Regulatory Support provided by the CCC

Disclaimer: The Clinical Coordinating Center of the NHLBI Gene Therapy Resource Program does not and will not hold the IND or serve as Study Sponsor in any capacity. Further, when providing assistance to an NHLBI-approved investigator in the preparation of any regulatory or regulatory-related document(s), the responsibilities of the IND-Sponsor and/or the Principal Investigator of the study cannot be delegated or assigned in any way to the Clinical Coordinating Center.

Assistance with Data Safety Monitory Board (DSMB)

• Assist in compiling documents required for DSMB review
• Assist with submission of serious and unexpected adverse events that occurred in the course of the trial

Assistance with Institutional Biosafety Committee (IBC)

• Assist in securing IBC for sites without a standing IBC
• Assist with registration of the IBC with NIH-Office of Biotechnology Activities (OBA)
• Assist in compiling documents required for IBC review including relevant communications from the FDA, NHLBI, and the NIH-OBA
• Assist in responding to IBC comments, modifications and recommendations
• Assist with submission of annual reports of studies for IBC review
• Assist with submission of IBC annual reports for NIH OBA review

Assistance with Institutional Review Board (IRB)

• Assist in compiling documents required for IRB review including relevant communications from the FDA, NHLBI, and the NIH-OBA
• Assist with submission of serious and unexpected adverse events that occurred in the course of a clinical trial
• Assist with submission of annual reports of studies for IRB review

Assistance with Food and Drug Administration (FDA)

• Assist in administrative preparation of IND submission in compliance with 21CFR312
• Assist with submission of serious and unexpected adverse events that occurred in the course of the trial
• Assist in submission of IND annual report for FDA review

 
Assistance with NHLBI and NIH-OBA Requirements

• Assist with submission of final, approved clinical protocol to both NHLBI and NIH-OBA
• Assist with submission of serious and unexpected adverse events that occurred in the course of the trial to NHLBI and NIH-OBA
• Assist with NHLBI-required study reports for clinical trials funded by the GTRP