Clinical Trial Data Handling and Recordkeeping Section

A Clinical Trial Data Handling and Recordkeeping Section is a data handling and recordkeeping section within a clinical trial protocol document.

• Context:
  • It can contain a:
    • Clinical Trial Data Collection Instruments Section.
    • Clinical Trial Data Management Procedures Section.
    • Clinical Trial Data Quality Control and Reporting Section.
    • Clinical Trial Archival of Data Section.
    • Clinical Trial Availability and Retention of Investigational Records Section.
    • Clinical Trial Monitoring Section.
    • Clinical Trial Subject Confidentiality Section.
    • …
• Example(s):
  • the section in https://hub.ucsf.edu/sites/g/files/tkssra261/f/Protocol_Template_052217.doc.
  • …
• See: Clinical Trial.

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References

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