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Regulatory Writing – An Integral Part of Clinical Research

Medical Writing Team

There are two main areas in medical writing, medical communications and regulatory writing; this blog focuses on the latter area of specialisation, which involves the preparation of clinical study and regulatory submission documentation.

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Topics: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report

Exploring CDISC Analysis Data Model (ADaM) Datasets

Clinical Programming Team

Clinical Data Interchange Standards Consortium (CDISC) defines and manages industry level data standards that are widely used during the analysis, reporting and submission of clinical data. For instance, the Study Data Tabulation Model (SDTM) is the submission data standard into which raw study data are mapped and collated. ADaM is a companion standard for use with analysis data and it is best practice to use SDTM data as the source for these datasets. Doing this allows for the easy documentation of any data processing with Define-XML, the CDISC standard for data definition files.

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Topics: Traceability, CDISC SDTM, CDISC, Standardization, Adverse Events (AEs), Clinical Trial Documentation, Clinical Programming, SDTM, CDISC Standards, ADaM Datasets, Analysis Data Model, ADSL

Compiling the Appendices for a Clinical Study Report

Medical Writing Team

For any clinical regulatory writer, compiling the appendices for a clinical study report (CSR) can feel like a daunting task, but it doesn’t have to be. To make this task easier and less time consuming you need to start thinking about it before you even begin to write the CSR.

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Topics: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report

The Challenges of Writing Patient / Safety Narratives

Medical Writing Team

There are a number of unique challenges that a medical writer might encounter while writing / managing patient / safety narrative projects. This blog describes the scope of narrative projects and outlines the associated challenges and provides some ideas to help you successfully manage narrative projects.

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Topics: Case Report Form (CRF), Adverse Events (AEs), Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report, Serious Adverse Events (SAEs), Patient Narratives, Safety Narratives, Data Clarification Form (DCF), Quality Control

Ben Goldacre Discusses Clinical Data Transparency [Video]

Statistical Consultancy Team

Dr Ben Goldacre, author of 'Bad Pharma' presented a keynote speech at the Clinical Data Live! symposium on clinical data transparency. 

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Electronic Medical Record (EMR), Adverse Events (AEs), Historical Data, European Medicines Agency, Clinical Trial Documentation, Clinical Documents, Ethics, Accessible Data, Data Transparency

Medical Writing Tips For Managing Multiple Priorities

Medical Writing Team

 

 

A Regulatory Medical Writer in a Clinical Research Organization (CRO) is usually involved at the start (writing a study protocol) and/or end (writing a clinical study report(CSR)) of a project. The start and end of a clinical study can be the most stressful time for the team as they work together to meet important deadlines. For the Medical Writer this stress can be further exaggerated by multiple projects converging and study teams demanding more and more of their time with last minute changes. The Medical Writer, as part of a team, will also have to do their fair share of quality control (QC) and/or peer reviewing.

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Topics: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report

Becoming a Regulatory Writer

Medical Writing Team

Whether working for a pharmaceutical company or a clinical research organisation (CRO), most regulatory writers started out as academics.  Although a PhD is not a pre-requisite, most employers will be looking for a scientific or medical degree, not to mention certain character traits such as problem solving and analytical skills, fastidiousness and a readiness to embrace new fields of research.

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Topics: Medical Writing, Regulatory Writing, Clinical Trial Documentation, Clinical Documents, Clinical Study Report

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