by chuck_ltd | 15 Apr, 2018 | CHCUK News & Articles, Data Privacy, Digital Health Technology, eConsent
While the shift to digital technologies is pervasive across multiple industries, the informed consent process for clinical trials has been historically paper-based. Given the inefficiencies in the traditional process and the increasing complexity of clinical studies,...
by chuck_ltd | 9 Apr, 2018 | CHCUK News & Articles, News, NIS, PASS, Real Word Evidence, Registry
Germany – Professional Advice under Section 15 BO Ärzte: Speeding up the Process for Non-Interventional Studies? Author: Mark Heinemann, Principal Regulatory Advisor, CHCUK Consulting German Ethics Committees (ECs) make an important step towards the...
by chuck_ltd | 30 Mar, 2018 | 21 Century Cures Act, Cures Act, EHR, Real Word Evidence, Virtual Clinical Research
The Trump Administration is launching the MyHealthEData initiative which aims to empower patients by ensuring that they control their healthcare data and can decide how their data is going to be used, all while keeping that information safe and secure CMS is committed...
by chuck_ltd | 29 Mar, 2018 | Biosamples, CHCUK News & Articles, Human Tissue Research
The Brazil profile in ClinRegs has been reviewed and updated to reflect the implementation of RDC No. 172 of 8 September 2017. This resolution states that ANVISA will analyze imported human biological samples and goods and products intended for use in human subject...
by chuck_ltd | 24 Mar, 2018 | CHCUK News & Articles, Digital Health Technology, FDA Guidance
This DRAFT guidance addresses how to comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016 (81 FR 92603, hereafter the “combination product PMSR final rule,”...
