GOV.UK
It pays to be compliant!
In a bid to drive improved compliance and to cover the cost of managing more resource-intensive cases, the Inspectorate intends to apply the existing office-based assessment fee more broadly.
Compliance matters
Is it really a First in Human trial? Categorising and assessing the risks correctly
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.
Dose Escalation - is it GCP compliant?
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.
Making GCP Training Relevant and Applicable: It’s Not Just for Clinical Staff
We often receive questions about GCP training for laboratory staff, which suggests that this is a topic that causes quite a few laboratories issues!
Cross-contamination control and Health Based Exposure Limits (HBEL) Q&As
Q&As clarifying expectations for implementation of the HBEL guide and cross-contamination control requirements were published in April 2018
eConsent
A joint MHRA/HRA statement has been published which sets out the legal and ethical requirements for seeking and documenting consent using electronic methods.
Sponsor Oversight- Part 2
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.
National and International GCP Symposia
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.
What to expect from GPvP inspections
The GPvP webpage has recently been updated to provide additional information about the current inspection process. This post provides some further information about GPvP inspectors and inspections.
The Responsible Person named on the WDA- Part 3: Expectations for the engagement of consultants as contract RPs
This is the final of three posts centered around the Responsible Person named on a Wholesale Distribution Authorisation (WDA) and covers the engagement of a contract RP