» Protocol and CRF Review

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Biostatistics

Protocol and CRF Review


ACORN CRO provides biostatistical review of protocols, case report forms (CRF), and other study documents. Review of protocols includes consideration of the appropriateness of the biostatistical content, including consistency of objectives with study measures and planned analyses. It also includes evaluation of the completeness of biostatistical content, and the quality of scientific presentation.

Review of CRFs entails matching of CRF content to protocol and/or statistical analysis plans. It also includes evaluation of the nesting structure of the data as implied by the CRF

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