Clinical Research Glossary

master protocol master protocol

CDISC

An overall research plan that guides sub-studies that have their own research questions.

Example of master protocol in a sentence

A master protocol includes information about more than one study and allows the research to happen more quickly.

More Info

A Master Protocol is the main protocol that guides sub-studies that can each be done at the same time.

Master Protocols are used because they can help get answers more quickly and efficiently. They generally need fewer participants and offer more study options.

Basket Trials, Umbrella Trials, and Platform Trials are all types of Master Protocols.

Other info to think about when joining a study

You may see studies refer to a “Master Protocol.”

These studies will have sub-studies that participants join. You can ask all about how the studies are designed, whether you can choose which sub-study you will be in, and how your experience in one sub-study may be different from other sub-studies.

Version 2.0 September 2024

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