Clinical trial protocol document
The clinical trial protocol is a document that contains information on the objective of the clinical trial, design, methods used to perform the trial and other statistical information the organization considers for the clinical trial. The document also contains the information on the reason why such a trial is conducted. However, this information can also be present on the regulatory submission document done after performing the phase 1 to 3 trials.
A protocol is a predefined set of principles used. Similarly, a clinical trial protocol contains a study plan that has to be carried over in the form of clinical trials. The protocol includes information that includes the type of people who can participate in the clinical trial, number of participants, methods used to perform the clinical trials, procedures followed during the trial, dosage of medicines to be given during the trial, schedule of the tests and the time limit of performing the trial. It aims at safeguarding the participants’ health without any adverse effects. The clinical trials are performed generally in an inpatient atmosphere, where the staff can monitor the participants’ health and effectiveness of the drug or its adverse effects.
The staffs generally are doctors or nurse well versed in the field of test. When clinical trials are considered at multiple centers following different procedures it results in confusion and wrong analysis of the available data. That is the reason; the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has standardized the clinical trial protocol based on the Good Clinical practice guide. In most countries like USA, Japan, China, and European Union, the protocol is standardized. Therefore, when the clinical trials are run on various centers, they still follow exactly the same procedures and same tests. Therefore, with the data generated, all the data can be grouped and analyzed as though they have been obtained by working together.
