The Clinical Study Protocol: The Basics

If you are new to the clinical research industry, it’s important to know how clinical studies are developed and run. The basis for all such studies is the study protocol, about which this piece will provide a high-level overview.

A study protocol is a document that provides an overview of the study. It includes information such as design, objectives, and methodology, and guides research conduct during the study.

There are general templates that may be used to construct a protocol. Typically, a study protocol has the following sections:

Note: This ordering is general and can be rearranged to what appropriately fits your study.

TABLE OF CONTENTS:

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1) Protocol Summary: This section is a synopsis of the study protocol document. It includes general information such as:

• • Study title;
  • Relevant contact information of sponsors, CRAs, investigators, etc;
  • Objectives of the study;
  • Methodologies used in the study;
  • WHO the targets are;
  • WHAT the study is about;
  • WHEN the study will take place; and
  • WHERE the study will take place.

2) Introduction: This section provides a concise summary of the study and covers information such as:

• • The study objective;
  • What compound or therapy is being used in the study; and
  • Explanations on the science behind the drug and the possible outcomes.

3) Objectives & Purpose: This section contains a detailed description of primary and secondary objectives. These objectives are simple and specific. Primary objectives are generally constructed around the safety and efficacy of a study; secondary objectives are minor, supporting objectives that can be met during the course of the study.

4) Study Design: The study design section overviews how the research will be conducted. It covers the structure and methods used for the study. The design section includes:

• • Design choice – What type of design is being carried out? For example, the study might be classified as an Observational, Interventional, or Cross-sectional study, followed by an explanation of why the design is the optimal choice for meeting particular objectives of the study.
  • Inclusion/Exclusion criteria – What population are you examining? This section defines the criteria for the eligibility of participating subjects. Factors like gender, age, and ethnicity are considered. Any study arms being used should also be justified.
  • Sample size – How many subjects will take part in the study? The power of the sample size plus any randomization methods used to capture an unbiased sample is included here, in addition to the informed consent process.
  • Dosing/Intervention – What drug is being used and how is it being routed and administered? Pharmacokinetics of the drug is detailed here as well as dosing information in alignment with a general study visit plan that may be constructed. Also, the pharmaceutical and brand name of the drug along with where the drug was developed and other related information is included in this section.

5) Risks: This section outlines the potential risks that are associated with the study. These are subject and non-subject related. It also discusses how adverse events are handled and documented. In accordance with GCP, every adverse event must be captured and documented even if it is not drug-related.

6) Data Management & Statistical Analysis: This section is extremely important to include especially if you are using an electronic means of capturing data. A detailed list of tools and software being used to capture data should be mentioned along with supplemental certification documents (eg: 21 CFR Part 11). Also, any HIPAA and other regulatory and compliance measures must be stated with accuracy and supporting documentation.

In addition, any methods used to measure statistical significance should be listed along with details of the variables being used in the study.

7) Project & Budget Management: This section lists and describes the various budgetary costs associated with the study. The following costs should be enumerated:

• • Employee hours and wages;
  • Capital expenditures;
  • Study-related care costs;
  • Drug costs;
  • Data and process management fees; and
  • Travel and meeting expenses.

Along with this, study milestones with respect to their study and site teams are listed.

8) Ethical Considerations: This section indicates whether the study procedures adhere to the Declaration of Helsinki. Alternative patient approaches along with benefits and all possible risks need to be detailed. Along with this, information regarding the informed consent forms is listed here.

9) References: It’s crucial to include a list of references in accordance with the Vancouver or Harvard citation guidelines. If another’s researcher’s idea is mentioned in the protocol, he/she must be cited as a reference in this section. This avoids plagiarism and copyright/trademark violations.

10) Documentation/Appendix: What are the necessary supporting documents that you may have referred to in the protocol? The following should be provided along with the study protocol:

• • Informed consent form;
  • Approval from the ethics committee;
  • Case Report Forms;
  • Study/site budget;
  • Delegation of duties; and
  • FDA 21 CFR Part 11 and any other certification and validation documents.

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This is a general outline of a study protocol. You’ll find that every protocol will have these elements in some form, with its own way of sectioning.

It’s also important to know that it often takes an entire team of experts to design a protocol. Anywhere from research coordinators to pharmacokinetic experts and project managers to outsourced medical writers can pitch in to design the protocol. It’s up to the design team to ensure that the study protocol is comprehensive, detailed, and covers all regulatory and compliance requirements. Reliable checklists and guidelines should be utilized by following the Standard Protocol Items: Recommended for Interventional Trials (SPIRIT) whose sole intention is to improve study protocol development standards.

CONCLUSION

There are numerous considerations to keep in mind when designing a protocol. Even though there are several templates and checklists out there, it’s essential to consider the opinions and advice of experts while designing the protocol. A comprehensive study protocol can decrease the chances of protocol amendments and can increase data fidelity.

Once your study protocol has been approved by the IRB, you are now a step closer to commencing your study.

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