The EMA has warned sponsors must take “great care” when outsourcing to niche subcontractors to avoid violating GCP.
Use of niche subcontractors for tasks such as data management and IVRS (interactive voice response services) broadens the number of parties involved in a clinical trial. The European Medicines Agency (EMA) has expressed concerns about the model’s impact on good clinical practice (GCP) compliance.
“This fragmented distribution of tasks could put additional strain on the maintenance of quality assurance and compliance and obscure the clear responsibility and reporting lines for these tasks”, the EMA said in its GCP question and answer document .
Sponsors working with a network of subcontractors must take “great care” to ensure distribution of tasks is documented and agreed, EMA said, and “properly” inform ethics committees of the activities.
Responsibility lies with the sponsor or investigator but the EMA wants the distribution of all tasks to be documented in the protocol, procedures, or contracts. The US Food and Drug Administration (FDA) has a similar stance on transferring responsibility to contract research organisations (CROs).
Sponsors should also consider the specifics of each particular clinical trial from the planning phase onwards. “This is important where entering into novel arrangements that may arise, for instance in the case of SMOs (site management organisations)”, the EMA said.
SMOs are highlighted by the EMA because they perform roles linked to the “responsibilities of the investigator” but have their “contract and funding with the sponsor”. Tasks handled by SMOs may also put them in contact with study subjects.
Sponsors must pay particular attention when subcontractors have direct contact with patients. Personal details must only be shared with parties that have ethics committee approval, the EMA said, and as such use of subcontractors in these roles must be considered in advance.
The EMA published the text in response to the following question: “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?”