study you are conducting has a sub-study associated with it or a caregiver consent form, be sure to find out if compensation plans are required for those as well. Including any special compensation worksheets or attachments that your study will use is very helpful.
If there is no compensation for these items, please be sure to indicate that with the SIQ submission. Quorum can not make assumptions regarding compensation for these items and will hold the submission in order to clarify.
Timing of Payments (Question # 13b)
This particular section of the SIQ is often overlooked when completing the compensation section.Quorum requests detailed information when compensation will be given to participants. This will not be listed on the ICF unless site provides specific language to that affect.
#14Reimbursement of Study Participants
This question asks about gifts, study equipment, travel and parking, and other forms of participant reimbursement.
Question 14b asks about the timing of payments. This section is often overlooked when completing the compensation section.
Section III – Must be completed if site will consent participants
#15Consent Form
Unique Consent Forms:
The unique changes must be provided in electronic, Word format, and must be tracked using the ‘Track Changes’ feature in Word and be in the current Quorum approved consent form. Please include sponsor approval for every unique change made to the model consent form. Email correspondence showing the sponsor or CRO’s email address is acceptable. Additionally, Quorum needs to receive rationale for each requested change from the model consent form. Email format is fine for this information as well.
#16Address(es) to Appear on Consent Form(s)
Alternative Addresses:
If using the primary address as listed in SIQ question # 2 the 2nd box should be checked. If the 3rd box is checked, we need to receive a separate ASIQ form for each distinct address provided. This form can be found on our website at and is form # F-038.
#17Consent Process
This section of the SIQ does not present any significant issues with regards to site holds when completed in full.
#18Vulnerable Populations
Answers should be logical. For example, a site who is participating in a pediatric study needs to mark ‘yes’ for 18b and ensure that18bi and 18bii are completed. If a site is participating in a study involving dementia patients, 18e, 18ei, and 18eii need to be completed.
Non-English speaking participants (Question 18d):
Please be sure to note the actual language /dialect when answering YES to this question. There is a space next to the check box for this to be noted. Also there is a sub part question that asks about safety measures if answering “yes”.
Section IV – Must be completed if the research involves a drug and/or device
#19Drug/Device Storage
N/A Box
This box is sometimes selected in error and is usually only appropriate for observational studies. Before checking the N/A box, please ensure that there is no drug or device involved.
#20Emergency Measures
This section of the SIQ does not present any significant issues with regards to site holds when completed in full.
Section V – All sites must complete this section
#21The Quorum Web Portal (OnQ)
This section of the SIQ does not present any significant issues with regards to site holds when completed in full.
#22Institutional/Other Contact
This section of the SIQ does not present any significant issues with regards to site holds when completed in full.
#23Principal Investigator’s Statement and Signature
Noted below the question is the wording, *A signature is not required if your site is submitting this form through the OnQ Portal. If submitted to Quorum Review by the sponsor or CRO a wet signature from the principal investigator or designee is required.
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