5.10 Post-Study Patient Follow-up 
The detailed data for the study will accrue during the baseline period, the 
vehicle control period and the AdCFTR experimental treatment period through 
day 60. Following discharge (see section 5.6.4 for criteria), there will be 
follow-up monthly for months 5-12, every 6 months for months 18 and 24, and 
thereafter on a yearly basis. 
5.11 Clinical Facilities for the Study 
The study will be conducted on the Pulmonary Branch, NHLBI 7 West in-patient 
care unit in the NIH Clinical Center. The patient rooms to be used will be 
devoted entirely to this study and will be converted to negative pressure to 
the corridor and filtered as approved by the Biosafety Office, NIH. The 7 West 
in-patient care unit is appropriately equipped to handle all relevant inter- 
current illnesses and adverse reactions and the Pulmonary Branch physicians 
are fully qualified to handle these patients and relevant possible 
complications. Following discharge, follow-up evaluations of the patients will 
be in regular patient rooms on the NHLBI 7 West in-patient care unit or in the 
NHLBI Outpatient Clinic, ACRF. 
5.12 Privacy and Confidentiality 
The privacy of the patients and all confidentiality issues will be handled in 
accordance with the NIH Clinical Center guidelines 
5.13 Informed Consent 
The informed consent document that follows is in the format required by the 
NIH and is found at the end of section, after 5.15. 
5.14 Reporting of Serious Adverse Effects 
As detailed in section 5.6.6, reports of adverse reactions will be made to the 
ICRS, NHLBI, IBC, NIH, RAC, and the FDA within 24 hours of its recognition in 
accordance with the guidelines of each of these groups. 
5.15 Future Directions 
Based on this initial safety and efficacy data, future studies will be 
designed regarding dose, frequency of administration and safety and efficacy 
parameters. Appropriate statistical and data base considerations will be 
determined in consultation with the Biostatistics Research Branch, NHLBI. 
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