EU: Clinical Trials Regulation – General Information & Guidelines (12-Mar-2015)

General information All clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive(126 KB) until the new Clinical Trials Regulation (CTR) EU No 536/2014 (875 KB) will become applicable, which will be no earlier than 28 May 2016. For further information please see the information on the Clinical […]

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UK: MHRA Grants First Scientific Opinion (11-Mar-2015)

Dr Ian Hudson, Chief Executive of Medicines and Healthcare Products Regulatory Agency, comments on the first scientific opinion granted in the UK. Chief Executive of the Medicines and Healthcare Products Regulatory Agency, Dr Ian Hudson said: “We are delighted to issue the first positive Early Access to Medicines Scheme (EAMS) scientific opinion. Following assessment of […]

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UK: New MHRA Website (11-Mar-2015)

As of 28 January 2015, the Medicines and Healthcare Products Regulatory Agency (MHRA) website is now on GOV.UK New web address is www.gov.uk/mhra. The contact has been rewritten so it is easier and clearer to understand. How does this affect you? Bookmarks and saved links to MHRA’s old website will still take you to the information […]

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EU: eConsent Considerations in Europe (11-Mar-2015)

eConsent Considerations in Europe  Legal Framework for eSignatures The eSignature Directive (Directive 1999/93/EC) establishes the legal framework at European level for electronic signatures and certification services. The aim is to make electronic signatures easier to use and help them become legally recognised within the Member States. eConsent is a combination of eSignature (eID) and electronic […]

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USA: FDA Guidance on eConsent (11-Mar-2015)

This draft guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. FDA’s requirements for electronic records/electronic signatures, informed consent, and IRBs are […]

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UK: Replacing Research Governance Framework (11-Mar-2015)

Upon becoming a Non-Departmental Public Body (NDPB) on 1 January 2015, the HRA took responsibility for issuing guidance for research in England, in place of the Research Governance Framework (RGF). The HRA and Devolved Administrations committed to the ambition of having a single framework for research across the UK and established a UK wide Steering […]

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Global: ClinRegs Update – Sierra Leone (26-Jan-2015)

ClinRegs is an online database of country-specific clinical research regulatory information designed to save time and effort in planning and implementing clinical research.  With the publication of Sponsorship, Informed Consent, Investigational Products, and Specimens topics, the ClinRegs Sierra Leone profile is now complete. To receive notification of content updates, sign up for email updates using […]

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USA: Use of a Single Institutional Review Board for Multi-Site Research (26-Jan-2015)

Release Date: December 3, 2014 Response Date: January 29, 2015 Issued by: National Institutes of Health (NIH)   The National Institutes of Health (NIH) is seeking public comments on a draft policy to promote the use of a single Institutional Review Board of record for domestic sites of multi-site studies funded by the NIH. Background The NIH is […]

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UK: HRA Protocol Template Released for Consultation in Use (26-Jan-2015)

[Acknowledgements: Prof David Hutchinson, Canary Ltd] In collaboration with a wide range of partners, the Health Research Authority (HRA) has published a template and guidance for protocols for clinical trials of investigational medicinal products (CTIMPs). This is the first in a suite of templates for health research. The templates will be particularly valuable to new researchers, […]

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