Making the Switch: Writing a Protocol

Part 3 – How to Write a Protocol to Encompass an Electronic Data Capture (EDC) System 

Welcome to Part 3 of our series, “Making the Switch: From Paper to EDC.” In this installment, we will dive into the importance of a study protocol, what to include in your protocol, and how to incorporate Electronic Data Capture (EDC) system details into a protocol. 

What Is a Study Protocol? 

A study protocol is a comprehensive document that outlines the objectives, design, methodology, and procedures of a clinical or lab trial. It answers many questions, including “what is the point of the study?” and “what will be accomplished?” The protocol also serves as a detailed guide for researchers, clinicians, and other stakeholders involved in the trial. It provides a standardized framework for conducting the trial and ensures that all participants are treated consistently and ethically. 

A protocol is an essential document for a clinical or lab research study. All aspects of the study, including details about the EDC system to be used, must be documented. Therefore, writing a comprehensive protocol is a key step when conducting this type of research. 

Why Are Protocols Important? 

Study protocols are important because they: 

1. Standardize study procedures, ensuring consistency and reliability of results. 
2. Protect participant rights and ensure ethical conduct. 
3. Facilitate study reproducibility and verification of results. 
4. Help in regulatory compliance and obtaining necessary approvals. 
5. Enhance communication and collaboration among research team members. 
6. Guide data analysis and interpretation, ensuring meaningful insights. 

Overall, the study protocol ensures reliable and ethical conduct of the study, promotes transparency, and facilitates the generation of valid results. 

What Is Included in the Protocol? 

A study protocol, authored by the sponsor, includes several key components that provide a comprehensive description of the study, collectively providing a detailed guide for researchers, clinicians, and other stakeholders involved. It ensures consistency, transparency, and adherence to ethical and scientific standards. There are commonalities between studies following Good Clinical Practices (GCP) and Good Lab Practices (GLP). In either case, a high standard of documentation is required, including details of computers and software, such as an EDC, used during the conduct of the study. 

A study protocol contains key elements such as: 

1. Study Title and Identification: A concise and descriptive title and a unique study identification number. 
2. Background and Rationale: A summary of the scientific and clinical background that justifies the need for the study. 
3. Study Objectives: Clear statements of the study’s goals. 
4. Study Design: Detailed description of the study design, randomization (if applicable), blinding (if applicable), and data collection methods.  
5. Participants: Includes any inclusion/exclusion criteria defining who can participate in the study. 
6. Interventions or Procedures: Detailed information about the interventions, treatments, procedures, or tests to be performed during the study, including dosages, frequencies, and duration. 
7. Outcomes and Endpoints: The specific outcomes and endpoints that will be measured and evaluated during the study. 
8. Data Collection and Analysis: Description of the data collection methods, tools, and instruments to be used, as well as the statistical analysis plan detailing how the collected data will be analyzed. 
9. Data Management and Quality Control: Description of data management processes, including data handling, storage, and quality control measures to ensure data integrity. 
10. Ethics and Regulatory Compliance: Procedures to ensure adherence to GCP or GLP guidelines and regulatory requirements. 
11. Study Timeline and Organization: Timeline and roles/responsibilities of the research team. 
12. References: Citations to relevant literature and sources that support the study rationale and design. 

A GCP study protocol will also include details around: 

1. Informed consent: Description of the informed consent process for participants. 
2. Safety monitoring and reporting: Procedures for monitoring participant safety throughout the study, including adverse event reporting and measures to minimize risks. 

While a GLP study protocol will include information regarding: 

1. Test substance information: Detailed description of the test substance, including identity, composition, and stability. 
2. Quality control measures: Procedures for equipment calibration, validation, and maintenance to ensure reliable data. 
3. Standard operating procedures (SOPs): References to relevant SOPs for consistent and standardized procedures. 

These elements in a study protocol demonstrate adherence to GCP or GLP principles and ensure the conduct of a well-designed, accurate, ethical, and scientifically rigorous trial.

“Including the crucial information about your EDC in your protocol can save time and reduce the number of questions the regulators may have about your data collection, retrieval, and archiving.”

Ann-Marie Kiser, Director of Compliance at Prelude

I’m Using an EDC. Where Do I Put Information About My EDC? 

There are several places in the protocol where it is appropriate to include information about your EDC system. These include: 

• Data Collection: Are the forms used to collect data paper or electronic? Who will collect the data? What is the backup system (i.e., if the EDC goes down, how will data be collected)? 
• Randomization in the Study Design: Include what randomization tool you are using. EDCs, such as Prelude’s EDC, offer randomization tools that can be seamlessly added to the EDC’s functionality. 
• Data Review: Who is reviewing the data? Who is blinded? Who is authorized to review the data? What forms can the monitor review? What forms can the investigator review? 
• Data Archiving and Retention: How is the data being archived? How long will data be stored? 

• Validation: It is necessary to confirm the system is validated. When submitting study data to a regulatory authority, the sponsor must include a statement that they validated the system. Learn more about validating an EDC. 

Regulatory bodies review the protocol before the start of the trial. Therefore, any information pertaining to the use of the EDC should be included before the initial submission to regulators. 

Remember to Incorporate the EDC Details into Your Protocol 

A study protocol ensures that clinical and lab trials are conducted in an ethical, consistent, and scientific manner. The objectives, design details, methodology, statistical considerations, safety parameters, and other important aspects of the research trial must be outlined – all of which are reviewed and approved by a regulatory body. This includes encompassing your Electronic Data Capture (EDC) system information from the start before the protocol review takes place.