What if I have a reaction to a study drug?
When thinking about taking part in a study you need to consider that all drugs, prescribed or over-the-counter (OTC), may have side effects. Any information including that on expected side effects that has been gathered from previous studies will be presented to you in writing during the Informed Consent process in the form of the Volunteer Consent Document, which is written in an easy-to-understand format and has been approved by the Independent Ethics Committee.
It is possible that you may experience some side effects (adverse events) such as headache, nausea or dizziness as a result of taking the study medication. During the study the clinical staff will record the information you give them about any side effects you may be experiencing and this information will be forwarded to the sponsor of the clinical trial who will ultimately include the findings in the patient information leaflet which accompanies all marketed drugs. |
