What is a Clinical Trial Protocol? Decoding Study Design, Clinical Trial Plan, and Research Study SOP
If you have decided to participate in a clinical trial or start researching about various clinical trials, you have been overwhelmed by various technical terms used while describing a medical study. Through this blog post (a part of the clinical primer series), “What is Clinical Trial Protocol?” we attempt to help you decode one of the most commonly used terms in clinical trial jargon – “protocol”.
A Clinical Study Protocol can be defined as a document that depicts the scientific rationale, study design, and methodology of the clinical trial. In simple, layman’s language, protocol is the study plan on which a medical study is based upon. The protocol includes all aspects of the research study including the participant inclusion/exclusion criteria, test schedules, procedures, medications and their dosages, length of the study, methods used to analyze the data collected, and all other facets of the clinical trial.
Due to the critical nature of this document, the research teams have to follow a standardized format, based upon the good clinical practice guide issued by ICH (International Conference on Harmonization), while designing their clinical study protocol.
The protocol is the most important document related to any clinical trial, for it guides each and every action taken by the research team and determines how exactly the clinical trial will be conducted. The protocol is one of the first documents that the monitoring agencies verify before allowing a clinical trial study to be conducted.
The clinical trial protocol of the medical study you are planning to participate in will be explained to you in an easy to understand language before asking for your informed consent. Do ask all the necessary questions to the clinical research coordinator and ensure that you understand the protocol of the medical study clearly before giving your consent.