Quality Assurance & Collaborators 2018-02-23T23:07:25+00:00

Quality Assurance & Collaborators

Quality Assurance & International Recognition

IAOCR is the only organization in the world to provide truly internationally recognizable, robust and meaningful accreditation of clinical research professionals, training programs and companies based on competence.  Contact us to request your PDF of how accreditation provides a more robust and meaningful alternative to traditional certification programs and how it compares to academic qualifications.

In addition to working to a number of internationally and industry recognized frameworks and quality assurance standards, we work collaboratively with industry regulators, commercial companies, not-for-profit bodies and experts to formulate and share best practice frameworks and guidelines, which are freely available to download from our resources page.

Collaborators

We are grateful to the organizations below for enabling their staff to be involved in collaborative initiatives so that we can jointly continue to shape best practices for clinical research globally.

Clinical Research Competencies – Core Global Standards

The first four clinical research competencies frameworks were released in 2014:

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

These Core Global Standards were developed over an 18 month period in collaboration with four independent task forces comprised of individuals working in a variety of clinical research roles across Europe, North America and Asia.  In 2015 they underwent regulatory review and guidelines will be released later this year.  The clinical research competencies frameworks – core global standards are available to download free of charge from our resources page.

Following demand from industry, task force groups are now drafting competency frameworks for other key roles – join the IAOCR LinkedIn page to keep up to date on the latest developments.

Acknowledgements

We would like to thank the following people for volunteering their insights, time and expertise:

Mark Arquiza, Helena Bowle, Celia Gibson, Neil Gray, Alison Ingram, Alex Knibbs, Susy Laws, Rebecca Li, Dawn Livingstone, Sarah Marshall, Tammi Masters, Sam McGarvey, Janet Messer, Kyle Patrick, Sue Rees, Keith Richardson, Lesley Robson, Iain Searle, Caroline Smith, Mona Soderblom, Ian Thomas, Clare Wallis.

GxP Training Guidelines

The GXP Training Guidelines were first released in 2012.  Their purpose is to provide best practice recommendations for the training lifecycle, to enable organizations to be able to demonstrate individuals’ competence.  The Guidelines are currently being reviewed and an updated version will be available later in 2016.

The Guidelines were produced by IAOCR (then known as the International Academy of Clinical Research) with input from an independent task force of clinical research professionals working in training and quality assurance roles across Europe, North America and Asia.  More than 30 not-for-profit and educational bodies across South America, North America, Europe, Asia Pacific and Africa were invited to review and provide feedback on the original draft.

Acknowledgements

We would like to thank the following people for volunteering their insights, time and expertise:

Emma Hancox, Katharina Kurpanek, Susy Laws, Tammi Masters, Harish Sankarankutty.

The following organizations were invited to review and provide feedback on the Guidelines prior to a public consultation period:

ACDM (Association of Clinical Data Managers) – UK, ACRES (Alliance for Clinical Research Excellence & Safety) – USA, ACRO (Association of Clinical Research Organizations) – USA, ACRP (Association of Clinical Research Professionals) – USA, APCR (Academy of Physicians in Clinical Research) – USA, Asan Medical Centre – Korea, Asian Training Consortium – APAC, BARQA (Association of Research Quality Assurance) – UK, Birmingham University – UK, Brazilian Clinical Research Institute, Federal University of Sao Paulo – Brazil, CCRA (Clinical Contract Research Association) – UK, Clinical Research Centre – Malaysia, Clinical Trials Honor Roll – Australia, DIA – USA, Dr. Cecilia Grierson Foundation – Argentina, Duke University – USA, EDCTP (European and Developing Countries Clinical Trials Partnership), EMTRAIN – Europe, European Training Conference – Europe, Harvard Medical School – USA, Hibernia College Dublin – Ireland, Hochschule Hannover – University of Applied Sciences and Arts – Germany, ICR – UK, ISCR (Indian Society for Clinical Research), Japan Medical Association Center for Clinical Trials, KoNECT (Korea National Enterprise for Clinical Trials), Lee Kong Chian School of Medicine – Singapore, Medical Research Council – UK, MRC – The Gambia Unit, Napier University – UK, NIHR – UK, PACRA – Asia Pacific, Peking University Clinical Research Institute – China, SACRA (South African Clinical Research Association), Singapore Workforce Development Department, SOCRA (Society of Clinical Research Associates) – USA, University King Juan Carlos I of Spain Center Foundation – Spain.

Join the IAOCR LinkedIn Page