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BB639E7904HTSA1 开发手册 - Infineon（英飞凌）
制造商:
Infineon（英飞凌）
分类:
变容二极管
封装:
SOD-323-2
描述:
Infineon BB639E7904HTSA1 30V 36pF 变容管, 最小调谐比: 13.5 VHF, 2引脚 SOD-323封装, 使用于调谐器
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BB639E7904HTSA1数据手册
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BB-IND 11184 Diphtheria Antitoxin (DAT) Protocol CDC IRB #4167 Version 7.0
Page 2 September 21, 2016
TABLE OF CONTENTS
Page
1.0 OBJECTIVE ......................................................................................................................................... 3
2.0 BACKGROUND .................................................................................................................................. 3
3.0 PRODUCT INFORMATION ............................................................................................................... 4
4.0 CLINICAL DESIGN .......................................................................... Error! Bookmark not defined.
5.0 ELIGIBILITY ....................................................................................................................................... 5
5.1 Therapeutic use ........................................................................................................................... 5
5.2 Prophylactic use .......................................................................................................................... 6
6.0 DAT TREATMENT PROCEDURES .................................................................................................. 6
6.1 Informed Consent/Parental Permission ....................................................................................... 6
6.2 Precautionary measures ............................................................................................................... 7
6.3 Tests for Sensitivity to DAT ....................................................................................................... 8
6.4 Desensitization ............................................................................................................................ 8
6.5 DAT Administration ................................................................................................................... 9
6.6 Possible adverse reactions following administration of DAT ................................................... 10
7.0 REQUIRED PATIENT MONITORING AND REPORTING OF ADVERSE EVENTS ................. 11
7.1 Patient Monitoring .................................................................................................................... 11
7.2 Definitions of Adverse Events (21 CFR 312.32) ...................................................................... 11
7.3 Recording and Reporting Adverse Events ................................................................................ 12
8.0 LABORATORY TESTING ............................................................................................................... 13
9.0 OPTIONAL BLOOD DRAWS .......................................................................................................... 13
10.0 LOCAL AND STATE HEALTH DEPARTMENT NOTIFICATION .............................................. 14
11.0 DATA COLLECTION AND STORAGE .......................................................................................... 14
12.0 REFERENCES ................................................................................................................................... 17
Appendix 1: Informed Consent/Parental Permission Form for Use of DAT for Suspected Diphtheria
Cases
Appendix 2: Diphtheria Antitoxin Treatment and Adverse Effects Form
Appendix 3: CDC Diphtheria Worksheet
Appendix 4: Information for Close Contacts
Appendix 5: Optional Additional Blood Draws: Instructions for Processing Serum Samples for
MassBiologics
Appendix 5A: Informed Consent/Parental Permission Form for Additional Blood Draws
With the Use of DAT for Suspected Diphtheria Cases
Appendix 5B: Assent for Additional Blood Draws with the use of DAT for Suspected
Diphtheria cases aged 12-17 years old
Appendix 5C: Assent for Additional Blood Draws with the use of DAT for Suspected
Diphtheria cases aged 7-11 years old
Appendix 6: Form FDA 1572 (Statement of the Investigator)
Appendix 7: A copy of CDC IRB’s Approval Letter
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