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Trials is experimenting with a new way of structuring study protocols for randomised trials. The simple innovation is to include all 51 SPIRIT headings and item identifiers within the protocol itself.
9 sie 2022 · What Are the Elements/Sections of a Research Protocol? According to Good Clinical Practice guidelines laid by WHO, a research protocol should include the following: 1. General Information. Protocol title, protocol identifying number (if any), and date. Name and address of the funder.
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). Provided preferably on a separate page, it should summarize all the central elements of the protocol, for example the rationale, objectives, methods, populations, time frame, and expected outcomes.
26 paź 2022 · The ICH M11 Clinical Electronic Structured Harmonised Protocol Template provides comprehensive clinical protocol organization with standardized content with both required and optional components.
2 paź 2016 · A research protocol is best viewed as a key to open the gates between the researcher and his/her research objectives.
The protocol was designed and written by the research team following feedback from anonymous external peer review and discussion with the Primary Care Research Engagement Group (PRIMER) at The University of Manchester and Adele Cresswell, deputy chair of Nottingham Healthwatch.
The IRB provides several protocol templates on this page. They follow the format of typical NIH and industry multicenter protocols. The Intervention template is ICH GCP compliant. None of the templates is likely to be perfect for a given study without some modification. It is expected that the investigator will adapt the template to suit their ...
