New Informed Consent regulation in Czech Republic

New Informed Consent regulation in Czech Republic

(8. 1. 2015)

Czech national regulatory authority issued new regulation providing detailed guidance on patient information and informed consents for clinical trials in Czech Republic.

The new regulation (KLH-22, version 1) comes into effect on 1 Feb 2015. Currently only CZ version is available and we will link the english wording once it becomes available.

The new regulation provides specific guidance and expectations on wording of several sections required according to ICH GCP. It also limits the lenght of the patinet information to upto 8 pages (10 pages in specific cases), gives recommendation on formating of specific sections and provides quidance for informed consent/assent in pediatric populations or trials with vulnerable subjects. The document also lists several types of consents not approved by the authority (consent for personal data processing, calibration procedured etc.). These are reviewed and approved only by ethic committees.

Pharmnet team was trained on the regulation in January 2015 and we are ready to support to create or adapt you patient information and informed consent form according this new regulation for your trial in Czech republic.

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