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KLH-22 version 5

Requirements Governing the Text of Patient Information Leaflet Trial Subject Information Sheet /Informed Consent Form  

With effect as of June 1, 2022, the Guideline supersedes guideline KLH-22 version 4.


The guideline is issued on the basis and in accordance with the provisions of Section 51 (2) of Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (the Act on Pharmaceuticals), as amended, and Annex No. 2 to Decree No. 226/2008 Coll., on the Good Clinical Practice and More Detailed Conditions for Clinical trials on Pharmaceuticals as amended.

The Guideline is for recommendation.

KLH-22_version5.pdf, file type pdf, (317.66 kB)

KLH-22_version5_rev.pdf, soubor typu pdf, (362.15 kB)