Investigational Applications. 3.7.1 If an IND is required, ICD will be the IND Sponsor and will submit an IND. All Clinical Investigators must have completed registration documents on file (1572 forms).
Investigational Applications. 3.7.1 If an IND is required, the Parties will decide which Party will be the IND Sponsor and the IND Sponsor will submit an IND. All Clinical Investigators must have completed registration documents on file (1572 forms).
Investigational Applications. 3.7.1 If an IND is required either IC or Collaborator, as indicated in the Research Plan, will submit an IND, and all Clinical Investigators must have completed registration documents on file (1572 forms).
Investigational Applications. If an IND (or the equivalent application in other countries) is required, VA will be the IND sponsor, and will submit the IND to FDA. Collaborator agrees to provide to VA background data and information necessary to support the IND.
Investigational Applications. 3.7.1 If an IND is required to be filed after the Effective Date to conduct the Research Plan, IC and Collaborator will mutually determine on a case-by-case basis which Party will be the IND Sponsor. The Party selected to be the IND Sponsor will submit the IND. All Clinical Investigators must have completed registration documents on file (1572 forms).
Investigational Applications. 3.7.1 The Collaborator, as indicated in the Research Plan, will submit an IND and all required documents to the FDA. The Collaborator will comply with all FDA requirements, including obtaining and maintaining all Clinical Investigator registration documents (1572 forms).
Investigational Applications. 3.7.1 If an IND is required to perform the research and development activities under this CRADA, then the IC will submit an IND and ensure all Clinical Investigators have completed all necessary registration documents (1572 forms).
