investigator. These forms are an integral part of the study and 
reports must be complete. Study patients should be identified on 
Case Report Forms by initials and study number, not name. The 
investigator must keep a separate log of patient names and 
addresses. This log is not subject to FDA inspection. 
13.5 Study Administration 
13.5.1 Monitoring the Study 
The study site will be monitored. The investigator and 
staff are expected to cooperate and provide all relevant 
study documentation upon request for review by the 
monitor, at each site visit. 
13.5.2 Interpretation of the Protocol 
The procedures defined in the protocol and in the Case 
Report Forms will be carefully reviewed at the time of the 
Pre-study meeting with the investigators and their study 
staff members to insure standardized interpretation and 
implementation. 
13.5.3 Maintenance of Study Documentation 
It is the responsibility of the investigator and the study 
staff to maintain a comprehensive and centralized filing 
system of all relevant study documentation including: 
a. Case Report Forms - which must be kept legible, 
accurate and up-to-date. Copies of finalized 
computer generated forms will be supplied to the 
site(s) by the sponsor. 
b. Patient Files /Signed Informed Consent - which 
substantiates the data entered on the Case Report 
Forms for all required tests and procedures and 
verifies that patients have signed an informed 
consent to enter the study. 
c. Non-Qualifier Screening List - which should reflect 
the reason any patient was screened for the study 
and found to be ineligible. 
d. Monitoring Log - which lists dates of monitor 
visits. 
e. Regulatory Documents - including protocol(s), 
investigator brochure, 1572, CVs, IRB correspond- 
ence, IRB approval(s) /renewals and IRB approved 
consent form(s). 
f. Sponsor Correspondence 
g. Device /Drug Accountability Records- if applicable 
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