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Why definitions are important

Following on from my blog on the subtle shift in RBQM language, we’ve seen a number of challenges around common RBQM definitions that have adversely affected clients. This happens when one person or group interprets something one way, and another group has a different perspective. This not only causes confusion, it can cause delays and relationships to be strained. In part the challenge lies with the ICH guidance which could be viewed as not being prescriptive enough. Our smarter clients have used the problem to engineer conversations and closer working relationships between Sponsors and CROs.

For what it’s worth, here’s my definitions on some of the key terms and phrases. I’m up for debating them, but they are a good starting point if you’re not sure.

On-site Monitoring Visit

Monitor physically visits site. Conducts activities that cannot be completed remotely:

  • Drug accountability

  • ISF Review

  • Facility Review

  • SDR (SDV) activities as per monitoring plan

Requires a monitoring visit report to be generated

Remote Monitoring Visit

An official 'visit' conducted remotely. Can cover the majority of items similar to an on-site visit. Requires a remote monitoring visit report to be generated.

Remote Data Review

A review of electronic systems used within the study to cross-check data, ensure compliance with the protocol schedule, determine any potential issues that may need to be investigated further. Could be via patient profiles.

Central Monitoring / KRIs / Data Analytics (Depending on terminology)

A review of the KRIs and QTLs to identify any areas of concern i.e. high-risk sites, potential systematic errors at the study or site level, site performance issues. Should be used to identify trends and allow the team to try and course-correct the current trend, or identify any emerging risks.


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