Regulatory Compliance and Human Subjects Protection Program (RCHSPP) – Document Control (DC)

 
CMRP staff working in the Regulatory Compliance and Human Subjects Protection Program (RCHSPP) Document Control (DC) group are at the core of RCHSPP’s quality system. The DC group maintains and archives critical documents, including RCHSPP controlled documents and Clinical Research’s Trial Master Files. DC offers many services to assist with the document control needs of the various RCHSPP groups. These services include: (1) the protocol review process; (2) the paper and electronic file storage and maintenance of various documents; (3) the creation of CDs, various databases and logs; (4) the archival and scanning of documents; and (5) training on the DC system and the various electronic documents maintained in the system.  DC also helps to improve the protocol review process by utilizing new systems that offer audit trails and other features that allow for better control of this documentation.