/ Quorum Review
Institution Cover Page
Version 2, dated 02/09/15 / Icahn School of Medicine at Mount Sinai
For prompt assessment and Board review, Institution site submissions are submitted with the Site Information Questionnaire (SIQ) and should contain general elements as noted in the Site Submission Checklist found on Quorum’s website at . Including the Institution Cover Page will ensure proper handling of your initial site submission.
NAME OF INSTITUTION / Icahn School of Medicine at Mount Sinai
PRINCIPAL INVESTIGATOR
PROTOCOL NUMBER
SPONSOR NAME
Instructions for Mount Sinai Staff:
Quorum will always insert your institution’s “pre-negotiated” client template consent language into the sponsor’s model consent form; however, please indicate below the applicable information that should be included for this particular study.
Indicate the applicable information that should be included in this study’s consent form by checking boxes to the left for any that apply:
  1. Identifiable Data to be Collected:
dates directly related to the individual (birth, admission, discharge, date of death, etc.) - please specify here
email/internet protocol (IP) addresses or web universal resource locators (URL’s)
social security number
medical records number
health plan numbers
account numbers
certificate/license numbers
vehicle identifiers
device identifiers
biometric identifiers
photographic images
other – please specify here:
taking a medical history (includes current and past medications or therapies, illnesses, conditions or symptoms, family medical history, allergies, etc.
doing a physical examination that generally also includes blood pressure reading, heart rate, breathing rate and temperature
completing the tests, procedures, questionnaires and interviews explained in the description section of this consent.
reviewing HIV-related information, which includes any information indicating that you have had an HIV related test, or have HIV infection, HIV related illness or AIDS, or any information which could indicate that you have been potentially exposed to HIV
reviewing mental health records
reviewing alcohol and/or substance abuse records
reviewing psychotherapy notes – please provide special HIPAA language needed in this case either on this document or provide a separate attachment:
reviewing genetic tests
  1. Who, outside Mount Sinai, might receive participants’ protected health information?
Other collaborating research center(s)
Either list a max of 6 here: or identify the website that maintains a current list of sites here:
Research data coordinating office.
Identify the name of this group/company here:
Outside laboratory.
Identify the name of this company/organization here:
Contract Research Organization (CRO)
Identify the name of this company here:
Other groups and WHY:
  1. Certificate of Confidentiality: Has a Certificate of Confidentiality been obtained specifically for this study? (please choose one) Yes or No
  2. If a Certificate of Confidentiality has been obtained, please include it in the submission.
  1. Disclosure of Financial Interests
A conflict of interest has been reported to MSSM. Please note that the investigator is required to attach the specificdisclosure language that has been submitted to Mount Sinai School of Medicine Financial Conflicts of Interest in Research Committeefor review here:
***Please also note that the investigator is required to notify Quorum Review, IRB if the Mount Sinai School of Medicine Financial Conflicts of Interest in Research Committee requireschanges to this language in the consent form.
  1. Other: Are there any other changes to the consent form beyond your institution’s previously negotiated language that you would like to add to the sponsor’s model consent form? Yes or No
  2. If YES, please include a tracked consent form in your submission along with rationale and sponsor approval.
* Contact Quorum Site Support Team via email at or phone at (206) 448-4082 for a current approved copy of the model consent form.
Acknowledgement byMount Sinai
The Investigator(s) named at the beginning of this form are authorized to conduct the above referenced investigational research study in this institution under the jurisdiction of Quorum Review.
Signature of Ms. Liz Carroll or authorized Designee:Date:
Please give portal account access to the following individuals:
Name: Liz Carroll
Email address:
Name: Lori Jennex
Email address:
THIS SECTION DESCRIBES CURRENT HANDLING REQUIREMENTS FOR THE INSTIUTION ABOVE AND IS FOR QUORUM USE ONLY
Please see Icahn School of Medicine at Mount Sinai account attachments for handling requirements.