Clinical Document Preparation (Protocol, ICF, IB, IND/NDA)

Course Description

Formerly "Document Preparation: Protocols, Reports, Summaries."

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.