Trial Master File


Documents are an integral part of clinical research. Essential documents are those documents that individually and collectively allow the evaluation of the conduct of a trial and the quality of the data generated. Good Clinical Practice (GCP) guidelines require that all documents and information about a clinical trial be handled, stored, and recorded in such a way that it can be reported, interpreted, and verified accurately.

Clinical trial documents also demonstrate the degree of compliance of the investigator(s), sponsor, and monitors with applicable regulations and GCP guidelines. They are usually audited by the Sponsor and inspected by the regulatory authorities to confirm data validity and integrity. Appropriate filing of these documents at the sites and with the investigator/institution also aids the efficient management of the trial conduct.

This comprehensive course for Essential Documents will give you all the required information you need regarding the documentation required for the conduct of a clinical trial.

What will I learn?

  • Design and elements of Protocol; Protocol Amendments
  • Informed Consent Form – definition, elements, exceptions to the informed consent principles, revisions, protection of vulnerable subjects
  • Green Light Package
  • Essential documents prior, during and after the clinical trial
  • Trial Master File – composition, set up, index, filing plan, e-mail correspondence, storage and end of study activities
  • Source document verification procedure