Accord Update/Training Events 2019
Setting up NHS/HSC research in the UK: A UK Local Information Pack will be introduced on 5th of June 2019
Management of Deviations & Violations Training Materials available.
UK Local Information Pack - preparing for change on 5 June 2019 *SLIDES AVAILABLE*
The Health Research Authority (HRA) in association with the devolved administrations, has launched a consultation on research transparency. Last year the organisation was tasked by the House of Commons Science and Technology Committee to devise a new strategy to ensure that trusted information about health and social care research studies is publicly available for the benefit of all.
Downtime notice for EudraCT Results & New Release of EudraCT 10.4.0.0.
ACCORD: Bursaries for patient and public involvement in research
MHRA suspends use of certain Gadolinium contrast agents (GdCAs), and restricts uses of others.
A class 2 medicine recall – action within 48 hours – has now been issued by the MHRA for Magnevist (Bayer plc) and Omniscan Solution (GE Healthcare).
The General Data Protection Regulation (GDPR) was implemented on 25 May 2018, together with a new Data Protection Act.
Update to IRAS, the Integrated Research Application System, will introduce a single, e-submission of IRAS Forms and associated documents.
The Association of British Insurers (ABI) have confirmed to the Health Research Authority that participation in clinical trials does not affect eligibility criteria for travel insurance and have now withdrawn their guidance document “Clinical research trials and insurance”.
Setting up NHS / HSC research in the UK– preparing for change on 5 June 2019
A two-day course providing a comprehensive overview of the methods and frameworks currently required to perform cutting-edge clinical research.
We are writing to draw your attention to a change in the way that NHS costs are reviewed during grant applications. This is being driven primarily by new ways of handling NHS Excess Treatment Costs (ETCs) in England, but will also affect Scottish organisations applying to UK funders.
The eHealth IT Security policy is available here: http://www.accord.scot/researcher-access/ehealth-it-security-policy
Statement from the MHRA on inspections of Labs analysing human samples as part of a clinical trial.
New HRA Approval documents are available
CSO Research Strategy launched October 2015.
The HRA have developed six new eLearning modules as an aid for researchers, R&D staff, study sponsors, research ethics committee members and the wider research community.
Please update your recruitment figures regularly
Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
27-May-19: The Four Nations Group have issued further communication regarding the UK Local Information Pack.
Updates following Implementation of the UK Local Information Pack
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