Frequently Asked Questions on clinical study participation.

Why should I enrol in a clinical study at Synexus Clinical Research SA?

There are various reasons why people participate in a clinical study:

• Many people are interested in receiving the latest, most advanced medication long before it is made available to the general public.
• Others consider participation as a reliable alternative to their current treatment.
• Clinical studies also offer patients the benefit of professional medical examinations, study related medical tests and investigational medications.

Do I need Medical insurance to participate in a clinical study at Synexus Clinical Research SA?

Medical aid insurance is not necessary for your study related procedures.  The Company that is doing the study would cover the costs of the study related tests and procedures.

What can I expect when I participate in a clinical study?

Your participation begins after a medical evaluation and diagnosis.  You will receive a complete verbal and written explanation of the benefits and risks of the clinical study.

You will then have the opportunity to ask questions and discuss all aspects of your participation with our medical staff as well as your regular physician, should you wish to do so.

Once you have given informed consent, you are eligible and enrolled in a clinical study, you will receive a study-related medical excamination, study medication, laboratory tests, and the study related procedures necessary.

During the course of the study, the medical personnel will monitor you closely.

What about my Regular Physician?

We would like to encourage you to speak to your physician about your interest in a clinical research study.  S/he will recommend or refuse your participation on the study, due to your health condition and her/his medical judgement.

Your physician will be notified in writing when you participate in our clinical studies.  The Synexus Clinical Research SA staff is happy to consult with your physician about possible participation in one of our clinical studies.  The clinical studies do not replace your healthcare providers, but work with them to enhance your health.

Your patient file and records will always remain confidential but may be shared with your physician at your request and with your consent.

What are my rights?

You may only participate in a clinical study if you have voluntarily given your written informed consent.

You need to listen to the information the study doctor or sister give you about the study, then read through the document.  You should only sign the informed consent after all your questions have been answered to your satisfaction.

The Informed Consent document must have contact details for the study doctor, the Ethics Committee that has approved the study as well as the mailing address of the Medicine
Control Council (MCC).

You have the right to contact the Ethics Committee if you feel that your rights have been violated, or if you have any questions you need answered, or to lodge a complaint if you feel your rights have been abused.

You have the right to contact the MCC in writing if you should need additional information.

Your safety and well-being should be protected at all times when you participate in a clinical study, by the study doctor and any other study staff.

What are my responsibilities when participating in a clinical trial?

Your responsibilities will vary from protocol to protocol, i.e. study to study.

In general, it would entail you to take the study medication as per instructions from your study doctor, and not to change the dosages yourself.

To refrain from taking other medication without consulting with your study doctor or treating doctor first.

In order to continuously monitor your wellbeing and safety, it is important to attend the appointments with your study doctor.

To inform any other healthcare professionals, that might need to treat you for emergencies or ailments in between study visits, that you are participating in a clinical study and that they should contact your study doctor for more information.

To report any changes in your health and/or wellbeing to your study doctor, even if you feel that it is not important.  The doctor needs to document any changes in your health or condition while you are participating in the study.

It is very important to notify your study doctor if you have been admitted to an Emergency Room or Hospital or if you have received other treatment from another healthcare professional.

To report any other medication which you might have taken during the study, even over-the-counter medication from your local pharmacy.