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

Principal investigators/investigators should be an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner. In addition, the coordinating investigator and principal investigators should have experience in conducting trials in accordance with ICH GCP and relevant laws and regulations governing clinical drug trials.

Participating investigators and other healthcare professionals should be sufficiently qualified to perform their tasks, and they should have access to necessary resources in their institution to conduct the trial.

Other trial staff should have relevant expertise and be qualified for the allocated task. Trial staff should conduct trials in accordance with the protocol, ICH GCP, the law and regulations governing clinical drug trials and other relevant regulations.

The qualification of the investigators and other healthcare professionals should be described in a current curriculum vitae (CV), preferably no older than 2 years. Any previous training in the principles of good clinical practice or experience obtained from work with clinical trials and patient care shall be described. In addition, a certificate of GCP training should be provided.

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.

To ensure that all investigators and trial staff have the necessary qualifications, a trial-specific training log should be prepared and used, for example, during the trial initiation meeting/start-up meeting.

Content of the Training Log

The training log, or equivalent documentation, should document the following:

• Title of the trial protocol.
• Names of trainees.
• Name of the person(s) who have provided the training.
• Training on clinical trials and other relevant law and regulations.
• Training on ICH GCP.
• Training on the protocol and investigational product.
• Training on trial specific procedures and agreements.
• Training on the electronic CRF (if applicable).
• Date of training.
• Signatures of the trainees and trainers.

Documentation 

The completed training log and other training documentation will be filed in the study files (master files (TMF/ISF)).

The qualifications of the coordinating investigator, investigator and all the relevant trial staff will be documented on their CV.

Trial specific training should be documented on the Training Log - Template or another training record. CVs and any training materials (e.g. agenda, slides, handouts etc.) will be kept in the TMF/ISF. Tasks can only be delegated to trained personnel, see Delegation Log - Template.

• Training Log - Template
• Delegation Log - Template
• Protocol Deviation Handling Plan - Template