Correction of data on the case report form will be made in a manner that leaves the previous 
entry identifiable. Each correction must indicate the individual making the correction and 
the date of the correction. 
Completed case report forms will be submitted to the Sponsor as directed by the study 
monitor. Case report forms will be reviewed by the monitor, who will decide as to their 
acceptability. 
If possible, data will be electronically transferred to Targeted Genetics Corporation. When 
certain data are not available via electronic methods, Case Report Form pages will be 
provided for each study patient. 
12.13 Pre-Investigational Documents 
Prior to initiation of the study, the Investigator will supply the Sponsor with the following: 
1) The original signed FDA Form 1572 
2) Principal Investigator and Co-Investigator(s) curricula vitae 
3) IRB-approved consent form 
4) A copy of the Institutional Review Board approval 
5) The name and address of the IRB 
6) A list of ERB members, including their occupations and affiliations 
7) Evidence of laboratory certification and the name and address of the laboratory 
8) A list of laboratory normal ranges 
9) Signed Investigator Agreement 
Recombinant DNA Research, Volume 20 
[135] 
