Regulatory Compliance Education & Resources
Research Compliance and Education Program
The Research Compliance and Education Program provide education and regulatory guidance on clinical study management to ensure research teams implement good research practices.
The Research Compliance and Education Program offers:
- Good Clinical Practice (GCP) Education
- Training and Consultations (Department and One-on-One)
- On-site Compliance Monitoring
- External Monitor and Audit Preparation
- Study Tools and Templates
Research teams are encouraged to reach out to the Research Compliance and Education Program to schedule training sessions, access resources or for any questions relating to study conduct.
The ISMMS Research Compliance and Education Program offers monthly in person GCP training sessions entitled “Clinical Research, Are You Doing It Right? Attending this training fulfills the Human Subject GCP training requirements for FDA regulated research and the requirements of the new NIH training in GCP policy.
Researchers and staff who are required to take GCP training or who would like to refresh their GCP knowledge are encouraged to attend. To register for upcoming training sessions:
- Log into PEAK
- Select “Classroom Based Training”
- Select “Functional”
- Select ” Clinical Research – Are You Doing it Right?”
The PPHS IRB University Program offers training courses for investigators and research teams who are involved in the design, conduct, and/or reporting of human subject studies at the Mount Sinai Health System. The courses provide hands-on training on the IRB submission requirements, protocol and consent writing, as well as useful tips to ensure documentation is complete and compliant.
- IRB 101: Basic Steps of the IRB Submission
- IRB 201: Document Analysis & Evaluation: Protocol and Consent
Upcoming training sessions are announced through the research administration emailing system, Research Listserv. Click here to sign up for Research Listserv.
Essential Documents - Regulatory Binder
According to ICH GCP 8.1 Guidelines, Essential Documents are those documents that individually and collectively permit evaluation of the conduct of a trial and the quality of data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements.
Industry sponsored trials typically provide investigators with a tabbed regulatory binder to house essential regulatory documents. However, with investigator initiated studies and NIH sponsored studies it is often up to the study teams to create their own regulatory binder. It is essential the regulatory binder is up-to-date, contains all of the required documents and is available for review during monitor visits, audits and regulatory inspections.
For guidance, tools and templates to assist creating, organizing, and maintaining your regulatory binder, refer to the following:
- Essential Documents and the Regulatory Binder
- Regulatory Binder Checklist
- Delegation Authority
- Adverse Event (AE) Tracking
- Concomitant Medication Tracking Log
- Protocol Training Record
- Monitor Log
- Screening and Enrollment Log
- Sample Investigational Product Accountability Log
- Site Initiation Checklist
- Site Initiation Visit (SIV) Attendance Sheet
- Site Initiation Visit (SIV) via Teleconference
- ISMMS IRB Membership
- BRANY IRB Membership
- ISMMS Clinical Laboratory Permit (CLIA) (scroll to the bottom of the page)
- MSMC College of American Pathologists (CAP) Certificate (scroll to the bottom of the page)
Questions – For regulatory binder questions, contact the Research Compliance and Education Program.
Regulatory Requirements - IRB Continuing Review
Before you submit your continuing review, a new IF# must be generated in Sinai Central and all research staff must make their annual FCOIR disclosure under the assigned IF#. Studies using an external IRB are also required to complete an IF form in Sinai Central (exception - studies using BRANY for both IRB review and contracting). When an external IRB is used, ISMMS only cedes study review to the external IRB. ISMMS remains responsible for FCOIR reviews, conditional office reviews (Biosafety, IDS, Radiation Safety etc.) and ensuring study teams meet the institutional training requirements.
For more information visit the Investigator Form (IF) Instructions page.
An application to the GCO is required to be submitted each year of the project.
For more information visit the GCO Annual Submission page.
Please read the outlined information before submitting to the PPHS office for human research review.
Continuing review applications are required to be submitted to the IRB at least once a year, or at more frequent intervals if determined by the IRB.
For studies using the ISMMS IRB, continuing review applications must be submitted at least 6 weeks prior to the study/project expiration date that is listed on the most recent IRB approval letter.
To coordinate your submission, refer to "2019 ISMMS IRB Review Deadlines & Board Meeting Dates."
Ideate: For studies that have been approved in Ideate, continuing review applications are required to be submitted in Ideate.
Legacy Studies: These are studies that were originally approved by the IRB before the Ideate system was implemented. Continual renewals, modifications and amendments for legacy studies do not go through Ideate, they continue to utilize HRP FORMS and email irb@mssm,edu for submission. Refer to FORM HRP-212 for the specific continuing review submission requirements.
To submit a modification along with your continuing review application in Ideate, you need to do the following:
- Create a modification application in Ideate
- Attach signed and completed form HRP-212 Continuing/Final Review Progress Report (see "Forms")
Note: This only applies if the study is not expired. Otherwise a continuing review must first be submitted, followed by the modification.
Studies using an external IRB are required to submit continuing reviews to the external IRB of record.
ISMMS PPHS Requirements: Once continuing review approval has been obtained from the external IRB, study teams are required to make a Continuation submission in Ideate. For more information, refer to "Continuations" under "Icahn School of Medicine at Mount Sinai IRBs and External IRBs.
Contact the PPHS at (212) 824-8200 or IRB@mssm.edu.
If BRANY is being used for both contracting and IRB review, you are exempt from creating an IF and submitting your FCOI disclosure in Sinai Central. BRANY has their own FCOIR forms and all key study personnel (i.e. involved in the design, conduct, or reporting of the research) must disclose financial interests by completing BRANY FORM 01 and FORM 02 (if applicable) and submitting these forms along with their IRB application through the BRANY IRB Manager platform.
Regulatory Requirements - IRB Modifications and Reportable New Information
All proposed modifications to a study require IRB approval prior to implementation.
Exempt Studies: If the research is determined to be "exempt", and a proposed modification affects the design and conduct of the research in the approved protocol, a modification must be submitted to the IRB.
Note - if a modification is a study personnel change, you will be required to modify the Investigator Form (IF) in Sinai Central.
Ideate: For studies that have been approved in Ideate, modifications are required to be submitted in Ideate.
Legacy Studies: These are studies that were originally approved by the IRB before the Ideate system was implemented. Continual renewals, modifications and amendments for legacy studies do not go through Ideate, instead they continue to utilize HRP FORMS and email firstname.lastname@example.org for submission. Refer to FORM HRP-213 for the specific submission requirements.
Studies using an external IRB are required to submit all modifications and unanticipated problems to the external IRB of record.
ISMMS PPHS Requirements: Refer to Requests to Rely (R2R) on an External IRB.
GCO Annual Submission
All* research and sponsored projects, including industry sponsored clinical trials must submit an annual application (also referred to as a yearly renewal) to the GCO. The application must be submitted each year of the project.
*Exceptions – BRANY Projects (BRANY CLASSIC studies or investigators utilizing BRANY services for contracting, budgeting and IRB) are not required to submit studies through InfoEd and therefore are exempt from the annual InfoEd submission requirements. Investigators using BRANY solely for IRB services are required to submit annual applications to GCO through InfoEd.
Annual applications are submitted in InfoEd.
The application in InfoEd should be created in tandem with the Ideate or Legacy submission to the IRB.
The GCO will begin to review your application once:
- All personnel who are listed on the Investigator Form have completed the Financial Conflict of Interest in Research (FCOIR) Form
- The IRB application has been submitted
- Department(s) approvals have been obtained
Routing and Approval Process
PI Approves InfoEd Application ⇒ Routed to Dept(s) ⇒ Dept(s) Approves ⇒ Submitted to GCO for Review ⇒ Email Notification Receipt from GCO ⇒ Email Notification of GCO Approval
Clinical Research Unit (CRU)
Study teams using the Clinical Research Unit (CRU) resources are responsible for providing updated IRB approvals and consents. Patient appointments will not be scheduled beyond the IRB expiration date. If the study team would like to request additional CRU resources to an approved protocol, they must submit a revised CRU application and MD orders.
Documents should be emailed to the CRU Program Coordinator, Joanne Zephir.
Annual IDE Device Continuation Notification
An Annual Continuation notification of participation in IDE trials is required to be submitted to the Medicare Administrator Contractor (MAC).
Notification, along with the IRB Continuation approval letter are sent to NGS IDE Requests-Wellpoint (Shared Mailbox) – NGSIDERequests@anthem.com.
Contact Debra Fitzpatrick.
Research 411 Portal
Still Need Help?
Research Roadmap Feedback
Please provide feedback about your experience on this website.