February 2019

1. Does anonymization or de-identification require consent under the GDPR?

In this Khalid El Amam and Mike Hintze article, these experts make the case that consent is NOT required to anonymize or de-identify clinical trial data..

2. "Opinion" on the interplay of the CTR and GDPR

Opinion 3/2019 - dated 23 January 2019 - concerning the "Questions and Answers on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection regulation (GDPR) (art. 70.1.b))” is by the European Data Protection Board (EDPB).

This legal "Opinion" should be shared widely in the clinical research industry, including amongst legal departments.

Review of standard Informed Consent Template and Protocol Template texts for appropriate wording is recommended.

3. 'Big Data' - consultation on acceptability of evidence

The role of big data for evaluation and supervision of medicines in the EU is being assessed. Stakeholders are invited to submit feedback and observations on the recommendations to inform the upcoming work of the group.

4. UK government national strategy to boost clinical trial reporting

The UK government has announced that a national clinical trial transparency strategy will be published before the end of 2019.

The statement marks a significant step towards ensuring that all clinical trials conducted in Britain will be registered and will publish their results. Read TranspariMED's summary report on the status of the strategy.