CRU-3-05: Study Close-Out Activities

SOP: Study Close-Out Activities
Number:
CRU-3-05		 Date:
Version 2.0,
06/Mar/2026		 Supersedes:
Version 1.0,
05/Nov/2024		 Responsible Authority:
CRU Director		 Page
1 of 3

  1. PURPOSE

    The purpose of this document is to describe the procedures related to close-out of a clinical research protocol.

  2. REVISIONS FROM PREVIOUS VERSION

    2.1Version 1.0, 19Sept2024: Initiation of new SOP.

    2.2Version 2.0, 06/Mar/2026: reviewed the SOP, updated version number and date, corrected minor errors, added CRU staff to the SOP.

  3. POLICY

    N/A

  4. RESPONSIBILITIES

    4.1Principal Investigator (PI)

    1. 4.1.1Review the project's financial status with the CRU Director or Sponsored Research Administrator.
    2. 4.1.2Ensure that affiliate sites/subcontractors have submitted or will submit all required deliverables, reports, and invoices, if applicable.
    3. 4.1.3Plan for updates and changes to payroll, transitioning either to a renewal period or to award expiration.
    4. 4.1.4Submit final report to IRB.
    5. 4.1.5Meet sponsor's deadline(s) for final reports.
    6. 4.1.6Submit required final invention report, if applicable.
    7. 4.1.7Review the final financial report.
    8. 4.1.8Ensure retention of the project records for the required period of time, as specified in applicable regulations or sponsor correspondence/contract.
    9. 4.1.9Submit study results http://clinicaltrials.gov (if applicable).
    10. 4.1.10 Ensures all activities have been completed by the CRP(s) as outlined in this SOP.

    4.2Clinical Research Professional (CRP)/CRU staff

    1. 4.2.1Ensure all participant study visits or participant transfer processes have been completed per sponsor and IRB.
    2. 4.2.2 Ensure all data collection forms have been completed, submitted to sponsor (if applicable), and filed in appropriate participant research binder.
    3. 4.2.3Ensure completion of all action items, resolution of data queries and data lock (if applicable).
    4. 4.2.4Ensure all used and/or unused IP is collected from all participants, inventoried, and returned to sponsor or destroyed.
    5. 4.2.5Ensure regulatory binder is current and complete and ready for archiving.
    6. 4.2.6Assist PI in preparing all study files for storage in a secure location.

  5. PROCEDURE

    5.1All participant study visits or participant transfer process must be completed per sponsor and IRB instructions prior to initiating study close-out activities.

    5.2Study close-out activities should not occur without approval from the sponsor (if applicable) and PI.

    5.3Review and ensure all regulatory documentation are current, complete, and filed correctly in the regulatory binder.

    5.4Review and ensure all participant research files are complete (data collection forms, labs, etc.).

    5.5Review and ensure all data queries have been resolved and all data collection forms have been signed by the PI (where applicable).

    5.6Ensure a close-out letter has been obtained from the sponsor (if applicable) and filed in the regulatory binder.

    5.7Ensure a plan is in place to appropriately follow up on on-going adverse events as required per protocol.

    5.8Notify ancillary departments/colleges and third-party vendors involved in the conduct of the study of study closure.

    5.9Review and confirm that all IP has been returned or destroyed at the site as specified by the sponsor. File copies of study packing slips and shipment receipts in the regulatory binder.

    5.10Ensure return or destruction of all other study-related materials (i.e. unused study lab kits, data collection forms, recruitment materials) as instructed by the sponsor.

    5.11Ensure that any equipment on loan has been returned and file the appropriate shipping return documents in the regulatory binder.

    5.12Ensure final participant payments have been distributed.

    5.13Ensure final payment is received from funding sponsor.

    5.14Confirm requirements for data retention and storage per applicable regulations and per sponsor, if applicable.

    5.15Notify the IRB that the study is complete by submitting Final/Termination Report, if applicable.

    5.16Confirm study results have been submitted to http://clinicaltrials.gov (if applicable).

    5.17Documentation

    1. 5.17.1Complete study close-out checklist, suggested.

  6. MATERIALS

    6.1 Templates

    1. 6.1.1Study Close-Out Checklist

  7. REFERENCES

    7.121 CFR 312.62

    7.2ICH E6 Section 4.9.5

SIGNATURES

Prepared by: Judyta A. Kociolek, MSN, RN
Director of CRU Operations
Date: 10 Mar 2026

Approved by: Peter J. Holland, MD
CRU Medical Director
Date: 10 Mar 2026

Executed signature pages are available in the Initiating Authority Office