Study Closeout or Termination

When

The principal investigator is required to close out the study with the governing IRB when the following conditions have been met:

• Enrollment is closed and research related activities, interventions or interactions with human subjects have been completed
• All queries have been resolved
• PHI data, and  records are no longer required by study team or sponsor (data locked)
• Sponsor has conducted a close out visit and issued a close out letter (sponsor grants permission to close the study with the IRB)

Reports should be submitted within 30 days of the completion of the study.

How

ISMMS IRB

For studies where ISMMS is the IRB of record, close out reports are required to be submitted in RUTH by clicking the CR link.

Legacy or Paper Studies

Legacy or paper studies have been transitioned to RUTH. Notification of closeout, terminations and suspensions must be submitted through RUTH.

External IRB

Submit a close out report to the external governing IRB.

ISMMS PPHS Requirements: Study teams are also required to report the study closure to ISMMS PPHS via RUTH.

What

If a study is terminated or suspended the study team is required to notify the governing IRB immediately.

How

ISSMS IRB

Study termination or suspension is reported via RUTH.

Legacy or Paper Studies

These are studies have been transitioned to RUTH. Notification of closeout, terminations and suspensions for these studies must be submitted through RUTH.

External IRB

Study termination/suspension is reported to the external governing IRB. Study teams are also required to report study termination/suspension to ISMMS PHHS.

During the close out visit, any remaining investigational product will be destroyed or returned per the sponsor’s request. Once all investigational product is destroyed/returned and IDS closed out, the pharmacy file will be returned to the study team for archiving.

What

Because all interventional clinical trials (e.g., trials involving drugs or devices) are required to be registered in Epic by research teams (PI or designee), clinical trials also must be closed out in Epic when they end.

In addition, a research team’s clinical research coordinator is responsible for updating a patient’s study status in Epic when that participation status changes, including when the clinical trial has ended.

When

A study team’s clinical research coordinator must go into Epic and update a patient’s study status to the appropriate status from among the following, Declined, or Completed, or Disqualified, or Withdrawn, or Off-Study, as soon as possible after a patient withdraws or completes a study, and after a study ends.

To close out a clinical trial in Epic, you need to request that the Epic Applications Team do so. The Epic Application Team’s technical work generally takes about one business day. The study team should submit their request to Epic Applications team via the IT Help Desk at least week prior to the close of the study, to allow enough time for the MSHS Epic team to schedule and complete this work as soon as the study closes.

How

For directions on how to update a patient’s study status in Epic for a clinical trial because the patient has withdrawn from a study, completed it, or because the clinical trial has ended, please see this tipsheet for “Linking a Patient to a Study“.

To close out a clinical trial altogether, call email ITHELPDESK@mountsinai.org and provide them with the following information:

Short Study Name (to uniquely identify protocol): __________________

Brief Description (Intervention, etc.): __________________

And at least one of the following:

Study Code (GCO#): __________________

NTC #: __________________

IRB Approval #: __________________

What

The PI or PI’s designee is responsible for submitting a final report to the GCO.

EXCEPTION – 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 GCO final report submissions. Investigators using BRANY solely for IRB services are required to submit a final GCO report through InfoEd.

When

At the end of the project.

How

Final reports are required to be submitted in InfoEd.

For step-by-step instructions, refer to “Creating a Non-Competing Continuation, No-Cost Extension or Final Report Submission“.

Study teams or department administrators should review the study budget and subject enrollment log/ledger to ensure that all study related expenses have been invoiced to sponsor and the funds have been received prior to the sponsor close out visit. Refer to the contract for payment terms, invoicing time limits and holdback payments. Ensure final payment for any holdback amounts are received from the sponsor when the study is closed.

What

Upon completion of a clinical research study, the remaining research funds may be transferred to the departmental account.

How

If the remaining balance in the fund account is $2,500 or less:

The PI and the department administrator shall submit a memo certifying that the project has been completed and all obligations to the sponsor have been met with a request that the remaining balance be transferred to the departmental account. This memo should be submitted to Rosaria McEntee, Director of Finance, FACTS.

If the remaining balance is greater than $2,500:

A letter from the sponsor is required stating that all obligations have been met and no money is due back to them. If a letter from the sponsor cannot be obtained, please download and fill out the Closeout Letter Template and have it signed by the chairperson of the department. The letter should be submitted to Rosaria McEntee, Director of Finance, FACTS.

Overhead will be charged on the remaining balance before the net unexpended balance is transferred to the department account.

If the account balance is negative:

The department has to provide a funding source to cover the deficit so the account can be closed.

Questions

Contact Rosaria McEntee, Director of Finance, FACTS.

Study teams must notify the following ancillary departments (if applicable) of study closure or termination:

• BioMedical Engineering and Imaging Institute (BMIEE) – Email Christopher Cannistraci
• Clinical Research Unit (CRU) – Email CRU