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DAIDS Adverse Event Grading Tables Current: |
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- Table for Grading the Severity of Adult and Pediatric Adverse Events
Version 1.0 - December 2004 (Clarification dated August 2009) |
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- Memo Regarding the Clarification to the Table for Grading Severity of Adult and Pediatric Adverse Events
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- Addendum 1-Female Genital Grading Table for Use in Microbicide Studies
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- Addendum 2-Male Genital Grading Table for Use in Microbicide Studies
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- Addendum 3-Rectal Grading Table for Use in Microbicide Studies
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Previous: |
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- Table for Grading Severity of Adult Adverse Experiences
August 1992 |
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- Table for Grading Severity of Pediatric Adverse Experiences
less than 3 months of age April 1994 |
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- Table for Grading Severity of Pediatric Adverse Experiences
greater than 3 months of age April 1994 |
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Expedited Reporting Manual |
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Pending Implementation: |
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- Manual for Expedited Reporting of Adverse Events to DAIDS
Final 2.0, January 2010 |
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- Memo regarding the release of the EAE Manual 2.0
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- DAIDS Letter of Amendment Template for updates due to the EAE Manual, Version 2.0, dated January 2010 (Effective May 13, 2010)
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- DAIDS Required Protocol Template
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Current: |
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- Manual for Expedited Reporting of Adverse Events to DAIDS
Final 1.0, 6 May 2004 |
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Previous: |
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- SAE Reporting Manual - ACTG, AIEDRP, CPCRA, IMPAACT, and IRP
1 Aug 1998 |
Available upon request
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Expedited Reporting of AEs Electronic Reporting - DAERS: |
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- Frequently Asked Questions (FAQs)
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- DAERS Emergency Information - Frequently Asked Questions
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- Access and Usage of DAERS
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- Instructions for DAERS Site Enrollment
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- DAERS Reference Guide- Site Reporters and Study Physicians- for sites currently using DAERS
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- DAERS Reference Guide - Site Enrollment Users - for sites currently not having access to DAERS
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- Physician Electronic Signature Attestation Form
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- DAERS System for Submission of EAE Information
30 January 2008 |
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Paper Reporting: Pending Implementation: |
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- Division of AIDS Safety Office Expedited Adverse Event (EAE) Form
Version 2.0, 27 April 2010
NOTE: DO NOT USE this new EAE reporting form unless your IRB has approved a protocol amendment or LOA to use DAIDS Expedited Reporting Manual Version 2.0. |
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- Completion Instructions for the DAIDS EAE Form
Version 2.0, 27 April 2010 |
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Current: |
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- Division of AIDS Safety Office Expedited Adverse Event (EAE) Form Version 1.1, 25 Oct 2004
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- Completion Instructions for the DAIDS EAE Form
Version 1.0, 25 Oct 2004 |
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Previous: |
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- SAE Form - ACTG, AIEDRP, CPCRA, IMPAACT, and IRP
6 July 2004 |
Available upon request
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Safety Training |
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- Safety Workshop Part I – Safety (August 2010)
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- Safety Workshop Part II – Expedited Reporting (August 2010)
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- Pregnancy Case Study (August 2010)
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- Missing Info. Case Study (August 2010)
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- Symptom Clusters Case Study (August 2010)
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- Casuality Case Study (August 2010)
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- HVTN Training - Expedited Reporting
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- Training Resource Information Memo
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