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BMC Medical Research Methodology
Published in: BMC Medical Research Methodology 1/2017

Open Access 01-12-2017 | Research article

Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned

Authors: Belinda von Niederhäusern, Annette Orleth, Sabine Schädelin, Nawal Rawi, Martin Velkopolszky, Claudia Becherer, Pascal Benkert, Priya Satalkar, Matthias Briel, Christiane Pauli-Magnus

Published in: BMC Medical Research Methodology | Issue 1/2017

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Abstract

Background

In spite of efforts to employ risk-based strategies to increase monitoring efficiency in the academic setting, empirical evidence on their effectiveness remains sparse. This mixed-methods study aimed to evaluate the risk-based on-site monitoring approach currently followed at our academic institution.

Methods

We selected all studies monitored by the Clinical Trial Unit (CTU) according to Risk ADApted MONitoring (ADAMON) at the University Hospital Basel, Switzerland, between 01.01.2012 and 31.12.2014. We extracted study characteristics and monitoring information from the CTU Enterprise Resource Management system and from monitoring reports of all selected studies. We summarized the data descriptively. Additionally, we conducted semi-structured interviews with the three current CTU monitors.

Results

During the observation period, a total of 214 monitoring visits were conducted in 43 studies resulting in 2961 documented monitoring findings. Our risk-based approach predominantly identified administrative (46.2%) and patient right findings (49.1%). We identified observational study design, high ADAMON risk category, industry sponsorship, the presence of an electronic database, experienced site staff, and inclusion of vulnerable study population to be factors associated with lower numbers of findings. The monitors understand the positive aspects of a risk-based approach but fear missing systematic errors due to the low frequency of visits.

Conclusions

We show that the factors mostly increasing the risk for on-site monitoring findings are underrepresented in the current risk analysis scheme. Our risk-based on-site approach should further be complemented by centralized data checks, allowing monitors to transform their role towards partners for overall trial quality, and success.
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Metadata
Title
Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned
Authors
Belinda von Niederhäusern
Annette Orleth
Sabine Schädelin
Nawal Rawi
Martin Velkopolszky
Claudia Becherer
Pascal Benkert
Priya Satalkar
Matthias Briel
Christiane Pauli-Magnus
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2017
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/s12874-017-0308-6

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