Examples of ICH in a sentence
It is of mutual agreement to conduct the Trial in accordance with the principles contained in the last version of the Declaration of Helsinki and in accordance with the ICH (International Conference of Harmonization) Guidelines for Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP).
SPOLOČNOSŤ CITIBANK NESCHVAĽUJE ANI NERUČÍ ZA ŽIADNU Z ODKAZOVANÝCH WEBOVÝCH STRÁNOK, ZA ICH PREVÁDZKOVATEĽA ALEBO ZA ICH OBSAH.
Institution and Principal Investigator will report ICH GCP breaches, breaches of Protocol, serious breaches of Regulation (EU) No 536/2014 as well as adverse events and/or serious adverse events experienced by Trial Subjects at any time in accordance with instructions in the Protocol, or if not addressed in the Protocol, within 24 hours of notice, and Applicable Law.
Participants or their legally authorized representative will be required to sign a statement of informed consent or a certified translation if applicable, that meets the requirements of 21 CFR 50, local regulations, EU General Data Protection Regulation (GDPR), ICH guidelines, Health Insurance Portability and Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC or study center.
Zdravotní záznamy nebo jiné zdrojové dokumenty, definované ve směrnici ICH, které dokládají výsledky studie, zůstanou majetkem zdravotnického zařízení.