What is clinical protocol development?
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 is protocol development?
Protocol Development is a legal requirement which is relevant to all trials. The protocol provides information on the background and rationale for a trial and outlines the study plan. The plan must be carefully designed to safeguard the health and safety of the participants, as well as answer the research question(s).
How long does protocol development take?
It is often thought that the clinical trial study design is not really the concern of statisticians and that it takes only about one week in total to develop the complete protocol document.
What are the key elements of a 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.
What is an example of protocol?
A protocol is a standard set of rules that allow electronic devices to communicate with each other. Protocols exist for several different applications. Examples include wired networking (e.g., Ethernet), wireless networking (e.g., 802.11ac), and Internet communication (e.g., IP).
What is a 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 is CRF clinical trial?
A Case Report Form (CRF) is a printed or electronic document that is created and used in clinical trial research to capture standardised clinical data from each patient separately and to transfer it to Data Management.