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What does the DAIDS/RSC Safety and Pharmacovigilance team do?

The RSC Safety team receives adverse events reported by sites participating in DAIDS-supported studies, processes the events for review by the DAIDS Medical Officer, and prepares the reports for submission to the Food and Drug Administration (FDA), if required. They work closely with the OPCRO Safety and Pharmacovigilance Team (SPT) to establish internal procedures and develop Safety and EAE training for the clinical research sites.


Bullet DAIDS Adverse Event Grading Tables
 
Current:
 


  • Table for Grading the Severity of Adult and Pediatric Adverse Events
    Version 1.0 - December 2004 (Clarification dated August 2009)
Adobe PDF DocumentMicrosoft Word Document



    • Memo Regarding the Clarification to the Table for Grading Severity of Adult and Pediatric Adverse Events
Adobe PDF Document



  • Addendum 1-Female Genital Grading Table for Use in Microbicide Studies
Adobe PDF Document



  • Addendum 2-Male Genital Grading Table for Use in Microbicide Studies
Adobe PDF Document



  • Addendum 3-Rectal Grading Table for Use in Microbicide Studies
Adobe PDF Document


  Previous:
 


  • Table for Grading Severity of Adult Adverse Experiences
    August 1992
Adobe PDF Document



  • Table for Grading Severity of Pediatric Adverse Experiences
    less than 3 months of age
    April 1994
Adobe PDF Document



  • Table for Grading Severity of Pediatric Adverse Experiences
    greater than 3 months of age
    April 1994
Adobe PDF Document

Bullet Expedited Reporting Manual
 

  Pending Implementation:
 


  • Manual for Expedited Reporting of Adverse Events to DAIDS
    Final 2.0, January 2010
Adobe PDF Document
 



    • Memo regarding the release of the EAE Manual 2.0
Adobe PDF Document



    • DAIDS Letter of Amendment Template for updates due to the EAE Manual, Version 2.0, dated January 2010 (Effective May 13, 2010)
Microsoft Word Document



  • DAIDS Required Protocol Template 
Microsoft Word Document


  Current:
 


  • Manual for Expedited Reporting of Adverse Events to DAIDS
    Final 1.0, 6 May 2004
Adobe PDF Document


  Previous:
 


  • SAE Reporting Manual - ACTG, AIEDRP, CPCRA, IMPAACT, and IRP
    1 Aug 1998
Available
upon
request


Bullet Expedited Reporting of AEs
 
Electronic Reporting - DAERS:
 




  • Frequently Asked Questions (FAQs)
Web Site Link



  • Administrative
 



Web Site Link



E-mail Address Link



E-mail Address Link



    • DAERS Emergency Information - Frequently Asked Questions
Web Site Link



    • Access and Usage of DAERS




      • Instructions for DAERS Site Enrollment 
Adobe PDF Document



      • DAERS Reference Guide- Site Reporters and Study Physicians- for sites currently using DAERS 
Adobe PDF Document


 
      • DAERS Reference Guide - Site Enrollment Users - for sites currently not having access to DAERS
Adobe PDF Document



      • Physician Electronic Signature Attestation Form
Adobe PDF Document



    • DAERS System for Submission of EAE Information
      30 January 2008
Adobe PDF Document


  Paper Reporting:
 
Pending Implementation:
 


  • 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.

Microsoft Word Form



    • Completion Instructions for the DAIDS EAE Form
      Version 2.0, 27 April 2010
Microsoft Excel Document



Current:
 

  • Division of AIDS Safety Office Expedited Adverse Event (EAE) Form Version 1.1, 25 Oct 2004
Microsoft Word Form



    • Completion Instructions for the DAIDS EAE Form
      Version 1.0, 25 Oct 2004
Adobe PDF Document



Previous:
 

  • SAE Form - ACTG, AIEDRP, CPCRA, IMPAACT, and IRP
    6 July 2004
Available
upon
request


Bullet Safety Training
 

 
  • Safety Workshop




    • Safety Workshop Part I – Safety (August 2010)
Microsoft PowerPoint 
Document



    • Safety Workshop Part II – Expedited Reporting (August 2010)
Microsoft PowerPoint 
Document



    • Case Studies



      • Pregnancy Case Study (August 2010)
ZIP Archive



      • Missing Info. Case Study (August 2010)
ZIP Archive



      • Symptom Clusters Case Study (August 2010)
ZIP Archive



      • Casuality Case Study (August 2010)
ZIP Archive


 
  • Network Training
 



    • ACTG Network (June 2010)
Zip Archive



    • HPTN Network (June 2010)
ZIP Archive



    • HVTN Training - Expedited Reporting
Microsoft PowerPoint 
Document


 
  • DAERS Training Slides
Microsoft PowerPoint 
Document



  • Administrative
 



    • Training Resource Information Memo
Microsoft PowerPoint Document

 

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