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Informed consent signatures must be archived in accordance with 21 CFR Part 11.
Ensuring that our participants fully understand the scope and purpose of our clinical study is a priority.
Informed consent is more than just a requirement—it is an ethical commitment to transparency, trust, and participant safety.
Before agreeing to participate in clinical research, essential information is provided to the participants including:
– The objectives of the research
– Detailed descriptions of the procedures involved
– Any potential risks, discomforts, or benefits
– Participant rights, including the option to withdraw at any stage without penalty