Are You Still Using A Paper Driven Trial Master File?

There are many moving parts to conducting a clinical trial. Sponsors have to coordinate investigators, CROs, IRBs, patients, and investors - often that coordination is across multiple countries. Many trials can generate more than 10,000 pages per trial.

Regulatory authorities require Sponsors to keep a Trial Master File (TMF). A TMF must contain all "essential study documents" required for each clinical trial; those include, but aren't limited to, documents such as medical and scientific curriculavitae, investigator brochures, study protocols, informed consent, case report forms, contract information, images, and safety documents. These serve to demonstrate the compliance of the investigator, sponsor, and monitor with GCP standards. The end result is thousands upon thousands of documents for each site, which must be compiled and managed by the Sponsor. No easy task.

Earlier this year, the Drug Information Association reported on a benchmark survey of the Life Science industry's use of Trial Master Files. It found that 50% of survey respondents maintained paper based TFMs, 7% maintained electronic TMFs, while 28% used a combination of paper and eTMFs.