1 Table of Contents: “...Objective and purpose of study audits -- How to select studies -- Performing study audits...”

2 Table of Contents: “... implementation -- Independent monitoring -- Programme of audits/inspections -- Audit personnel Recording...”

3 Table of Contents: “...? -- SOP: CRO selection -- SOP: QA considerations -- SOP: audit of vendors -- CRO/third party vendor...”

4 Table of Contents: “... -- Before and during data recording -- ALCOA -- Data management -- Carousel loading -- Data audit trail...”