Clarification on the interpretation and implementation of the GXP DI guidance in the clinical trial setting
Paula Walker is currently the MHRA GCP Inspectorate Operations Manager and a Senior GCP inspector, having worked for the Agency since April 2009. Paula has a Masters in Biotechnological Law & Ethics, a Post-Graduate Diploma in Clinical Trials and a BSc in Biomedical Science.
Prior to joining the Agency Paula worked in research governance and clinical trials regulation in the non-commercial sector. She started in the NHS working in research and development in a number of roles including ethics management and training, and subsequently worked as a research manager in the higher education sector. Following this she moved back into clinical research and trials regulation working in a number of universities, providing operational and regulatory support for sponsored trials. Paula has been a GCP inspector since 2009 and an MHRA Inspectorate Operations Manager since 2013.
A joint MHRA/HRA statement has been published which sets out the legal and ethical requirements for seeking and documenting consent using electronic methods.
On the 5 and 6 September, the GCP Inspectorate held their symposium and were joined by colleagues from the FDA, the Brazilian authority ANVISA and the Israeli Ministry of Health.
As with most activities in clinical trials, the development of electronic systems is playing an increasing role in methods for data collection. As inspectors we are therefore continually seeing new systems while out and about on inspection, and adapting our …
Happy New Year! Having pestered my team for ideas for the blog and articles it seems only fair I start 2016 by writing one myself, with a focus on stakeholder engagement and the new EU Clinical Trials Regulation update. My …