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- What is Informed Consent?
- Where is it used in clinical trials?
- How does Clinion implement it?
- What does it look like in practice?
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What is Informed Consent?
Informed consent is the process of clearly explaining a clinical trial to a potential participant and obtaining their voluntary agreement to take part. It ensures the person understands the study’s purpose, procedures, risks, benefits, and their rights, including the right to withdraw at any time, before any trial-related activities begin.
Where is it used in clinical trials?
In clinical trials, Informed Consent is obtained before any study-related procedures are carried out on a participant. It ensures individuals clearly understand the study’s purpose, procedures, potential risks, expected benefits, and their rights, including the option to withdraw at any time. This process supports transparent communication during participant discussions and screening. Consent is ongoing throughout the trial, and when protocol amendments or new safety information arise, participants are updated so they can make an informed decision about continuing their participation.
How does Clinion implement it?
Clinion implements Informed Consent by supporting a structured and traceable consent process within the study workflow. The system allows sites to record consent status, version details, and consent dates for each participant before any study activities begin. It also supports re-consenting when updated documents or protocol changes are introduced. All consent-related actions are logged automatically, helping sites maintain clear records and ensuring that participants are only involved in study activities after valid consent is in place.
What does it look like in practice?
In real-world use, Informed Consent in Clinion looks like site staff confirming and recording a participant’s consent in the system. The consent date and version are saved, and the participant is then allowed to move forward in the study. A copy of the signed informed consent is also provided to the participant for their records. If consent needs to be updated later, the new consent is recorded, keeping all consent details clear and up to date throughout the trial.
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