Clinical Research Glossary

non-compliance non-compliance


Not following research requirements.

Example of non-compliance in a sentence

Non-compliance with the research protocol can impact the outcomes of the research.

More Info

Non-compliance can apply to either researchers or participants not following the study requirements. Researchers must comply with the laws and regulations of research and the protocol as written. Participants must comply with study procedures.

Participant non-compliance could result in the principal investigator removing a participant from the study for not following the study instructions.

Regulators, sponsors or the IRB could check a research team for non-compliance with research laws and regulations.

Other info to think about when joining a study

You might hear the term “non-compliance” when study team tells you about things you should do while in the study in order for the data to be complete. If you do not do these things, non-compliance could be an issue. For example, the study team may say you have to take an investigational medicine 3 times a day. If you only take it twice a day, it would be considered non-compliance with the study procedures. There may also be things you cannot do while you are in the study and if you do them, that is also considered non-compliance.

Before signing up for a study, be sure to ask for clarification if you are unsure about what you need to do while you are in the study and what you cannot do. You may also want to ask what will happen if you are non-compliant. For example, if you have to take the investigational medicine once a day but you forget to, you can ask the study team what you should do in that situation.

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