ADaM Conformance Rules v2.0   NOW AVAILABLE

ADaM Conformance Rules v2.0 is composed of 350+ rules, which can implemented with software to test rules defined in the ADaM Implementation Guide v1.0, ADaM Implementation Guide v1.1, and the ADaM Structure for Occurrence Data v1.0.

Version 1.1 of the Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-MD v1.1) defines data standards for medical device-related data in clinical research. SDTMIG-MD v1.1 covers devices under investigation as well as ancillary devices in non-device trials, and is appropriate for regulatory submission and non-submission studies. The standards include core data that are shared by most devices, providing guidance and examples on organizing, structuring and formatting device datasets.  

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 36.9 million people worldwide living with HIV/AIDS at the end of 2017. Of these, 1.8 million were children (<15 years old).

Version 1.0 of the HIV Therapeutic Area User Guide (TAUG-HIV) was developed under the CDISC Standards Development Process and covers the areas of prevention, vaccines and cure. TAUG-HIV describes the most common biomedical concepts relevant to HIV, and the necessary metadata to represent data consistently with CDASH, SDTM, and ADaM.

CDISC Therapeutic Area Standards extend the Foundational Standards to represent data that pertain to specific indications within disease areas.

CDASH Model v1.0 Japanese Translation

Comments due: 9 March 2019

The Japanese Translation Team in coordination with the Japan CDISC Coordinating Committee is pleased to announce CDASH Model v1.0 has been translated into Japanese; this translation is available for Public Review.

Blue Ribbon Commission Insights

Comments due: 4 April 2019

The Blue Ribbon Commission has been created to shape and guide CDISC’s future. Composed of global leaders from academia, the pharmaceutical industry, government agencies (including regulatory bodies), patient foundations and fellow standards development organizations, the Blue Ribbon Commission has agreed on the following insights to advise the CDISC Board and leadership in serving clinical data standards needs now and in the coming decade.

CDISC is inviting our stakeholders to comment on these insights during a 60-day Public Review period. Make your voice heard; your feedback is essential in shaping CDISC Standards to impact the future of clinical research.

SENDIG-Animal Rule v1.0

Comments due: 29 April 2019

The SENDIG-Animal Rule v1.0 is based on the SDTM v1.8 and is intended to be used in conjunction with the SENDIG v3.1 for data being submitted to the US Food & Drug Administration (FDA) under the Animal Rule. The regulations, commonly known as the Animal Rule (AR), provide a regulatory mechanism for the approval of drugs and licensure of biological products when human efficacy studies are not ethical or feasible.

Under the AR, efficacy is established based on adequate and well-controlled studies in animal models of the human disease or condition of interest, and safety is evaluated under the pre-existing requirements for drugs and biological products. Like other implementation guides based on the SDTM, the SENDIG-AR is intended to guide the organization, structure, and format of standard tabulation datasets.

Study Data Tabulation Model (SDTM) v1.8

Comments due: 29 April 2019

SDTM v1.8 serves as the model for the SENDIG-Animal Rule v1.0 and is intended to be used in conjunction with the SENDIG v3.1 for data being submitted to the US Food & Drug Administration (FDA) under the Animal Rule.

CDISC relies on the subject matter expertise of volunteers to create our data standards. We invite you to join this effort.

The CDISC Protocol Entities Team is looking for additional volunteers to join a fun and dynamic team focused on harmonizing terms and definitions used within the context of the clinical study protocol. We are looking for individuals with experience in protocol writing and development, familiarity with interventional and/or observational study protocols (including epidemiological protocols), and an appreciation of, and sensitivity to, semantic distinctions.