Study Closure
- Obtain Funding & Types of Clinical Research completed
- Planning & Activation Process completed
- Study Conduct completed
- Study Closure
- Data Analysis, Publications, and Dissemination of Results not completed
Activities During Study Closure
Proper close-out of clinical studies ensures that the appropriate regulatory and oversight bodies involved in human subjects protections are informed of study status and assists in ensuring data integrity and the validity of study outcomes. Study close-out activities should be initiated once participant enrollment and research activities (including all follow-up visits) have been completed and can consist of activities including but not limited to:
- Updating regulatory and oversight bodies of study status.
- Data clean up and electronic database lock.
- Confirming final disposition of biospecimens, investigational product, study equipment, and supplies.
NIDCR provides as a resource a study close-out checklist that outlines the specific activities that might be necessary in this stage. Additional study close-out resources are also listed below:
Tools & Templates for Study Closure
Study Close-Out Checklists
| Resources | Description | Type of Study |
|---|---|---|
| Study Close-Out Checklist | Helps the investigator and research team plan orderly closure of study documents, data, and publication. |
Interventional/Observational |
| Site Close-Out Visit Readiness Checklist | Checklist to clarify the items required prior to scheduling a site close-out visit for an NIDCR-supported study. |
Interventional/Observational |
Final Safety Committee Report Templates
| Resources | Description | Type of Study |
|---|---|---|
| Clinical Study Oversight Committee Report: Final Report Template | Provides a recommended structure for reporting data to the Clinical Study Oversight Committee (CSOC) to be used as a starting point for preparing the final CSOC report associated with a completed or terminated study. Includes a proposed structure, draft language, and guidance. |
Observational |
| Data and Safety Monitoring Board Report: Final Report Template | Provides a recommended structure for reporting data to the Data and Safety Monitoring Board (DSMB), to be used as a starting point for preparing the final DSMB report associated with a completed or terminated study. Includes a proposed structure, draft language, and guidance. |
Interventional |
| Data and Safety Monitoring Committee Report: Final Report Template | Provides a recommended structure for reporting data to the Data and Safety Monitoring Committee (DSMC) to be used as a starting point for preparing the final DSMC report associated with a completed or terminated study. Includes a proposed structure, draft language, and guidance. |
Interventional/Observational |