Study Closeout | Overview
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Closeout the study
| Study closeout checklist | There are a plethora of activities that need to be conducted by the investigator and study team during the study closeout phase that involve: data management, adverse events reporting/reconciliation, review of site files, review for completeness the various study logs and documents, management of remaining investigational product, review of collected laboratory specimens, analysis of the study data, manuscript preparation and submission and more. A Study Closeout Checklist can be accessed and modified to meet the needs of a particular study. |
| Data cleaning | Many different types of data that are collected during and interventional trial. Prior to the final analysis, any outstanding or errant data needs to be identified and corrected. Particular attention must be paid to adverse event reporting as significant medical events. |
| Data analysis | Work with your statistician to complete data analysis. |
| ClinicalTrials.gov posting | Clinical trials are required to be registered and submit summary results to ClinicalTrials.gov. In addition, the International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition of the publication of research results generated by a clinical trial. |
| Dissemination of research results | Disseminating the findings from your research in the form of presentations, publications, and posters is an important professional responsibility. It's equally important to disseminate the findings of your study to the study subjects that participated in your research. |