Patient: Rights &

Responsabilities

When participating in a clinical trial, a participant has rights designed to safeguard their wellbeing, and ensure that they are participating freely in a clinical trial. Alongside their rights, a participant also agrees to having certain responsibilities to ensure that the trial is carried out correctly.

Patient: Rights

Ethics Comittee Review

Informed Consent Form

Medical attention

Good Clinical Practice

Notification of any changes to the study.

Patient: Responsabilities

Correct use of the medication.

Contact the Investigator when needed and follow their instructions.

Follow the protocol schedule of visits and procedures.

Follow the protocol instructions.

Fill out the daily eDiary.

Informed Consent Form (ICF)

As mentioned above, one of the key rights of a participant is signing the Informed Consent Form in which they: agree to participate in the study and confirm they are willing to comply with the requirements of the study. In the following video you can find more information regarding the Informed Consent Form (ICF). This consent is not binding, and the participant can rescind their consent at any time.
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