1 / 10

STUDY CLOSE OUT

STUDY CLOSE OUT. Definition. This relates to the closure of a study at a participating site once all subjects have completed the study and all data queries have been resolved. Note:. Close out is not a one-off visit but is a process that may take weeks to months to complete

yale
Download Presentation

STUDY CLOSE OUT

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. STUDY CLOSE OUT KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  2. Definition • This relates to the closure of a study at a participating site once all subjects have completed the study and all data queries have been resolved. KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  3. Note: • Close out is not a one-off visit but is a process that may take weeks to months to complete • Can have multiple close out visits • It is essential that data and information are retrievable and stored in a safe and logical manner. This process must be conducted in accordance with GCP and regulatory requirements. KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  4. Key areas Use the study close out SOP to provide guidance but the key areas are as follows: • Study documentation • Data Management • IRB/RA • Drug Accountability • Sample storage KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  5. Study Documentation • Study filing: Ensure filing of documentation has been maintained throughout the study and provides a clear audit trail • Archiving: Meet archiving requirements and make corresponding arrangements KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  6. Data Management • Data Validation: Completed data entry and all queries are resolved. • Electronic Data: mainly sponsor responsibility • Serious Adverse Event (SAE) Reconciliation KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  7. IRB/RA • Inform IRB, RA (if applicable) and local institution. • The reason for premature termination of a site if study stopped early. • All relevant safety issues and safety updates at and after close-out • The date of site closure KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  8. Drug Accountability • Reconcile accountability, supply and inventory logs for the study product. • Ensure proper documentation for return of product or drug destruction. • Any deviations should be documented. KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  9. Sample storage • Ensure long-term storage of clinical samples meets the requirements and is documented e.g. storage of baseline(screening) malaria slides or exportation of pk samples KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  10. Closing remarks • The study should be closed out such that its ready for an audit or inspection at a later date, as late as 10 years from now! KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

More Related