A European Medicines Agency (EMA) spokesperson told us the agency added the new question (No. 8) in January to address possible contractual arrangement pitfalls with clinical trial electronic systems vendors.
“This question was added because sponsors increasingly contract out tasks related to clinical trials, in particular in relation to the development of electronic systems, and an increasing number of deviations from good clinical practice (GCP) standards have been identified by the inspectors,” the spokesperson explained.
The Q&A focuses on the areas where there is increased frequency of deviations and/or other deviations that inspectors wish to highlight to stakeholders.
‘What are the pitfalls to be aware of regarding contractual arrangements with vendors for electronic systems in connection with clinical trials?’ The question asks.
“Experience suggests that vendors accepting tasks on electronic systems are frequently knowledgeable on IT systems and sometimes on data protection legislation, but not necessarily on GCP requirements, quality systems, etc.,” the agency said.
Consequently, according to the EMA, “special consideration” should be given to training and quality systems.
Examples of deviations covered include, status of contracts, distribution of delegated tasks, standards to be followed, audits and inspections, serious breaches, compliance with the protocol, output, and exemptions.
For more information, visit http://www.ema.europa.eu/ema.