16 Components of a Study Protocol in Clinical Research
A clinical study protocol in clinical research outlines the entire study design, objectives, and methodologies. It typically contains study details that are pertinent to follow when conducting a clinical trial. If any deviations from the protocol occur, a protocol deviation form must be filed and submitted to the appropriate authorities. It’s important to focus on study objectives, review inclusion and exclusion criteria, follow the treatment regimen, understand statistical methods, and look for safety monitoring procedures. This can all be found in the protocol.
Please see the following 16-component breakdown of what is typically included in a protocol to help you get familiarized with and navigate the clinical trial.
1. Title Page
On the title page, you will find the name of the study. From the title, you can usually tell what is being studied or tested. The page also includes a unique protocol number, version, and date. It’s important to use the most up-to-date version of the protocol. Additionally, it would include the study sponsor and any key investigators.
2. Table of Contents
As you might have already guessed, the table of contents page provides a roadmap of the document. Based on your needs throughout the study timeline, you can refer to this protocol for clarifications.
3. Background and Rationale
The background and study rationale include a brief explanation of why the study is being conducted. This often contains a review of existing data, scientific literature, or unmet medical needs. Furthermore, it might include information from previous studies or research that led to the need for this trial.
4. Objectives and Purposes
This section contains the primary objective that addresses the main question or outcome the study is designed to answer. For example, assessing the efficacy and safety of a drug, vaccine, medical device, and biomarkers.
5. Study Design
This section shows the type of study being performed. It could be interventional, observational, randomized, double-blinded, etc. It also states design characteristics such as how the study is structured. Some of these characteristics include phase and duration. It will also mention if the study requires any randomization to minimize any bias and any required control groups.
6. Study Population
This section includes the inclusion and exclusion criteria of the study. The inclusion criteria include any specific characteristics required for subjects to be eligible to participate in the study, whereas the exclusion criteria show the characteristics that would disqualify potential participants. Additionally, it might also include information on how many participants are expected for the study.
7. Interventions
This section included a detailed description of the investigational product (IP) or procedures that are being studied. It also includes all the different groups or interventions that will be tested, specific dosages, and routes of administration.
8. Treatment Regimen
This section includes the dosing schedule, duration of treatment, and monitoring. This will give you information on how often participants will receive the intervention, how long each participant will undergo treatment or observation, and the types of assessments and tests that will be performed during the study.
9. Study Assessments
The section includes the primary and secondary endpoints and study monitoring information. The endpoints are the outcomes that are being measured to evaluate the success of the intervention and measure other important outcomes like quality of life. Furthermore, It will also provide information on plans for tracking and reporting any adverse events.
10. Statistical Considerations
This section includes a sample size calculation and further information on how the data collected from the study will be used to determine the endpoints.
11. Risk Management and Safety Monitoring
In this section, there will be information on safety reporting in case of adverse events (AEs) or serious adverse events (SAEs). If a Data Safety Monitoring Board (DSMB) is involved, they may have a role in evaluating the safety data and making recommendations to stop or modify the study.
12. Ethical Considerations
In this section, the informed consent process is mentioned by which participants are made aware of the study’s risks and benefits before agreeing to participate. It will also mention the approval from the Institutional Review Board (IRB) to ensure the study complies with ethics standards and how the patient data will be protected and used.
13. Data Management
This section describes how data will be collected, recorded, and managed in the eSource and EDC systems. Additionally, it will also include how the data quality will be monitored and ensured during the study.
14. Study Procedures
This section includes a timeline or chart to explain study visits, outlining when and what assessments will be made.
15. Study Termination
This section mentions the criteria and conditions under which the study might be prematurely terminated. It will also include exit procedures in case a participant completes or withdraws from the study.
16. Appendices
Finally, the appendices will include any necessary regulatory documents, case report forms (CRFs), informed consent forms (ICFs), and more.
Please note that these sections in the protocol may vary based on the type of the study. The purpose of this blog is to give you a generic idea of what it typically includes to get you familiarized with the components of a protocol.
