9.3 Required Documentation : Documentation will be by 
molecular biologic techniques done in the Hematology 
Branch, NHLBI, as well as blood counts and bone marrow 
pathology reports from the NIH Clinical Center. 
10.0 DOCUMENTATION. RECORD KEEPING. CRFs 
The investigator must maintain adequate records so that 
the conduct of the study can be fully documented and 
monitored. 
Copies of protocols, case report forms (CRFs) , test 
result originals, all product accountability records, 
correspondence, patient informed consent, and any other 
documents relevant to the conduct of the study must be kept 
on file by the investigator for (five) years after all 
investigational use of product is discontinued and the FDA 
is so notified or until five years after a Product Licensing 
Application (PLA/ELA) is approved. Study documents should 
not be destroyed without prior written agreement between GTI 
and the study investigator. The Study Monitor should be 
notified if the investigator wishes to assign the study 
records to another party, or move them to another location. 
The investigator will supply GTI on request with any 
required background data from all patient records and 
related documents. This may become necessary if the CRFs 
are illegible or when errors in data transcription are 
questionable. For FDA inspections, it is also necessary to 
have access to complete study patient records, provided that 
patient confidentially is maintained. 
The investigator should obtain a separate release of 
medical information form to be signed by the study patient 
in order to facilitate access to the patient's medical 
records should the patient be hospitalized at an institution 
with which the study investigator is not associated. 
A record must be kept of all patients considered (and 
screened) for the study and subsequently deemed ineligible. 
The reason for ineligibility must be recorded. 
11.0 DATA COLLECTION AND STUDY MONITORING 
11.1 Data Collection 
Case Report Forms (CRFs) will be utilized for each 
patient entered into the study. Study participants 
will NOT be identified by name on any study documents. 
Patients will be identified by a patient identification 
number (PIN) . Investigators will need to keep a 
patient code list accessible. 
11.2 Study Monitoring 
It is understood that the GTI -designated person 
responsible for study monitoring of patient data will 
be permitted to contact and visit the investigator at 
regular intervals and will be allowed, on request, to 
review original documents such as consent forms, drug 
accountability records, case report forms, and 
pertinent hospital or clinic records for confirmation 
of study data provided that patient confidentiality is 
maintained in accord with local (IRB) requirements. It 
will be the monitor's responsibility to verify the 
adherence to the protocol and the completeness and 
accuracy of the data being entered on the CRFs. If 
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