Clinical Trial (CT) Protocol Document Section
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A Clinical Trial (CT) Protocol Document Section is an research study document section within a CT protocol document.
- Context:
- It can (typically) be produced by a Clinical Protocol Development Task (supported by a clinical protocol development system).
- It can associated to a Clinical Trial Protocol Template.
- …
- Example(s):
- Clinical Trial Title Page.
- Clinical Trial Background Information Section.
- Clinical Trial Objectives/Purpose Section (with objectives).
- Clinical Trial Study Design Section (with design).
- Clinical Trial Selection and Exclusion of Subjects Section.
- Clinical Trial Treatment of Subjects Section.
- Clinical Trial Assessment of Efficacy Section.
- Clinical Trial Assessment of Safety Section.
- Clinical Trial Adverse Events Section.
- Clinical Trial Discontinuation of the Study Section.
- Clinical Trial Statistics Section (with statistical considerations).
- Clinical Trial Quality Control and Assurance Section.
- Clinical Trial Ethics Section.
- Clinical Trial Data Handling and Recordkeeping Section / Clinical Trial Data Integrity Section.
- Clinical Trial Publication Policy Section.
- Clinical Trial Project Timetable/Flowchart Section.
- Clinical Trial References Section.
- Clinical Trial Supplements/Appendices Section.
- Clinical Trial Schedule of Activities Section (for a CT SoA).
- …
- Example(s):
- …
- Counter-Example(s):
- See: Healthcare Protocol, Research Project Specification, Informed Consent Form, Data Monitoring Committee (DMC) Charter, Pharmacovigilance Plan, Investigational Product Management, Site Management.
References
2023
- chat
- Here's a summary of the sections that are typically contained within a Clinical Trial Protocol Document:
- Introduction: This section provides an overview of the trial and its objectives.
- Background: This section provides background information on the disease or condition being studied and the rationale for conducting the trial.
- Objectives: This section outlines the specific objectives of the trial, including the primary and secondary endpoints.
- Study Design: This section describes the design of the trial, including the study population, study treatments or interventions, study procedures, and data collection and analysis.
- Inclusion and Exclusion Criteria: This section outlines the criteria that will be used to select participants for the trial.
- Study Treatment: This section describes the treatment or intervention being studied, including the dosing regimen and administration route.
- Assessment of Efficacy: This section outlines the methods that will be used to assess the efficacy of the study treatment or intervention.
- Assessment of Safety: This section outlines the methods that will be used to assess the safety of the study treatment or intervention.
- Adverse Events: This section outlines the procedures for reporting and managing adverse events that occur during the trial.
- Data Management: This section describes the procedures for collecting, managing, and analyzing study data.
- Quality Control and Assurance: This section outlines the procedures for ensuring the quality and integrity of the study data.
- Ethics: This section describes the ethical considerations that have been taken into account in the design and conduct of the trial.
- Publication Policy: This section outlines the policies and procedures for publishing the results of the trial.
- References: This section lists the references cited in the protocol document.
- Schedule of Activities: This section provides a detailed timeline of the specific clinical research activities that will be conducted during the trial.
- These sections together provide a comprehensive and detailed protocol document that guides the conduct of the clinical trial.
- Here's a summary of the sections that are typically contained within a Clinical Trial Protocol Document:
2017
- https://hub.ucsf.edu/protocol-development
- QUOTE: Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.
A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. According to the ICH Good Clinical Practice guidelines, a protocol should include the following topics:
- Title Page (General Information)
- Background Information.
- Objectives/Purpose.
- Study Design.
- Selection and Exclusion of Subjects.
- Treatment of Subjects.
- Assessment of Efficacy.
- Assessment of Safety.
- Adverse Events.
- Discontinuation of the Study.
- Statistics.
- Quality Control and Assurance.
- Ethics.
- Data handling and Recordkeeping.
- Publication Policy.
- Project Timetable/Flowchart.
- References.
- Supplements/Appendices.
- QUOTE: Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.