If you’re new to clinical research studies, you might wonder: How do all these moving parts come together in one cohesive study? After all, clinical research studies engage countless participants, researchers, and clinical staff while adhering to rigorous safety and consent regulations. How does anyone keep it all straight? The answer: through an expertly designed clinical research study protocol. But what is a clinical research study protocol?
What Is a clinical research study Protocol?
A clinical research study protocol, otherwise known as a research protocol, is a document that dictates every aspect of a given clinical study. That includes the rationale for the study, the study objectives, and specifics guiding the design, methodology, and organization of a study. More specifically, the protocol will instruct researchers on how to execute the study. It will also outline recruiting guidelines and data collection methods. Finally, protocols are used to demonstrate the intent and outcomes of a study, usually in conversation with study regulators and review boards.
How Are Protocols Designed?
The National Institutes of Health (NIH) provides a number of resources that help experts design protocol documents. While some clinical studies are created using precise NIH protocol templates, others merely use the templates as a loose guide. However, if you are signing up for a clinical research study, rest assured that the protocol document has already been approved.
What Does a Protocol Include?
We briefly touched on the components of a clinical research study protocol above. Now, let’s dig in a bit further. In addition to other relevant information, all protocol documents will include the following:
- Study background and rationale: This explains why a clinical research study is being conducted. For example, some studies may be conducted to determine if a drug is safe, while others may be conducted to determine how effective a drug is compared to the current clinical standard.
- Study objectives: This refers simply to the goal of the product being tested. For example, if a study aims to examine a new skin cream to alleviate allergy symptoms, the primary objective may be for the subject to experience less itching or burning. Secondary objectives may include greater quality of life, including better sleep or improved mental health.
- Recruiting criteria: All clinical research studies will include a section for recruiting criteria. This section covers who is allowed to participate in the clinical research study. For example, if it is evaluating a new chemotherapy drug, the protocol will likely restrict the recruiting criteria to individuals currently undergoing chemotherapy. This criterion will also outline any age restrictions or other requirements specific to the study, like location.
So, what is a clinical research study protocol? These carefully reviewed documents outline the why, what, and how behind every single study. If you are considering participating, rest assured that your protocol document is created with your safety and comfort in mind.
Have you ever thought about participating in a clinical research study? You could be a part of history! QPS Missouri is looking for new participants. Since opening its doors in 1994, QPS Missouri has conducted more than 1,500 FDA-regulated studies, paying out nearly $50 million to local participants. Your local participation could have a global impact, as QPS is an international leader in contract research with facilities in North America, Europe, and Asia. Our mission is to accelerate the development of drugs worldwide by enabling breakthroughs in pharmaceutical innovation. This includes several pediatric studies across several age ranges. If you would like to join us in this crucial healthcare mission, consider applying for a clinical research study.
To get started, you simply need to fill out an online application. After that, within 48 business hours, a recruiting coordinator will contact you for your pre-screening assessment. To learn more, please visit the QPS Missouri website, review the study participation process, or check out our list of frequently asked questions.