Study Management

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.

GCP Training

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?”

IRB University

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.

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 inspection

Resources:

• Clinical Research Coordinator (CRC) Vault
  • MSHS Clinical Laboratory Permits (CLIAs)
  • MSHS College of American Pathologists Certificates (CAPs)
  • ISMMS IRB Roster
  • Brany IRB Roster
• 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

Questions – For regulatory binder questions, contact the Research Compliance and Education Program.

What

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.

When

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.

How

ISMMS IRB

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.

External IRBs

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.

Questions

Contact the PPHS at (212) 824-8200 or IRB@mssm.edu.

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.

Ancillary Review(s) for Modifications
Some modification submissions require certain ancillary office reviews. In order to assign the correct ancillary offices to review your modification submission, use the HRP-388 worksheet as a guide. This worksheet is located in the RUTH library, on the Worksheets tab. The HRP-388 worksheet is not required to be uploaded in your RUTH application. Note - if a modification is a personnel modification, you must assign an FCOI review in RUTH via the Ancillary Review Form.

ISMMS IRB

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.

External IRBs

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.

When

• 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.

What

Projects requiring GCO review must submit an annual application (also referred to as a yearly renewal) to the GCO each year of the project.

How

Annual applications are submitted in InfoEd. 

For step-by-step instructions, refer to Research IT – GCO – InfoEd Knowledge Base – All Documents (sharepoint.com) >  Non-Competing Continuation, No-Cost Extension and Final Report.

When

The application in InfoEd should be created in tandem with the RUTH submission to the IRB.

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

Last Updated: January 2024

What

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.

How

Documents should be emailed to the CRU.

What

An Annual Continuation notification of participation in IDE trials is required to be submitted to the Medicare Administrator Contractor (MAC).

How

Notification, along with the IRB Continuation approval letter are sent to NGS IDE Requests-Wellpoint (Shared Mailbox) – NGSIDERequests@anthem.com.

Questions

Contact Debra Fitzpatrick.

What

The Research Subjects Payment memorandum outlines the ISMMS human subject payment policy. Refer to this memo for guidance on subject payment methods and procedures.

How

Petty Cash

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.

Location:
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

Checks for subject payment may be requested through Sinai Central from Accounts Payable. For detailed guidance, refer to Check Requests Financial Policies & Procedures.