The primary objective of the Investigator’s Brochure (IB) in a Phase 1 trial is to serve the responsible investigator for reliable benefit-risk assessment, however, experience teaches us that it is mostly viewed and written as a Clinical Trial Authorisation document. The PI’s need to fully understand the implications of the translational study results in order to decide on the required risk mitigation steps to be taken in the interest of participant protection, is not reliably implemented in the current practice.

Help us to create a more meaningful IB process for translational results interpretation, investigator-centred presentation and decision-making in this Workshop on developing the IB in line with all existing and upcoming international requirements but focusing on the needs in early phase trials. Based on the results from this Workshop EUFEMED will prepare a guideline for public consultation and final publication.

In the final discussion the opinions of the participants will be collected in anonymized polls.