SSStudyParticipantsInformedConsent object
KLH-22: Guidance document on "Requirements Governing the Text of Patient Information Leaflet Trial Subject Information Sheet /Informed Consent Form" is available on SUKL website in section: Medicines / Clinical trial on pharmaceuticals / Details of clinical trials / Guidelines and Forms
An expression of willingness to take part in a clinical trial which shall be
1. written,
2. dated and signed by the trial subject in his/her own hand,
3. taken freely after being duly informed of the nature, significance, implications, and risks of the clinical trial,
4. appropriately documented,
5. granted by a person capable of giving the informed consent or where the person is not capable of giving the informed consent by his or her guardian; if the person concerned is unable to write, oral consent in the presence of at least one witness may be given and a written record thereof taken;
