Safety Measures and Serious Breaches. Institution will inform CRO immediately (directly or through Principal Investigator) of (a) any urgent safety measures taken by Principal Investigator to protect Study Subjects against immediate hazard and (b) any serious breaches of the Protocol or of ICH GCP guidelines of which Institution becomes aware.
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Safety Measures and Serious Breaches. Principal Investigator and the Institution (directly or indirectly through the Principal Investigator) will inform CRO immediately (directly or through Principal Investigator) of (a) any urgent safety measures taken by Principal Investigator to protect Study Subjects against immediate hazard hazard. Principal Investigator and Institution (bdirectly or indirectly through the Principal Investigator) will inform CRO immediately of any serious breaches of the Protocol or of ICH GCP guidelines of which Principal Investigator or Institution becomes aware.
5.1 Účtování poplatků Subjektům studie. Hlavní zkoušející ani Instituce nebude
Appears in 1 contract
Samples: Clinical Study Agreement
Safety Measures and Serious Breaches. Principal Investigator and the Institution (directly or indirectly through the Principal Investigator) will inform CRO immediately (directly or through Principal Investigator) of (a) any urgent safety measures taken by Principal Investigator to protect Study Subjects against immediate hazard hazard. Principal Investigator and Institution (bdirectly or indirectly through the Principal Investigator) will inform CRO immediately of any serious breaches of the Protocol or of ICH GCP guidelines of which Principal Investigator or Institution becomes aware.
Appears in 1 contract
Samples: Clinical Study Agreement