Regulatory Compliance Education & Resources
The Research Compliance and Education Program provide education and regulatory guidance on clinical study management to ensure research teams implement good research practices.
- 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 with questions or issues relating to study conduct, to schedule training session or access resources.
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.
Regulatory Binder & Study Management Tools
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 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
- Master Drug Accountability Log
- Monitor Log
- Screening and Enrollment Log
- Sample Investigational Product Accountability Log
- Protocol Training Record
- IND Safety Report 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.
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.
If the IRB has provided a three year approval and there is no external sponsored project funding (e.g., ISMMS, industry clinical trials negotiated by FACTS, and cooperative trial research projects), GCO submissions are also only then required every three years.
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 Office of Industry Engagement and Conflict of Interest Office ("COI 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.
To coordinate your submission, refer to "2020 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 (also called paper submissions). Continuation renewals and, modifications 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.
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. Continuation renewals, and modifications for legacy studies do not go through Ideate, instead they continue to utilize HRP FORMS and email email@example.com 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.
ClinicalTrials.gov Regulatory Requirements
IDE Regulatory Requirements
Click here for the IDE maintenance requirements.
IND Regulatory Requirements
Click here for the IND maintenance requirements.
IACUC Annual Renewal/Progress Report
An annual progress report is required to be provided to the IACUC via eIACUC.
- An Annual renewal (Progress Report) is required in year 1 and year 2 of the approved protocol.
- A Triennial renewal is required in year 3 of the protocol approval period. (Note- Year 3 annual renewal is imbedded in the triennial renewal smartform)
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