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. 6.3
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. 2.18
Protocol Deviations. Any deviation from this protocol will be reported to the IRB.
Protocol Deviations. The principal investigator or designee must document any protocol deviation. The IRB/EC must be notified of all protocol deviations in a timely manner by the principal investigator or designee as appropriate. Protocol deviations will be documented by the responsible monitor during monitoring visits, and those observations will be communicated to the investigator. If there is an immediate hazard to a patient the principal investigator may deviate from the protocol without prior Sponsor and IRB/EC approval. The Sponsor and IRB/EC must be notified of the deviation.
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. 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. 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. [***] from [***] will be [***] and the [***].
Protocol Deviations. H. ODCHYLKY OD PROTOKOLU: CRO will not pay Healthcare provider 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, incorrected or unverifiable CRFs. CRO poskytovateli zdravotních služeb 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. In the event of any deviation from the Protocol, 6.3 Odchylky od protokolu. V případě jakýchkoliv odchylek od protokolu
