Medical Writing of Clinical Trial Documents
12 Contact Hours - 3 Days
No clinical trial can begin until a protocol has been written, and no clinical trial is complete until the final report is assembled, signed, and submitted to the regulatory authorities. Good documentation for clinical trials must be clear and scientifically sound, and it must conform to instructions. In this training, attendees will be introduced to the basic principles of clear medical writing of clinical trials essential documents and study the rules governing effective clinical trial documentation.
At the end of the training, participants will:
- Know the regulatory bodies behind clinical trial authorization
- Understand the guidelines for running and documenting clinical trials
- Understand the structure and sections of clinical trial essential documents
- Learn the step-by-step processes and strategies to design clinical trial documents like Standard Operating Procedures, Case Report Forms, Informed Consent Document, Research Protocol, Clinical Study Report etc. in compliance with the regulatory guidelines