and report AEs to the Data and Safety Monitoring Board (DSMB) in a format that highlights trends or signals. Support human subjects’ data and biospecimen repository and regulatory activities, as □ appropriate. For programs collecting, processing, assaying, storing or distributing biospecimens, ensure that systems are in place to maintain subject confidentiality and to 6 track subject informed consent. B. FDA Related Regulatory Requirements Identify and make available expert regulatory staff involved in IND/IDE management for □ 1 assistance and advice on IND/IDE regulations and preparation for inspections. □ Establish a process for preparing and managing IND/IDE reports and other requirements. 2 C. OHRP Related Regulatory Verify center(s) Federal-wide Assurance status when the DCC is responsible for site □ 1 selection. As appropriate, develop an online regulatory documents library that accepts site submissions □ and produces reports and email alerts about outstanding or expired documents, specifically 2 IRB annual approvals.
and report AEs to the Data and Safety Monitoring Board (DSMB) in a format that highlights trends or signals. 6 Support human subjects’ data and biospecimen repository and regulatory activities, as appropriate. For programs collecting, processing, assaying, storing or distributing biospecimens, ensure that systems are in place to maintain subject confidentiality and to track subject informed consent. □ B. FDA Related Regulatory Requirements 1 Identify and make available expert regulatory staff involved in IND/IDE management for assistance and advice on IND/IDE regulations and preparation for inspections. □ 2 Establish a process for preparing and managing IND/IDE reports and other requirements. □ C. OHRP Related Regulatory 1 Verify center(s) Federal-wide Assurance status when the DCC is responsible for site selection. □ 2 As appropriate, develop an online regulatory documents library that accepts site submissions and produces reports and email alerts about outstanding or expired documents, specifically IRB annual approvals. □