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. 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. 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. 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.
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. 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. The investigator will not deviate from the protocol except in medical emergencies or in unforeseen, isolated instances where minor changes are made that will not increase the patient’s risk or affect the validity of the trial. All deviations related to study inclusion or exclusion criteria, conduct of the trial, patient management or patient assessment must be appropriately documented and reported. Other protocol deviations to be considered include non-adherence to the protocol that results in a significant additional risk to the patient, or non-adherence to FDA regulations and/or ISO 14155. The investigator must document and explain any protocol deviation. The IRB should be notified of all protocol deviations in a timely manner. Protocol deviations should be reported to the IRB periodically, according to their requirements.
Protocol Deviations. Prior to the commencement of the Study conduct, Institution, including se dozví, že se má uskutečnit inspekce ze strany státního/správního nebo kontrolního úřadu, resp. pokud státní/správní nebo kontrolní úřad inspekci předem neoznámí, pak ihned po zahájení inspekce nebo šetření. Zdravotnické zařízení vyvine nezbytné úsilí za účelem oddělení, nikoli zpřístupnění veškerých Důvěrných informací, jejichž zpřístupnění není vyžadováno během takových kontrol. Pokud státní/správní nebo kontrolní úřad vydá zprávu se zjištěními, oznámení o porušení předpisů, upozornění nebo jiné sdělení týkající se Studie, Zkoušejícího nebo Institucionální hodnotící (nebo pokud nějaký jiný úřad vydá podobný dokument), zašle Zdravotnické zařízení nebo případně Zkoušející kopii takového dokumentu společnosti IQVIA neprodleně, nejpozději však do dvaceti čtyř (24) hodin po takové události, a požádá Zadavatele nebo případně společnost IQVIA o písemný souhlas s návrhem odpovědi na takový dokument, než ji odešle příslušnému úřadu, a to vše v rozsahu povoleném příslušnými právními předpisy. 1.3.4 Tento článek je záměrně ponechán prázdný. 1.3.5
Protocol Deviations. The investigator or designee must document and explain in the subject’s source documentation any deviation from the approved protocol. The investigator may implement a deviation from, or a change to, the protocol to eliminate an immediate hazard to study subjects without prior IRB approval. As soon as possible after such an occurrence, the implemented deviation or change, the reasons for it, and any proposed protocol amendments should be submitted to the IRB for review and approval, to SIGA for agreement, and to the regulatory authorities, if required. A protocol deviation is any change, divergence, or departure from the study design or procedures defined in the protocol. An important protocol deviation (sometimes referred to as a protocol violation or a major protocol deviation) is a subset of protocol deviations that might significantly affect the reliability of the study data or that might significantly affect a subject's safety. An important deviation can include nonadherence to inclusion or exclusion criteria or nonadherence to FDA regulations or ICH E6(R2) guidelines. Protocol deviations will be documented by the clinical monitor throughout the course of monitoring visits. The investigator will be notified in writing by the monitor of deviations. The IRB should be notified of all protocol deviations, if appropriate, in a timely manner.
