CLINICAL PROTOCOL 
Product: VCL-1102 
July 7, 1994 
VICAL INC. 
9373 Towne Centre Dr., Ste. 100 
San Diego, CA 92121 
access to the patient's confidential medical record and the possibility of media 
attention.. 
10.2 Institutional Review 
The study site Institutional Review Board must approve the Clinical Protocol and 
Informed Consent Document and agree to monitor the conduct of the study and 
periodically review its progress at no less than one year intervals. Before the study 
begins, the Investigator will provide the Sponsor with documented evidence, i.e., a 
letter from the IRB or a copy of the IRB minutes, of: 
o Clinical Protocol and Informed Consent approval, 
o The IRB agreement to monitor the conduct of the study and review it 
periodically. 
10.3 Updates To The Informed Consent Documents 
The Sponsor will notify the Investigator if significant new findings develop during the 
course of the study that may relate to the patient's willingness to continue participation. 
It is the Investigator's responsibility to: 
o Notify the local IRB. 
o Update the Informed Consent Document, 
o Notify each patient accordingly. 
o Obtain a signed copy of the updated Informed Consent Document from each 
patient. 
o Send the Sponsor a copy of each patient's signed updated Informed Consent 
Document. 
11.0 PATIENT PRIVACY, USE OF INFORMATION AND PUBLICATION 
The sponsor is concerned for the individual patient's privacy and, therefore, all patient 
data will be identified only by initials and number. In the informed consent document, 
the patient will be informed that the patient's medical chart may be reviewed by the 
sponsor and information related to the study may be shared with the Food and Drug 
Administration, and other government agencies. The patient will be told that every 
effort will be made to maintain confidentiality but because it is a gene therapy trial it 
may draw the attention of the media. 
Recombinant DNA Research, Volume 20 
[615] 
