Pharmaceutical Sponsored Study Start-Up

STUDY CLOSEOUT or TERMINATION CHECKLIST

IRB#:______Funding #:______Sponsor(s):______PI: ______

Study Title: ______

ITEM COMMENTS COMPLETION DATE

Unit Evaluation to determine whether or not study is ready for closeout or termination:
All subject contact has ceased,
All data has been collected and verified,
Sponsor has communicated that no further queries will be generated for the site (i.e., database is locked), and,
All financial matters with subject(s), Sponsor or contract research organization (CRO) are complete /  ____/____/____
Submit IRB Closure Notification to study IRB of record and request acknowledgment. File copy of acknowledgement in the regulatory binder and provide copy to Sponsor and/or CRO. / This may include Cooperative IRB(s). /  ____/____/____
Submit Final Reportto reviewing IRB and request acknowledgment. Final report should include:
Summary of trial’s outcome and date the study is complete
Number of subjects who signed the informed consent form
Number of subjects who were given TA (if applicable)
Number of subjects who were study screen failures
Number of subjects who withdrew (or were withdrawn) before study completion
A brief summary of Serious Adverse Events (SAEs) or unexpected adverse events (UAEs) that occurred during the clinical study
Any outstanding information not previously submitted (e.g., protocol deviations), and,
Any additional information required by the Sponsor or IRB.
File copy of acknowledged report in the regulatory binder and provide copy to Sponsor and/or CRO. /  ____/____/____
ITEM / COMMENTS / COMPLETION DATE
If applicable, work with the Sponsor representative to schedule and arrange the Closeout Visit.
Site Closeout Visit scheduled: ______/  n/a
Arrange for ancillary support staff to attend, when necessary (e.g., Investigational Drug Services, sub-investigators, etc.) /  ____/____/____
Complete TA accountability, reconciliation and final disposition (prior to or at the conclusion of the Closeout Visit) /  n/a /  ____/____/____
Submit notice of Closure to all Departments that received an Impact Statement and any others as applicable. /  n/a /  ____/____/____
Submit notice of Site Closeout Visit completion to reviewing IRB(‘s) /  n/a /  ____/____/____
Remove any study financial identifiers or “fsc number” within the electronic VMMC subject file /  n/a /  ____/____/____
Submit an email request to to remove the study listing from any on-line location; e.g., BRI (BenaroyaResearch.org) and ClinicalTrials.gov website. /  n/a /  ____/____/____
Remove other study materials and documents (e.g., ads posted in clinics, protocols from sub-investigators offices, etc.) from various departments where the study is conducted /  n/a /  ____/____/____
Complete ‘Notification Checklist’ (FRM 0018) /  n/a /  ____/____/____
Return equipment supplied by Sponsor or contact CRP for review of alternate plan /  n/a /  ____/____/____
Work with Unit Manager to close study file in the Clinical Trials Management System (CTMS) /  n/a /  ____/____/____
Financial reconciliation and closure notification (BRI Accounting, Grants & Contracts or department utilized for internal funding) /  n/a
Comments: /  ____/____/____
Archive Study Records according to the procedure (GCP 0028) /  n/a /  ____/____/____

Person Completing Form: ______Date: ______

Upon completion, file in front of regulatory binder with Closure Notification Checklist

FRM 0013.B Page 2 of 2 Effective Date: 18-Jul-07