DDA35 Safety and Contraception Information for the Informed Consent

The purpose of the Informed Consent Form (ICF) is to provide potential study participants with a clear summary of the risks involved in the study. This information should be written in easy-to-understand language so that participants can make an informed decision whether to participate in a clinical trial. It is essential for project and trial teams in clinical research to regularly update this information. Medical writers with expertise in regulatory and lay language writing can contribute valuable skills in developing and updating the risk information.

Participant profile: This workshop is ideal for medical writers with experience in creating documents for regulatory or non-specialist readers. It is especially beneficial for medical writers involved in developing informed consent materials for potential study participants. Medical writers who may need to produce written information in lay language about the safety and contraceptive aspects of a drug in clinical research will find this workshop particularly useful. Ideally participants understand an investigator brochure and a clinical trial protocol.