Recommendation paper DCT, V01, dd 13 December 2022 7
2. CLINICAL TRIAL OVERSIGHT: ROLES AND RESPONSIBILITIES
When parts of the clinical trial are conducted off-site, and when additional service providers such
as home nurses or providers of technology become involved, it is essential that the specific roles
and responsibilities of the sponsor, investigator, and any additional parties are clearly defined and
understood prior to the start of the trial. In addition, when trial participants are visiting the clinical
trial site less frequently, alternate methods of clinical monitoring of the trial participants’ current
health status and related data collection may need to be utilised. Data may be received from
different routes, for example collected at home by the participants themselves, by visiting
(external) healthcare professionals, or by digital tools. This poses a challenge to the oversight on
the rights, safety, dignity and well-being of the trial participants as well as the reliability of trial
results. As a general concept, introducing decentralised elements should be considered as an
extension of the clinical trial site with the inclusion of the trial participants’ home, resulting in an
additional obligation of oversight for investigators and sponsors. It is therefore important that,
when decentralised elements are implemented, it is ensured that the investigator and sponsor still
can fulfil their legal obligations as laid down in the CTR or the CTD and ICH E6. In addition, with a
potential increase in the number of parties involved in the clinical trial, adherence to the GDPR
needs to be safeguarded.
The protocol should reflect that the sponsor and the investigator are in full control of their
respective areas of responsibilities at all times, e.g. with respect to the data processing, the
communication flow, and ultimately the rights, safety, dignity and well-being of the trial
participants and reliability of the trial data. In this section considerations in relation to investigator
and sponsor oversight are outlined.
Considerations on responsibilities
• Notwithstanding the potential involvement of additional service providers, the clinical trial
specific tasks as described in the protocol are ultimately the responsibility of either the
investigator or the sponsor, in accordance with ICH E6. Great care should be taken that the
delegation of tasks to the different parties is well defined. The introduction of decentralised
elements in a clinical trial may have a relevant impact in the trial conduct, therefore, it should
be clearly documented which tasks are conducted when, by whom, and in which setting (e.g. at
the clinical site, at the trial participant’s home, etc.),
and how the required oversight by the
sponsor and/or supervision by the investigator is achieved. The general overview of the
workflow of these different tasks and actions to be taken within the trial should be described in
the protocol, and in more detail in a protocol related document.
• In case service providers have been delegated trial specific tasks, a corresponding rationale and
the extent of their involvement should be described in a high level in the protocol, and in detail
in a protocol related document. The investigator retains the ultimate responsibility for tasks
involving trial related medical decisions (i.e. trial participant eligibility and enrolment, protocol
specified medical procedures, changes in medication, etc.) and for the rights, safety, dignity
and well-being of the trial participants. See also the appendix for current national provisions
regarding the involvement of external health care providers.
• Any trial specific task that is delegated to a service provider should be specified in a written
agreement between the responsible party for the task (according to ICH E6) and the service
provider (see also the EMA GCP IWG Q&A B.2, and B.8
). When the sponsor selects a service
provider and the investigator is not involved in the contractual arrangement with this service
provider, the contract between the sponsor and the investigator should clearly document the
contractual arrangements with the service provider if it concerns tasks under investigator’s
responsibility. This allows the investigator to agree or not to the deployment of service
providers for certain trial specific tasks related to the medical care of trial participants. As
stated previously, in the general considerations of this paper, it is recommended that the
investigator should be involved in an early stage when designing the decentralised elements in