CT SOP version 2.0

Changes from version 1.1: Updated according to ICG GCP R3 with details concerning feasibility of delegation of tasks to satelite sites and IMP shipment.

CT SOP version no 1.1.

Updated to reflect Agreement template adapted by the working group for decentralised clinical trials.

The sponsor has overall responsibility for:

• Describing the potential use of satellite sites in the protocol and which tasks can be performed at a satellite site and to which extent. This includes how and to whom trial data, including serious adverse events, should be reported.

The principal investigator at the main site is responsible for:

• The conduct of the trial in their own institution and that the tasks transferred to satellite site are performed according to the agreement with sponsor (oversight).
• Training and documenting the training of the responsible investigator at the satellite site.
• Ensuring agreement with the satellite site is in place, see Agreement for Transfer of Clinical Trial Tasks in decentralised trials.

The responsible investigator and trial staff at the satellite site must perform the tasks as described in the protocol and in accordance with the agreement with the main site. The satellite site can only perform protocol procedures in which they are properly trained.

Sponsor tasks

Sponsor should describe the possibility for transmission of trial tasks from the central hospital to the satellite site, the kind of tasks and the extent of transmission. The protocol should also describe how and to whom the satellite site should report the trial data and possible serious adverse events.

An example of protocol text could be:

• In order reduce the travelling burden for patients in the trial, the principal investigators will be allowed to enter into agreement with satellite sites to assure patients’ local follow up.

  The satellite sites will be trained in tasks and relevant parts of the protocol.

• The satellite sites may perform the following tasks after appropriate training is conducted:

  • List tasks.

• The satellite sites will provide the following information to the principal investigator:
  • List information.
• The principal investigator will inform the sponsor of which satellite sites are treating which trial patients.

The protocol must be approved by REK and NoMA, see SOP Application Process, Approvals.

The risk evaluation of the trial should include an assessment of whether the satellite sites should be monitored or not. Processes and data to be monitored as well as frequency of the monitoring visits should be described in a monitoring plan.

To ensure systems and logistics are feasible before start of trial or initation of the satelite site, involvement from intended participant populations and/or healthcare professionals are recommended.

Principal investigator tasks

The main site should enter into agreement with the appropriate satellite sites. The agreement should at least include:

• If IMP is provided from sponsor, line of distribution to the satelite site should be approved by sponsor and specified in agreement with the satelite site, taking into consideration the characteristics of the investigational products, the route and complexity of administration and the level of existing knowledge about the investigational product’s safety profile.

• Which tasks the satellite sites should perform and what should be reported to the main site.
• Specification of the requirements for archiving of source data.
• How serious adverse events should be reported and to whom to ensure reporting within time limits.
• The satellite site must allow monitoring and possible audit/inspection from authorities.
• Any financial compensation.

Agreement for Transfer of Clinical Trial Tasks in decentralised trials may be used.

The principal investigator should ensure and document relevant training of personnel at the satellite sites.

The principal investigator should have an overview over which satellite sites have been contracted and who is responsible at each satellite site, as well as the patients treated in the different satellite sites.

The principal investigator should keep a copy of all signature logs, including previous versions if applicable.

Tasks at the satellite site

Each satellite site should have a responsible investigator ensuring that the requirements in the agreement and the protocol are followed. As a minimum this includes:

• That the requirements for archiving of source data are met.
• That a signature log is completed on an ongoing basis and sent to the principal investigator whenever changes are made.
• That an identification and enrollment log includes the patients treated at the satellite site.
• That serious adverse events are reported according to protocol.
• That the protocol, agreement, signature logs, identification and enrollment log, documentation of investigational medicinal product dispensed and adverse events are gathered in a study file.

• Agreement for Transfer of Clinical Trial Tasks in decentralised trials - Template
• Signature Log - Template