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A Review and Evaluation of Risk Based Monitoring Procedures as Implemented in the Sickle Cell Disease and CardiovAscular Risk – Red Cell Exchange (SCD-CARRE) Trial

Balchak, Deidra (2021) A Review and Evaluation of Risk Based Monitoring Procedures as Implemented in the Sickle Cell Disease and CardiovAscular Risk – Red Cell Exchange (SCD-CARRE) Trial. Master Essay, University of Pittsburgh.

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Abstract

Risk Based Monitoring (RBM) is the process of monitoring clinical trial activity based on a set of predetermined hazards that, if not controlled, threaten the integrity of the trial data. RBM is completed through protocol risk assessment, addressing high impact hazards through set stages of increased monitoring, and centralized monitoring the vast majority of hazards. Clinical research trials were traditionally monitored through 100% source data verification and trial site visits by research monitors, whereas RBM has the potential to streamline the process of clinical trial monitoring while maintaining the data’s integrity. The Sickle Cell Disease and CardiovAscular Risk - Red cell Exchange Trial (SCD-CARRE) team designed and implemented a Risk Based Monitoring Plan (RBMP) to monitor clinical trial activity. The purpose of this work was to review the most current literature on RBM and assess the SCD-CARRE RBMP for possible points of weakness. Literature on RBM and studies utilizing RBMPs from approximately the last 10 years were reviewed to understand the purpose and typical RBM practices that are utilized by other clinical research trials. The SCD-CARRE Risk Assessment Tool (RAT) was also reviewed and compared to study reports and centralized data checks to ensure the hazards identified by the RAT were addressed. A log of these forms was created and gaps in reporting were recognized for further assessment. Through the review of the RBMP and associated study specific reports, four areas of weakness were identified. These included tracking clinical site engagement and staff turnover, inconsistent quality of ECHO data, and regular reporting of serious adverse events (SAE) outside of the Data Safety Monitoring Board (DSMB). An additional quarterly report was proposed that summarizes site activities and an ECHO form to help remind clinical staff of critical study data. Clinical trial monitoring is an important process that protects the quality and integrity of clinical trial data that can have lasting impacts on medical practice which is significant to public health as a whole.


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Details

Item Type: Other Thesis, Dissertation, or Long Paper (Master Essay)
Status: Unpublished
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Balchak, Deidradmb185@pitt.edudmb1850000-0003-0298-6718
Contributors:
ContributionContributors NameEmailPitt UsernameORCID
Committee ChairBertolet, Marniemhb12@pitt.edumhb12UNSPECIFIED
Committee MemberNovelli, Enriconoveex@upmc.eduUNSPECIFIEDUNSPECIFIED
Committee MemberKing, Wendykingw@edc.pitt.edukingwUNSPECIFIED
Date: 13 December 2021
Date Type: Completion
Submission Date: 14 December 2021
Access Restriction: 2 year -- Restrict access to University of Pittsburgh for a period of 2 years.
Number of Pages: 78
Institution: University of Pittsburgh
Schools and Programs: Graduate School of Public Health > Epidemiology
Degree: MPH - Master of Public Health
Thesis Type: Master Essay
Refereed: Yes
Uncontrolled Keywords: risk-based monitoring, clinical trials
Date Deposited: 06 Jan 2022 14:52
Last Modified: 06 Jan 2022 14:52
URI: http://d-scholarship.pitt.edu/id/eprint/42104

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