Study Closeout

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.

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patient’s study status to the appropriate status from among the following, Declined, or Completed, or Disqualified, or Withdrawn, or Off-Study, as soon as possible after a patient withdraws or completes a study, and after a study ends.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 (intranet)“.

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

Once a study has concluded and there is no plan to renew or continue the research outlined in an approved IACUC protocol, the Principal Investigator must ensure that the protocol has been closed and the IACUC has been informed regarding the disposition of the protocol.

When

A final report must be submitted within 1-10 business days of ending the study.

How

For detailed guidance on the final report and other requirements for close out, refer to Closing an IACUC Protocol.

For detailed guidance on the reporting requirements and timelines, refer to Reporting Results.

What

Investigators using the Department of Pharmacy Investigational Drug Service (IDS) are required to notify IDS when a study is terminated or closed. The study team must schedule a meeting with IDS to conduct closeout activities including;

• drug reconciliation
• study drug return or destruction
• return of pharmacy file to study team for archiving

How

For contact information, along with policies and manuals refer to Investigational Drug Service (IDS).

 

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

• BioMedical Engineering and Imaging Institute (BMEII) – Email Christopher.Cannistraci@mssm.edu
• Clinical Research Unit (CRU) – Email CRU