Method
Flexible
Term
FALL
Units
1.5 QUARTER UNITS
Estimated Cost
$625

Skills you will gain

  • Clinical Trial Documentation: Master regulatory requirements and the structure of clinical trial documents.
  • Study Protocols & Reports: Learn to prepare effective study protocols, reports, and summaries.
  • Informed Consent & SAE Narratives: Create clear and compliant informed consent forms and adverse event reports.
  • Document Version Control: Implement best practices for maintaining version control in clinical trial documentation.
  • Regulatory Submissions: Understand the role of clinical documentation in regulatory submissions and marketing approvals.

Course Description


Clinical trial documentation must be clear, scientifically sound, conform to regulations and established standard operating procedures, and follow regulatory guidelines. Despite pressure to start the trial "yesterday," a clinical trial cannot begin without a study protocol in place. Many other documents are needed before and during the trial, and the trial does not end until a final report has been submitted. Documentation of the trial often continues with articles in the biomedical literature. This course provides insight into the processes for preparing effective study protocols, reports, and summaries. Participants have opportunities to practice preparing documents and applying the rules governing clinical trial documentation.


Topics

  • Regulatory requirements – CTD and eCTD – IND, NDA, BLA
  • Protocol development
  • Informed Consent (ICF), Health Insurance Portability and Accountability Act
  • Detailed Clinical Study Reports (ICH E3)

Professional Credit

黑料不打烊 EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 15 contact hours

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This course applies to these programs:

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