Growing
demand in clinical studies and research makes the author write a precise
document to explain their context to their audience i.e. doctors or drug
regulators. Regulatory writing is a technical and scientific document which
represents pre and post-
clinical research.The
writing should be clear and accurate else it fails to make good research
reporting results in poorly reporting. Regulatory writers write the clinical document
based on the regulation of national authority. These documents include Clinical
Study Protocols, Informed Consent Form, Investigator Brochures (IBs), risk
evaluation and mitigation plans, the Common Technical Document (CTD), and
Clinical
Study Reports (CSRs). These writers are may not the original authors. They
develop the content or the protocol as per the requirement of the client to
communicate with the regulatory agencies or to the doctors. Protocols follow a
prescribed format of writing a regulatory document which includes the
background, design, participants, treatment and outcome along with the
statistical
determination of the efficiency.
Regulatory
writers should coherently articulate the modifications in case of performing
the changes in the documents. These documents include patient information
leaflets and prescribing information,
clinical
reports, and subject articles. The qualification of Regulatory writers will
be Doctorate in life science, medical or paramedical professionals, work as the
writers at pharmaceutical companies and
clinical research
organization. The submission documents are of two types, Common Technical
Document (CTD) modules and Aggregate safety reports. Clinical and non-clinical
summaries, efficiency of treatment and expert’s report are comes under CTD,
whereas, policy papers, periodic reports on adverse drug report and periodic
safety reports were placed among Aggregate safety reports.
Usually,
the regulatory writers work close with doctors, clinical researchers and
statisticians. Technically the regulatory writer should be familiar with concepts
and terminologies in medical field along with the good writing skill. Since
writing skill is important key factor to impress all the audience. Timeliness
and adhering to deadline are also another key factor for being a good writer.
Adaptability to fast updates and efficiency in adapting rapid changes in
protocols important skills. Regulatory writer should have good grounding
knowledge in pharmacology, Drug development process, drug safety and reporting
guideline prescribed by various regulatory agencies. Another main key factor
must be required by regulatory writer is statistics.
Statistics
was used in all clinical trials and mostly in writing the research outcome. The
statistical results gives interpretation about the reliability and criticality
of the research question to the clinician which will get implemented in
clinical practice. Every medical writers should have basic understandings about
confidence intervals,
regression analyses, randomization schemes, P
values, and t-tests. The writer should have knowledge about dissection of raw
data and communicate effectively in the document. The collection and management
of regulatory documents should be familiar to the writer. Along with all these
knowledge, the writer should harness the knowledge to enhance the document
through their education and experience of regulatory science(Clemow B., 2011).
Writer should poses solid background knowledge about writing the respective specialization.
Not alone advanced degree, a formal degree with solid background is enough for
writing variety of research essentials.
Beyond the education, few
other skills should be endorsed by the writer. For example Editorial
competence. This refined skill helps the writer in writing the document to
reduce errors and ensure comprehensiveness
of the document. Computational skills helps the writer to develop the knowledge
about the software which helps to extract and analyze the data and it benefits
in interacting the results with the other members of the team(Heisel-Stoehr &
Schindler, 2012). This skill
can be developed by developed by self-learning or onsite experience of the
writer in documenting the needs. Regulatory writer
with advance knowledge with the statistics is added benefit. This helps in
bring out the outcome in more effective way. Above all, the writer should be
familiar with the guideline and regulation of the regulatory needs of a
government body gives clear image of the work flow in accurate way.
Conclusion :
Regulatory writer was
considered as the main communicator among the research group and
the governing body. Collaboration of researchers, attention to the details and timeliness
are the key skills important the writer. Overall, the writer should have
interest in handling data; possess the quality and the achievement will be
easily derived.
Why pubrica?
When you
order our services, we promise you the following – Plagiarism free, always on
Time, outstanding customer support, written to Standard, Unlimited Revisions
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