Frequently Asked Questions
What is a clinical research study?
Before a medication or new device for treatment of medical issues is available to the public, it must be reviewed by the South African Health Product Regulatory Authority (SAHPRA) and an ethical committee, and approved for public use. To get SAHPRA and ethics approval, the company that makes the medication or device is required to conduct clinical research studies.
The companies ask people to volunteer for clinical research studies. In these studies, volunteers are given the investigational medication or device and are evaluated by study doctors and staff members. After clinical research studies are completed, the pharmaceutical company submits the study information to the SAHPRA. The SAHPRA reviews this information and decides if the investigational medication or device can become available to the public.
How do I qualify?
To participate in any clinical research study, you must meet all of the eligibility requirements. Requirements will differ for every study, but typically the requirements are related to your age, health, and reproductive status.
If you see a study that interests you, and you meet the posted eligibility requirements, the next step is for you to enter your information. After you submit your information, you will be invited to come to the clinic and register for the study.
At this visit you will be asked for your ID and fill in a database questionnaire form. Then you may register for the study you are interested in. You will now be invited to come for a screening visit.
At the first screening visit, doctors will talk with you about the study and you will sign a consent form. At the second screening visit (usually the next day), they will conduct various tests and assessments to see if you meet all of the eligibility requirements. If you meet all of the requirements, you qualify for study participation. More information will be given when you register.
What can I expect if I participate in a study?
Once you are eligible and agree to participate in a study, you will be asked to visit our clinic a certain number of times, depending on the length of the study.
You may also be asked to stay overnight. If you are asked to stay overnight, you will be provided with a bed and meals.
During your study clinic visits, study doctors and staff members will evaluate your health and response to any medication you have been given. Some of the tests and assessments they may use include:
- Reviews of your medical history
- Physical exams
- Vital signs measurements
- Blood and urine sample collections
- Questions about how you are feeling
- Reviews of any medications you are taking
- Reviews of any side effects you experience
Study doctors and staff members will go over all tests and assessments. You will be encouraged to ask questions about anything you don’t understand.
Your safety during a research study is our primary concern. You will be monitored throughout the study and only continue in the study if it is safe for you to do so.
If I qualify for a study, do I have to participate?
No, you do not have to participate. It is your decision whether or not you want to join a study.
If I join a study, do I have to complete the study?
No, you are free to leave a study at any time and for any reason. However, if you do leave a study, the study doctor or study staff may ask you some follow-up questions, and you will not be allowed to rejoin the study.
How many follow-up visits are required?
It depends on the study. Some studies may require more follow-up visits than others. The study doctor or the study staff will go over how many follow-up visits you may need to make.
Will I be paid for participating in a study?
Yes, you will be compensated for any inconvenience or costs incurred due to study participation. Each study is different and it would be best to contact our clinical team to get more information. Additionally, all medical tests and assessments pertaining to your health profile will be provided to you by trained physicians at no cost.
Can I get study medication outside of clinical research studies?
No, only study volunteers are eligible to receive study medication. Clinical research study medications are not available to the public.
Should I talk with my family, friends, and personal doctor before participating in a clinical research study?
It is always a good idea to discuss study participation with people you trust. Your GP may also be able discuss other treatment options with you.
Volunteer to participate
We are currently recruiting patients and healthy volunteers to participate in clinical research studies at our clinic. If you are a healthy volunteer or would like assistance in finding the right study for you, please join our Volunteer Mailing List by filling out the Volunteer List form and we will contact you when new studies are available.