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.

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 Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: a scoping review

2020 ◽  
Author(s):  
William J Cragg ◽  
Caroline Hurley ◽  
Victoria Yorke-Edwards ◽  
Sally P Stenning
Keyword(s):  
Clinical Trials ◽  
Scoping Review ◽  
Research Question ◽  
Trial Data ◽  
Monitoring Methods ◽  
Central Monitoring ◽  
Statistical Monitoring ◽  
Site Monitoring ◽  
Central Statistical ◽  
Monitoring Activity

AbstractBackground/AimsIt is increasingly recognised that reliance on frequent site visits for monitoring clinical trials is inefficient. Regulators and trialists have in recent years encouraged more risk-based monitoring. Risk assessment should take place before a trial begins in order to define the overarching monitoring strategy. It can also be done on an ongoing basis, in order to target sites for monitoring activity. Various methods have been proposed for such prioritisation, often using terms like ‘central statistical monitoring’, ‘triggered monitoring’ or, as in ICH Good Clinical Practice guidance, ‘targeted on-site monitoring’. We conducted a scoping review to identify such methods, to establish if any published methods were supported by adequate evidence to allow wider implementation, and to point the way to future developments in this field of research.MethodsWe used 7 publication databases, 2 sets of methodological conference abstracts and an internet search engine to look for methods for using centrally held trial data to assess site conduct during a trial. We included only reports in English, and excluded reports published before 1996 and reports not directly relevant to our research question. We used reference and citation searches to find additional relevant reports. We extracted data using a pre- defined template. We contacted authors to request additional information about included reports and to check whether reports might be eligible.ResultsWe included 30 reports in our final dataset, of which 21 were peer-reviewed publications. 20 reports described central statistical monitoring methods (of which 7 focussed on detection of fraud or misconduct) and 9 described triggered monitoring methods. 21 reports included some assessment of their methods’ effectiveness. Most commonly this involved exploring the methods’ characteristics using real trial data with no known integrity issues. Of the 21 with some effectiveness assessment, most presented limited or no information about whether or not concerns identified through central monitoring constituted meaningful problems. Some reports commented on cost savings from reduced on-site monitoring, but none gave detailed costings for the development and maintenance of central monitoring methods themselves.ConclusionsOur review identified various proposed methods, some of which could be combined within the same trial. The apparent emphasis on fraud detection may not be proportionate in all trial settings. Although some methods have self-justifying benefits for data cleaning activity, many have limitations that may currently prevent their routine use for targeting trial monitoring activity. The implementation costs, or uncertainty about these, may also be a barrier. We make recommendations for how the evidence-base supporting these methods could be improved.

scholarly journals Evaluation of source data verification in a multicentre cancer trial (PROTECT)

Trials ◽  
2013 ◽  
Vol 14 (S1) ◽  
Author(s):  
J Athene Lane ◽  
Michael Davis ◽  
Elizabeth Down ◽  
Rhiannon Macefield ◽  
David Neal ◽  
...  
Keyword(s):  
Cancer Trial ◽  
Data Verification ◽  
Source Data ◽  
Source Data Verification

An Advanced Automatic Remote Meter Detection Method Based on Machine Vision

2014 ◽  
Vol 568-570 ◽  
pp. 994-1000
Author(s):  
Han Li ◽  
Shao Jun Liu ◽  
Ku Wang ◽  
Xia Liu
Keyword(s):  
Risk Assessment ◽  
Machine Vision ◽  
Correlation Coefficient ◽  
Detection Method ◽  
Correlation Coefficients ◽  
Histogram Equalization ◽  
Inspection Robot ◽  
Site Monitoring ◽  
Template Image ◽  
Otsu’S Method

There are a great amount of electronic meters equipped in the distribution substations, which were traditionally monitored by operators. On-site monitoring for risk assessment of these meters is very important. In this paper, we presented an advanced machine vision based automatic meter detection method toward the development of an online automatic meter reading intelligent inspection robot in substation. Firstly, the image received from the inspection robot was enhanced using histogram equalization. Then, the image was segmented into two parts based on the threshold obtained by Otsu’s method. Using these two parts, and the whole enhanced image, circular Hough transformation was applied on these three images and detected the circle with highest probability on them. The normalized correlation coefficients were calculated between the corresponding areas of those three circles from three images and the template image of SF6meter. Finally, the circle with highest correlation coefficient, which was higher than a certain threshold, was determined to be the meter. If it is lower than the threshold, the algorithm would decide that no meter was found in the image. The method was tested with 222 images obtained in one substation in Xi’an, Shanxi, China, and an 87.4% accuracy was achieved using these images, which indicated the potential of this method.

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.

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