How to write a protocol for clinical trials

Click here for our seminar cancellation policy. Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 15 hours 1. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. Hold this course at your company! Checkout 0. If you are involved in clinical investigation, you may need to contribute to the preparation of a clinical trial protocol.

A clinical trial protocol is a document describing how a clinical trial will be conducted, including the objective s , design, methodology, statistical considerations, and organization of the trial to guarantee the safety of the participants and the integrity of the collected data. The protocol also provides the background and rationale for conducting the study and the research questions that it addresses, as well as considerations on ethical issues.

The protocol is a key quality control tool for all aspects of a clinical trial, being necessary for several reasons:. The protocol synopsis is the basis to write the complete clinical trial protocol, being usually developed by the sponsor or the sponsor together with the CRO.

The synopsis is a short document listing the primary and secondary objectives of the clinical study and providing an overview of the study design and details about treatment s.

You can find an example of protocol synopsis from the World Health Organization in this link. The protocol synopsis and the complete protocol document should be prepared following ICH E6 compliant templates to ensure consistency and the inclusion of all key elements. The protocol synopsis includes the following information: study title, product, clinical phase, protocol number, disease indication, trial identification number, information about sponsor and investigator, and information about clinical sites.

Moreover, the synopsis describes the objectives, study design, study population, sample size, eligibility criteria for inclusion and exclusion , treatment, and type and timing of assessment based on objectives with a clear schedule or flowchart. A precise definition of the objectives and the study design increases the efficiency of writing and avoids inconsistencies.

Sample size calculation should be based on the primary objective, with additional objectives categorized as secondary. After preparing the protocol synopsis, the whole protocol can be developed.

The complete protocol includes additional elements listed below , such as the introduction including clinical and non-clinical data , the rationale, a more detailed description of the assessments, the description of statistical methods, prior or concomitant treatments, and the conditions under which the study needs to be suspended or cancelled.

The ICH website reports the full list of topics that should be included in the protocol. Different specific guidelines have been developed depending on the anticipated study design, most of them containing a full list of items to be covered.

Clinical trial protocols are not usually prepared by a single person. Instead, they are written by a multi-disciplinary team that frequently includes a medical expert, a statistician, a pharmacokinetics expert, the clinical research coordinator , the project manager, and a medical writer that includes all inputs in a final document, among other experts. This page last updated on July 12, Back to Top.

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