The sponsor must receive a copy of the letter of approval from 
the IRB which specifically identifies the documents approved 
before shipping drug/devices to the investigator. 
The IRB must also approve any significant changes to the 
protocol as well as a change of principal investigator, and 
documentation of this approval must be sent to the sponsor. 
Records of all study review and approval documents must be 
kept on file by the investigator and are subject to FDA inspection 
during or after completion of the study. 
Adverse experiences must also be reported to the IRB. See 
Section 9.5 for requirement. 
The IRB should receive notification of the completion of the 
study and final report within three months of study completion 
or termination. A copy of these reports must be sent to the 
sponsor. The investigator must maintain an accurate and 
complete record of all submissions made to the IRB, including a 
list of all reports and documents submitted. 
13.3 Documentation 
The following will be submitted to the IRB with appropriate 
documentation further submitted to the FDA as addenda to the 
protocol prior to initiation of the study: 
a. A completed and signed Form FDA 1572, "Statement of 
Investigator." 
b. A copy of the approval letter from the IRB for the protocol 
and consent form (or a copy of minutes of the meeting 
pertaining to this decision) in compliance with FDA 
regulations. 
c. A copy of the IRB approved Consent form used to elicit 
and record patient consent in compliance with FDA 
regulations. 
d. Curricula vitae for the investigator(s) and all sub- 
investigators. 
e. A signed and dated protocol. 
f. A description of clinical laboratory facilities that will be 
used including name, address, certification, license, and 
ranges of values considered normal by the laboratory for 
those determinations which it performs for the study. 
13.4 Data Collection 
Data will be collected for patients on case report forms provided 
by the sponsor. Accurate completion of the case report forms for 
all patients enrolled in the study is the responsibility of the 
Recombinant DNA Research, Volume 20 
[261] 
