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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