GCP inspection findings/observations in clinical trials forming the basis for an application for marketing authorizations for new medicinal products or for extending indications to already authorized products have two main implications: Some findings point to GCP non-compliance issues affecting the safety, well-being and the rights...
According to the updated ICH GCP, section 5.2.2: The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s). The challenging question is how to ensure...
The European Medicines Agency (EMA) has issued a draft guideline, which lays down the principles for management of the IMP (investigational medicinal products) by the sponsor for use in a clinical trial in accordance with GCP and GMP. The guideline is currently available for public consultation...
During a period of one year from 2016 to 2017, the UK GPvP (Good Pharmacovigilance Practice) Inspectorate conducted 36 inspections of marketing authorisation holders (MAHs) and one inspection of a pharmacovigilance service provider. The purpose of these inspections was to examine compliance with existing EU and...
The EU GDPR (General Data Protection Regulation), effective from 25th May 2018, replaces the Data Protection Directive 95/46/EC, is designed to harmonise the data privacy requirements across Europe, to protect and empower all EU citizens data privacy, and to strengthen the way of handling personal...
The investigator should agree to archive the documentation (both electronic and paper-based records) during the retention period as required according to GCP 5.5.11 - 5.5.12. General practice is 15 years after end of trial or longer. If the investigator cannot archive the documents at the...
