may be subjected to tissue disruption in an attempt to obtain and expand 
T-cells present in the tissue. 
18.0 Records and Data Collection Procedures 
18.1 Mayo Oncology records 
18.1.1 The Oncology Records will be utilized for patients. Data will be 
entered into the computer within 3 weeks after each evaluation of 
the patient. After the patient goes off treatment, follow-up 
information will be collected and entered into the computer every 3 
months. 
18.1.2 Pathology diagnosis made by frozen section is reported in a 
conventional way with a record being placed in the patient's 
permanent medical record. 
18.1.3 Data from the Cellular Immunology Laboratory may be entered 
into their computer using the patient's clinic number as a key. 
Summary reports of samples received will be sent to the principal 
investigator monthly. 
18.2 Vical records 
Case report forms, regulatory documents and study source documents 
will collected and reviewed in conformance with FDA Good Clinical 
Practices. 
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