Instruct: Identify the main category of Medrxiv papers based on the titles and abstracts
Query: Statistical modeling for quality risk assessment of clinical trials: follow-up at the era of remote auditing BackgroundAs investigator site audits have largely been conducted remotely during the COVID-19 pandemic, remote quality monitoring has gained some momentum. To further facilitate the conduct of remote Quality Assurance (QA) activities for clinical trials, we developed new quality indicators, building on a previously published statistical modeling methodology.

MethodsWe modeled the risk of having an audit or inspection finding using historical audits and inspections data from 2011 - 2019. We used logistic regression to model finding risk for 4 clinical impact factor (CIF) categories: Safety Reporting, Data Integrity, Consent and Protecting Endpoints.

ResultsWe could identify 15 interpretable factors influencing audit finding risk of 4 out of 5 CIF categories. They can be used to realistically predict differences in risk between 25 and 43% for different sites which suffice to rank sites by audit and inspection finding risk.

ConclusionContinuous surveillance of the identified risk factors and resulting risk estimates could be used to complement remote QA strategies for clinical trials and help to manage audit targets and audit focus also in post-pandemic times.
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The categories of this paper are: sports
67
The categories of this paper are: transplantation
46
The categories of this paper are: therapeutics
58
The categories of this paper are: hematology
69
The categories of this paper are: palliative
14
The categories of this paper are: cardiovascular
12
The categories of this paper are: genomic
53
The categories of this paper are: pathology
30
The categories of this paper are: radiology
57
The categories of this paper are: primary
49
The categories of this paper are: intensive
36
The categories of this paper are: economics
33
The categories of this paper are: physical
73
The categories of this paper are: toxicology
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The categories of this paper are: gastroenterology
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The categories of this paper are: reproductive