11. EVALUATION OF SAFETY AND EFFICACY 21 
11.1 Baseline Evaluation 21 
11.2 Evaluation of TIL cells prior to Week-1 22 
11.3 TIL Infusion Evaluation 22 
11.4 Treatment Day Evaluation 23 
11.5 Follow-up Evaluation During Treatment 23 
11.6 Post Treatment Follow-up 23 
12. TUMOR ASSESSMENT 24-25 
13. CRITERIA FOR CLINICAL RESPONSE 25 
14. TIL PROCESS EVALUATION 25-26 
15. RETROVIRAL TRANSDUCTION AND STUDIES 26 
15.1 LNL6 (neoR) vector 26 
15.2 GIN (neoR) vector 26 
15.3 Testing of retroviral supernatants 27 
15.4 Transduction of CD8( + ) and CD4(-f-) TIL and PBL 27 
15.5 Tests on transduced TIL population 27-28 
15.6 Clinical studies 28-29 
16. STATISTICAL CONSIDERATIONS 29-30 
17. ETHICAL AND REGULATORY CONSIDERATIONS 30 
17.1 Informed Consent 30 
17.2 Adverse Experiences 30-31 
17.3 Case Report Forms 31-32 
17.4 Initiation of Study 32 
17.5 Maintenance of Study Documentation 32-33 
17.6 Patient Privacy 33-34 
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Recombinant DNA Research, Volume 15 
