Blog — Clinical Pathways

Now Available! ICH E6(R3) Comparison Tool. Includes Final Principles, Annex 1, and draft Annex 2. Click here to purchase.

GDPR

Draft GDPR Adequacy Decision for UK

3/02/2021

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When the Brexit transition period ended at the end of 2020, the United Kingdom (UK) officially left the European Union (EU) single market and customs union. This means that for the purposes of the General Data Protection Regulation (Regulation (EU) 2016/679 or GDPR), the UK is a third country with regards to data transfer. As a third country, personal data transfers require additional safeguards. At the beginning of 2021, the EU-UK Trade and Cooperation Agreement came into effect. A part of this Agreement includes a provision which allows data transfers to continue without additional mechanisms until an adequacy decision is adopted, for a maximum of six months.

Now Available for Purchase: GDPR and Clinical Trials eLearning

12/15/2020

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Why Take a Course in The General Data Protection Regulation (GDPR) and Clinical Trials?

Clinical trials are increasingly global by nature. The GDPR may apply to your clinical trial if conducted in a country within the European Economic Area (EEA) or the United Kingdom (UK). The GDPR data protections are broad in nature but it makes it clear that protection of personal data includes data created during the course of a clinical trial. Understanding the role your organization plays, which data are personal, and what constitutes a valid consent under GDPR requirements is key to compliance. This course highlights how HIPAA differs from GDPR, including reporting of data breach and notice requirements.

Safeguarding Study Participant Data while Remote Monitoring

9/29/2020

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During the current COVID-19 pandemic, it has become necessary for sponsors of clinical trials to rely on remote methods to access electronic health records and electronic source data. With risk-based monitoring becoming more common, and with sponsor/CRO monitors reviewing electronic source data remotely, many questions have arisen regarding what security measures need to be in place to ensure the protection of study participants’ data. Here is one such question.

GDPR and Clinical Trials Amid COVID-19

5/26/2020

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The World Health Organization (WHO) is recommending using telehealth during the COVID-19 pandemic. To keep subjects and site personnel safe, many sites have transitioned to using telehealth for study visits. What about safeguarding data and privacy? The General Data Protection Regulation (GDPR) has some stringent rules for collecting or processing data which includes during the conduct of a clinical trial.

From Safe Harbor to Privacy Shield eLearning Course Now Available for Purchase!

1/28/2020

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What is Privacy Shield?

Privacy Shield is the current agreement for legal transfer of data from the European Union (E.U.) to the United States (U.S.). It is designed to offer stronger personal data protections and insurances of personal data for data subjects in the E.U. When organizations certify under the Privacy Shield Principles, they are benefitting from the European Commission’s adequacy decision for data transfer from the E.U. to the U.S.