A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project .
Why is a research protocol important?
Writing a protocol allows the investigator to carefully consider the research question, its clinical importance , and the feasibil- ity of conducting the study. ... It permits third parties (mentors and peers) to carefully scru- tinize the question and design, thereby allowing for additional input into study design.
How do you write a protocol?
Protocol summary: Give a concise overview of the project. Describe the purpose of the study, including problem to be investigated and hypothesis(es) to be tested, the population, and the methods that will be used. Avoid the use of acronyms. Include the expected benefit of the study.
Who writes protocol in clinical research?
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 protocol in simple words?
A protocol is a set of rules and guidelines for communicating data . Rules are defined for each step and process during communication between two or more computers. Networks have to follow these rules to successfully transmit data.
What should a research protocol include?
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 is protocol give example?
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 are the different types of protocols?
- Transmission Control Protocol (TCP)
- Internet Protocol (IP)
- User Datagram Protocol (UDP)
- Post office Protocol (POP)
- Simple mail transport Protocol (SMTP)
- File Transfer Protocol (FTP)
- Hyper Text Transfer Protocol (HTTP)
- Hyper Text Transfer Protocol Secure (HTTPS)
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 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.
What is study protocol in clinical trial?
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 clinical research protocol?
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 best definition of protocol?
1 : an original draft, minute, or record of a document or transaction . 2a : a preliminary memorandum often formulated and signed by diplomatic negotiators as a basis for a final convention or treaty.
What is protocol in English?
Protocol is a system of rules about the correct way to act in formal situations . He has become something of a stickler for the finer observances of royal protocol. ...minor breaches of protocol. Synonyms: code of behaviour, manners, courtesies, conventions More Synonyms of protocol.
What is the difference between protocol and procedure?
A Protocol defines a set of Procedures or steps to be followed for the accomplishment of a given task . Procedures are task oriented. Procedures provide step-by-step instructions on how to do a task.
How do you create a research protocol?
- Protocol title, protocol identifying number (if any), and date.
- Name and address of the sponsor/funder.
- Name and title of the investigator(s) who is (are) responsible for conducting the research, and the address and telephone number(s) of the research site(s), including responsibilities of each.
