April 2019

1. Health Canada’s Final Guidance on “Public release of clinical information” 12 March 2019

Health Canada have concluded their "Public Release of Clinical Information" consultation.

The overview and table of contents for the final HC guidance document is helpful for navigation purposes.

Read the full final HC guidance document.

2. No-deal Brexit Scenario: Guidance on UK public registry postings for clinical trials

On 20 March 2019, the UK Government released guidance on the registration of clinical trials for investigational medicinal products and publication of summary results.

This guidance contains information about registration of clinical trials, publishing trial results and future requirements if the UK leaves the EU without a deal.

Remember that until the UK’s exit from the EU is clearer (date and manner of exit), this guidance represents the UK’s preparedness position in the event of a ‘no deal’ only.

3. PhUSE White Paper

Read the ‘Retrospective versus proactive anonymization of narratives’ White Paper dated 14 March 2019 from PhUSE.

Regularly review the PhUSE White Paper archive for new and updated material.

4. ISMPP 'OA and Medical Publishing' White Paper

ISMPP have released their 'Open Access and Medical Publishing' White Paper. ISMPP state in the Introduction to this 23-page White Paper that its aim is to "... provide an awareness of the options and implications of open access publishing for industry and other stakeholders in medical publishing against the backdrop of a rapidly changing landscape."

5. EC Guideline on Interplay Between CTR and GDPR

In the CORE Reference News Summary dated February 2019, I shared Opinion 03/2019 of the European Data Protection Board. This Opinion is now incorporated into the European Commission Guideline titled 'Questions and Answers on the interplay between the Clinical Trials Regulation and the General Data Protection Regulation'.

6. WHO/ICMJE - ClinicalTrials.gov Cross Reference Resource

This World Health Organization (WHO)/International Committee of Medical Journal Editors (ICMJE) – ClinicalTrials.gov Cross Reference document may be useful in your daily work.

7. Revised Common Rule Mandates ICF Posting

Clinical trial Informed Consent Form posting is now mandated (45 CFR 46.116(h)). This HHS.gov page shows you where and how to post the ICF.