Build skills to prepare accurate, regulatory-ready documents for clinical trials.
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
- Flexible Attend in person or via Zoom at scheduled times.
This class meets simultaneously in a classroom and remotely via Zoom. Students are expected to attend and participate in the course, either in-person or remotely, during the days and times that are specified on the course schedule. Students attending remotely are also strongly encouraged to have their cameras on to get the most out of the remote learning experience. Students attending the class in-person are expected to bring a laptop to each class meeting.
To see all meeting dates, click “Full Schedule” below.
Electronic Course Materials: You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
