Development of the Informed Consent Form

Categories: Medical writing
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About course

This training is designed to help medical writing professionals effectively write Informed Consent Forms (ICFs) for participants taking part in clinical studies.

What will you learn?

  • The learning objectives of this training are:
  • 1) understand the key terminology in the field of informed consent for participation in clinical studies,
  • 2) understand the regulatory basis for informed consent,
  • 3) know the required elements of an ICF and the source materials to use when writing an ICF, and
  • 4) be prepared for challenges and be aware of some general tips and tricks for writing an ICF.

Course content

Development of the Informed Consent Form
The learning objectives of this training are:1) understand the key terminology in the field of informed consent for participation in clinical studies,2) understand the regulatory basis for informed consent,3) know the required elements of an ICF and the source materials to use when writing an ICF, and4) be prepared for challenges and be aware of some general tips and tricks for writing an ICF. "

  • Introduction Informed Consent Form for Medical Writers
    01:41
  • Definitions Informed Consent
    05:36
  • Regulations and guidelines
    03:16
  • Informed consent form content and structure
    16:11
  • Source materials and relation to other documents
    01:59
  • Recommendations for writing
    07:51
  • Congratulations
    00:20

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A course by

Thary Jacob
Thary Jacob

Currently, I’m a motivated specialist medial writer at Emtex Life Science.

I studied biomedical sciences at the University of Ghent, mastered in immunology and did a PhD at the laboratory for veterinary animal sciences in Merelbeke on alphaherpesviral spread, triggered by interesting research along my path.

While I enjoyed doing this, I wanted to be closer to patients in my career path, which is why I chose to go to the industry. I wanted to be near the end, the patient, the finalized stage - to contribute to telling the story. Medical writer seemed the perfect job for me, and I haven’t had any regrets during the past 8 years that I’m a medical writer at Emtex.

Emtex offers worldwide professional medical writing and related services to the pharmaceutical (human & veterinary), biotech, medical device and other industries, CROs and academic institutions.

With over 20 years of experience in the field, we guarantee the best possible medical writing and related services.