Protocol violation definition

Protocol violation. The subject’s findings or conduct failed to meet the protocol entry criteria or failed to adhere to the protocol requirements (e.g., treatment noncompliance, failure to return for defined number of visits). The violation necessitated premature termination from the study. Clinical visits are scheduled with a -1/+1 week window. Visits during this two- week window are not considered to be protocol violations. Every effort should be made to establish contact with participants who fail to show up for scheduled visits to determine the cause of the non-compliance. Failure to complete one scheduled visit within the mentioned -1/+1 week window due to disease or other factors outside the participant’s control is acceptable whereas failure to complete two consecutive visits shall be regarded as a protocol violation that necessitates premature study termination.
View Source
Protocol violation means an intentional act (from the perspective of the PI and study staff) in which the protocol is not followed. Examples of protocol violations include the PI prescribing or administering the wrong drug on the study, or the study subject being scheduled to return for follow-up intervention outside the protocol-dictated window as a convenience to the PI or the study staff.
View Source

Examples of Protocol violation in a sentence

  • The Entity will not receive any remuneration for patients who cannot be assessed due to failure to observe the Protocol, violation of the rules of Good Clinical Practice or failure to comply with the laws applicable to clinical drug trials.

  • In the event that any subject withdraws from the Study at any time and for any reason, including without limitation due to an adverse event, failure to appear for follow-up visits, or due to a Protocol violation that effects the evaluability of the subject, the Institution shall only qualify for payments for those services rendered prior to such subject’s withdrawal from the Study.

  • CRFs will not qualify for payment as follows: • Major, disqualifying Protocol violation.

  • Reasons for discontinuation include, but are not limited to, the following: • Physician decision • Adverse Event any AEs continuing at the time of withdrawal should be followed until resolution or determined by the Investigator to be chronic or stable • Pregnancy • Withdrawal by subject • Study terminated by sponsor • Protocol violation • Disallowed concomitant medication.

  • INSTITUTION and/or PRINCIPAL INVESTIGATOR will notify SPONSOR and INSTITUTION’s Institutional Review Board (“IRB”) prompltly upon becoming aware of any such Protocol violation, and shall ensure that all such deviations from Protocols are properly recorded in the Study records.

  • The Institution acknowledges that Sponsor may refuse to make payment in case of a breach of this Agreement, including but not limited to, a Protocol violation or an incomplete CRF.

  • CRFs will not qualify for payment in the event of a violation by Institution or Investigator as follows: • Material Protocol violation.

  • Site will notify Sponsor and IRB after becoming aware of any material Protocol violation.

  • The Institution acknowledges that PSI may refuse to make payment in case of a breach of this Agreement, including but not limited to, a Protocol violation or an incomplete CRF.

  • Platební podmínky In case of major, disqualifying Protocol violations, payment shall be made up to the patient’s last visit before the occurrence of such Protocol violation.

Related to Protocol violation

  • Technical violation means a noncriminal violation of the conditions of parole. This rule is intended to implement Iowa Code section 905.7.

  • Serious traffic violation means a conviction when operating a commercial motor vehicle of:

  • Serious violation means a violation of this act, an order issued under this act, or a rule promulgated or adopted by reference under this act for which a substantial probability exists that death or serious impairment of a body function to an individual other than the violator may result unless the violator did not and could not, with the exercise of reasonable diligence, know of the presence of the violation.

  • Wildlife violation means any cited violation of a statute, law, regulation, ordinance, or administrative rule developed and enacted for the management of wildlife resources and the uses thereof.

  • Behavioral violation means a student’s behavior that violates the district’s discipline policies.