CT SOP version no. 1.0.

Minor changes from LM SOP No. 1.07 version No. 3.0.

The monitor’s line manager is responsible for the monitors that perform co-monitoring of clinical drug trials and ensuring compliance with this SOP.

General requirements for co-monitoring

Co-monitoring is part of a monitor's continuing professional development. Co-monitoring provides opportunities for sharing experience, clarification of procedures and monitoring practice and assessing additional need for training.

Each monitor should ideally participate in a co-monitoring visit every other year.

A co-monitoring visit should be done as part of an ordinary scheduled monitoring visit, and not cause extra work for the investigator/trial personnel.

Co-monitoring should be carried out by a person with extensive experience in monitoring, who preferably belongs to a different institution than the site where the co-monitoring visit is done. It is recommended that the co-monitor already is familiar with the study, and is monitoring own sites in the same study and may well be the lead monitor of the trial.

Preparation

The monitor shall notify the principal investigator/trial personnel about co-monitoring visit in advance.

The co-monitor will prepare for the visit by familiarising themselves with the:

• Status of the trial
• Protocol
• Procedures for the trial
• Monitoring plan

Conduct of the visit

The co-monitor will verify that the monitoring plan for the trial is followed and observe how the different monitoring tasks are done.

The monitor and co-monitor should discuss their common understanding of protocol, study procedures and monitoring plan.

The co-monitor and the monitor should prepare a Co-monitoring visit report - Template together with lessons for both parties.

Unresolved/significant issues, or issues that can be of value to discuss in the monitoring group, will be escalated to the head of the monitoring group. The co-monitoring report will be signed and dated by both parties and sent to the head of the monitoring group within 14 calendar days after the co-monitoring visit.

The issues raised in the report will be discussed in the monitoring group at the bi-annually meetings.

All monitors should plan for at least one co-monitoring visit across the region per year and inform the head of the monitoring group about the plan. The head of the monitoring group has the responsibility to update the co-monitoring log.

Review of co-monitoring

The monitoring group will review the “topics of interest to the monitoring group” identified on co-monitoring visit reports on an annual basis, and take action as required to ensure compliance with ICH GCP monitoring requirements and NorCRIN SOPs.

• Co-monitoring Visit Report - Template