The Informed Consent Process
This is the first process you will go through when participating in a clinical trial and it continues throughout the trial. During this process, all study details will be explained to you and all your questions are answered. You will be given ample time for consideration. You can even take time to discuss study details with your family or even consult with your primary care physician. Through this process, you will be informed if any additional and relevant safety information becomes available.
You will be asked to sign the informed consent document (ICD) once all your questions/concerns have been addressed satisfactorily. The investigator or a properly delegated staff will also sign the ICD on the site’s behalf. A copy of the signed ICD will be provided to you. The original will be filed at the site.
Ensures voluntary, informed consent is obtained before any study procedures
- Study purpose, procedures, and duration
- Potential risks and benefits
- Alternative treatments
- Patient rights (including the right to withdraw at any time)
- Confirms participants understand the information and have time to ask questions.
- Explains