Guiding Principles for Medical Writers

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Guiding Principles for Medical Writers
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Who are Medical Writers?
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• 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

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• 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.

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• 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.

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What is Good Publication Practice Guideline?
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• 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. 

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• 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.

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How Good Publication Practice Guideline 3 Helps
in Maintaining Standards for Medical Writers?
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• 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.

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What are the Salient Features of Good Publishing
Practice Guidelines?
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• 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.

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