A Case Report Form must be completed and signed by the principal or co- 
investigator for each subject enrolled, including those removed from the study for 
any reason. The reason for removal must be noted on the Final Subject Report 
Form by the investigator for each subject. 
Case Report Forms must be kept current to reflect subject status at each phase 
during the course of the study. Subjects are not to be identified on case report 
forms by name; appropriate coded identification and subject initials must be used. 
The investigator must keep a separate log of subject names and addresses. This 
log is subject to FDA inspection. 
Because of the potentials for errors, inaccuracies, and illegibility in transcribing 
data onto case report forms, originals of laboratory and other test results must be 
kept on file with the subject’s case report form or clinical chart. Case report 
forms and copies of test results must be available at all times for inspection by the 
FDA. 
17.4 Initiation of Study 
Prior to the initiation of the study, the following must be completed: 
Letter of Institutional Review Board approval 
Signed copy of the protocol 
Written Informed Consent Form approved by an IRB. 
FDA form 1572 (Statement of Investigator) signed by the principal 
investigator 
The curriculum vitae of the investigator(s) 
17.5 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. 
Such documentation includes: 
Case Report Forms - which must be kept legible, accurate, and up-to-date 
Patient Files - which must substantiate the data entered in the Case Report 
Forms with regard to lab data, patient histories, and treatment regimens 
Patient exclusion Record - which should reflect the reason any patient was 
screened. 
Recombinant DNA Research, Volume 15 
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