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Regulatory and governance information

The UKCRN Regulatory and Governance team has identified a variety of useful resources which are useful reference points for regulatory and governance information.

Website of the month
Each month, the Regulatory and Governance team will feature a website in more detail.

The Association for Clinical Research Professionals (ACRP) was founded in 1976 to address the specific educational and networking needs of individuals involved in clinical investigations. ACRP is now a global association comprised of more than 20,000 individuals in over 60 countries, including the UK, dedicated to clinical research and development. Its aim is to provide global leadership to promote integrity and excellence for the clinical research profession.

The ACRP website contains sections on public policy, education, certification, conferences, and careers. The public policy section predominantly focuses on US regulatory issues and includes items on FDA updates, trends to watch and changes in US legislation that affect clinical research. Whilst this may have limited value for researchers working solely in the UK, for organisations sponsoring international trials this may be particularly useful.

The education and conferences section contains items that are more broadly applicable and ACRP are currently collaborating with the NHS R&D Forum to offer a course in Monitoring Skills Training for the Non-Commercials (for the UK sector).

ACRP also offer certification exams based on the following regulatory requirements: FDA, ICH and European for all types of clinical research professionals including clinical research associates, researchers and principal investigators. Certification is granted in recognition of documented and verified work experience and after successful performance on a multiple-choice exam.

 
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