Clinical trial monitoring effectiveness: Remote risk-based monitoring versus on-site monitoring with 100% source data verification

2020 ◽  
pp. 174077452097125
Author(s):  
Osamu Yamada ◽  
Shih-Wei Chiu ◽  
Munenori Takata ◽  
Michiaki Abe ◽  
Mutsumi Shoji ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Confidence Interval ◽  
Remote Monitoring ◽  
Remote Monitoring System ◽  
Data Verification ◽  
Critical Data ◽  
Site Monitoring ◽  
Source Data ◽  
Source Data Verification

Background/Aims: Traditional on-site monitoring of clinical trials via frequent site visits and 100% source data verification is cost-consuming, and it still cannot guarantee data quality effectively. Depending on the types and designs of clinical trials, an alternative would be combining several monitoring methods, such as risk-based monitoring and remote monitoring. However, there is insufficient evidence of its effectiveness. This research compared the effectiveness of risk-based monitoring with a remote monitoring system with that of traditional on-site monitoring. Methods: With a cloud-based remote monitoring system called beagle View®, we created a remote risk-based monitoring methodology that focused only on critical data and processes. We selected a randomized controlled trial conducted at Tohoku University Hospital and randomly sampled 11 subjects whose case report forms had already been reviewed by data managers. Critical data and processes were verified retrospectively by remote risk-based monitoring; later, all data and processes were confirmed by on-site monitoring. We compared the ability of remote risk-based monitoring to detect critical data and process errors with that of on-site monitoring with 100% source data verification, including an examination of clinical trial staff workload and potential cost savings. Results: Of the total data points (n = 5617), 19.7% (n = 1105, 95% confidence interval = 18.7–20.7) were identified as critical. The error rates of critical data detected by on-site monitoring, remote risk-based monitoring, and data review by data managers were 7.6% (n = 84, 95% CI = 6.2–9.3), 7.6% (n = 84, 95% confidence interval = 6.2–9.3), and 3.9% (n = 43, 95% confidence interval = 2.9–5.2), respectively. The total number of critical process errors detected by on-site monitoring was 14. Of these 14, 92.9% (n = 13, 95% confidence interval = 68.5–98.7) and 42.9% (n = 6, 95% confidence interval = 21.4–67.4) of critical process errors were detected by remote risk-based monitoring and data review by data managers, respectively. The mean time clinical trial staff spent dealing with remote risk-based monitoring was 9.9 ± 5.3 (mean ± SD) min per visit per subject. Our calculations show that remote risk-based monitoring saved between 9 and 41 on-site monitoring visits, corresponding to a cost of between US$13,500 and US$61,500 per trial site. Conclusion: Remote risk-based monitoring was able to detect critical data and process errors as well as on-site monitoring with 100% source data verification, saving travel time and monitoring costs. Remote risk-based monitoring offers an effective alternative to traditional on-site monitoring of clinical trials.

scholarly journals Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sharon B. Love ◽  
Emma Armstrong ◽  
Carrie Bayliss ◽  
Melanie Boulter ◽  
Lisa Fox ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Remote Monitoring ◽  
Research Collaboration ◽  
Monitoring Task ◽  
Critical Data ◽  
Site Monitoring ◽  
Clinical Trials Unit ◽  
Third Person ◽  
Trial Monitoring ◽  
The Uk

AbstractThe COVID-19 pandemic has affected how clinical trials are managed, both within existing portfolios and for the rapidly developed COVID-19 trials. Sponsors or delegated organisations responsible for monitoring trials have needed to consider and implement alternative ways of working due to the national infection risk necessitating restricted movement of staff and public, reduced clinical staff resource as research staff moved to clinical areas, and amended working arrangements for sponsor and sponsor delegates as staff moved to working from home.Organisations have often worked in isolation to fast track mitigations required for the conduct of clinical trials during the pandemic; this paper describes many of the learnings from a group of monitoring leads based in United Kingdom Clinical Research Collaboration (UKCRC) Clinical Trials Unit (CTUs) within the UK.The UKCRC Monitoring Task and Finish Group, comprising monitoring leads from 9 CTUs, met repeatedly to identify how COVID-19 had affected clinical trial monitoring. Informed consent is included as a specific issue within this paper, as review of completed consent documentation is often required within trial monitoring plans (TMPs). Monitoring is defined as involving on-site monitoring, central monitoring or/and remote monitoring.Monitoring, required to protect the safety of the patients and the integrity of the trial and ensure the protocol is followed, is often best done by a combination of central, remote and on-site monitoring. However, if on-site monitoring is not possible, workable solutions can be found using only central or central and remote monitoring. eConsent, consent by a third person, or via remote means is plausible. Minimising datasets to the critical data reduces workload for sites and CTU staff. Home working caused by COVID-19 has made electronic trial master files (TMFs) more inviting. Allowing sites to book and attend protocol training at a time convenient to them has been successful and worth pursuing for trials with many sites in the future.The arrival of COVID-19 in the UK has forced consideration of and changes to how clinical trials are conducted in relation to monitoring. Some developed practices will be useful in other pandemics and others should be incorporated into regular use.

scholarly journals Monitoring Advances Including Consent; Learning from COVID-19 Trials and Other Trials Running in UKCRC Registered Clinical Trials Units During the COVID-19 Pandemic

2020 ◽  
Author(s):  
Sharon Love ◽  
Emma Armstrong ◽  
Carrie Bayliss ◽  
Melanie Boulter ◽  
Lisa Fox ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Remote Monitoring ◽  
Monitoring Task ◽  
Critical Data ◽  
Site Monitoring ◽  
Clinical Trials Unit ◽  
Third Person ◽  
Trial Monitoring ◽  
The Uk ◽  
Staff Resource

Abstract BackgroundThe COVID-19 pandemic has affected how clinical trials are managed, both within existing portfolios and for the rapidly developed COVID-19 trials. Sponsors or delegated organisations responsible for monitoring trials have needed to consider and implement alternative ways of working due to the national infection risk necessitating restricted movement of staff and public, reduced clinical staff resource as research staff moved to clinical areas, and amended working arrangements for sponsor and sponsor delegates as staff moved to working from home. Organisations have often worked in isolation to fast track mitigations required for the conduct of clinical trials during the pandemic; this paper describes many of the learnings from a group of monitoring leads based in UKCRC Clinical Trials Unit (CTUs) within the UK.MethodsThe UKCRC Monitoring Task and Finish Group comprising monitoring leads from 9 CTUs, met repeatedly to identify how COVID-19 had affected clinical trial monitoring. Informed consent is included as a specific issue within this paper, as review of completed consent documentation is often required within trial monitoring plans (TMPs). Monitoring is defined as involving on-site monitoring, central monitoring or/and remote monitoring. ResultsMonitoring, required to protect the safety of the patients, the integrity of the trial and ensure the protocol is followed, is often best done by a combination of central, remote and on-site monitoring. However, if on-site monitoring is not possible, workable solutions can be found using only central or central and remote monitoring. eConsent, consent by a third person, or via remote means is plausible. Minimising datasets to the critical data reduces workload for sites and CTU staff. Home working caused by COVID-19 has made electronic trial master files (TMF’s) more inviting. Allowing sites to book and attend protocol training at a time convenient to them has been successful and worth pursuing for trials with many sites in the future.ConclusionsThe arrival of COVID-19 in the UK has forced consideration of and changes to how clinical trials are conducted in relation to monitoring. Some developed practices will be useful in other pandemics and others should be incorporated into regular use.

scholarly journals Impact of source data verification on data quality in clinical trials: an empiricalpost hocanalysis of three phase 3 randomized clinical trials

2015 ◽  
Vol 79 (4) ◽  
pp. 660-668 ◽  
Author(s):  
Jeppe Ragnar Andersen ◽  
Inger Byrjalsen ◽  
Asger Bihlet ◽  
Faidra Kalakou ◽  
Hans Christian Hoeck ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Quality ◽  
Randomized Clinical Trials ◽  
Phase 3 ◽  
Data Verification ◽  
Three Phase ◽  
Source Data ◽  
Source Data Verification

scholarly journals Risk-Based Monitoring in Clinical Trials: Past, Present, and Future

2021 ◽  
Author(s):  
Brian Barnes ◽  
Nicole Stansbury ◽  
Debby Brown ◽  
Lauren Garson ◽  
Geoff Gerard ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Risk Indicators ◽  
Remote Site ◽  
Trial Quality ◽  
Site Monitoring ◽  
Source Data Verification ◽  
Landscape Survey ◽  
Trial Monitoring ◽  
The Individual

AbstractRisk-based monitoring (RBM) is a powerful tool for efficiently ensuring patient safety and data integrity in a clinical trial, enhancing overall trial quality. To better understand the state of RBM implementation across the clinical trial industry, the Association of Clinical Research Organizations (ACRO) conducted a landscape survey among its member companies across 6,513 clinical trials ongoing at the end of 2019. Of these trials, 22% included at least 1 of the 5 RBM components: key risk indicators (KRIs), centralized monitoring, off-site/remote-site monitoring, reduced source data verification (SDV), and reduced source document review (SDR). The implementation rates for the individual RBM components ranged 8%–19%, with the most frequently implemented component being centralized monitoring and the least frequently implemented being reduced SDR. When the COVID-19 pandemic emerged in early 2020, additional data were collected to assess its impact on trial monitoring, focusing specifically on trials switching from on-site monitoring to off-site/remote-site monitoring. These mid-pandemic data show that the vast majority of monitoring visits were on-site in February 2020, but an even higher percentage were off-site in April, corresponding with the first peak of the pandemic. Despite this shift, similar numbers of non-COVID-related protocol deviations were detected from February through June, suggesting little or no reduction in monitoring effectiveness. The pre- and mid-pandemic data provide two very different snapshots of RBM implementation, but both support the need to promote adoption of this approach while also highlighting an opportunity to capitalize on the recent shift toward greater RBM uptake in a post-pandemic environment.

scholarly journals Evaluation of Data Errors and Monitoring Activities in a Trial in Japan Using a Risk-Based Approach Including Central Monitoring and Site Risk Assessment

2021 ◽  
Author(s):  
Hidenobu Kondo ◽  
Tomoaki Kamiyoshihara ◽  
Kenji Fujisawa ◽  
Toshiaki Nojima ◽  
Ryohei Tanigawa ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Cost Savings ◽  
Central Monitoring ◽  
Critical Data ◽  
Data Errors ◽  
Monitoring Time ◽  
Site Monitoring ◽  
Research Associate ◽  
Source Data ◽  
Source Data Verification

Abstract Background Risk-based monitoring (RBM) is a slow uptake in some trial sponsors. There are three main reasons for this. First, there is the fear of making large investments into advanced RBM technology solutions. Second, it is considered that RBM is most suitable for large, complex trials. Third, there is the fear of errors in both critical and non-critical data, appearing as reduced on-site monitoring is being conducted. Methods Our RBM team identified, evaluated, and mitigated trial risks, as well as devised a monitoring strategy. The clinical research associate (CRA) assessed the site risks, and the RBM team conducted central monitoring. We compared all data errors and on-site monitoring time between the partial switching sites [sites that had switched to partial source data verification (SDV) and source data review (SDR)] and the 100% SDV and SDR sites (sites that had implemented 100% SDV and SDR). Results Partial switching sites did not require any critical data correction and had a smaller number of data corrections through on-site monitoring than the 100% SDV and SDR sites. The RBM strategy reduced the on-site monitoring time by 30%. Conclusions The results suggest that RBM can be successfully implemented through the use of site risk assessment and central monitoring with practically no additional investment in technology and still produced similar results in terms of subject safety and data quality, as well as the cost savings that have been reported in global complex studies.

scholarly journals Reducing Clinical Trial Monitoring Resource Allocation and Costs Through Remote Access to Electronic Medical Records

2013 ◽  
Vol 9 (1) ◽  
pp. e13-e16 ◽  
Author(s):  
Shannon C. Uren ◽  
Mitchell B. Kirkman ◽  
Brad S. Dalton ◽  
John R. Zalcberg
Keyword(s):  
Clinical Trial ◽  
Resource Allocation ◽  
Electronic Medical Records ◽  
Medical Records ◽  
Remote Access ◽  
Data Verification ◽  
Source Data ◽  
Source Data Verification ◽  
Trial Monitoring ◽  
Clinical Trial Monitoring

Remote access to patient medical records for source data verification is feasible and is potentially an avenue through which resources can be more efficiently used.

scholarly journals Critical utility of e-solutions in risk based monitoring

2016 ◽  
Vol 3 (4) ◽  
pp. 199
Author(s):  
Pranjal R. Chaturvedi
Keyword(s):  
Clinical Trial ◽  
Real Time ◽  
Clinical Practices ◽  
Time Data ◽  
Data Verification ◽  
Source Data ◽  
Real Time Data ◽  
Source Data Verification

<p class="abstract"><span lang="EN-IN">As the clinical trial industry is evolving from a traditional 100% SDV (source data verification) approach to reduced SDV &amp; Centralized Monitoring by applying a risk based monitoring (RBM) approach, hence forth leveraging of e-Solutions and real time data integrations would be critical in RBM. Technological considerations are critical to collect data real time to assess, monitor and mitigate risk in compliance with Good Clinical Practices. This article will examine the importance of e-Solutions and real time analytics in alignment with various systems for developing an effective RBM strategy</span>.</p>

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