Safety and Security
As with all medical records, participant privacy and confidentiality in trials are protected by law. Once consent is signed, you will be given a trial code. Your trial records will not include your name or personal identity but will identify you with a trial code. This code can only be tracked back to you via a code key which is held by the responsible physician. Your name or personal identity will never be disclosed.
Yes, participants are volunteers and may withdraw from a clinical trial at any time.
Regulatory agencies have strict guidelines that research teams must follow to ensure all patients are treated fairly and safely, and that the trial’s potential benefits outweigh risks. Each trial has a “protocol” that includes necessary protections, and an Institutional Review Board/Ethics Committee (IRB/EC) that reviews the data and can end the trial at any time.
During any trial, side effects may occur and identifying them is an important part of the intervention approval process. Any known side effects are outlined in the Informed Consent Form (ICF), which participants will read and review with a healthcare provider during the pre-screening and consent process, but there may also be unknown risks. Your research team will closely monitor any side effects and you always have the option to withdraw from the trial at any time.