More Time to Comment on Proposed Rule for Waiver of Informed Consent


The U.S. Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking (NPRM) in the Federal Register November 15, 2018 entitled, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” The NPRM seeks to amend regulations 21 CFR Parts 50, 312, and 812 in alignment with provisions in the 21st Century Cures Act (Cures Act). Our previous blog details the proposed rule.

Optimizing eConsent for Patient Centricity: Recording Now Available


Do you understand the difference between consent and centricity? Perhaps you already know that patient centricity is the process where the patient has control over information and are free to make choices they are comfortable with. Learn from subject matter experts about challenges to integrating patient centricity into clinical trials and how eConsent supports subject comprehension and decision making. Our own Sandra “SAM” Sather and an expert panel present information to help you support patient centricity with eConsent.

CTTI Releases Recommendations for Decentralized Trials


Currently, clinical trials are conducted at a center where the subjects have to return for study visits. This can be burdensome and may slow down enrollment or lead to reduced compliance or retention. In decentralized trials (DCT), subjects may meet study requirements without the need to return to the study site. CTTI has released its recommendations for DCT.

Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You: January 29, 2019 Webinar


Topic: Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You

Date: January 29, 2019

Time: 1:00 p.m. – 2:30 p.m. EST

Duration: 90 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session. Recording will be available for 30 days.

Sign up here.

Steps to Modernization of 510(k) Device Approvals


The Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH) have announced efforts to modernize the 510(k) clearance pathway for medical device approval. Device manufacturers more frequently use the 510(k) pathway than other pathways to market. To gain market approval under 510(k), the manufacturer demonstrates that their device is substantially equivalent to an already marketed, or predicate, device. The 510(k) pathway is faster and easier than for devices that have no predicate. Modern devices are more technologically advanced than devices from even ten years ago. Because of its reliance on existing devices, there are concerns that following the 510(k) pathway may inhibit advancements in technology.