Short Clinical Trial Topics: Writing Study Protocols and Designing CRFs
  • CODE : FLAR-0002
  • Duration : 60 Minutes
  • Level : Beginner
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Dr Flavio De Rosa is the founder and Managing Director of Paracelsus Science GmbH and holds a diploma in Pharmaceutical Medicine (ECPM, Basel, Switzerland), a PhD in Clinical Psychology (University of Basel). as well as a MSc and a BSc from Virginia Commonwealth University (Richmond, VA. USA).

Dr De Rosa has more than 32 years of drug development industry experience in all phases of drug development covering diverse therapeutic areas and in diverse areas - from drug safety analyses to study design (protocol & CRF) and conduct, to regulatory support, to strategic overviews in small, medium-sized and large Pharma and Biotech companies. He has worked globally: conducting studies, instructing clinicians/colleagues and presenting at congresses in the Americas, Europe, and the Asia-Pac region.

Known for successfully delivering complex projects and analyses within set timeframes, budgets and to a very high standard over his career in the industry, Dr De Rosa can provide one-off, project and task focused, short-term and medium-term drug development support to pharma and biotech start-up, small and medium-sized companies and to academic research groups.

Writing an effective clinical trial protocol and designing the accompanying CRF that collects the needed data in an efficient and – above all – analyzable way, are the cornerstones of a successful clinical study.

As both protocols and CRFs contain both “Boiler Plate” and de novo “free texts”, knowing the advantages (and disadvantages) of recycling, rewriting and creating new text are useful tools when designing both documents.

This webinar will cover not only the fundamentals of the protocol and CRF but will also explore not only how a well-written protocol can make a CRF more efficient in collecting data but also how a well designed CRF can impact on the ongoing utilization of the protocol.

The webinar will also address issues of language, medical and scientific standards, and data collection technology. A brief look of the role of the statistician in this process will also be made.

Writing the protocol and designing the CRF are complex tasks, often the responsibility of diverse departments with differing approaches and – sometimes – different objectives for each exercise. This webinar provides an overview of each process (with suggestions for best practices based on long experience).

Areas Covered

  • Writing a protocol
    o    What is the purpose of a protocol?
    o    The protocol as a “living document”
    o    “Boiler Plate” and de novo “free texts”
    o    Rewrite or recycle?
    o    Style, language and clarity
    o    Medical and Scientific Standards (writing locally or internationally)
    o    How much data is enough?
    o    What makes for a successful protocol?
  • CRF design
    o    Modules: standards and “one-offs”
    o    Paper or electronic? – the pros and cons of both
    o    On screen or hard copy – the importance of sequence
    o    Style, language and clarity
    o    Medical and Scientific Standards (writing locally or internationally)
    o    Aids to completion
  • Our friend: the Statistician

Course Level - Basic/Fundamental    Basic knowledge about clinical trials is required.

Who Should Attend

Clinical Scientists, Study Physicians and other medical/scientific professionals responsible for developing, designing and writing study protocols and case report forms (CRF)

Why Should Attend

In many companies writing the protocol and designing the CRF is the responsibility of diverse departments (such as medical affairs and data management), with differing approaches and – sometimes – different objectives for each exercise. This can lead to conflict over what data to collect and how to collect it for an effective analysis.

Both the protocol and CRF are complex and multilayered “living” documents; effective protocols and CRFs must also address the needs of all stakeholders. This webinar is thus designed to review the basics of protocol and CRF design and highlight recommended practices, based on many years of experience, to protocol writing and CRF design.

  • $179.00



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