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Worksheet designed to assign risk levels to protocols for prioritizing clinical site monitoring resources.

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

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DAIDS expedited adverse event (EAE) reporting template.

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DAIDS final protocol template language for protocol registration (April 2010).

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Division of AIDS review of imformed consent forms, impact of the HIPAA privacy rule.

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DAIDS protocol registration timelines.

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

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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

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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

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

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

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DAIDS Therapeutic Research Program protocol eligibility criteria for pregnancy prevention.

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PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult and pediatric patients 3 years of age and older. PREZISTA must be co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents. (1)

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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.

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The following side effects have been associated with the use of didanosine:

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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.

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

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

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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.

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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.

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