Chalking Up Components of Clinical Research

For any clinical trial, there are a lot of details to understand, and a lot of people who need to understand them. From before the trial begins until well after it ends, research doctors and nurses, study participants, the study sponsor, and even regulatory agencies such as the U.S. FDA need to know how and when the study will be conducted and what happens during and after the trial.

That’s why study documentation is so important. Talk about big data! Multiple thousands of data points are collected and analyzed to ensure that the study—and, ultimately, the new medication we hope is developed—is safe and effective.

So, who needs to know what and when, and how do they get that information? Check out the “chalkboard” display below for an overview of the documents that communicate key components of clinical research.

To learn more about each component, read on for more details, or give us a shout on Twitter to ask a question.

1. Protocol (coming soon)
2. Informed Consent
3. Case Report Forms (coming soon)
4. Clinical Study Report