Planning and monitoring safety

Planning for your safety before the trial

Scientific review

Before a trial begins, the sponsor creates a detailed plan called a protocol. This plan is reviewed by experts, including doctors, researchers, and specialists in the condition or treatment being studied. They check that the trial is safe, well-designed, and likely to provide meaningful results.

For trials of potential treatments or certain medical devices, the U.S. Food and Drug Administration (FDA) also reviews the protocol to make sure it meets strict safety and design standards before the trial can start. Learn more about the FDA’s role in clinical trial safety.

Ethics review

An independent review board (IRB) reviews the trial to make sure it is ethical, fair, and protects participants’ rights. The board includes doctors, scientists, and community members.

They make sure the trial only asks what’s necessary from participants and that safeguards are in place to minimize risk. Learn more about the IRB’s role in clinical trial safety.

Careful dosage

Before a trial begins, researchers carefully study how a potential treatment or medical device will be used. This includes early testing to determine safe doses, timing, and how the dose will be administered.

Monitoring safety during the trial

Informed consent

Before joining a clinical trial, you receive clear information about what the trial involves and any possible risks. This process is called informed consent. Informed consent isn’t just a form to sign—it’s an ongoing conversation.

Regular check-ins

During the trial, doctors and research staff check on your health and monitor for any side effects. This includes reviewing vital signs, lab results, and symptoms. A research coordinator or nurse is also available to answer your questions or address your concerns at any time.

Independent safety oversight

A Data Safety Monitoring Board (DSMB) watches the clinical trial as it happens, reviewing data and participant safety. The FDA also sets rules that all trials must follow to ensure participants are protected and the trial is conducted properly. These groups can recommend changes to the trial or even stop it if safety concerns arise. Learn more about independent oversight.