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patients. All revisions of the protocol must be reflected in the consent form and 
reviewed by the IRB. 
A ppendix VI are the Patient Informed Consents (attachments) 
13.2 Patient Confidentiality 
All reports and patient samples will be identified only by a coded number to maintain 
patient confidentiality. All records will be kept confidential to the extent permitted by 
law. The investigator should keep a separate log of patients’ codes, names, and 
addresses. Documents which identify the patient by name (informed consent) should be 
kept in strict confidence. 
14.0 CRITERIA AND PROCEDURES FOR PROTOCOL MODIFICATION 
AND STUDY TERMINATION 
Modifications which may effect the safety of the study patient, or which may alter the scope of 
the investigation, the scientific quality of the study, the study design, dosages, duration of 
therapy, patient assessments (added evaluation that poses potential risk or inconvenience to the 
patient), number of patients, and patient eligibility criteria, may be made only after appropriate 
consultation between the sponsor and the investigator. 
If the consensus is to revise the current protocol, a formal List of Changes will accompany the 
amended protocol and these will be submitted to the FDA, the site’s IRB, and other committees 
as required! 
Both the sponsor and the investigator reserve the right to terminate the study at any time. If this 
becomes necessary, appropriate procedures for continuing the long-term follow-up requested by 
the regulatory agencies will be arranged after review and approval by both parties. 
15.0 PUBLICATION OF RESEARCH FINDINGS/PROTECTION OF COMPANY TRADE 
SECRETS 
The investigator will agree to inform the sponsor of all study results. Any manuscript, abstract, 
or presentation will be made available to the sponsor and all participating study investigators for 
review prior to submission of manuscripts, abstracts, or scientific meetings. This will allow the 
sponsor to protect proprietary information and to provide comment based on information that 
may not yet be available to the investigator. 
16.0 BIOHAZARD WARNINGS AND PRECAUTIONS 
Patients will be treated in standard hospital and clinic rooms. No special patient precautions will 
be taken. 
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