Frequently Asked Questions |
For Volunteers
What happens during a study?
A study usually requires participating volunteers to take the study medicine, a placebo or a comparator drug. A pre-study physical examination is usually required, which will take place in IMU. The examination could involve heart monitoring, vision tests or drawing blood samples to determine the medical status of a volunteer. Some studies require repeated blood samples while others may require urine, stool or other samples.
As the nature of each study may differ, so can the number of visits and the tests required, change. A research nurse will be present to explain clearly to each volunteer, the details of every test and the number of visits within a study. Such details can also be found in the patient consent form and on the document given to volunteers during the screening appointment. Volunteers are given sufficient time to read through the patient consent form and they are free to clarify study details with the research nurse or the Investigator. Volunteers who agree to participate in a particular study will be asked to sign a patient consent form pertaining to that study.
How long is the study?
The duration of each study varies. The length of a study will be clearly indicated in the volunteer's copy of the patient consent form. It is important for each volunteer to complete the entire study so that all required data might be captured. However, if the safety of a volunteer is at risk during the study, the Investigator may withdraw the volunteer from the study.
In addition, volunteers can withdraw from a study at any stage if they have changed their minds about their participation.
Is it safe?
All clinical trials conducted in Singapore, unless exempted under the Medicines (Clinical Trials) Regulations, must be approved by the Ministry of Health and comply with the Singapore Guidelines for Good Clinical Practice (GCP). The Singapore GCP guidelines is based on the international ethical and scientific standard for designing, conducting, recording and reporting of trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well being of trial subjects are protected.
The patient consent form will provide information on known side effect(s) of the study medication, gathered from previous studies. Volunteers can then decide if they want to participate in a study. Should more information be gathered from other studies during the conduct of the clinical trial, the Investigator will inform the volunteers accordingly.
Who can volunteer?
Each study has pre-stated study requirements that must be fulfilled. Certain studies may require healthy volunteers while other studies may require volunteers with certain disease conditions e.g. high blood pressure, asthma, diabetes.
If you would like to volunteer to participate in a study, please click here.
What are adverse events?
Any unfavourable and unintended sign, symptom or disease temporarily associated with the use of medicinal products is considered an adverse event. It may or may not necessarily be related to the treatment given.
Every medicine has the potential to cause adverse effects. We are unable to predict who may develop adverse effects, or which adverse effects may occur. Volunteers will be informed of the potential side effects gathered from previous studies before they to agree to participate. During the study, volunteers should inform their respective Investigator or research nurse about any side effect(s) they think they might be experiencing. This will form part of the important information collected during a clinical trial.
Expenses for treatment of adverse effects are covered by trial insurance, which will be provided by the trial sponsor.
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