clinical hold clinical hold
A pause to all or parts of a research study ordered by the government agency that oversees research in a country.
Example of clinical hold in a sentence
A clinical hold can be placed on studies involving a product (like a drug or device) by regulators like the FDA for many reasons, including safety concerns.
More Info
A clinical hold is a mandatory study suspension imposed by a government regulator.
Reasons for a clinical hold include concerns about participant safety, study quality, or insufficient information.
A complete clinical hold means all clinical study work is paused or delayed. A partial clinical hold means only a part of the clinical work must be paused or delayed.
In contrast, an “administrative hold” is a voluntary pause by the principal investigator. Ethics committees can also pause or stop research through a “suspension or termination of IRB approval.”
Other countries have a similar process, though they may use different terminology.
Other info to think about when joining a study
If there is ever a clinical hold on a research study you are participating in, you can ask the study team, what caused it and if there are plans to respond to the clinical hold so the research can continue.
If there is a clinical hold, your study team will contact you to let you know. For your safety, please pay extra attention to any phone calls or messages you get about “clinical holds.”
