1/17/18

FDA Announces Least Burdensome Provisions Draft Guidance to Modernize Medical Device Approval.

Background:

• Current regulations for medical device marketing approval in the United States were enacted more than 40 years ago.

1/16/18

CRF Health has released an electronic Clinical Outcome Assessments (eCOA) best resources list of 2017. eCOA uses connected electronic devices to directly report clinical trial outcomes and is utilized by subjects, caregivers, and Investigators. By encouraging timely data entry, eCOA supports the ALCOA principle.

1/12/18

Date: January 22, 2018

Time: 11:00 am – 12:30 pm EST

Duration: 90 minutes

Sponsored by: Life Science Training Institute

Webinar: Live interactive session and recorded

Sign up here

11/21/17

The purpose of the Informed Consent Process is to ensure the subject’s understanding of the study prior to enrollment, to protect data integrity and the subject’s safety and rights, and to reduce noncompliance and study drop-outs. Paper consent forms have been used traditionally, but due to more complex clinical trials and longer, more complicated consent forms, they may not be the best option moving forward.

11/16/17

The 2018 edition of the International Compilation of Human Research Standards has been released by the Office for Human Research Protections (OHRP) and can be found here. The Standards compile more than 1,000 laws, regulations, and guidelines from 130 countries, including new countries to the 2018 edition Algeria, Madagascar, Mali, and Saint Lucia. The Standards were created for Sponsors, Investigators, Ethics Committees, and other stakeholders in clinical research, globally. Social-Behavioral research is newly included in the 2018 edition of the Compilation.