Establishment and Operation of Clinical Trial Data Monitoring Committees

U.S. Food and Drug Administration. (2006). Establishment and Operation of Clinical Trial Data Monitoring Committees.

Type

Unclassified

Intellectual base

Unclassified

Year

2006

Link

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishment-and-operation-clinical-trial-data-monitoring-committees

Cited by

1 citation across 1 artifact.

Each citation links to the sentence it supports in the citing article.

Mechanisms

• Adaptive Stop, Reclosure, and Rescue Protocol
  • A stop authority that is independent only on paper — really answerable to the people who want the change — will not fire when it must; this is the quiet, common way the safeguard fails.

    This sourceWarns that a nominal monitoring body may lack meaningful independence when its members are closely involved with the trial or answerable to interested sponsors.

Verification

Does it exist? Not checked yet. This entry carries no identifier to resolve. It was extracted from the citation as written in the article, normalized, and deduplicated against the rest of the registry.

Does it back the claim? Not recorded. The single citation of this work carries no recorded support check.

Support is checked per citation rather than per work — the same source can be cited soundly in one article and wrongly in another. Per-citation recording began recently, so a citation with no recorded check is a gap in the record rather than evidence it went unchecked.

See how references were verified.

Registry ID ref:4b5cf54c8ef5 · see in the full table