Data Entry, Validation, and Access Control: Summary and Assessment

Recommended sources for this chapter include Good Clinical Practice, clinical data management practice guidance, REDCap platform publications, FDA guidance on computerized systems and electronic source data, and data integrity guidance [@ich2016gcp; @scdm2024gcdmp; @harris2009redcap; @harris2019redcap; @fda2007computerized; @fda2013esource; @mhra2018dataintegrity]. These references are especially relevant when explaining source data, validation, audit trails, user access, electronic records, and data integrity expectations in clinical research systems. ---