Clinical Monitoring (SDV / SDR)
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Clinical monitoring is the sponsor's oversight of trial conduct at sites to confirm that participant rights and safety are protected and that reported data are accurate, complete, and verifiable against source. It combines source data verification (SDV — checking recorded data against the original records) with source data review (SDR — assessing the quality and consistency of source processes and documentation), delivered through on-site, remote, and centralized methods. Under a risk-based model the mix is proportionate to risk rather than 100% SDV of every field.
SDV answers "does the reported value match the source?"; SDR asks the broader question "are the site's records and processes sound, and do they hang together?" Risk-based monitoring targets both toward critical data and critical processes rather than treating all data equally.
Centralized (statistical) monitoring reviews accumulating data across sites to detect outliers, implausible patterns, and QTL excursions — often catching systematic issues that per-site SDV would miss.
- —SDV = data vs source; SDR = quality of source records/processes
- —On-site, remote, and centralized methods combined
- —Risk-based: concentrate on critical data and critical processes
- —Centralized statistical monitoring surfaces cross-site systematic signals
ICH E6(R3) monitoring provisions; FDA "A Risk-Based Approach to Monitoring"; EMA reflection paper on risk-based quality management in clinical trials.
Frequently asked questions
What is Clinical Monitoring (SDV / SDR)?
Clinical monitoring is the sponsor's oversight of trial conduct at sites to confirm that participant rights and safety are protected and that reported data are accurate, complete, and verifiable against source. It combines source data verification (SDV — checking recorded data against the original records) with source data review (SDR — assessing the quality and consistency of source processes and documentation), delivered through on-site, remote, and centralized methods. Under a risk-based model the mix is proportionate to risk rather than 100% SDV of every field.
Which regulations cover Clinical Monitoring (SDV / SDR)?
ICH E6(R3) monitoring provisions; FDA "A Risk-Based Approach to Monitoring"; EMA reflection paper on risk-based quality management in clinical trials.