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Frequently asked questions
Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioural intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective in people.
Without the brave participation of persons willing and choosing to assist in clinical research trials the prevention and treatment of thousands of diseases and persons suffering from these illnesses.
Thank you for being a participant.
Informed Consent is a voluntary agreement to participate in research, it is an essential document that contains all related aspects about the trial/study that you would like to participate in that will help you understand the risks and benefits of the treatment.
Informed consent and the consenting process is about the protection and respect for you as the research participant.
Obtaining consent involves informing you about your rights, the purpose of the study, the procedures to be undergone, and the potential risks and benefits of participation.
• Purpose of the research
• Procedures involved in the research
• Alternatives to participation
• All foreseeable risks and discomforts that might be experienced
• Benefits of the research to society and possibly for you
• Length of time you are expected to participate
• Person to contact for answers to questions or in the event of a research-related injury or emergency.
• Statement indicating that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that are otherwise entitled to receive.
• Statement regarding your right to confidentiality and right to withdraw from the study at any time without any consequences.
You as the patient have the right to make decisions about your own health and medical conditions.
It is essential that you understand that participating in a research study is completely voluntary; you can withdraw from the study at any time or choose not to participate.
Participants sign and date the informed consent as to indicate that they understand all the aspects relevant to the study. You confirm that you have read, understood and agree to participate.
You also have the right to ask questions before signing to ensure that you make an informed and voluntary decision to participate in the clinical study.
The informed consent document will be co-signed by the person who explained all the related aspects after ensuring that all your questions have been answered and you understand and agree to all of them.
Both form part of the safety reporting conducted during a trial or study. Data relating to adverse events and serious adverse events are collected to determine the safety profile of a drug or device. It is also collected to evaluate the risks and benefits of a product and to provide information for the package insert, if the product is approved for marketing.
An adverse event (AE) is any undesirable/untoward medical occurrence/experience associated with the use of a medical product which does not necessarily have a causal relationship with this treatment.
An AE can therefore be any unfavourable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether it is related to the medicinal (investigational) product or not.
An AE is reported as a Serious Adverse Event (SAE) when the following criteria is present:
• results in death,
• is life-threatening (real risk of dying)
• requires inpatient hospitalization or prolongation of existing
• results in persistent or significant disability/incapacity, or
• is a congenital anomaly/birth defect
Clinical trial team members are reliant on you as the participant receiving the treatment to assist in disclosing all that you experience while participating in the relevant trial.
A crucial part of the trial being conducted is not only to ensure the efficacy of the product but also to gather data that will indicate if the product is safe to use and whether or not there is any related precautionary measures to consider.
Please ensure to communicate any signs or symptoms, illnesses, hospitalisations, etc. with your study team as soon as possible.
Guided by Good Clinical Practice Principles and Governed by law because of the additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus, no research activities involving pregnant women and fetuses may be undertaken and no fetus in utero may be involved as a participant in any research activity. Women currently pregnant or breastfeeding will not be allowed in a clinical trial that does not relate to pregnant or breastfeeding women.
Strict adherence to these legal requirements is mandatory. You will be asked if you are pregnant or breastfeeding, in most studies if you are still perceived to be a woman of childbearing potential, pregnancy tests will be conducted, and you will be required to start contraceptive measures to prevent you from becoming pregnant during participation in the study.
Contraceptive measures will also be necessary for male participants during the trial participation period.
There are multiple contraception measures available to choose from. Your investigator will guide you in selecting the appropriate one depending on your individual needs. The information below indicates most of the available options currently in South Africa and also provide you with information on how effective they are.
Fasting means not eating or drinking for a period before your blood tests are done. Some blood tests are sensitive to food and drinkable beverages in your system. By fasting you ensure that the test results are more accurate. Some common tests that require fasting are blood cholesterol and glucose level tests.
If your doctor orders a fasting blood test, you should not have anything to eat or drink for 12 hours before the blood sample is taken. You may drink small amounts of plain water.
Your responsibilities as a trial subject include the following:
• Come to all of your trial visits as scheduled.
• Provide accurate information about your medical history and current conditions.
• Provide accurate information about any health problems you are having, even if you do not think they are important.
• Follow the instructions as given by your trial doctor, and as explained on the information documents that you will be given to take home with you.
• Follow the instructions given by your trial doctor or study team regarding the storage, usage and procedure for the product and all trial related devices.
• Tell the trial staff if you want to stop taking part in the trial.
• Tell the trial doctor about all other medications you are taking, regardless of the reason or condition for which they are for. This includes prescription or over-the-counter medications, including herbal or “natural” remedies.
• Do not change any of your medicines without checking with your trial doctor.
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