Managing the Full Lifecycle of Informed Consent: Informing Patients and Ensuring Quality

Session details:

Informed consent remains one of the most critical yet challenging aspects of clinical trial management. The first version of a consent form is often drafted under significant time pressure, which can create quality issues and inefficiencies that carry through the life of the trial. Too often, attention shifts away after start-up, leaving ongoing updates and oversight under-prioritized. While there is broad recognition that consent forms should be less complex, industry is still trying to find the balance between length and content. This session will examine end-to-end informed consent management—from the pressures of initial drafting through site activation, amendments, and ultimately study closeout.

• The protocol/ICF connection
• Why spending time ensuring quality in ICFs at the study level is so critical
• Assessing approved ICFs and why it’s so important to do so

Have you taken a closer look at the informed consent forms approved and implemented at sites? As versions move through negotiations between sponsors, CROs, IRBs/IECs, and sites, small differences can appear that influence how study details are communicated. What insights might you gain by comparing them side by side?