must be maintained for 2 years after the investigation was discontinued. The 
Sponsor will notify the Investigator when records are no longer required. 
Upon the request of authorized Targeted Genetics or FDA personnel, the Investigator will 
make available for inspection source documents, e.g., records of each subject who 
participates in this study, pharmacy records, etc. This information will be treated as 
confidential. 
12.4 Monitoring 
The Investigator will be contacted by the sponsor at periodic intervals by telephone or visit 
to assess the progress of the study. Case report forms and subject records will be reviewed 
at on-site visits in an effort to verify and achieve completeness of all entries. The status of 
drug storage, dispensing, and accountability will also be assessed. 
12.5 Information Materials 
Before the study begins, the Investigator will have received an Investigator Brochure 
describing all known contraindications, warnings, precautions, and adverse reactions 
associated with the administration of the study drug. If such information is revised while 
the study is in progress, the latest revision will also be sent to the Investigator at that time 
who will inform the IRB of any relevant new information. 
12.6 Termination of Study 
Targeted Genetics Corporation reserves the right to terminate this study at any time. The 
Principal Investigator or the FDA may also terminate the study. If the study is terminated 
prior to scheduled completion, the Investigator will be notified and given any necessary 
instructions concerning final examinations that are required. 
12.7 Use of Information 
The information provided in support of or generated as a result of this study is confidential. 
Any use or reproduction thereof, including but not limited to publications or presentations 
by the Investigator or his associates, must be submitted to Targeted Genetics Corporation 
for review and approval prior to publication or presentation in any form. Such review will 
be completed within 30 days of receipt. 
All personal information pertaining to patients in this study and in any subsequent reports 
will be kept confidential. Patients will identified only by their initials and by a patient 
number. It is the responsibility of the Investigator, therefore, to keep a patient listing for 
cross-referencing. 
All information not previously published concerning the tgAAVCF vector and Targeted 
Genetics Corporation operations, such as patent applications, formulas, manufacturing 
processes, basic scientific data, and formulation information supplied by Targeted Genetics 
to the Investigator is considered confidential and shall remain the sole property of Targeted 
Genetics. The Investigator agrees to use this information only to accomplish this study and 
not for other purposes without written consent. 
It is understood by the Investigator that the information developed in this clinical study will 
be used by the Sponsor in connection with the development of AAV-CFTR vectors and, 
therefore, may be disclosed as required to other clinical investigators, to the United States 
Food and Drug Administration, and to other government agencies. 
Recombinant DNA Research, Volume 20 
[133] 
