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New FDA Guidance on Informed Consent Waiver for Clinical Investigations Involving No More than Minimal Risk

by chuck_ltd | 27 Jul, 2017 | 21 Century Cures Act, CHCUK News & Articles, Pragmatic Trials, Real Word Evidence

FDA issues guidance for immediate implementation- IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects Author: Patricia Garcia, Regulatory Consultant, Late Stage, Clinical Division, Inventiv...

Final Revisions to the Common Rule

by chuck_ltd | 20 Jan, 2017 | CHCUK News & Articles, HIPAA, News, NIS, Real Word Evidence

The U.S. Department of Health and Human Services and 15 other federal agencies today (19 January 2017) issued a final rule to update regulations that safeguard individuals who participate in research. Most provisions in the new rule will go into effect in 2018. The...

US: Proposed Revision to Common Rule Includes Public Posting of Informed Consent

by chuck_ltd | 20 Nov, 2015 | CHCUK News & Articles, Consultation, News, NIS, Pragmatic Trials, Real Word Evidence

Proposed Revisions to Modernize, Strengthen, and make more Effective the Federal Policy for the Protection of Human Subjects Various US departments and agencies propose revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection...

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