Monitoring Services

Risk handling in a clinical trial can be multifaceted: Sometimes a procedure to describe how to handle a lab sample can be what is needed to mitigate a risk. Other times good training of the study staff is what is required. You can reduce or remove risk by having good monitoring; for instance by checking that the patients fulfil the enrollment criteria to take part in the trial, that the end points entered in the database are correct and in accordance with the information in the patient’s medical chart, or that the correct drug is given to the patients.

Physical visits by the monitor will be described in the monitoring plan. The most common practice is that the monitor will visit the site once before you initiate the trial, to ensure that all required documents are present in the study binder and that necessary equipment, procedures and clinical supplies are in place. Thereafter, the monitor will visit you again after inclusion of the first few patients. Then there will be regular visits, once or twice a year, as long as there are patients in the trial.

After the monitoring visit, you will receive a report from your monitor describing what to be corrected and followed up on. You will be given a few weeks to solve the issues.

Between the monitoring visits the monitor will be available for you for questions and advice on how to conduct the study and handle challenges that may occur.

Section for monitoring provides complete monitoring services of high quality and to a favorable cost, to all hospitals in South-Eastern Norway Regional Health Authority. Monitoring and support with writing a monitoring plan will be invoiced according to current fees agreed by NorCRIN, “NorCRIN-takster”, and should be included in the budgeting of your project. It is important to remember that this cost will help ensuring compliance with laws and regulations, provide significantly higher quality and may save you from spending resources in vain.

All advising from the section for monitoring is free of charge.