Microsoft Word search phase 3 Title Page Amendment

8.
 
HUMAN SUBJECTS ............................................................................................................ 1
 
8.1. 
GOALS ........................................................................................................................... 1 
8.2. 
OVERVIEW:
  
BACKGROUND
 
INFORMATION ....................................................... 1 
8.3. 
PROTOCOL
 
DEVELOPMENT
 
AND
 
MAINTENANCE ............................................. 2 
8.4. 
CENTER
 
SPECIFIC
 
GUIDELINES .............................................................................. 2 
8.5. 
RECRUITMENT
 
AND
 
METHODS
 
TO
 
ENTER
 
STUDY .............................................  2 
8.6. 
HIPAA
 
PRIVACY
 
ACT ................................................................................................. 3 
8.7. 
RESEARCH
 
MATERIALS ............................................................................................ 3 
8.7.1.
  Case Registration ........................................................................................................ 3 
8.7.2.
  Collection of Core Variables ...................................................................................... 3 
8.7.3.
  Medical Record Abstraction (MRA) ........................................................................... 4 
8.7.4.
  Initial Participant Survey (IPS) .................................................................................. 4 
8.7.5.
  In-Person Research Visit (IPV) .................................................................................. 4 
8.8. 
STUDY
 
DATA ............................................................................................................... 5 
8.9. 
CONSENT
 
FORMS ........................................................................................................  5 
8.10.  ASSENT ......................................................................................................................... 6 
8.11.  PARTICIPANT
 
REMUNERATIONS ........................................................................... 6 
8.12.  PARTICIPANT
 
SAFETY ...............................................................................................  6 
8.13.  RESULTS ....................................................................................................................... 6 
8.14.  PARTICIPANT
 
RISKS
 
AND
 
BENEFITS ..................................................................... 7 
8.14.1.
 
Protection Against Risk ........................................................................................... 8
 
8.14.2.
 
Potential Benefits of the Proposed Research to the Participants and Others ...... 11
 
8.14.3.
 
Importance of the Knowledge to be Gained ......................................................... 11
 
8.14.4.
 
Data and Safety Monitoring Plan ......................................................................... 12
 
8.15.  REPOSITORY ..............................................................................................................  12 
8.15.1.
 
Sample Types ........................................................................................................ 12
 

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Section 8A - Human Subjects (Phase 3 - 12/2010) 
Section 8A - Page ii 
 Registry 
Study
 
 
8.15.2.
 
Consent for Sample Storage.................................................................................. 13
 
8.15.3.
 
Sample Maintenance ............................................................................................. 13
 
8.15.3.1.  Duration of Storage ........................................................................................... 13 
8.15.3.2.  Sample Destruction ........................................................................................... 13 
8.15.3.3.  Use of Repository Samples ............................................................................... 13 
8.16.  ANCILLARY
 
STUDIES .............................................................................................. 13 
8.17.  FUTURE
 
STUDIES ......................................................................................................  14
 
 

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Section 8A - Human Subjects (Phase 3 - 12/2010) 
Section 8A - Page 1 
 Registry 
Study