Study Recordkeeping and Product Storage

The IDS uses an electronic accountability system to manage site inventory, label supplies being dispensed for outpatient use, and track supplies that are received, dispensed, returned by subjects, and destroyed on-site or returned to suppliers. Accountability logs can be generated from the system and are exportable to NCI DARF, NCI ORAL DARF, ACTG, De-Identified and other formats, significantly facilitating audit and reconciliation processes. Additionally, the system seamlessly integrates with other CHOP systems for protocol, patient, and document management and accountability records are easily retrievable when the study closes.

Investigational product supplies are stored securely and separated from commercial supplies in on- or off-site pharmacy location in compliance with the protocol as well as all applicable institutional, local, and federal regulations (e.g. CFR, FDA, PA State BOP) and accrediting bodies (e.g. Joint Commission). A continuous electronic temperature monitoring system is in place for all IP storage locations. Temperature records are maintained indefinitely and are easily retrievable when the study closes.