A clinical study protocol is a document that describes the study objectives, design, methods, assessment types, collection schedules, and statistical considerations for analyzing the data . The protocol also outlines steps for protecting subjects and obtaining quality data.
What is 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. ...
What are clinical research protocols?
A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project .
What is the study protocol?
The study protocol is a document outlining the design of a study, describing the objectives, methodology and overall organisation of the research to be carried out forming a template and guide to the research process as a whole. The course is aimed at everyone involved in clinical research.
What are the main aspects of clinical study protocol?
The protocol includes a description of the research design to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data .
Who prepares protocol in clinical trials?
The actual writing of a protocol is a team effort with contributions from a medical expert , a statistician, a pharmacokinetics expert, the clinical research coordinator, and the project manager, who all provide input to the medical writer to produce the final document.
What is an example of a protocol?
A protocol is a standard set of rules that allow electronic devices to communicate with each other. ... Examples include wired networking (e.g., Ethernet), wireless networking (e.g., 802.11ac), and Internet communication (e.g., IP).
What are the types of clinical trials?
- Pilot studies and feasibility studies.
- Prevention trials.
- Screening trials.
- Treatment trials.
- Multi-arm multi-stage (MAMS) trials.
- Cohort studies.
- Case control studies.
- Cross sectional studies.
What is CRF clinical trial?
A case report form (CRF) is designed to collect the patient data in a clinical trial; its development represents a significant part of the clinical trial and can affect study success.[1] Site personnel capture the subject’s data on the CRF, which is collected during their participation in a clinical trial.
What are different phases of clinical trials?
There are 3 main phases of clinical trials – phases 1 to 3 . Phase 1 trials are the earliest phase trials and phase 3 are later phase trials. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed. Some trials are randomised.
How long is a research protocol?
Like the abstract of a research paper, the project summary, should be no more than 300 words and at the most a page long (font size 12, single spacing).
What is included in a protocol?
The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analysed. It should highlight how ethical issues have been considered , and, where appropriate, how gender issues are being addressed.
What makes a good protocol?
For a network protocol to be well designed, it must have five attributes: Focus, Unity, Simplicity, Clarity, and Generality. ... A good network protocol has very clear objectives , is designed to serve those objectives, and avoids doing things that distract from those objectives.
What are the components of a clinical study?
Clinical Research embraces a continuum of studies involving interactions with patients, diagnostic clinical materials or data, or populations in any of the following categories: (1) disease mechanisms (etiopathogenesis); (2) bi-directional integrative (translational) research; (3) clinical knowledge, detection, ...
What is a protocol violation?
Protocol violations are any unapproved changes, deviations or departures from the study design or procedures of a research project that are under the investigator’s control and that have not been reviewed and approved by the IRB.
Which of the following is a part of clinical research protocol?
Project summary, general information, rationale and background, references, study goals and objectives, study design, methodology, safety considerations, follow up , data management and statistical analysis, quality assurance, expected outcome, dissemination of results and publication policy, duration, ethical ...
