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Source Data Verification

A document describing source data and associated verification activity.
National Institutes of Health

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
2016
2016
eSource and Risk-Based Monitoring
The growing cost of drug development paves the way for newer technologies in clinical research. Taking its cue from success… 
2015
2015
Scientific and Practical Substantiation of Ways of Developing and Introducing Electronic Case Report Forms to Ensure the Quality of Bioequivalence Studies
Nowadays, in Ukraine the number of clinical trials conducted with the purpose of establishing bioequivalence of domestic drugs to… 
2014
2014
Monitoring Clinical Trials with a SAS Risk-Based Approach
With global regulatory encouragement, the life sciences industry is gaining momentum to embrace a risk-based approach to the… 
Review
2014
Review
2014
Risk Based Monitoring - Current Challenges with Implementation
Background: The FDA issued guidance for the industry on the “Oversight of Clinical Investigations-A RiskBased Approach to… 
Review
2014
Review
2014
Risk-Based Monitoring of Clinical Trials Using JMP
Guidelines from the International Conference on Harmonisation suggest that clinical trial data should be actively monitored to… 
2013
2013
Less is More: Risk-Based Monitoring of Site Performance
Over the past few decades, the complexity of clinical trials has increased dramatically as has the obligation on sponsors to… 
2009
2009
Internationales, prospektives Register zur Erfassung der Initial- und Dauertherapie von Patienten mit pulmonaler Hypertonie (CompERA-XL)
Die pulmonale arterielle Hypertonie (PAH) tritt häufiger auf als früher angenommen: Man geht von etwa 95 000 Patienten in der… 
1991
1991
Abstracts
s Ignacio Navarrete, Decentering Garcilaso: Herrera’s Attack on the Canon 21 Fernando de Herrera carefully crafts in his… 
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