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. 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. This trial will be conducted as described in this protocol, except for an emergency situation in which the protection, safety, and well-being of the subject requires immediate intervention, based on the judgment of the Investigator (or a responsible, appropriately trained professional designated by the Investigator). In the event of a significant deviation from the protocol due to an emergency, accident, or mistake, the Investigator or designee must contact Revance at the earliest possible time by telephone. This will allow an early joint decision regarding the subject’s continuation in the trial. This decision will be documented by the Investigator and the Sponsor.
Protocol Deviations. A protocol deviation is defined as an event where the Investigator or site study personnel did not conduct the trial according to the investigational plan, applicable laws or regulations, the Investigator Agreement or Clinical Trial Agreement. Per regulations, Investigators are required to maintain accurate, complete and current records, including documentation of any deviations from the investigational plan including the date of and reason for the deviation. The deviations must also be reported to the Sponsor Investigators are required to obtain prior approval from the Sponsor before initiating changes in or deviations from the investigational plan, except where necessary to protect the life or physical well-being of a patient in an emergency. Such approval will be documented in writing and maintained in the study files. Prior approval is generally not expected in situations where unforeseen circumstances are beyond the Investigator’s control, (e.g., patient did not attend scheduled follow-up visit, etc.), however, is still considered a deviation. Deviations shall be reported regardless of whether medically justifiable, pre-approved by the Sponsor, or taken to protect the patient in an emergency. Deviations to protect the life or physical wellbeing of the patient in an emergency must be reported to the Sponsor immediately. A notice shall be given to the sponsor no later than 5 working days after the emergency occurred and to the IRB according to their requirements. Patient specific deviations will be reported on a Protocol Deviation Form. Deviations that are not patient specific will be reported to the Sponsor in writing. Investigators will also adhere to procedures for reporting deviations to their IRB in accordance with their IRB.
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Protocol Deviations. This study should be conducted as described in this protocol, except for an emergency situation in which the protection, safety, and well-being of a subject requires a protocol deviation, based on the judgment of the investigator (or a responsible, appropriately trained professional designated by the investigator). If the deviation from the protocol is necessary to protect the physical well-being of a subject in an emergency, such protocol deviations must be reported to the Sponsor and the reviewing IRB or EC as soon as possible, but no later than five working days after the emergency occurred. In the event of a significant deviation from the protocol due to an accident or mistake, the investigator or designee must contact the Sponsor at the earliest possible time by telephone to discuss the deviation and its impact on the study and subject continuation in the study. These discussions will be documented by the investigator and the Sponsor, and reviewed by the monitor.
Protocol Deviations. Physician shall not deviate from the Protocol without prior written approval of Sponsor and the IRB, except when necessary to protect the safety, rights, or welfare of a Subject and permitted under Applicable Law. In the event of a Protocol deviation, Physician shall immediately notify Sponsor and the IRB of the action taken or to be taken and the reason therefor.
Protocol Deviations. In the event of any deviation from the Protocol, 6.3 Odchylky od protokolu. V případě jakýchkoliv odchylek od protokolu
Protocol Deviations. The investigator should document and explain any protocol deviations. The investigator should promptly report any deviations that might have an impact on patient safety and data integrity to the Sponsor and to the IRB/EC in accordance with established IRB/EC policies and procedures. The Sponsor will review all protocol deviations and assess whether any represent a serious breach of Good Clinical Practice guidelines and require reporting to health authorities. As per the Sponsor's standard operating procedures, prospective requests to deviate from the protocol, including requests to waive protocol eligibility criteria, are not allowed.
Protocol Deviations. Any deviation from this protocol will be reported to the IRB.
