Day: March 16, 2023

Electronic Records are an integral part of clinical practice and hence also of clinical trial source documents. In its 2017 Guidance on using electronic records in clinical trials FDA provided several suggestions on best practices for sponsors and clinical research organizations. This week FDA released an updated Guidance that expands on the original guidance to … Read more

Over the last 3 decades, expanded access or emergency use treatments have become quite common and clinical experience from expanded use of investigational products has even been used to provide additional safety data to the FDA and enrich the real-world evidence (RWE), particularly for rare diseases. But use of expanded access protocols also raises concerns … Read more