Protocol Adherence Sample Clauses

Protocol Adherence. Each Investigator must adhere to the protocol as detailed in this document and agree that any changes to the protocol must be approved by ImmunoGen’s authorized representative in writing before seeking approval, where necessary, from the IRB/IEC, Research Ethics Committee (REC), or Ethics Review Board (ERB). Each Investigator will be responsible for allowing only those patients who have met protocol eligibility criteria to be enrolled. Modifications to the protocol should not be made without agreement of the Investigators and ImmunoGen. Changes to the protocol will require written IRB/IEC, REC, or XXX approval/favorable opinion before implementation, except when the modification is needed to eliminate an immediate hazard(s) to patients. The IRB/IEC/REC/ERB may provide expedited review and approval/favorable opinion for minor change(s) in ongoing studies that have the approval/favorable opinion of the IRB/IEC/REC/ERB. ImmunoGen will submit all protocol modifications to the appropriate regulatory authorities in accordance with the governing regulations. When immediate deviation from the protocol is required to eliminate an immediate hazard(s) to patients, the Investigator will contact ImmunoGen, if circumstances permit, to discuss the planned course of action. Any departures from the protocol must be fully documented in the source documentation. Prospective waivers or exemptions are not permitted.
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Protocol Adherence. Protocol Sponsor or CRO shall ensure the Sites and Site Principal Investigators conduct the Study through the exercise of Good Clinical Practice at the Site, in strict compliance with the Protocol, all Applicable Laws, applicable terms of this Agreement, and the terms of approval for the Study from the IRB. 2.3.1 The Protocol will be considered final for regulatory submission following approval by each RedHill, HJF, CRO and the designated IRB. The terms of the Protocol are incorporated herein by reference as part of this Agreement. The Protocol may only be amended with the approval of RedHill, HJF, and CRO, and will be subject to subsequent IRB review following an amendment agreed upon in advance by both RedHill, CRO and HJF. 2.3.2 In the course of conducting the Study, if generally accepted standards of clinical research and medical practice relating to the benefit, wellbeing, and safety of Study Subjects require a deviation from the Protocol, such standards will be followed in accordance with Applicable Law and IRB regulations. Site Principal Investigators will promptly notify CRO and the IRB of the facts supporting any deviation from the Protocol and provide notice of the deviation to CRO and the IRB as soon as Site Principal Investigator or Site become aware of such deviation or as may be otherwise required by Applicable Law. After receipt of notice from the Site and/or Site Principal Investigator, the CRO will provide prompt notice to Protocol Sponsor and RedHill of the deviation.
Sample 1
Protocol Adherence a. The Investigator shall ensure that the Trial is conducted at the Site identified in the Protocol and in strict compliance with the Protocol and the Regulations, including but not limited to all applicable laws, rules, regulations and guidelines governing patient confidentiality and privacy. b. The Protocol shall be considered final following approval by the Institution, Sponsor and the designated IRB. The Protocol may only be amended by Sponsor in agreement with the Institution, and will be subject to subsequent IRB review if requested by the Institution. In the course of conducting the Trial, if generally accepted standards of clinical research and medical practice relating to the benefit, well- being and safety of subjects require a deviation from the Protocol, such standards will be followed in accordance with applicable law and/or IRB regulations. Institution shall notify Sponsor and the IRB of the facts supporting major deviation(s) from the Protocol and provide notice of the deviation to Sponsor and the IRB within ten (10) days of the occurence.
Sample 1

Related to Protocol Adherence

  • Protocol The attached Protocol shall be an integral part of this Agreement.

  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • DRUG-FREE WORKPLACE FORM The Drug-Free Workplace Form is attached and shall be completed and submitted with your bid.

  • Adherence to Standards For purposes of clarity, consistency, and ease of understanding, the State, as an acquiring agency of private property for public use, has adopted standards and formats for right-of-way mapping which have proven to facilitate the processes of negotiation, appraisal, relocation assistance, and condemnation. The Engineer’s Surveyor shall adhere to these standards and formats to every extent possible to ensure that the needs of the State are met.

  • Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.

  • Drug-Free Workplace Contractor represents and warrants that it shall comply with the applicable provisions of the Drug-Free Work Place Act of 1988 (41 U.S.C. §701 et seq.) and maintain a drug-free work environment.

  • DRUG AND ALCOHOL FREE WORKPLACE 20.1 All employees must report to work in a condition fit to perform their assigned duties unimpaired by alcohol or drugs.

  • Standards of Conduct Whenever the Member is required or permitted to make a decision, take or approve an action, or omit to do any of the foregoing, then the Member shall be entitled to consider only such interests and factors, including its own, as it desires, and shall have no duty or obligation to consider any other interests or factors whatsoever. To the extent that the Member has, at law or in equity, duties (including, without limitation, fiduciary duties) to the Company or other person bound by the terms of this Agreement, the Member acting in accordance with the Agreement shall not be liable to the Company or any such other person for its good faith reliance on the provisions of this Agreement. The provisions of this Agreement, to the extent that they restrict the duties of the Member otherwise existing at law or in equity, replace such other duties to the greatest extent permitted under applicable law.

  • Drug Free Work Place Grantee shall establish and maintain a drug-free work place policy.

  • CERTIFICATION REGARDING DRUG-FREE WORKPLACE REQUIREMENTS 1. The Contractor certifies that it will provide a drug-free workplace by: a. Publishing a statement notifying employees that the unlawful manufacture, distribution, dispensing, possession or use of a controlled substance is prohibited in the Contractor’s workplace and specifying the actions that will be taken against employees for violation of such prohibition;

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