CT SOP version 2.0

Main changes from version 1.0: Revised to reflect changes in ICH GCP R3.

CT SOP version no 1.0.

Main changes from LM SOP no. 2.03. Adapted to the wording of the clinical trial regulation no 536/2014. 

The sponsor has overall responsibility for ensuring that this SOP is followed.

The sponsor’s responsibilities shall be described in the quality system of the sponsor institution. Tasks are delegated according to SOP Roles and Responsibilities in clinical trials implemented in the institution.

The sponsor may transfer any or all of the sponsor's trial-related duties and functions to a third-party vendor such as a Contract Research Organisation (CRO), but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf. Transfer of duties shall be specified in a written agreement.

The sponsor is responsible for ensuring that monitors and other sponsor functions that perform tasks on behalf of the sponsor such as statisticians and data managers have the necessary qualifications.

The coordinating investigator is responsible for ensuring that principal investigators have the required professional and scientific expertise to conduct the trial.

The coordinating investigator shall ensure that training and guidance is provided to principal investigators and other trial staff in compliance with the protocol and laws and guidelines, ICH GCP. Training should be documented.

Qualifications

Tasks should only be delegated to qualified persons.

Principal investigators should be qualified doctors or dentists.

Investigators, study nurses/study coordinators and other site trial staff should conduct trials in accordance with the protocol, ICH GCP, the law and regulations governing clinical drug trials and other relevant regulations. Trial-related training to persons assisting in the trial should correspond to what is necessary to enable them to fulfil their delegated trial activities that go beyond their usual training and experience (ICH GCP R3, section 2.3.2.) This applies both to GCP-training and the trial specific training.

At least principal investigators and study nurses must be GCP-trained. GCP training should not be more than 3 years old and should ensure training in the newest implemented GCP revision.

Qualifications should be documented on an up-to-date  Investigator Curriculum Vitae and Non-investigators Curriculum Vitae and GCP training certificate.  All trial-specific training should be documented on a training log, see Training Log

Tasks can only be delegated to trained personnel, see Delegation Log.

Start-up Meeting

The coordinating investigator should make sure that all trial staff are adequately informed about the protocol, investigational product(s), and all trial-related tasks and procedures assigned to them.

The coordinating investigator should arrange a start-up meeting for all principal investigators (minimum) and study nurses (recommended) to ensure all sites are properly trained and receive the same information.  The start-up meeting is not to be confused with the site initiation visits and should be held prior to start of the trial before the site initiation visit and start of inclusion of participants at the study site.

For multi-centre and multi-national trials, the start-up meeting should preferably be one joint meeting for all sites and countries, if possible. The meeting can be digital or face-to-face depending on the complexity of the trial. For larger and/or complex trials a face-to-face meeting is recommended.  See Start-up Meeting Agenda  for recommended topics.

Minutes should be written from the start-up meeting with a list of participants enclosed. Minutes should be filed in the TMF/ISF to document the training provided/received.

If the start-up meeting is held at site, the start-up meeting and the trial initiation visit performed by the monitor may be done sequentially on the same day, see SOP Monitoring.

Training should be maintained throughout the trial, see SOP Trial Oversight.

Tasks

The coordinating investigator shall ensure that:

• Monitors have access to the protocol, trial information, investigator’s brochure (IB), investigator’s site file (ISF), case report form (CRF) and all necessary trial documents.
• Data managers, statisticians or other team members have access to the protocol, CRF and other information required to perform their assigned tasks.
• All site staff who are assigned tasks in connection with a trial receive the necessary training and information about the protocol, trial drug and the trial-related tasks and procedures.

• Training Log - Template
• Delegation Log - Template
• Start-up Meeting Agenda - Template
• Investigator Curriculum Vitae - Template
• Non-investigators Curriculum Vitae - Template