When most people hear the phrase “Informed Consent,” they think of the legal document that explains the study and contains the required dated signatures. However, informed consent is first and foremost a continuing process. This includes a person voluntarily agreeing to participate in a research study after being fully informed…
As appreciation grows for the contribution of real-world evidence (RWE) and real-world data (RWD) to clinical research, the application of RWE/RWD within this space is treated with circumspection. The Renewed Importance of Documentation Inadequate/inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites….
