Protocol – is a document that outlines the objectives, design, methodology, and procedures for conducting a clinical trial. It serves as a guideline for investigators to follow throughout the study, ensuring consistency, accuracy, and ethical conduct.
Definitions
ICH E6(R2)
- 1.44 Protocol:
- A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments [1].
Requirements for study protocol
Study protocols are essential for maintaining the integrity of the research process and protecting the rights, safety, and well-being of study participants. Study protocols serve as reference documents for investigators, monitors, regulatory authorities, and other stakeholders involved in the research process.
Protocol development
Protocols are typically developed by the study sponsor or principal investigator in collaboration with a multidisciplinary team of medicine scientists, clinicians, statisticians, and regulatory experts [2].
Typical structure of a clinical trial protocol
General information
- title of the study, and a unique identifier for the protocol
- information on sponsor/CRO/investigator
- protocol synopsis
Background and scientific rationale
- the need for trial conduct
Study objectives
- clear and specific statements outlining the primary and secondary objectives of the study
Study design
- type of study (e.g. randomized controlled trial, observational study), study phase, allocation of participants to different study groups
- definition of primary and secondary endpoints (i.e. outcome measures) used to assess the effectiveness and safety of the interventions
- definition of study population, this section contained inclusion and exclusion criteria
- descriptions of the investigational product(s), treatments, procedures, or interventions of study
- instructions for conducting of study, including participant recruitment, screening, randomization, treatment administration, follow-ups, and data collection procedures
Safety monitoring
- safety parameters
- monitoring of participant safety
- adverse event (including SAE, SUSAR, AE of special interest) reporting procedures
- measures to mitigate risks associated with the study interventions
Statistical analysis plan
- study hypotheses
- statistical methods and analyses planned to evaluate study outcomes and assess the significance of the results
Ethical considerations
- confirmation of compliance with ethical principles, regulatory requirements, and guidelines for the protection of human research participants
- protection of confidentiality and privacy of participant data throughout the study
Data management and quality assurance
- data collection, handling, and storage
- quality control to ensure the reliability and integrity of the study data
Publications
- publication policies
References
- relevant literature, regulatory documents, and guidelines that support the study design and methodology
Review and approval
Once finalized, protocols undergo review and approval by the relevant regulatory authority and institutional review boards or independent ethics committees to ensure regulatory compliance, as well as scientific and ethical conduct.
See also
Another relevant pages
Links to this page
- Clinical research (← links)
- Phase I clinical trials (← links)
- Phase II clinical trials (← links)
- Protocol Amendment (← links)
- Audit (← links)
- Essential documents (← links)
- Independent ethics committee (← links)
- Regulatory inspection (← links)
- Institutional review board (← links)
- Monitoring (← links)
- Quality assurance (← links)
- Corrective and Preventive Action (← links)
- Source data (← links)
- Sponsor (← links)
- Standard operating procedures (← links)
- Trial site (← links)
References
- ↑ ICH, 2016, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf Accessed Sep 2023
- ↑ Cimino, Jonathan, and Claude Braun. 2023. Design a Clinical Research Protocol: Influence of Real-World Setting Healthcare 11, no. 16: 2254. https://doi.org/10.3390/healthcare11162254 Accessed Apr 2024
External links
- The SPIRIT Statement https://spirit-statement.org/spirit-statement/
- CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials https://www.equator-network.org/reporting-guidelines/consort/