Safety for participants
Principles governing the performance of clinical trials
In accordance with Good Clinical Practice (GCP), which governs all of the clinical trials Novo Nordisk conducts, the interest and the well-being of the trial participants must always prevail over the interests of science, society and commerce.
Approval of trial activities
Any trial activity in Novo Nordisk-sponsored clinical trials will only be initiated upon approval from external local ethics committees and health authorities.
Novo Nordisk's obligations as the trial sponsor
It is the responsibility of the clinical trial sponsor, ie Novo Nordisk, to ensure the physician conducting the clinical trial is skilled in the therapeutic area, is trained in the principles governing the conduct of clinical trials (GCP), and has access to the necessary equipment, time and resources for conducting the trial.
The products used in a clinical trial are manufactured and controlled according to international and local laws and regulations.
Novo Nordisk personnel will visit the trial sites frequently to monitor and ensure the trial is executed according to the trial protocol (which is approved by an ethics committee and health authorities).
It is the obligation of Novo Nordisk as a sponsor to ensure that available information about the trial product is submitted to the physician and health authorities, and that the information is updated when new information becomes available.
Physician's obligations
The physician responsible for the trial has the obligation to ensure and protect the interests of the trial participant. Before the initiation of any trial activity, the trial participant must give his or her informed consent.
Adverse events
If a trial participant experiences an adverse event, the physician responsible for the trial must be notified in order to ensure that adequate medical care is provided.
The responsible physician will monitor closely and report to the trial sponsor / health authorities any adverse event that occurs during the course of the trial irrespective of whether the event is considered related to the trial product.
Safety monitoring in clinical trials
Novo Nordisk has established safety committees for all investigational medicinal products that follow the reporting of adverse events globally. It is the responsibility of the safety committee to take immediate action if needed on safety aspects.