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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
10.1.4. Dissemination of Clinical Study Data ....................................................118
10.1.5. Data Quality Assurance ..........................................................................119
10.1.6. Source Documents ..................................................................................120
10.1.7. Study and Site Start and Closure ............................................................121
10.1.8. Sponsor’s Qualified Medical Personnel .................................................121
10.2. Appendix 2: Clinical Laboratory Tests ...............................................................123
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording,
Evaluating, Follow-up, and Reporting ....................................................................125
10.3.1. Definition of AE .....................................................................................125
10.3.2. Definition of SAE ...................................................................................126
10.3.3. Recording/Reporting and Follow-up of AEs and/or SAEs.....................128
10.3.4. Reporting of SAEs ..................................................................................131
10.4. Appendix 4: Contraceptive Guidance .................................................................132
10.4.1. Male Participant Reproductive Inclusion Criteria ..................................132
10.4.2. Female Participant Reproductive Inclusion Criteria ...............................132
10.4.3. Woman of Childbearing Potential ..........................................................133
10.4.4. Contraception Methods ...........................................................................134
10.5. Appendix 5: Liver Safety: Suggested Actions and Follow-up Assessments ......136
10.6. Appendix 6: Abbreviations .................................................................................138
10.7. Appendix 7: Stopping and Alert Rules for Enhanced COVID-19 ......................142
10.8. Appendix 8: Criteria for Allowing Inclusion of Participants With Chronic
Stable HIV, HCV, or HBV Infection ......................................................................145
11. REFERENCES ................................................................................................................146
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