Remote Monitoring of Protocol Deviations

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Presentation transcript:

Remote Monitoring of Protocol Deviations Dee Blumberg, PhD

Protocol Deviation Monitoring It is vital to monitor protocol adherence throughout the lifecycle of a study. One method of monitoring adherence is by identifying, tracking, and resolving PDs Protocol Deviation Definition: A protocol deviation/violation is generally an unplanned excursion from the protocol that is not implemented or intended as a systematic change (BIMO, 2015)

Protocol Deviation Monitoring Major: Inadequate or delinquent informed consent Accidental distribution of incorrect study medication or dose Ineligible participant enrolled Unreported Serious Adverse Events (SAEs) Minor: Missed assessment/lab test Missed or out of window study visit

Protocol Deviation Review Process The Emmes Clinical Coordinating Center (CCC) supports the CTN in its general operations and developed a process designed for rapid reporting, notification, and resolution of protocol deviations...

Protocol Deviation Types Informed Consent Procedures Inclusion/Exclusion Criteria Laboratory Assessments Study Procedures/Assessments Adverse Event Randomization Procedures Study Medication Management Study Behavioral Intervention Other Significant Deviations

Protocol Deviation Types ADVERSE EVENT AE not reported - SAE not reported AE/SAE reported out of protocol specified reporting timeframe AE/SAE not elicited, observed and/or documented as per protocol Safety assessment (e.g. labs, ECG, clinical referral to care) not conducted per protocol Other: specifiy

Protocol Deviation Review

Protocol Deviation Review

Cumulative PD Data Cumulative report generated weekly Allows patterns, systemic errors, to be detected PD TYPE PD Description PD Resolution STUDY ASSESSMENTS: Other The participant's Week 16 visit was completed 1 day out of Window. Research staff will continue to attempt to have participant's complete their weekly visits as scheduled within their visit window. Participant week 3 visit was completed 3 days outside of the visit window due to participant needing to reschedule. Encourage participants to complete visits on time, have reminder calls

Conclusion Advantages: Real time attention to PDs Group discussion/consensus Immediate training reduces similar issues from reoccurring but if it’s protocol wide then protocol needs amendment (e.g., tight windows) This is a metric for site performance- helps identify a need for retraining

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