Informed consent forms are structured patient-oriented digital or printed documents designed to provide guidance and detailed information on study objectives, nature, risks and other information to the study participants.
Designed by health care workers or research groups, the informed consents are collected before the clinical trials and confirm that all parties are fully aware of all aspects of the study.
Informed consents must contain detailed, clear, accurate information that can be fully understood by non-professional trial participants. As such, informed consent forms are localized and translated by interdisciplinary expert teams with rich experience in medical translation and localization.
All informed consent forms at Ciklopea are localized in accordance with the guidelines from EMA, the local regulatory bodies and the appropriate version of ICD-10.