Skills sample Assessment Protocol to Informed Consent (Medical Writing)

Work Portfolio 6 Translating the Protocol into an Informed Consent Form 

Introduction 

One of the objectives of this course is for learners to write and edit sections of clinical regulatory documents that are part of Investigational New Drug (IND) and New Drug Applications (NDA), including Investigator's Brochures, Informed Consent Forms, and Clinical Study Reports. In addition, learners should use the appropriate style and terminology to write with the target audience in mind, implementing concepts such as health literacy and health equity, plain language, patient-focused writing, lean writing, and structured content.  

Goal 

Regulatory medical writers frequently interpret clinical trial Protocols so that they can be understood by a general audience. In this assignment, you use the techniques of health literacy and health equity to translate the Schedule of Assessments of a Protocol into an Informed Consent Form (ICF). 

What to Do 

On clinicaltrials.gov, locate the Protocol for the pivotal Phase 3 study of zavegepant for the treatment of acute migraine (NCT045701060 Links to an external site.).  

Then, download the NIH Informed Consent Document Template Links to an external site..

Implementing the resources for plain-language writing provided by NIH Links to an external site., the Tips for Including Plain Language in the Informed Consent Form Links to an external site., and the NIH ICF template, compose the Introductory Paragraph and Sections 1 through 4 of an ICF that you would use to recruit participants to the study. Note that italicized text in the template is instructional and should be deleted once you have written original text that follows the instructions. Italicized text in parentheses is also instructional and should be replaced with updated text from your study.

Then, score an excerpt of your ICF using the online Flesch-Kincaid calculator located here: https://readabilityformulas.com/free-readability-formula-tests.php Links to an external site.

Finally, write a brief reflection (~2 paragraphs) on your experience of translating the Protocol into an ICF, answering the following questions: 

  • What did you find particularly easy or difficult about translating each section?  
  • Which techniques of plain-language writing did you use in developing your ICF excerpt?
  • How did your ICF excerpt score on the Flesch-Kincaid scale? Do you feel that this score accurately reflects the readability of your writing?
  • Did this assignment give you any new insight into the experiences of potential clinical trial participants? 

Optionally, once you have completed writing your ICF, submit to ChatGPT (or your preferred generative AI language model) one of the sections of the Protocol that you used to develop your ICF. Ask the software to rewrite the text at the eighth-grade level, and compare it to the ICF that you wrote. As part of your reflection, describe what you learned from using AI.  

What to Submit 

Submit your Informed Consent Form excerpt and brief reflection as a single Word document, with headers clearly demarcating the two sections.