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A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. [1] SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations .
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient.
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirement(s). (ICH E6) Multicenter study. A clinical trial that is carried out at more than one medical institution. (NCI)
Part 1 of the manual approaches the process of research and writing. This includes providing "practical advice" to formulate "the right questions, read critically, and build arguments" as well as helping authors draft and revise a paper. [3] Initially added with the seventh edition of the manual, this part is adapted from The Craft of Research ...
Documentation development may involve document drafting, formatting, submitting, reviewing, approving, distributing, reposting and tracking, etc., and are convened by associated standard operating procedure in a regulatory industry. It could also involve creating content from scratch. Documentation should be easy to read and understand.
Technical writing is most commonly performed by a trained technical writer and the content they produce is the result of a well-defined process. Technical writers follow strict guidelines so the technical information they share appears in a single, popularly used and standardized format and style (e.g., DITA, markdown format, AP Stylebook, Chicago Manual of Style).
A research proposal is a document proposing a research project, generally in the sciences or academia, and generally constitutes a request for sponsorship of that research. [1] Proposals are evaluated on the cost and potential impact of the proposed research, and on the soundness of the proposed plan for carrying it out. [ 2 ]
A research statement is a summary of research achievements and a proposal for upcoming research. It often includes both current aims and findings, and future goals. Research statements are usually requested as part of a relevant job application process, and often assist in the identification of appropriate applicants. [1]