IAOCR Lobbying, Regulatory & Parliamentary Activities

IAOCR Lobbying, Regulatory & Parliamentary Activities

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Campaign for Competence

The competence of those undertaking clinical trials is inherently important from both an ethical and commercial perspective. Competence ensures clinical research is carried out more effectively and efficiently, thus enabling the bringing of new treatments to market quicker.

2011 – Launch of IAOCR Campaign for Competence

2012 – IAOCR hosts first Clinical Research Industry Leaders Think Tank at the Carlton Club, London to raise the importance of competence with stakeholders from the CRO, sponsor and Regulatory community.

2012 – IAOCR Releases GxP Training Guidelines, recommendations for using a competence-based approach to training and evaluating clinical research professionals (scheduled for review and re-release).

2012 – IAOCR forms multi-stakeholder, international task force of 20 organizations to develop core competency frameworks for four key roles in clinical research.

2013 – IAOCR participates in Joint Task Force (JTF) for Clinical Trial Competency hosted by Multi-Regional Clinical Trial (MRCT) Center at Harvard University.

2013 – IAOCR presents case for competence-based accreditation at Clinical Research Industry Leaders Think Tank in New York.

2014 – IAOCR presents the case for competence-based accreditation of clinical research professionals to industry leaders in the USA, including Board of ACRO (Association of Contract Research Organizations) and leadership team at ACRP (Association of Clinical Research Professionals).

2014 – UK Shadow Health Minister, Andrew Gwynne MP speaks at IAOCR Industry Leaders Think Tank stating “It is striking that clinical research is one of the only regulated industries without a uniform standard of competence.  This is an anomaly that has no clear cause, but it is an anomaly that should be ended.”

2014 – Participants at IAOCR Clinical Research Industry Leaders Think Tank voice unanimous support for competence-based accreditation of clinical research professionals.

2014 – Core competency frameworks for 4 key roles are published.

  • Clinical Research Investigator
  • Clinical Research Associate
  • Clinical Research Project Manager
  • Clinical Research Training Manager

Over 200 organizations internationally are invited to review the frameworks prior to publication.

2015 – MHRA (Medicines and Healthcare Products Regulatory Agency) reviewed and provided feedback on the Global Clinical Research Competency Frameworks : Core Global Standards. Importance of competence verification discussed at length.

2015 – IAOCR approaches FDA and EMA to discuss importance of qualification by competence.

2016 – IAOCR works with industry experts to produce core competencies for the role of QPPV (Qualified Person for Pharmacovigilance).

2017 – IAOCR provides input into PostNOTE on EU Clinical Trials Regulation. PostNOTES are four page summaries of public policy issues for UK Parliamentary use.

2017 – IAOCR leads campaign to Close Loophole in ICH-GCP Guidelines; replacement requirement for individuals involved in conducting a clinical trial to be qualified by education, training, and experience. With a requirement for individuals to be competent.

To stay updated or get involved in awareness-raising or lobbying please contact us.

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