I. INTRODUCTION............................................................................................................. 1

II. BACKGROUND............................................................................................................... 2

III. SCOPE ............................................................................................................................... 3

IV. RECOMMENDATIONS.................................................................................................. 3

A. Study Protocols ..............................................................................................................................3

B. Standard Operating Procedures...................................................................................................3

C. Source Documentation and Retention..........................................................................................4

D. Internal Security Safeguards ........................................................................................................4

1. Limited Access ................................................................................................................................4

2. Audit Trails .....................................................................................................................................4

3. Date/Time Stamps ............................................................................................................................5

E. External Security Safeguards .......................................................................................................5

F. Other System Features ..................................................................................................................6

1. Direct Entry of Data ........................................................................................................................6

2. Retrieving Data...............................................................................................................................6

3. Dependability System Documentation ............................................................................................. 6

4. System Controls ...............................................................................................................................6

5. Change Controls ..............................................................................................................................7

G. Training of Personnel ....................................................................................................................7

DEFINITIONS............................................................................................................................. 8

REFERENCES............................................................................................................................. 9

APPENDIX A.............................................................................................................................. 10