A clinical trial protocol is a legal document which outlines the study plan of the clinical trial in a detailed, yet comprehensive and concise manner. The protocol must provide a valid scientific rationale for the conduct of the clinical trial as well as make sure that the rights of the patient is safeguarded, maintaining the health and safety of the patient. The general outline of a protocol describes about the participants of the study, the types of tests to be conducted, the schedule of the tests, the procedure, medication and dosages and also about the duration of the study. A research protocol should incorporate in it all recommendations made by the Medicines for Human Use (Clinical Trial) Regulations.
The protocol title, identifying number and date should be mentioned at the beginning in the protocol and any amendment thereafter should bear the amendment date and number. All protocols are required to have a number, which is unique to them. It is essential that version number and the status of the protocol (as in whether it is draft or final copy) are clearly indicated. All amendments are required to be numbered and dated so that the chronological development of the protocol leaves a trail. The protocol should mention the sponsor’s name and address, the title of the study, the title of the Investigator conducting the study, the contact details of the person responsible for all trial and site related medical decisions (if he is someone other than the Investigator) name and addresses of the laboratory, technical departments etc. in its General Information section. Any other relevant detail should also be included in this section. The footer of the protocol should contain the name and role of the person authorizing the protocol, along with a space for signature and date.
Generally, a well written protocol begins with a section called the Background Information containing Sections like the Introduction, Name and description of the Investigational Product, a summary of previous findings which are known to have significant clinical relevance to the trial, description and justification for the route of administration, dosage, regimens and treatment period and finally, a brief description of the population to be studied.
The subsequent sections of the protocol include trial objectives and purpose and brief description about the trial design. This is followed by the selection and withdrawal criteria of the participants. The treatment of participants section contains notes on treatment to be administered, permissible and non permissible medicines during/on/after trial and procedures on monitoring compliance.
Next comes the assessment of efficacy parameters followed by assessment of safety parameters. The protocol then provides a statistical description of the methods to be employed. This is followed by brief sections on Quality Control and Assurance, Ethics, Data Handling & Record Keeping, Finance and Insurance, Publication Policy and Appendices. References are cited at last in a protocol.
A protocol is applicable to all study members at a site, and any deviation from it must be immediately documented and must be informed to the sponsor or its representative without fail. A glossary of all important terms related to the trial should be also included in a well written protocol.