The UK-based International Academy of Clinical Research (IAoCR) is developing a set of training guidelines for the clinical research industry as part of its efforts to realise consistent training standards across the sector.
The IAoCR has put together an independent task force of industry experts from diverse backgrounds including pharmaceutical companies, contract research organisations and independents from Europe, North America and Asia.
They will draw up a draft document, GxP Training Guidelines (GxP being a general term for Good Practice quality guidelines or regulations), setting out minimum requirements for best practice in training all parties involved in pharmaceutical development and manufacturing.
The draft recommendations will go out for consultation to a wider community of individuals and organisations from industry, academia, government and regulators on 1 August 2012. Interested parties can register online to receive the draft document by using the webform at www.iaocr.com/gxpt.
The deadline for feedback on the draft training guidelines is 21 September 2012. After that, the task force will finalise the document for publication in October 2012.
Global framework
It is hoped the guidelines will be adopted voluntarily across the clinical research industry, providing a global framework for best practice, the IAoCR says. To that end, the task force will be making a number of conference presentations from October 2012 and throughout 2013.
“We understand that in a complex industry such as ours, different parties will make their own interpretations of the training guidelines,” commented Jacqueline Johnson North, chief executive officer of the International Academy of Clinical Research.
“It is crucial that we engage the industry in creating the most cohesive, relevant set of recommendations possible,” she added. “The more people who review this document and provide feedback, the more valuable it will be.”
