Protocol Deviations. In the event of any deviation from the Protocol, Investigators shall record such deviation on a protocol deviation log (e.g., late or missed visits, tests not performed) and, in the event of a major deviation (e.g., enrollment of a Study subject not meeting all enrollment criteria), Institution and Investigators shall notify Sponsor and EC as soon as possible, but in no event later than five (5) working days after the deviation occurs. Deviation from the Protocol arising out of medical necessity for Study subject safety shall not be deemed a failure to adhere to the Protocol or a breach of this Agreement provided that the Principal Investigator shall, within twenty-four (24) hours, notify the Sponsor of any such deviations and confirm in writing the reason for such deviation within a reasonable time thereafter.
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 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.
Protocol Deviations. A listing of protocol deviations will be provided. This deviation listing will be based on the review of study data prior to locking the database and will include the nature of the deviation (e.g., inclusion/exclusion, prohibited therapies).
Protocol Deviations. All requests for protocol deviations by the Investigator have to be communicated to the sponsor in writing and if accepted by the Sponsor must be approved by the IRB. If a deviation occurs, the Investigator must inform the Sponsor and IRB in writing within 10 days.
Protocol Deviations. Any deviation from this protocol will be reported to the IRB.
Protocol Deviations. If generally accepted standards of ICH Harmonized Tripartite Guidelines for Good Clinical Practice ("ICH GCP") relating to the safety of Subjects require a deviation from the Protocol, these standards shall be followed. If Sponsor and/or Principal Investigator becomes aware of the need for a deviation from the Protocol, it shall inform Company of the facts causing the deviation. In addition, the principal investigator shall inform the Sponsor's IRB/IEC of the deviation. Sponsor and Principal Investigator may also make changes to the Protocol. Any such changes may not be implemented before approval by the applicable IRB/IEC and before approval by Company. Company may terminate this Agreement if the Study is no longer of sufficient scientific interest to the Company as a result of such a change.
Protocol Deviations. In the event of any deviation from the Protocol, 6.3 Odchylky od protokolu. V případě jakýchkoliv odchylek od protokolu
Protocol Deviations. ODCHYLKY OD PROTOKOLU:
Protocol Deviations. ODCHYLKY OD PROTOKOLU: CRO will not pay Institution for any Study subject whose enrollment in the Study deviates from the Protocol's eligibility criteria or from whom Study Data cannot be analyzed because of Protocol deviations, lack of proper records or incomplete, uncorrected or unverifiable CRFs. CRO zdravotnickému zařízení neproplatí náklady za studijní subjekty, jejichž nábor do studie se odlišuje od kritérií způsobilosti uvedených v protokolu nebo jejichž studijní údaje nemohou být analyzovány kvůli odchylkám od protokolu, nedostatku řádných záznamů nebo nekompletním, nesprávným nebo neověřitelným formulářům CRF.
Protocol Deviations. Patients Excluded from the Efficacy Analysis
