A clinical study is done in line with a research plan known as the protocol. The protocol is designed to answer specific research questions and safeguard the health of participants. It has the following information:
- The reason for doing the study
- Who may join the study (the eligibility criteria)
- The number of participants needed
- The schedule of tests, procedures, or drugs and their dosages
- The length of the study
- What information will be collected on the participants