Definition: A protocol is the set of rules, policies and procedures that the researchers and staff conducting a clinical trial must follow. If you are participating or considering participation in a clinical trial, you have a right to request the protocol. The protocol will have all the details about scheduling, dosages, monitoring and other procedures.

The analysis can only be restricted to the participants who fulfil the protocol in the terms of the eligibility, interventions, and outcome assessment. This analysis is known as an "on-treatment" or "per protocol" analysis. Also, the per-protocol restricts the comparison of the treatments to the ideal patients, that is, those who adhered perfectly to the clinical trial instructions as stipulated in the protocol. This population is classically called the per-protocol population and the analysis is called the per-protocol-analysis.

Clinical Trial Data Services (CTDS) are an organization that focus on clinical research. The organization also provide understanding about clinical trial processes, for example.

What should be included in a clinical trial

Clinical Trial Service Unit was created in 1975.