Quasar Features Advarra Director in Article About SDV and SDR
Claudia Malcolm, Director of GXP Services at Advarra, wrote the article Points to Consider when Performing SDV/SDR/ (On-Site or Remote) for Quasar.
In her article, Malcolm provides insight to research staff on what good clinical practice (GCP) auditors look for when performing source data verification (SDV) and source data review (SDR) during on-site or remote investigator site audits. It also covers how subjects are chosen for review and what data protection regulations must be taken into account when sharing source data (or certified copies) outside of the investigator site.
“To conduct SDV and SDR,” Malcom writes, “direct access to source data is required. However, this has its challenges, especially when conducting remote investigator site audits and/or remote monitoring.”
Quasar is a quarterly publication of RQA, an organization providing status and visibility for individuals concerned with the quality of research and development concerning pharmaceuticals, agrochemicals, chemicals, and medical devices.