MODULE I Close-Out Visit/Monitoring Reports Jane Fendl April 24, 2010 1Versions: Final 24-Apr-2010.

MODULE IClose-Out Visit/Monitoring Reports

Jane FendlApril 24, 2010

1Versions: Final 24-Apr-2010

Close-Out Visit (COV)

Usually conducted when:All subjects have completed the studyAll queries are resolved

Maybe conducted when:The sponsor or IRB decide to discontinue using a

certain Investigator or siteThe sponsor decides to discontinue the studyInvestigator requests that the study be discontinued at

the site.


Preparing for the COVSchedule the visit

Discuss with the Study Coordinator all tasks that must be completed

Allow enough time to complete the visit in one tripInsure Investigator will be presentConfirm visit with a letter that outlines all tasks that

must be completedBefore leaving the for the COV review:

Site communication documentsPrevious monitoring visit reports and outstanding issuesQuery reports or requestsAny information or issues requiring site notification


Preparing for to the COV

Protocol and amendmentsInstructions for returning or destroying

investigational productStudy specific requirementsThe Clinical Monitoring PlanAudit the Trial Master File


Conducting the COVThe CRA must:

Sign the Site Visit LogMonitor the ICF for all subjectsMonitor the CRFs

Retrieve all remaining CRFsMonitor the Investigational product

Prepare IP for return or destruction Total IP shipped – Total IP used = Total IP returned

If packaging IP for return, complete all necessary forms, pack the container, seal it and arrange for courier pick up. Container should be sealed in such a way that it is tamper proof. Do not leave IP for site tor return.


Conducting the COVMonitor the Site Master File to ensure all regulatory

(essential) documents are presentResolve outstanding queries

Arrange time with CRC to resolve outstanding issues Review outstanding issues from previous visits


Conducting the COVMeet with the Investigator & CRC to discuss:

Any significant findings IRB notification

Date of last subject and study completion Number of subjects screened, randomized, completed and withdrawn or dropped SAEs

Records retention 2 years after last approval of marketing application or until there

are no pending or contemplated marketing applications 2 years have elapsed since formal discontinuation of clinical

development Location of records retention Notification of address change of site or records retention


Conducting the COVInstructions for potential inspectionContinued obligations ICH GCPSponsor publication guidelinesFinancial disclosure requirements


Items to RetrieveCopies of:

The Subject Screening LogThe Subject Enrollment Log

Verify that all metrics are correct

Copy of the Delegation of Authority LogEnsure that all delegated individuals are listed and that the

form is up to dateCopies of drug inventory/return records

Tracking numbers for all shipmentsRandomization code envelopes if applicable

CRFs and outstanding query forms


After the COV VisitWrite the reportWrite the follow up letterEvaluate the Investigator

Enrollment of evaluable subjectsRate of enrollment

GCP/ICH complianceIRBProtocol AdherenceStaff performanceFacilitiesContract negotiation/budgetOverall performance


MODULE I Close-Out Visit/Monitoring Reports Jane Fendl April 24, 2010 1Versions: Final 24-Apr-2010.

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Transcript of MODULE I Close-Out Visit/Monitoring Reports Jane Fendl April 24, 2010 1Versions: Final 24-Apr-2010.