More Related Content Similar to Writing medical content for clinical research quick guide for clinical practitioners and Researchers (20) Writing medical content for clinical research quick guide for clinical practitioners and Researchers1. © 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
Medical Writing Experts™ -www.medicalwritingexperts.com
INDIA: Nungambakkam, Chennai – 600 034
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX
Writing Medical Content For Clinical Research-Quick Guide For Clinical Practitioners And
Researchers
Medical content Writing is an integral component of clinical research that is essential for
effectively taking research related scientific communications to the target audience like
medical specialists and health care professionals. Effective and well-structured medical
contents with appropriate research design and reference support is imperative for every
aspiring medical researcher to publish their clinical research studies in reputed national and
international medical journals.
Medical content writing in Clinical Research requires proper academic background in the
field of medical science and specialized writing skills that needs to be possessed by the
medical researchers and clinicians. The medical content writer must also possess good
understanding of the clinical perspectives like patient benefits, safety measures and needs
to present the medical research contents from the view point of medical or health care
professionals.
This medical content writing quick guide is intended to help the clinical practitioners and
researchers understand the nuances of clinical research writing that will enable them to
make effective clinical research paper presentations to their intended targeted audience.
Essential Regulatory documents of Clinical Research
Health care professionals and researchers involved in the clinical research must gain better
knowledge of various essential aspects in the preparation of regulatory documents involved
in the research study.
Some of the important documents that are essential for conducting and presenting clinical
research studies include,
2. © 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
Medical Writing Experts™ -www.medicalwritingexperts.com
INDIA: Nungambakkam, Chennai – 600 034
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX
Clinical Research study protocols
Standard Operating Procedures (SOPs) that covers all the features of the research
study like research design, methodologies and the conduct and report presentations
of the clinical trials
Clinical and non-clinical summaries and overviews relating to the research for the
concerned regulatory authorities.
Ethical standard protocols followed in the clinical research trials involving humans
and animals in accordance with the national standards laid down by the concerned
regulatory authorities like ICMR’s Ethical Guidelines for Biomedical research on
human participants
Narratives concerning safety of patients involved in the clinical research
Documents relating to pharmacovigilance and safety updates
Patient informed consents and safety brochures for patients participating in the
clinical research
Instructions for Clinical Writing
The medical writers must have a good understanding of the clinical research goals and
needs to ensure that the research ideas, methodologies and the scientific results of the
clinical research are conveyed precisely in order to maximize the impact of medical research
contents.
This quick clinical guide for healthcare professionals and researchers provides a list of
diverse documents necessary for conducting a well-structured clinical research paper
ranging from study protocol, research design, and Investigator’s brochure to clinical
research reports.
The clinical research paper must have following the features
Structured abstract section briefly describing the nature and scope of the research,
concepts, methods adopted and clinical findings
3. © 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
Medical Writing Experts™ -www.medicalwritingexperts.com
INDIA: Nungambakkam, Chennai – 600 034
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX
Appropriate sub-headings indicating the study background, research objectives,
samples used and analytical methods.
Brief introduction about the research indicating the scope of the study
Review of literature to provide the reasons and motivations for undertaking the
particular clinical research study
Sampling methods used for sample size calculation with inclusion and exclusion
criteria used while selecting the participating patients for the research study
Period with month and year of conducting the research along with the place of
research conduct.
Statistical methodologies, data analysis and interpretation techniques utilized in the
study
Medical terminologies with universally applicable disease and health care related
abbreviations
Relevant Tables and figures providing important statistical data to support the
research
Outline of the study and important scientific developments related to the research
with potential impact on patient care and public health
Complete discussion and conclusion section involving the usage of authentic medical
contents with proper terminologies
Complete Bibliographic section indicating the research title, author, journal
published and research year for the literature references used in the paper
Tables and Figures
Clinical research writing must include pertinent tables with appropriate titles, row and
column headings with units of measurement and statistical measurements properly
abbreviated and place below the respective column headings.
Randomized Clinical trial paper writing must include essentials information involving
protocols, assignment of inventions by clearly stating that the particular study protocol has
4. © 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
Medical Writing Experts™ -www.medicalwritingexperts.com
INDIA: Nungambakkam, Chennai – 600 034
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX
prior approval from the concerned ethics committee of the research institution. The
research paper must also mention that proper written consents relating the study have
been obtained from the patients participating in the clinical research.
The research writing can have a brief acknowledgement section for acknowledging the
specific scientific and financial assistance and the help the concerned researcher received in
the preparation of manuscripts.
The discussion section deals with the interpretation of the research findings and the medical
researcher must take due care not to repeat information given in the Results section. This
section can give comparison of new findings with the existing results in this topic and must
also mention any limitations, constraints and flaws of the study. Based on the discussion,
the researcher or healthcare professional must give their recommendations that are
relevant for the topic of the research study.
Professional medical research help is available for health care professionals and researchers
who have time, resources and writing skills constraints. Expert writing service companies
specializing in the writing of medical contents for clinical research studies can offer
customized service to the need and requirements of the medical researchers.