Study closeout
Study Close-Out Checklist
| No. | Task | Owner | Date Completed | Comments |
| Case Report Forms (CRFs)/Source Documents | ||||
| 1 | Confirm that appropriate source documentation is present for all subjects | |||
| 2 | Paper Studies: Confirm that all CRFs have been completed, collected, and the proper legible copies are present in study files
Electronic Data Capture (EDC) Studies: Confirm that all electronic CRFs have been completed and submitted to the DCC, as applicable |
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| 3 | Paper Studies: Confirm that all data clarification forms (DCFs) and queries issued to date have been submitted to the DCC (CROMS), appropriately resolved, signed and dated by the investigator, and that signed and dated queries are filed with the corresponding CRF page or subject
EDC Studies: Confirm that all electronic queries issued to date have been appropriately resolved, reviewed by the CRA/SC/DM as appropriate, and closed, where applicable |
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| 4 | EDC Studies: Ensure that all CRF pages requiring signature have been electronically signed and dated by the investigator | |||
| Data Management | ||||
| Note: If the site is using a Data Coordinating Center (DCC), tasks 5-8 will be owned by the DCC. | ||||
| 5 | Confirm all data is entered into the database | |||
| 6 | Ensure all queries have been issued, returned, and resolved | |||
| 7 | Once all queries have been resolved, clean and QC the database | |||
| 8 | Perform database lock | |||
| Adverse Event, Unanticipated Problem, and Serious Adverse Event Reporting/Reconciliation | ||||
| 9 | Ensure that all AEs, UPs, and SAEs have been captured, followed, and resolved per protocol, and reported to the appropriate parties (Sponsor, IRB, and FDA, if applicable) according to protocol reporting requirements | |||
| 10 | Confirm that all required follow-up documentation has been retrieved, communicated to appropriate parties, and is present in the study files | |||
| Investigator Site Files | ||||
| 11 | Confirm that signed consent forms are on file for all subjects | |||
| 12 | Reconcile study files with Trial Master File (TMF) list. For studies where the TMF is maintained at the lead site or by another DCC, ensure all required documents are present, including collection of all required documents from all Investigator Site Files, where appropriate.
These can include, but are not limited to: · protocols and amendments · approved consent document templates · IRB approvals · study team licenses · study certification documentation and CVs · laboratory documentation · Manual of Procedures (MOP) · Standard Operating Procedures (SOPs) |
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| 13 | Ensure reporting of study closure to the IRB and receipt/filing of study closure confirmation in the investigator site files | |||
| 14 | If study was terminated early, confirm notification of study termination has been sent to all enrolled subjects as appropriate* | |||
| 15 | Confirm that all protocol deviations have been noted in source documentation and reported to the IRB as appropriate | |||
| 16 | Consider appropriate storage of Quality Management (QM) reports / metrics | |||
| 17 | Confirm NIDCR/sponsor requirements for record retention and notify NIDCR/sponsor when study files will be transferred to long term off-site storage | |||
| Ensure the completeness of the following logs: | ||||
| 18 | Pre-Screening Log (if applicable) | |||
| 19 | Subject Screening and Enrollment Log | |||
| 20 | Monitoring Visit Log (if applicable) | |||
| 21 | Delegation of Responsibilities Log | |||
| 22 | Telephone Log | |||
| 23 | Training Log | |||
| 24 | Subject Code List | |||
| 25 | Randomization Log (if applicable) | |||
| 26 | Investigational Product Accountability Log: Stock Record (if applicable) | |||
| 27 | Investigational Product Accountability Log: Subject Record (if applicable) | |||
| 28 | Specimen Tracking Log (if applicable) | |||
| 29 | Freezer/Refrigerator Temperature Logs (if applicable) | |||
| Investigational Product | ||||
| 30 | Confirm that investigational product disposition forms and accountability records are complete and present for all subjects receiving study drug | |||
| 31 | Confirm final disposition of investigational product was completed per MOP, site pharmacy protocol, supplier, and sponsor requirements | |||
| Collected Laboratory Specimens (Samples) | ||||
| 32 | Confirm that all specimens have either been analyzed or stored for future use | |||
| 33 | Ensure that specimens collected for future use have been adequately processed, labeled/de-identified, and stored | |||
| 34 | Confirm site process for identification and disposition of future use specimens connected to subjects who withdraw consent or do not consent for their specimens to be saved | |||
| 35 | Confirm destruction, per institutional policies, of specimens not identified for future analysis | |||
| Analysis, Manuscripts, and Submissions/Publications | ||||
| 36 | Data analysis complete | |||
| 37 | Primary manuscript finalized | |||
| 38 | Results submitted to Pubmed and ClinicalTrials.gov (as applicable)
Intramural Studies: Confirm that notification has been made to the Office of Protocol Services (OPS) for change in study status and update to ClinicalTrials.gov Extramural Studies: Confirm that the appropriate party has updated ClinicalTrials.gov with the update in study status |
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| 39 | Confirm final disposition of study supplies and any equipment provided for the study: <insert study-specific items> | |||