Pre-IDE Submission: Clinical Protocol 
Neuroblastoma Bone Marrow Purging System 
BAXTER HEALTHCARE CORPORATION, HYLAND DIVISION 
6.3.6 MAINTENANCE OF CLINICAL SUPPLY 
The information regarding the maintenance of the clinical supply (the receiving and 
dispensing record for the new investigational product), which is the responsibility of the 
individual investigator or hospital pharmacist, is not available at this time. This 
information will be included in the DDE document. 
6.3.7 TERMINATION FROM THE STUDY 
Once the patient is terminated from the study, the termination report will be completed, 
listing in detail the reasons for termination. One of the following conditions should be 
met: 
1. Withdrawal by the physician for clinical reasons not related to treatment. 
(However, the Clinical Monitor should be notified before any patient is 
withdrawn). 
2. Death. 
3. Adverse reactions to the test material necessitating discontinuance of treatment 
(See Section 6.3.8). 
4. The patient elects to withdraw from the study. 
5. The patient is transferred to another institution. 
6. The patient completes the protocol. 
Regardless of the reason for termination, all data currently available for the patient at the 
time of termination should be logged on the case report forms and forwarded to Baxter 
Healthcare Corporation, Biotech Group, Immunotherapy Division, Santa Ana, California. 
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