clinical trial protocol number example

A clinical trial protocol number is a unique identifier assigned to a specific clinical trial protocol. It serves as a critical reference to identify and track the progress of the trial. In this article, we will provide an example of a clinical trial protocol number and discuss its significance.

Example of a Clinical Trial Protocol Number:

To illustrate how a clinical trial protocol number is structured, let's consider the following example:

Protocol Number: CT2021-001

In this example, "CT" denotes Clinical Trial, followed by the year of initiation (2021), and a unique sequence number (001).

The year indicates when the trial commenced, allowing researchers and regulatory bodies to determine its chronological order of initiation. The unique sequence number enables differentiation between multiple trials initiated in the same year.

Significance of a Clinical Trial Protocol Number:

1. Unique Identification: A clinical trial protocol number provides a unique identifier for each trial. This uniqueness is crucial, especially in multi-site trials or when referencing a specific trial in publications, regulatory submissions, or collaborations.

2. Verifiability and Credibility: The inclusion of a protocol number in publications or other documents enhances the transparency and credibility of the trial. It allows readers or reviewers to efficiently locate and validate the trial's details, methodology, and outcomes.

3. Regulatory Compliance: Clinical trial protocol numbers play a pivotal role in regulatory compliance. They are required in regulatory submissions, such as Investigational New Drug (IND) applications, to ensure regulatory authorities can effectively review and track each trial's progress.

4. Record-keeping and Tracking: Clinical trial protocol numbers are essential for maintaining accurate records and tracking the progress of trials. Sponsors, investigators, and regulatory authorities rely on these numbers to identify and retrieve specific trial-related information efficiently.

5. Standardization and Organization: By assigning a specific format to clinical trial protocol numbers, such as including the trial type and year of initiation, it facilitates standardized documentation and organization of trials. This standardization simplifies the categorization, retrieval, and analysis of clinical trial data.

6. Collaboration and Information Sharing: A clinical trial protocol number is often used in collaborations and partnerships between institutions or investigators. It allows for easy reference and communication regarding specific trials, ensuring efficient information sharing and potential synergies between research groups.

Conclusion:

In conclusion, a clinical trial protocol number is a significant identifier that plays a vital role in tracking and referencing clinical trials. It ensures uniqueness, improves verifiability and credibility, enables regulatory compliance, facilitates record-keeping and tracking, standardization, and organization, as well as encourages collaboration and information sharing. The example provided, CT2021-001, demonstrates how a clinical trial protocol number is structured. Researchers, sponsors, regulatory authorities, and other stakeholders rely on these numbers to effectively manage and monitor the progress of clinical trials.