1. Prepare, assembly and submission to the FDA, of IND submissions, amendments and annual reports2. Coordination of Serious Adverse Experience (SAE) reporting and evaluation for IND protocols and general management of the DAIDS safety reporting system for all protocols (IND and non-IND) conducted by the networks; 3. Initial collection and assessment of SAE reports; preparation of FDA Safety Reports and MEDWATCH reports; coordination of clinical protocol registration activities to ensure fulfillment of DAIDS regulatory obligation to the FDA as research sponsor; review of clinical protocols during the protocol development process to ensure compliance with all pertinent NIH, FDA, OHRP, and DHHS regulations including inclusion of minorities, children and underserved populations; 4. Review of protocol sample informed consents and site specific informed consents to ensure compliance with OHRP and FDA Human Subject Protection Codes and for compliance with DAIDS policy as the clinical trials sponsor; 5. Development of clinical trials agreements and other agreements as necessary between industry and DAIDS and other entities involved with DAIDS sponsored clinical trials. 6. Provide scientific and technical support to the DAIDS Clinical Science Review Committee (CSRC) and the Prevention Science Review Committee (PSRC) for review of concept sheets and protocols developed by DAIDS-sponsored clinical trials groups and grantees.
