A clinical trial can only start after researchers determine that the study is scientifically justified and approval is granted by local ethics committees and health authorities.

Before you officially enroll, the research team will go over the details of the study, including how long it will last, and what procedures you will encounter. Agreeing to participate after this thorough explanation is called agreement to take part, and it’s a key step in the process of getting you started.

During the trial, you’ll meet members of the research team, who will be available to you from start to finish. This team includes the investigator, another name for the doctor or scientist in charge of the entire trial. You will also have a lot of interaction with physicians and nurses who are there to guide you through the process.

Once you complete a clinical trial, you should feel a sense of pride knowing that you played a big role in the advancement of a medical treatment. At the end of the trial, the trial team will examine the results, and you will have an opportunity to see what the doctors discovered. The results will also be published for the public to review, because this is a part of Novo Nordisk’s commitment to transparency.

A clinical study in children/teenagers can only start after researchers have determined that the study can be justified, and approval is granted by local ethics committees and health authorities.

Participating in a clinical study is a very personal decision for every family. Before your child or you as a teenager is enrolled in a study, the study staff will explain the details of the study to both you and your parents. The information will among other include the treatment to be given, the procedures to be done and how long time the study will last.

Agreeing to participate after this thorough explanation is called agreement to take part and depending on the child’s age, both the child and the parents will need to sign an agreement to take part, before the child can start in the study.

During the study, you and your parents will meet members of the study team, who will be available to you from start to finish. This team includes study doctors and nurses, who will perform some of the procedures and support you and your family throughout the study.

Every child/teenager and their parents, who complete a study should feel a sense of pride as you have played a big role in potentially getting new medication available for other children.

At the end of the study, the researchers will look at the results of the information collected. You and your parents will get an opportunity to see what was discovered in the study. The results of the study will also be made available for the public to review, as Novo Nordisk has a commitment to show the results of all the studies we conduct.

When you have finished the study, the study doctor will ensure that you are offered the best possible treatment.

A clinical study in children/teenagers can only start after researchers have determined that the study can be justified, and approval is granted by local ethics committees and health authorities.

Participating in a clinical study is a very personal decision for every family. Before your child or you as a teenager is enrolled in a study, the study staff will explain the details of the study to both you and your parents. The information will among other include the treatment to be given, the procedures to be done and how long time the study will last.

Agreeing to participate after this thorough explanation is called agreement to take part and depending on the child’s age, both the child and the parents will need to sign an agreement to take part, before the child can start in the study.

At Novo Nordisk we focus on bringing new innovative medicine to the market and make them available across the world. We do this to defeat diabetes and other serious chronic diseases to the benefit of patients.

To develop new medicine, we need to do research to learn more about the disease. We collect infomration from patients and from clinical studies. Some of this information is personal data.

Examples of personal data are:

• human biosamples (for example tissues, blood and blood derivatives such as plasma, serum and cells)
• data colleced during clinical studies or from external parties (for example results, information and discoveries) medical images (for example scanning, radiography and x-ray)

We use and collect the personal data in a responsible and ethical way in accordance with our internal values, external requirements e.g. good clinical practice, and the applicable laws and guidance. When doing clinical research, we ensure that the participants are well informed about the study before they decide if they want to take a part.

For some research activities, we need data that we cannot collect ourselves. For this we may use data form external parties. We have high standards when doing so. We make sure that all data can be used for the intended purposes. We also carefully assess that the personal data have been lawfully and ethically collected.

 

It is important to Novo Nordisk to respect your rights and to keep your personal data private. The Privacy Notice explains how we protect and process your personal data, including human biosamples. How we collect, use, store, delete and share your personal data will be explained in more detail in the Privacy Notice.

As a general rule, we will not be able to identify you directly in our research activities. We do this by replacing personal identifiers (for example, name or address) with a participant number. This means that the information is coded data. We will only try to identify you if there is a serious safety concern.

When we resuse data from our clinical studies for new scientifi research purposes, we will try to use anonymised data, meaning that there is no way to re-identify you.

Figure 1 below illustrates the different levels of masking personal data, where identified is personal data that has not been masked.

If It is not possible for us to use anonymised data for a specific research activities, we may use coded personal data. The Privacy Notice applies to search activites where Novo Nordisk uses personal coded data and is not able to provide a notice of use directly to you. An example could be where we get your health data from hospitals, relatives, partners, suppliers or other external parties. This could also be if we reuse already collected personal data for new compatible research purposes.