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 (see ISMMS IRBs)
- 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 complete their Financial Interest in Research Disclosure Form under this new IF#. The Investigator Form (IF) is used by the institution to generate notification emails to each investigator and key personnel listed on the project-specific IF form to complete the Financial Interest in Research Disclosure Form. Principal investigators or their delegates must complete the Investigator Form (IF) in Sinai Central for ALL research projects at the time of continuing review in order for co-investigators and key study personnel to complete the Financial Interest in Research Disclosure Form under the newly 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 detailed guidance on the Request to Rely (R2R) process, click here.
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.
All research studies are required to submit continuing review applications to the IRB. The frequency of review is determined by the IRB. Refer to the expiration date listed on your project's most recent IRB approval letter.
Effective January 21, 2020, the PPHS has determined that certain minimal risk protocols will no longer require an annual continuation and will be granted a three year approval period. The PI/Research Team is responsible for ensuring CITI refresher training is completed every three years, and that Financial Conflicts of Interest are managed a by the FCOI committee in the Conflict of Interest Office independent of the project approval committee.
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.
- TIP: Projects are approved for up to one year, so if you renew early, your subsequent approval will expire less than one year from the current expiration date.
- Greater than Minimal Risk (GTMR) studies: Submit at least 6 weeks before your desired IRB meeting date.
- TIP: If a study team wishes to keep the same expiration date every year, this must be noted in the application. This would primarily be limited to NIH grants. The PPHS is able to link or de-link the approval periods, if requested
To coordinate your submission, refer to the PPHS website for the ISMMS IRB Board Meeting Dates.
For studies where ISMMS is the IRB of record, continuing review applications are required to be submitted in RUTH.
Legacy Studies: These studies have been transitioned to RUTH. Continual renewals, modifications and amendments for legacy studies must be submitted through RUTH.
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 follow on submission in RUTH. For more information, refer to Continuations under Requests to Rely (R2R) on an External IRB.
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.
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 personnel modification, you must assign an FCOI review in RUTH via the Ancillary Review Form.
For studies where ISMMS is the IRB of record, modifications are required to be submitted in RUTH.
Legacy Studies: Legacy studies (paper submissions) have been transitioned into RUTH. Follow on submissions (continuing reviews and modifications) must be submitted through RUTH.
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.
- Can be submitted at any time
- Minimal Risk (MR) studies: Submit at least six weeks before the date you wish to enact proposed changes.
- Greater than Minimal Risk (GTMR) studies: Submit at least six weeks before your desired IRB meeting date.
- TIP: For GTMR studies, use the attached 2020 IRB meeting schedule to determine the best meeting date for your project by counting back 6 weeks from the desired IRB meeting date.
GCO Annual Submission
ISMMS supported projects and sponsored projects with external funding, 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 RUTH 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.
Study Payments - Research Subject Payment
The Research Subjects Payment memorandum outlines the ISMMS human subject payment policy. Refer to this memo for guidance on subject payment methods and procedures.
Petty cash requests for research participants are made in Sinai Central. For guidance on creating a petty cash voucher, refer to these instructions.
Note - Petty cash vouchers cannot exceed $25 at a time. Payments over $25 must be made by check. Refer to the Petty Cash Policy along with the Research Subjects Payment memorandum for policies and procedures for submitting a petty cash voucher through Sinai Central.
Petty Cash - Main Cashier’s Office
Research participants may be allowed to pick up their payment from the Main Cashier’s Office (below) by presenting an approved petty cash voucher and valid identification.
Annenberg MC Level next to the escalator
1468 Madison Avenue
Hours of Operation: Monday thru Friday 8:30 AM to 5:00PM
Petty Cash Reimbursement Hours: Monday thru Friday 8:30 AM to 4:30PM
Telephone: (212) 241-6745 / (212) 241-6329
Checks for subject payment may be requested through Sinai Central from Accounts Payable. For detailed guidance, refer to Check Requests Financial Policies & Procedures.
For circumstances when checks cannot be used to pay a subject for reasons such as privacy and confidentiality, the department administrator and the PI may request a waiver from SPA.
NIH/Non-Profit Funded Studies: A completed Subject Fee Payment Form is required to be submitted to SPA.
Industry Funded Studies: A completed Subject Fee Payment Form is required to be submitted to the Director of Finance, FACTS.
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