Gene Therapy for Meningeal Carcinomatosis 
10.0 Documentation. Record Keeping, CRFs 
All documents relevant to the conduct of the study will be kept on file by the investigator 
for (five) years after all investigational use of product is discontinued and the FDA is so notified or 
until five years after a Product Licensing Application (PLA/ELA) is approved. 
A separate release of medical information form will be signed by the study patient to 
facilitate access to the patient's medical records should the patient be hospitalized at another 
institution. A record will be kept of all patients considered (and screened) for the study and 
subsequently deemed ineligible. The reason for ineligibility will be recorded. 
11.0 Data Colle ction and Study Monitoring 
11.1 Data Collection 
Case Report Forms (CRFs) will be utilized for each patient entered into the study. Study 
participants will NOT be identified by name on any study documents. Patients will be identified by 
a patient identification number (PIN) and a patient code list will be kept 
11.2 Study Monitoring 
The GTI-designated person responsible for study monitoring of patient data will be 
permitted to contact and visit the investigator at regular intervals and will be allowed, on request, to 
review original documents such as consent forms, drug accountability records, case report forms, 
and pertinent hospital or clinic records for confirmation of study data provided that patient 
confidentiality is maintained in accord with local (IRB) requirements. It will be the monitor's 
responsibility to verify the adherence to the protocol and the completeness and accuracy of the data 
being entered on the CRFs. 
12.0 Biostatistical Considerations 
Not applicable 
13.0 Ethical Considerations 
13.1 Informed Consent 
All study participants must sign an informed consent (see Appendix X). The investigators 
will inform all subjects as to the nature, aims, duration, potential hazards, and procedures to be 
performed during the study and that his or her medical records may be reviewed by the sponsors or 
the FDA. Patients will also be notified that they are completely free to refuse to enter the study or 
to withdraw from it at any time. The protocol will be discussed in detail with all potentially eligible 
patients. All revisions of the protocol will be reflected in the consent form and reviewed by the 
IRB. 
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 
investigators will keep a separate log of patients' codes, names, and addresses. Documents which 
identify the patient by name (informed consent) will 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 
[610] 
Recombinant DNA Research, Volume 18 
