Access to Study Drug
Melody I. Sanger, BSN, RN, MD, CCRC, CCRP holds the keys for the locked cabinets around her neck and is in charge of our “pharmacy.” She is the one that receives the drug, processes it, dispenses it, and ultimately does drug accountability with the CRA on close out. Melody is our HIPAA privacy officer and is a licensed nurse. She maintains CEU’s on GCP’s and audits the drug accountability process routinely. This usually occurs after hours when we (Melody and I, Dr. Saponaro) are in the office by ourselves. We have weekly office meeting where we teach GCP’s and go over system controls to ensure security.