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QUICK GUIDE FOR CLINICAL
PRACTITIONERS AND RESEARCHERS
-----
WRITING MEDICAL CONTENT FOR
CLINICAL RESEARCH
© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
PEPGRA Healthcare Pvt Ltd
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@pepgra.com, Web:www.Pepgra.com.
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 healthcare 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.
Quick Guide For Practitioners and Researchers
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 viewpoint 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.
© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
PEPGRA Healthcare Pvt Ltd
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@pepgra.com, Web:www.Pepgra.com.
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,
● 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, 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
● 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
© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
PEPGRA Healthcare Pvt Ltd
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@pepgra.com, Web:www.Pepgra.com.
● 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 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.
© 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent
PEPGRA Healthcare Pvt Ltd
INDIA: Nungambakkam, Chennai, 600 034.
UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX.
Email:info@pepgra.com, Web:www.Pepgra.com.
About Author,
Dr. Nancy,
Editor-in-chief,
PEPGRA Healthcare Pvt Ltd.

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Quick guide for clinical practitioners and researchers

  • 1. QUICK GUIDE FOR CLINICAL PRACTITIONERS AND RESEARCHERS ----- WRITING MEDICAL CONTENT FOR CLINICAL RESEARCH © 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent PEPGRA Healthcare Pvt Ltd INDIA: Nungambakkam, Chennai, 600 034. UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com, Web:www.Pepgra.com.
  • 2. 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 healthcare 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. Quick Guide For Practitioners and Researchers 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 viewpoint 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. © 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent PEPGRA Healthcare Pvt Ltd INDIA: Nungambakkam, Chennai, 600 034. UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com, Web:www.Pepgra.com.
  • 3. 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, ● 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, 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 ● 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 © 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent PEPGRA Healthcare Pvt Ltd INDIA: Nungambakkam, Chennai, 600 034. UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com, Web:www.Pepgra.com.
  • 4. ● 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 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. © 2017-2018 All Rights Reserved, No part of this document should be modified/used without prior consent PEPGRA Healthcare Pvt Ltd INDIA: Nungambakkam, Chennai, 600 034. UK: The Portergate, Ecclesall Road, Sheffield, S11 8NX. Email:info@pepgra.com, Web:www.Pepgra.com. About Author, Dr. Nancy, Editor-in-chief, PEPGRA Healthcare Pvt Ltd.