Optimizing eConsent for Patient Centricity Webinar December 13, 2018

11/28/2018

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 Released New Recommendations for Investigator Qualifications

11/27/2018

The regulations require investigators to have appropriate qualifications, but how to define it is not thoroughly described. Generally, sponsors or CROs have chosen to define qualification as completing training on Good Clinical Practice (GCP). Although having a knowledge of GCP is essential, the current method of training is not effective.

Proposed Rule Issued: IRB Waiver of Informed Consent

11/20/2018

The U.S. Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking (NPRM) in the Federal Register, “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).

FDA Releases New Guidance Document on Revised Common Rule

11/13/2018

Background:

The Federal Policy for the Protection of Human Subjects, also known as the “Common Rule,” specifies the requirements for the protection of human subjects in U.S. Department of Health and Human Services (HHS) sponsored clinical trials. A final rule published to the Federal Register in January 2017 revised the Common Rule, which has a compliance date of January 21, 2019.