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Phase I Studies:

Role and Obligations of the Medical Writer

Each phase of a clinical trial presents unique challenges in terms of conduct and data collection, analysis and reporting. Although introducing all phases of drug development, the emphasis of this article is upon the design, conduct and reporting of Phase I studies and specifically the role of the Medical Writer within the study team and their obligations when it comes to publishing results.

In this article you will learn how the medical writer supports the following:

  • Study Protocols
  • Clinical Study documentation such as Informed Consent Forms, Interim reports,  Statistical Analysis Plans (SAPs) and Investigator Brochures (IBs)
  • Clinical Study Reports (CSRs), including Phase 1/pharmacokinetic (PK) data
  • Data transparency and clear, accurate reporting


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