Common use of Protocol Deviations Clause in Contracts

Protocol Deviations. If principles outlined in the ICH Harmonized Tripartite Guidelines for Good Clinical Practice ("ICH GCP") relating to the safety of Subjects require a deviation from the Protocol, ICH GCP should be followed, and the deviation shall immediately be reported to SPONSOR or CRO in writing. Investigator shall also, within twenty-four (24) hours, notify CRO and SPONSOR of any Serious Breach of which he becomes aware. For the purposes of this provision, a "Serious Breach" shall mean a breach of ICH GCP or Study Protocol, which is likely to affect (i) the safety of physical or mental integrity of the Subjects of the Study; or (ii) the scientific value of the Study. In addition, Investigator shall promptly inform the IRB or EC and any governmental authority as may be required by Applicable Law of such deviation or breach.

Protocol Deviations. If principles outlined in the ICH Harmonized Tripartite Guidelines for Good Clinical Practice ("ICH GCP") relating to the safety of Subjects require a deviation from the Protocol, ICH GCP should be followed, and the deviation shall immediately be reported to SPONSOR or CRO in writing. Institution and Investigator shall also, within twenty-four (24) hours, notify CRO and SPONSOR of any Serious Breach of which he Institution or Investigator becomes aware. For the purposes of this provision, a "Serious Breach" shall mean a breach of ICH GCP or Study Protocol, which is likely to affect (i) the safety of physical or mental integrity of the Subjects of the Study; or (ii) the scientific value of the Study. In addition, Institution and Investigator shall promptly inform the IRB or EC and any governmental authority as may be required by Applicable Law of such deviation or breach.