Mandatory GDPR Information in Informed Consent Forms (ICF)

Informed Consent Forms (ICFs) are vital in clinical trials, mandated by ICH regulations and must adhere to the General Data Protection Regulation (GDPR). Their dual purpose is to ensure patients comprehend the study and their rights regarding data shared during the trial. Additionally, ICFs reflect how the sponsor adheres to GDPR. Understanding the specifics required in an EU ICF is crucial for sponsors on various levels. The infographic offers in-depth analysis of the key information that needs to be incorporated in these documents, ranging from responsibilities and legal foundations to data retention periods.