Creating a Medical Guide

By plissaman

Summary

The idea for the IB Update Guide came from something we were already doing every day. At Morula Health, we'd worked on a range of Investigator's Brochures and IB updates, building practical experience across different programmes and therapeutic areas.

Chapters

  1. The idea for the IB Update (0s)
  2. To fill the gaps in my (89s)
  3. The meeting was transcribed, giving me (97s)
  4. Once the initial draft was complete, (105s)
  5. After incorporating the feedback, the final (114s)

Transcript

The idea for the IB Update Guide came from something we were already doing every day. At Morula Health, we'd worked on a range of Investigator's Brochures and IB updates, building practical experience across different programmes and therapeutic areas. We realised we had a lot of knowledge that could be useful to others if we could capture it in one place. To fill the gaps in my understanding, I arranged a Teams discussion with colleagues who had hands-on experience with IBs. I asked questions about planning, timelines, source documents, reviews, quality control, and the common challenges teams face when updating an IB. The meeting was transcribed, giving me a detailed record of the conversation. Using those insights as a foundation, I used AI to help organise the information, structure the content, and expand the discussion into a practical guide covering the key stages of writing and updating an IB. Once the initial draft was complete, it was shared with the team for review. The writers checked the content, suggested improvements, filled any gaps, and ensured the guidance accurately reflected how IBs are developed and maintained in practice. After incorporating the feedback, the final guide was produced. What started as a few questions and a collaborative Teams discussion became a practical resource designed to help others understand how to write, update, and maintain Investigator's Brochures.