Protocol Deviation Clause Samples

Protocol Deviation. Prospective Protocol waivers or deviations will not be granted by Sponsor under any circumstance. deviations from the Protocol which are medically necessary for a Study participant’s safety in cases of emergency are not considered failure to comply with the Protocol. If, during the course of a Study participant’s post-randomization participation in the Study, it is discovered that the Study participant did not meet all eligibility criteria, s/he will be discontinued, unless the discontinuation presents an unacceptable medical risk. The justification to allow the Study participant to continue in the Study will be made by the Sponsor and Investigator, with medical input from the Investigator, and will be documented. If the Study participant is allowed to remain in the Study, this will be reported as a major Protocol deviation and not a waiver. All follow-up safety assessments must be completed and documented as outlined in the Protocol. Other Protocol deviations will be tracked and corrective measures will be put in place to prevent such deviations from being repeated. < Institution> CTA
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Protocol Deviation. A one-time, unintentional action or process that departs from the IRB-approved study protocol, involving one incident and identified retrospectively, after the event occurred. Any leukapheresis- related failure or deviation will be recorded, even if it does not constitute a per-protocol AE.
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Related to Protocol Deviation

  • 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.

  • Deviation Should Subrecipient wish to deviate from the requirements of this Paragraph F or wish to issue a sub-contract to other than the lowest bidder or competitor, Subrecipient shall submit written justification therefore to Administrator for approval or denial and shall withhold any further action until receipt of written notice of Administrator’s approval of said request. The decision of Administrator shall be final.

  • Deviations Deviations from the drawings and the dimensions therein given, whether or not error is believed to exist, shall be made only after written authority is obtained from the County, and shall be documented within the Detailed Scope of Work for the specific Job Order.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.