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The document is a protocol signature page for a clinical trial, requiring the principal investigator to confirm their understanding and agreement to conduct the trial in accordance with the specified protocol, regulations, and Good Clinical Practice guidelines.

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How do you write a protocol document?

Like a journal article, your protocol should detail your research question, background information on your topic, your data collection and analysis methods, and limitations. Additional information for the protocol may include budget, timelines, and safety and ethical considerations.

What is a protocol signature page?

Definition: Documentation signed by investigators confirming the agreement of the clinical trial site to follow the clinical study protocol. CDISC Definition: Documentation signed by investigators confirming the agreement of the clinical trial site to follow the clinical study protocol.

How to create a protocol document?

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.

How should a protocol be written?

Protocol Forms are a set of documents, prescribed by the Law Society that help standardise and streamline the conveyancing process. They are important because they ensure that nothing is missed and that both the buyer and seller have all the information they need to complete the property transaction in a timely manner.

What does a protocol document look like?

General information. 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.

protocol signature page template

Protocol signature page requirements Observational study protocol template Research protocol template retrospective chart review IRB Protocol Template CHOP IRB Templates Cohort study template Protocol requirements

What is protocol documents?

Project summary. 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). General information. Rationale background information. References (of literature cited in preceding sections) Study goals and objectives. Study design.

Who signs a protocol?

The final protocol should be signed off by the Chief Investigator as a minimum, but usually other signatures may be required such as those from the sponsor and trial statistician.