All early phase clinical trials have risks associated with them that require mitigation. Following not just the legislation but also all the associated guidance will help in maintaining public safety and the credibility of data.
Good clinical practice
Dose escalation practices should be the same regardless of whether a clinical trial involves healthy volunteers or patients. Good quality data and sound procedures are vital to ensure the safety of all trial subjects.
We often receive questions about GCP training for laboratory staff, which suggests that this is a topic that causes quite a few laboratories issues!
A joint MHRA/HRA statement has been published which sets out the legal and ethical requirements for seeking and documenting consent using electronic methods.
Part two of this post provides two case studies from inspections where critical and major findings have been identified in regards to Organisation’s Oversight of Clinical Trials of IMP.
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.
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.
The first of two posts focusing on sponsor oversight and how to improve compliance in this area.
Find out how to register for the 2018 GCP Symposium.
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.