EMA Q&A on GCP

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

• How should the packaging of IMP be performed?
• How should the packaging be documented?
• How should the containers be labelled?
• How should IMP administration to the subjects be documented?

GCP matters

• Can a sponsor prospectively approve deviations (so-called “protocol waivers”) from the inclusion/exclusion criteria of the approved protocol without additional approval of the ethics committee and competent regulatory authority?
• GCP sets out responsibilities for the sponsor and the investigator, but tasks are increasingly undertaken by a range of contractors – how should this situation be addressed?
• How and where should source data be defined?
• How can proper documentation of eligibility be ensured?
• What are the expectations of the investigator’s copy of the CRF (Case Report Form) when using a web based application?
• Can the sponsor require that the investigator contacts sponsor staff before unblinding study medication?
• How should data be presented when they are sent to the inspection team prior to a GCP inspection requested by the CHMP?
• What are the pitfalls to be aware of regarding contractual arrangements with vendors for electronic systems in connection with clinical trials?

Expectations of European Union (EU) competent authorities on the use of electronic trial master files

• What are the expectations of EU competent authorities concerning the use of electronic trial master files (e-TMFs)?

Records of study subject data relating to clinical trials

• What are the roles and requirements for the study subject record (medical record) and related source documents in the context of a clinical trial?

For more information please visit the EMA GCP homepage.