What Is a Protocol?

 A protocol is an action or research plan in a clinical trial. It explains what will be done in the trial, how it will be done, and why each step in the trial is necessary. Clinical trials use volunteers, or participants, to take part in each study and to follow the protocols. Sometimes the trial requires certain specifications to be met, such as only males or only females, or those already affected by certain diseases or ailments. Other times, the studies require healthy individuals. The protocol is designed to answer specific questions and safeguard the health of the participants in a clinical trial.

Followings are the protocol for Clinical Research and Clinical Trials-

  1. Purpose of the study
  2. Number of participants
  3. Length of the study
  4. Eligibility criteria
  5. Schedule of tests, procedures, drugs, and/or dosages
  6. Information to be collected

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