Clinical Trial (CT) Protocol Document
A Clinical Trial (CT) Protocol Document is an research protocol document that represents some portion of a clinical trial protocol (for a clinical trial).
- 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.
- It can range from being a Clear Clinical Trial Protocol Document to being an Unclear Clinical Trial Protocol Document.
- It can (often) contain CT Document Sections, such as:
- 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 (clinical trial schedule of activities).
- …
- It can be associated with a Clinical Trial Publication.
- It can be associated with a Clinical Trial Protocol Amendment [1]
- …
- Example(s):
- NCT02975336 CT Protocol Document (for NCT02975336) [2].
- DS8500-A-U202 CT Protocol Document (for DS8500-A-U202) “A Randomized, Double-Blind, Placebo-Controlled with Active Comparator, 12-Week Study of DS-8500a in Subjects with Type 2 Diabetes Mellitus on Metformin” [3].
- NCT04020341 CT Protocol Document (for NCT04020341) [4].
- NCT02489318 [5]
- …
- 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
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Clinical_trial#Clinical_trial_protocol Retrieved:2021-12-28.
- A clinical trial protocol is a document used to define and manage the trial. It is prepared by a panel of experts. All study investigators are expected to strictly observe the protocol.
The protocol describes the scientific rationale, objective(s), design, methodology, statistical considerations and organization of the planned trial. Details of the trial are provided in documents referenced in the protocol, such as an investigator's brochure.
The protocol contains a precise study plan to assure safety and health of the trial subjects and to provide an exact template for trial conduct by investigators. This allows data to be combined across all investigators/sites. The protocol also informs the study administrators (often a contract research organization).
The format and content of clinical trial protocols sponsored by pharmaceutical, biotechnology or medical device companies in the United States, European Union, or Japan have been standardized to follow Good Clinical Practice guidance [1] issued by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Regulatory authorities in Canada and Australia also follow ICH guidelines. Journals such as Trials, encourage investigators to publish their protocols.
- A clinical trial protocol is a document used to define and manage the trial. It is prepared by a panel of experts. All study investigators are expected to strictly observe the protocol.
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.
2010
- (Cipriani & Barbui, 2010) ⇒ Andrea Cipriani, and Corrado Barbui. (2010). “What is a Clinical Trial Protocol?. ” Epidemiology and Psychiatric Sciences 19, no. 2
- ABSTRACT: Trial protocols are documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials. Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice, and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards.