The informed consent form (ICF) will tell you about the study to help you decide whether to participate. A sufficient amount of time will be provided for you to review this document and discuss it with the recruitment and medical teams. Ask the study doctor (also named Investigator) or study staff as many questions as needed to understand and decide if you want to participate. This process is known as informed consent.
The ICF administration is the first process to take place after the participants arrive at the study site, and no other procedure can start before the ICF is administered and signed off by the participant.
You can discuss the informed consent form with your doctor or anyone else to better understand your options. Your participation is voluntary, and you must not sign and date this form unless the study doctor or staff has answered all of your questions and you decide to be part of this study.
If you are undecisive, ask the recruitment staff to provide you a copy of the ICF for your review offsite with your doctor or family.
Participation in a clinical trial is voluntary, and you can refuse to participate or decide to withdraw from the trial at any time without penalty or loss of benefits to which you are otherwise entitled.