(Approved by RAC on March 3, revised on March 4)
Recombinant vaccines not covered by footnote V-U.(Footnote V-U is a new definition of what constitutes a vaccine,written by RAC on March 3, 1994, and not yet published. It willbe available in the RAC meeting minutes for the March 3-4meeting.)
2. Lethally Irradiated Tumor Cells/No Replication CompetentVirus
RAC-approved vector constructs or RAC-approved vectorconstructs with minor modifications/additional tumor cells.
3. Additional Site
Principal investigator initiates study using RAC-approvedprotocol at additional site.
4. New Principal Investigator/New Site
Original protocol/new principal investigator/new site.
5. "Umbrella" Protocols
Principal investigator indicates intent to initiate study atmultiple sites.
6. Modifications not Related to Gene Transfer
Modification to clinical protocol that is not related to genetransfer portion of the study.
7. Gene Marking Protocols
RAC-approved vector constructs or RAC-approved vectorconstructs with minor modifications/additional target cells.
(c) 1997 American Health Consultants. All rights reserved.