Informed consent

Before you are invited to take part in a clinical research study, we will conduct a telephonic pre-screening interview. This is to check whether you are eligible and qualify to be screened for a particular study. You will be asked a lot of questions about your medical history, including any medicines you have, and are currently taking. Please be honest and answer as completely as you can, as this helps us determine which study you are eligible for, if any.

After you have completed the pre-screening process and are found to be eligible, we will schedule a screening appointment for you at in our clinic/ward, at Groote Schuur Hospital. It is vital that you follow any restrictions which were discussed with you during the pre-screening process, e.g. fasting requirements, which need to be adhered to for this appointment. Please bring a current and valid Identity Document with you and please arrive on time. The screening process can take up to 3–4 hours, so please allow enough time for this appointment.

Before any procedures are done at the screening visit, you will be given an Informed Consent document to read. The Informed Consent process will be discussed with you in detail and you will also be told all about the study and its aims. The Informed Consent document will explain what the study is about, what the study drug is being tested for and how much of it participants will receive, if any, and any known side effects reported so far with this drug.  This document will also give details of all the procedures that will be done during the study.  It is very important that you read this entire document so that you understand what the study is about and what your role will be in the study and any potential risks. You will be asked to sign this form to show that you have read and understand the document, and that you agree to take part. A trained staff member will be available to further explain the study and answer any questions you may have.

Screening procedures
Selected for a study
Admission and settling in

Once you have signed the Informed Consent document, we may take your medical history, asking questions about your health and any medicines that you may have taken/are taking, and do a medical examination (a physical examination to assess your health and to make sure it is safe for you to participate). We may measure your height and weight, collect a urine sample from you, check your blood pressure and draw a sample of blood. We may also measure if you have any heart problems, and check the performance of your heart, by doing an electrocardiogram (ECG). An ECG measures how your heart beats for a few minutes. Other study-specific procedures may be done as well during this visit, which you will be informed about. We may review your medical history with you to ensure that all information we have on file is correct.

After evaluating all of your medical history and the results of screening procedures, we will assess if you are a good fit for the study and if it is safe for you to participate. Your safety and well-being remain our priority. We will call you with the screening results and will invite you to participate in the study, if you are eligible. If selected, and you agree to participate, you will be given an appointment date to return for admission to the Research Ward at J51, Old Main Building, Groote Schuur Hospital. You will also be given instructions regarding your admission to the ward, and any restrictions, e.g. if you need to fast before your admission, or what activities, foods or supplements you need to avoid.

When you arrive at the Research Ward on the day of admission, our clinical staff will review all the criteria for the study to make sure you are still eligible. This is our “baseline day” and we will repeat the medical examination and some of the procedures done at your screening visit. These can include a blood pressure check, taking a blood or urine sample, and an ECG. If you are participating in a study that requires you to stay in the ward overnight, we will need to check your belongings to make sure you didn’t bring anything with you that would disqualify you from the study. If anything is found, we will store it for the duration of your stay, and return it to you when you are discharged from the ward. Our staff will instruct you further on the rules of the ward. Our Research Ward has 4 Bays, each containing 6 beds and you will be assigned to a bed for the duration of your stay. You will have a secure place to store your belongings. We want you to be comfortable and at ease while you are at the clinic. When you are not having procedures done, you can read, watch TV, play games, join in activities like pool, or use your laptop or phone if you’ve brought one. Whilst you are in the Research Ward, you are not allowed to leave or receive visitors. This is to maintain a safe and controlled research study.

Dosing day
Duration of stay

The first day of the study can at times be busy with procedures. the staff will be gathering baseline data from each participant. It is very important that you are ready and on time for all procedures. All procedures, even meals, are timed to the exact minute. If you are scheduled for a blood draw at 8:04 that is exactly when it needs to happen…not a minute earlier or later. It is essential that this data is accurate as this data will be analysed to determine if the study drug justifies further testing.

There might be a lot of people around on dosing day, including the study sponsor/monitor. Again, everyone wants to make sure that you are safe. On the second morning of your stay in the ward, we will first take safety bloods and a urine sample. You will be given study medication in the morning, and ECGs and measurements of your blood pressure and pulse will be done every one to two hours. For some studies, there will be extra blood samples taken, and/or you may be asked to collect your urine into a container for 24 hours. You will be closely monitored and the clinic staff will ask you often how you are feeling. Your answers are very important to our doctors as well as to the study sponsor. After dosing you may feel perfectly fine or you may have a few symptoms such as a rash, headache or an upset stomach. Our staff will be on hand to make you as comfortable as possible and to monitor and help manage your symptoms.

If you are required to stay in the research ward after the dosing day - the remainder of stay we may need to examine you, draw more blood and repeat the blood and urine testing and ECG measurement, and ask questions to check if you are well. If all is fine, we will discharge you. We will review any requirements or restrictions, as well as return any items that were removed from your luggage at check in. You will be given a list of instructions, reviewing all requirements and restrictions to ensure that you adhere to the study criteria.

Meals and activities
Follow up days

Three meals a day plus snack(s) will be provided, unless you are required to fast for a certain length of time. Some of the studies require that you eat a certain amount of your meals; some studies require a high fat diet while other studies are not as restrictive. The clinic staff will need to record what time you eat and how much. You will be in the clinic with other people doing different studies so you may see some people eating a different meal from you. Remember, each study has different requirements and procedures. We want your stay with us to be as positive as possible. When you are not having procedures done, you are free to relax or you can participate in group activities, catch up on some sleep, study, or watch some movies. However, we want you to be well rested and you will need to be in bed and lights out at 10pm, as procedures start very early in the morning.

Most clinical research studies require follow-up visits or phone calls. We will provide you with a schedule of appointments/appointment card and you will be reminded of your next follow up visit.  It is important that you keep all these appointments for the duration of the study. We may also want to know how you are doing after the study.