16-18 November 2021
The European Medicines Agency (EMA) recently published Questions and Answers on good clinical practice (GCP) on its website.
Question 8 regarding contractual arrangements with vendors for electronic systems under "GCP matters" Q&A (please see below) has been published in January 2017 and should be read together with question 2, which contains more general considerations on how contracting should be addressed.
EMA states that "sponsors contract out an increasing number of tasks in clinical trials. One area where sponsors typically lack internal knowledge or resources is development of electronic systems in clinical trials, such as systems used for randomization and IMP distribution management/accountability (Interactive Response Technology (IRT)) and/or clinical trial data capture (eCRF and ePRO systems). During inspections of commercial as well as academic trials, an increasing amount of deviations from good clinical practice (GCP) standards have been identified by the inspectors in view of sub-standard contractual arrangements and related procedures. This Q&A focuses on some areas where deviations are being given with an increased frequency and/or other deviations that inspectors wish to highlight to stakeholders. Special consideration should be given on training and quality systems. 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."
Examples of deviations are described as bullet points under the following headings: status of contracts, distribution of delegated tasks, standards to be followed, audits and inspections, serious breaches, compliance with the protocol, output, and exemptions.
The following questions and corresponding answers have been published on the EMA webpage:
Investigational medicinal products (IMPs) in bioavailability and bioequivalence trials
Expectations of European Union (EU) competent authorities on the use of electronic trial master files
Records of study subject data relating to clinical trials
For more information please visit the EMA GCP homepage.