Clinical Study Report (CSR) Audits

csrAPSI can conduct audits of your CSRs to help ensure that your clinical trial results are reported accurately.

APSI will work with you to define the scope of the CSR audit based on risks.

Full scope CSR audits will generally include a review of CSR body text for accuracy and consistency, Synopsis-to-CSR body text consistency, audit of in-text data tables and figures against source data tables, figures, and/or listings, review of the QC process for adequacy, and audit of CSR appendices.