Study Management

What

The Research Compliance and Education Program provide education and regulatory guidance on clinical study management to ensure research teams implement good research practices.

They offer:

• GCP Education
• Training and Consultations (Department and One-on-One)
• On-site Compliance Monitoring
• External Monitor and Audit Preparation
• Study Tools and Templates

How

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.

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.

Resources

• Clinical Trial Guidance Documents
• Compliance Manuals
• Clinical Investigator Inspection List (CLIIL)

 

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.

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 (intranet)
• Regulatory Binder Checklist
• Delegation Authority
• Adverse Event (AE) Tracking
• Concomitant Medication Tracking Log
• Protocol Training Record
• Monitor Log
• Screening and Enrollment Log (intranet)
• Sample Investigational Product Accountability Log (intranet)
• 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 Office of Industry Engagement and Conflict of Interest Office ("COI 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 or Paper Studies: These studies have been transitioned to RUTH.  Continuation , 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.

In addition to study registration, MSHS principal investigators are responsible for:

• Study Updates
• Reporting Results

Click here for the IDE maintenance requirements.

Click here for the IND maintenance requirements.

An annual progress report is required to be provided to the IACUC via eIACUC.

1. An Annual renewal (Progress Report) is required in year 1 and year 2 of the approved protocol.
2. 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)