Published on November 06, 2018

In our previous article, we talked about selecting a good research topic. In order to turn our research topic into a meaningful publication, we must first develop a research protocol. This could then lead into starting a clinical trial.

Clinical Research Protocol Considerations

A research protocol is a document that outlines the planning of your study. The plan must be designed to answer the research question and it must also provide a detailed description of the objectives, design, methodology and statistics used. The protocol in effect is the cookbook for conducting your study. In clinical research, the research protocol is of particular importance as it serves as the binding document that states what you are—and are not—allowed to study. Your research protocol will also be the most important document in your application with your institution’s review board (IRB).  So, how do you make sure your protocol is accepted? This article provides five tips on how to write a solid research protocol.

1. Find out if your research protocol requires IRB approval

When you write a research protocol for medical research involving human participants, you will most likely require approval by the hospital’s Institutional Review Board (IRB).

The primary responsibility of the IRB is to protect human participants from unethical research practices and compliance with applicable regulations and policies. In most hospitals, the IRB only meets periodically, so the goal should be to get your study approved without resubmission. If the IRB comes back with questions, chances are your study will be delayed for several months.

So before starting on your protocol, first determine if your study requires approval, and if so, make sure you follow your institution’s IRB guidelines.

Furthermore, in the United States, be aware of FDA guidance regarding protocol deviations.

2. Mention all research activities a participant will undergo

Good Clinical Practice (GCP) places special emphasis on protecting the health and safety of the participants. Therefore, make sure you detail all research activities a participant will undergo. It is common for IRBs to reject a research protocol on the basis of insufficient detail. Create a table outlining the steps of each study phase, and describe what study activities will occur during each subject’s visit or interaction. The rule of thumb is that the activities should be described in such detail that an independent investigator could carry out the study activities without additional information.

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3. Describe what statistical methods you will use

One of the key aspects of the clinical research protocol is to describe the statistical techniques that you will use for analysis once the data is collected. While we could write a whole book on this topic, let’s go over some of the most important points. We advise you to meet with a statistician to determine that:

  • The study design adequately addresses the research question;
  • The study design will yield the expected data;
  • The proposed number of participants is justified by the required power of your study;
  • The inclusion and exclusion criteria are properly defined;
  • The study setup contains adequate bias control measures.

4. Clearly discuss the scientific background literature

The decision by the IRB on whether your study is ethical is based to a large extent on the scientific background. The background will give the IRB insight into the safety of your intervention and whether it is important enough to expose patients to. It is therefore important to add to the research protocol a clear overview of the scientific literature and prior (pre)clinical studies you have performed on the topic. An omission of this information can lead to delays in IRB approval. Gathering and structuring the literature will not be in vain, as it will help you later on when writing your paper.

5. Have a group of (experienced) peers provide feedback

Before submitting your research protocol to the IRB, it is good practice to obtain critical feedback from your peers. If your colleagues are unclear on aspects of the protocol, then the IRB may have similar difficulties. Peers may also point out what practical matters you will run into during your study. Having the buy-in of peers could also help you during the study, as they will be familiar with your work.


As Benjamin Franklin said: “By failing to prepare, you are preparing to fail. Being well-prepared means having a well thought out and detailed research protocol that you can follow during the execution of the research project. Writing a protocol is also fun, and it will train you as a scientist. If you would like to see an example of a protocol, see this UCSF protocol here.