Guiding Principles for Medical Writers
                     Guiding 
Principles for 
Medical 
Writers
Who are Medical 
Writers?
 Medical writers are the professionals 
who write the content related to the 
medical field. Medical writers have 
detailed information about the area 
of medicine or pharmaceuticals that 
they are dealing with. 
 They are responsible for providing 
accurate, detailed and relevant 
information to the reader. They not 
only write fresh articles but also 
proofread and review the articles 
written by other medical writers. 
Medical writers deal with writing the 
following documents:
 General article: Medical writers write 
general information related to 
therapeutic diseases, treatments, and 
the latest researches. 
 Research article: Manuscript writing is 
another field for medical writers. The 
manuscript writers are experienced in 
writing the research article in a 
universal format that is globally 
accepted. 
 Regulatory documents: 
Medical writers are also involved in 
writing regulatory documents. The 
regulatory documents are submitted for 
obtaining the approval of either drugs or 
medical devices from the concerned 
regulatory authority. 
 Continuing Medical Education: The 
doctors generally present continuing 
Medical Education. For this, the writer 
prepares the presentation and writes 
the noted for the audience.
 Company Newsletter: Various 
companies have their own newsletters 
that incorporate the latest research or 
development. Medical writers write the 
newsletters.
 Medical case-studies: Doctors 
experience various unique cases during 
their medical practice. These cases are 
written to enhance the medical 
knowledge of medical fraternity.
What is Good 
Publication Practice 
Guideline?
 Pharmaceutical companies act as 
sponsors in clinical trials. The reports of 
the clinical trials are submitted to the 
regulatory authority for obtaining 
approval. In various cases, the clinical 
trial reporting is not transparent and the 
data may lose its authenticity. 
 Good publication practice guidelines are 
the guidelines provided to the regulatory 
medical writers. These guidelines ensure 
that the clinical trial reporting is done in 
a responsible and ethical manner. Good 
publication practice guidelines were 
developed for the first time in 2003 and 
from now they have been frequently 
revised. 
 In 2015, a new version of Good 
publication practice guidelines was 
developed. This version was known as 
GPP3. GPP3 expands the basic values 
incorporated in GPP and GPP2. The 
evidence base information for medical 
writers was also explained in detail in the 
new version. 
 The steering committee is responsible for 
revising the GPP. The steering committee 
responsible for revising GPP 2 was 
diverse and includes representatives of 
medical writers, the pharmaceutical 
industry, biomedical devices, medical 
communication companies, and editors 
and publishers.
How Good Publication 
Practice Guideline 3 
Helps in Maintaining 
Standards for Medical 
Writers?
 Prior to the good medical practice 
guidelines, there was a risk of inaccurate 
and incomplete information. International 
Committee of Medical Journal Editors 
states that medical writers are 
responsible for the publications done 
under their name. 
 Due to increased work and less time for 
writing by the Key opinion leaders, 
medical writers’ role becomes important. 
They provide data in simple and lucid 
language for publication and arrange the 
data from cross-functional teams.
What are the Salient 
Features of Good 
Publishing Practice 
Guidelines?
 Transparency: There should be 
transparency in performing the research 
and writing the article. 
 Completeness: The article should be 
complete and does not create confusion in 
the mind of the reader. 
 Accountability: The guarantor can be 
assigned for the research article. The 
authors and presenters should be 
accountable for their work.
 Responsibility: The author or the medical 
writer should have respect for various 
intellectual property rights such as 
copyright. 
 Integrity: There should be considerable 
integrity in article writing. 
Contact Us
E-mail: [email protected]
             
 Phone: 044-49595223
 URL: https://www.cognibrain.com/