Article | July 20, 2022

Beginner's Guide To eTMF, eISF, And Regulatory Research Documents

Source: Advarra

By Stuart Cotter, VP of Product Management


To protect human subjects in clinical research, the Food and Drug Administration (FDA) maintains and enforces specific regulations. Research stakeholders must track, document, and store the required information for trial oversight and monitoring to comply with regulations. This blog identifies applicable regulations and outlines regulated documents and data in clinical research and the systems used by sponsors, contract research organizations (CROs), monitors, and research sites to collect, exchange, and store them.


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