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.
- 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 or Paper Studies: These studies have been transitioned to RUTH. Continuation , 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 "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 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.
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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