Home / Public Review / HIV Therapeutic Area User Guide v1.0

HIV Therapeutic Area User Guide v1.0

Comments due: 
31 Jul 2018

HIV, the virus that causes AIDS, is one of the world’s most serious health and development challenges. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), there were approximately 36.7 million people worldwide living with HIV/AIDS at the end of 2016. Of these, 2.1 million were children (<15 years old).

CDISC and our community of stakeholders have developed version 1.0 of the HIV Therapeutic Area User Guide (TAUG-HIV), which specifies how to structure the data as an extension of the CDISC Foundational Standards and includes disease-specific metadata, examples and guidance on implementing CDISC standards for a variety of uses, including global regulatory submissions.  TAUG-HIV v1.0 was developed under the CDISC Standards Development Process and describes the most common biomedical concepts relevant to studies for the treatment and prevention of HIV and the necessary metadata to represent such concepts consistently with the CDISC standards CDASHSDTM and ADaM.

We invite you to provide comments on TAUG-HIV v1.0 during the open Public Review period. Public review is a key quality step in our Standards Development Process. We rely on your input to ensure neutral, consensus-based standards are developed and adopted by a diverse global community interested in improving clinical research. Topics included in this TAUG include:

  • Diagnosis of HIV
  • Risk Factors and Mode of Transmission
  • Menstrual History and Pelvic Examinations
  • Mother-Infant Pairs in HIV Studies
  • HIV Treatment with Oral Antiretroviral Therapy (ART)
  • Pre-Exposure Prophylaxis (PrEP)
  • CD4 Counts, Viral Detection, and Viral Load
  • Drug Susceptibility including phenotypic drug sensitivity and genetic resistance calculators
  • Several Analysis concepts including the FDA snapshot analysis and pregnancy outcome analysis

View the user guide: TAUG-HIV v1

You will need to log in or register for the CDISC Wiki to review the Read Me and provide comments.  

CDISC Wiki is a different login from www.cdisc.org.

CDISC will host a public webinar providing guidance on how to review TAUG-HIV v1.0 on 12 JUN 2018. Register here