4 High-Level Components to Include in Your Clinical Research Protocol

Clinical research protocol requires an exponential amount of information. However, there are four high-level components you have to consider for your Veristat clinical trial design to be approved. From general information that includes the title of your project and all the necessary steps, you will need for it to be a success to a detailed description of the trial. Here is a list of the four most important components you will need for your research protocol.

Study Design

This includes the clinical trial’s overall design, which can be altered depending on the trial you are conducting. It covers the clinical trial planning, which will include topics like the exclusion and inclusions criteria, the subjects required to have a successful trial, the duration of the study, and the number of clinical sites to be included in the study. In the study design, you will also need to include the type of clinical study you are conducting. It could either be a single-blinded or double-blinded, multi-center or single-center, or even prospective-retrospective study.

The General Information About the Clinical Trial

This is the most straightforward part of the clinical research protocol, which has the titles and the trial identification number.  It should include the name and address of the sponsor or the person who is funding the trial. Also, be sure to include the name of the laboratory carrying out the trials, and the departments of the institutions involved in your research. You can also include a brief schematic and schedule of all the activities that should take in the clinical trial and the order it is supposed to take.

Study Procedure

This is one of the most crucial sections of the protocol. It involves a detailed explanation of the procedure followed, measurements taken, and observations made during the trial. It is a detailed explanation of the steps taken from the beginning to the end of the study. This section contains a step-by-step manual of how the staff is supposed to consult the trial. It is essential to ensure that you avoid any gaps or clear out anything that might be unclear so that you can ensure the study does not divert from its intended plan.

Data Management and Statistical Analysis

Another critical aspect of the protocol is to provide information on how the collected data will be managed. This part should be prepared with the assistance of a statistician.  They will provide statistical methods on how best to analyze the proposed data for the best results. The data analysis process should include the power of the study, the level of significance for the study, and a research hypothesis. Data analysis will ensure that you interpret the trial results in the best way possible.

Writing the clinical research protocol is one of the most challenging stages of the clinical trial. However, when it is well written, the document makes the whole study a breeze. That’s because everyone is aware of the role they need to play and the steps to be taken at every point of the clinical trial.