Protocol Compliance. The Investigator will conduct this study in compliance with the protocol provided by the Sponsor and given approval/favorable opinion by the IRB/IEC and the appropriate Regulatory Authority(ies). Changes to the protocol will not be made without agreement of the Sponsor Medical Monitor. All changes to the protocol will require IRB/IEC approval prior to implementation, except when necessary to eliminate an immediate hazard to study subjects or when the change involves only logistical or administrative aspects of the study (e.g., change in Sponsor Medical Monitor or telephone number). The IRB/IEC may provide, if applicable regulations permit, expedited review and approval/favorable opinion for minor changes in ongoing studies. The Sponsor will submit all protocol changes to the appropriate Regulatory Authority in accordance with the governing regulations. In situations requiring a departure from the protocol, the Investigator or other physician in attendance will contact the Sponsor Medical Monitor by telephone, e-mail or fax. If possible, this contact will be made before implementing any departure from the protocol. In all cases, contact with the Sponsor Medical Monitor must be made as soon as possible in order to review the situation and agree on an appropriate course of action. The case report form and source document will describe any departure from the protocol and the circumstances requiring it.
Protocol Compliance. CONTRACTOR shall comply with the current Placer County 5150 Protocol and the specific policies and procedures developed to assist CONTRACTOR in fulfilling its contractual agreement.
Protocol Compliance. The Investigator will conduct this study in compliance with the protocol provided by the Sponsor and given approval/favorable opinion by the IRB/IEC and the appropriate Attachment 2, Attachment E-62 Regulatory Authority(ies). Changes to the protocol should not be made without agreement of the Sponsor Medical Monitor. All changes to the protocol will require IRB/IEC approval prior to implementation, except when necessary to eliminate an immediate hazard to study subjects or when the change involves only logistical or administrative aspects of the study (e.g., change in Sponsor Medical Monitor or telephone number). The IRB/IEC may provide, if applicable regulations permit, expedited review and approval/favorable opinion for minor changes in ongoing studies. The Sponsor will submit all protocol changes to the appropriate Regulatory Authority in accordance with the governing regulations. In situations requiring a departure from the protocol, the Investigator or other physician in attendance will contact the Sponsor Medical Monitor by telephone, email or fax. If possible, this contact will be made before implementing any departure from the protocol. In all cases, contact with the Sponsor Medical Monitor must be made as soon as possible in order to discuss the situation and agree on an appropriate course of action. The case report form and source document will describe any departure from the protocol and the circumstances requiring it.
Protocol Compliance. The Investigator is responsible for compliance with the protocol at the investigational site. The Investigator is also responsible for reporting all issues of protocol non-compliance to the respective IEC and to the Sponsor. A representative of the Sponsor will make frequent contact with the Investigator and his/her research staff and will conduct regular monitoring visits at the site to review subject and study device accountability records for compliance with the protocol, e.g., subject eligibility criteria, volume of product injected, procedures performed, and follow-up visit schedule.
Protocol Compliance. The Investigator will conduct the trial in compliance with the protocol provided by La Jolla. Modifications to the protocol may not be made without agreement of both the Investigator and La Jolla. Changes to the protocol will require a written IRB/IEC approval/favorable opinion prior to implementation, except when the modification is needed to eliminate an immediate hazard(s) to patients. The IRB/IEC may provide, if applicable regulatory authority(ies) permit, expedited review and approval/favorable opinion for minor change(s) in ongoing trials that have the approval/favorable opinion of the IRB/IEC. When immediate deviation from the protocol is required to eliminate an immediate hazard(s) to patients, the Investigator will contact La Jolla and/or the Medical Monitor, if circumstances permit, to discuss the planned course of action. Any departures from the protocol must be fully documented on the appropriate CRF and in the source documentation.
Protocol Compliance. Upon enrollment, a Pharmacist Program Coordinator designated by the pharmacy must review and sign the Pharmacist Naloxone Dispensing Protocol and Agreement (page one). This Agreement must be renewed every two years thereafter, or upon a change in the designated Pharmacist Program Coordinator. By signing the Protocol and Agreement, the designated Pharmacist Program Coordinator attests/agrees that pharmacist and patient education are met in accordance with the protocol.
Protocol Compliance. (1) Unless the Board determines otherwise based on the specific facts and circumstances, a covered QFC is deemed to comply with this subpart if it is amended by the universal protocol or the U.S. protocol.
