Resources

Definitions of the types of safety information distributed by DAIDS and methods of distribution.

Training workshop in Durban, SA supporting documents: Case Review: All About AEs - Safety Training Expedited Reporting and Assessment - Safety Training Expedited Reporting via DAERS - Safety Training Expedited reporting via DAERS - Case Study

Training workshop in Johannesburg, SA supporting documents: Case Review: All About AEs - Safety Training Expedited Reporting and Assessment - Safety Training Expedited Reporting via DAERS - Safety Training Expedited reporting via DAERS - Case Study

DAIDS sample Informed consent template, stored samples and associated health information for future research use.

Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.  

The following serious side effects have been associated with the use of darunavir given together with ritonavir (RTV). Contact your healthcare provider if you have any of the symptoms of liver problems that are listed and any skin changes with the symptoms listed below.

Instructions for using the Table for Grading the Severity of Severity of Adult and Pediatric Adverse Events version 2.0. Changes are highlighted visually within the document.

Instructions for using the Table for Grading the Severity of Adult and Pediatric Adverse Events. Changes highlighted, Corrected version 2.1, July 2017

Instructions for using the Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected version 2.1, July 2017

This clarification of the DAIDS Table for Grading the Severity of Adult and Pediatric AE’s provides additional explanation of the DAIDS AE Grading Table and clarifies some of the parameters.

Instructions for using the Table for Grading the Severity of Severity of Adult and Pediatric Adverse Events version 2.0. This version does not visually show changes with highlighting.

Expedited reporting form for Adverse Events fillable using Microsoft Word.

TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg.

DAIDS Core Risk List (side effects/risks of study drug) for Dolutegravir (DTG) version 2.0, September 2018 The DAIDS Core Risk Lists provides the DAIDS Medical Officer with a list of recommended risks (side effects) that will be used in the DAIDS Sample Informed Consent (SIC) Form. The list draws…