The term protocol refers to a document where in methods and procedures of any scientific experiment or a examinations or a study is predefined and written in a format so that when they are followed it produces reproducibility in the process or procedures in any scientific examination or an experiment, it also helps in understanding the principals and objectives and methods involved in the examination or an experiment or a study.
Protocol of a clinical trial is a document which provide complete information in detail about a study plan upon which a clinical trial is based, it describes objectives of a clinical trial, why there is a need of caring out the said clinical trial, clinical trail protocol also describes design and the methodologies for clinical readings and their statistical evaluations, with the objective of finding satisfactory answers about safety and efficacy of a treatment or therapy or a drug or a medical device. Participants assigned to a protocol are regularly seen by researchers and doctors to evaluate effect of a treatment, therapy or a drug or a device on their health.
Clinical trial protocol also describes about, who can participate in there clinical trail, as well as test schedules and medications, dosage regimen and other medical procedures and length or time period the study. Clinical trial protocol is required to provide in detail information about regulatory Sponsor, information about investigators and sponsor , Funding Sponsor, and their complete details as address and contact numbers ,contact details , Clinical trail protocol gives an idea about the necessity of study and with its background, such information can be provided in separate document in referenced in the protocol. Main objective of the clinical trial protocol is the protection of subjects participating in a clinical trial.
More over the content and the format of a clinical trail protocol for trials sponsored by a pharmaceutical and Biotechnology Company in United States of America, European union, Japan is standardized so as to follow regulations in good clinical practices guidelines issued by ICH. (International conference on harmonization of technical requirements for registration of pharmaceuticals for human use) authorizes in Canada and Australia responsible for regulation of pharmaceuticals and drugs also follow ICH guidelines.
Having a protocol in place for a clinical trial enables investigator to have a common reference document for the researchers' responsibilities and duties during the trial and it also facilitate them to conduct trails at many locations (multi center trial), with complete similarity at all places and at the end of study data is collected from all study centers and combines for final evaluations.
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