BEST PRACTICES FOR SCIENTIFIC WRITING
GUIDELINES AND STANDARDS TO BE FOLLOWED FOR SCIENTIFIC MANUSCRIPT WRITING
Medical Writers often seek information on global best practices that will enhance scientific manuscript writing skills while adhering to industry standards. Here we provide contemporary guidelines that should be followed while publishing manuscripts in reputed journals especially while working on data reporting from clinical trials, systematic literature review, and meta-analysis, and other forms of peer-reviewed publications.
Based on the type of study designs and manuscripts, there are different types of manuscript authoring guidelines such as CONsolidated Standards Of Reporting Trials (CONSORT) for randomized trials; STrengthening the Reporting of Observational Studies in Epidemiology (STROBE) for observational trials; CAse REport guidelines (CARE) for case reports; Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) for systematic reviews and meta-analyses; and STAndards for Reporting of Diagnostic accuracy studies (STARD) for diagnostic accurateness. Journals encourage researchers to follow specific guidelines for writing manuscripts because it helps readers gain a complete understanding of the study including its design, conduct, analysis, and interpretation, and also assess the validity of published results.
There is a regulatory obligation for the manuscript of a study to be submitted to a regulatory authority. Manuscripts of licensed products must be submitted to the journal within 18 months after the last patient’s last visit. On the other hand, the manuscripts of investigational products must be submitted to the journal within 18 months after regulatory approval/product discontinuation. Presentation in congress and disclosure of partial clinical trial data is not considered prior to publication. In general, manuscripts reporting original research are divided into five sections, namely Introduction, Methods, Results, and Discussion (called “IMRAD” structure), which reflects the process of scientific findings. Other types of articles such as systematic reviews/meta-analyses may necessitate different presentations; case reports, narrative reviews, and letters to the editor may have less structured or unstructured presentations. The general necessities for reporting within sections of manuscript formats have been recommended by the International Committee of Medical Journal Editors (ICMJE). For industry-sponsored research, it is advisable to follow Good Publication Practice guideline 3 (GPP3). The Committee on Publication Ethics (COPE) guidelines should be followed for the ethical aspect of publication, especially to handle cases of research and publication misconduct that include, but are not limited to, data manipulation, duplicate publication, plagiarism, misuse of statistics, and false citations.
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