UKCRC QA Representatives Away Day


Joanna Black has recently attended the first UKCRC QA representatives annual away day in London. This meeting was well organised and attended with representation from most of the registered Clinical Trial Units . The topics for discussion included scoping out the roles and job titles of those working in a QA capacity within a CTU, it was concluded that CTUs would benefit from a generic job description for QA, as the role varied substantially from unit to unit, with some units not benefitting from a QA person in role, but this function was part of the role of other job titles; working with Sponsors (with a discussion on CTU stand-alone SOPs as opposed to Sponsor SOPs); working with laboratories and the possibility of sharing laboratory audit checklists, revision to the model non-commercial agreement and issues which delay signing these agreements off. There was an update on where we are with the new EU Clinical Trials Regulation (to be implemented in 2016) and the remaining concerns whilst it is still in draft. The day also consisted of break out sessions to discuss the following sessions: setting up a QA system; internal audits, and MHRA inspections. There was a reminder on the CTU stand alone MHRA inspections that have started to take place from earlier this year. Anytime now OCTRU are expecting to receive a Risk Based Inspection Questionnaire from the MHRA.