Writing a proposal for a clinical trial is one of the most challenging tasks for all researchers. As this is a new area to work on, the researcher must consider all the aspects of it trying not to miss any item during the process.

Clinical research is conducted according to a plan (a protocol) or an action plan. The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. It also describes the eligibility of the participants, the length of the study, the medications and the related tests.

A protocol is directed by a chief researcher. The health of the participants’ will be regularly checked by members of the research team to ultimately ensure the study’s safety and effectiveness. The protocol is important as they outline the purpose of the research proposal and the benefits of the protocol for the researcher.


The key points of the proposal should include justification for the need of the project and a detailed plan for the investigation:

What is the question? (Hypothesis) What is it to be investigated?

  • Why is the study important? (Significance)
  • Where and when it will take place?
  • What is the methodology? (Procedures and methods to be used).
  • How are you going to do it? (Research design)
  • Proposed time table and budget.
  • Resources required (technical, scientific, and financial).

To do this right all the ethical points. There are some considerations that are to be made:

  • Patients' and research subjects' names, initials, hospital or social security numbers, dates of birth or other personal or identifying information should not be used.
  • Images of patients or research subjects should not be used unless the information is essential for scientific purposes and explicit permission has been given as part of the consent. Even where consent has been given, identifying details should be omitted if they are not essential.
  • If identifying characteristics are altered to protect anonymity, authors should provide assurances that such alterations do not distort scientific meaning.