| Project | Descriptions | Projected Completion |
|---|---|---|
| Protocol | ||
| Used for planning and designing a research protocol with focus on study characteristics such as study design, eligibility criteria and requirements from the ClinicalTrials.gov, World Health Organization (WHO) registries), and EudraCT registries. | ||
| Protocol Concepts |
| 2017 |
| Clinical Data Acquisition Standards Harmonization (CDASH) | ||
| Used for data acquisition and allows for efficient recording, exchange, analysis, submission, and archiving of clinical research and metadata. | ||
| CDASH Model and IG v2 | CDASH Model v1 corresponds with SDTM v 1.4 IG V 2.0 to add new domains to correspond to newer SDTMIG v3.2 domains. Preparing for publication 2017-09-20 | 2017 |
| CDASHIG v2.1 | Update CDASHIG to include new domains in SDTMIG 3.3. | 2018 |
| E2C (EHR to CDASH) | ||
| E2C | Complete mappings from Continuity of Care Document (CCD) to CDASH | 2017 |
| E2C | Initiate mappings from Fast Healthcare Interoperability Resources (FHIR) to CDASH | 2017 |
| E2C | White paper/demonstration project | 2018 |
| Study Data Tabulation Model (SDTM) | ||
Both FDA and PMDA require that data be submitted in SDTM-based formats for studies initiated after certain dates. Detailed requirements are available on their websites. SDTM also supports data aggregation, warehousing and other important data review activities. Implementation guides for the SDTM model support human clinical trials (SDTMIG) including data about associated persons (SDTMIG-AP), non-clinical studies (SENDIG), medical devices (SDTMIG-MD), and pharmacogenomics/genetics data (SDTMIG-PGx). | ||
| SDTMIG v3.3 | ongoing | 2017 |
| SDTMIG v3.2 Conformance Rules | Rules to assess conformance with SDTMIG v3.2. Completed and published | 2017 |
| Medical Devices | ||
Defines SDTM domains related to medical device data; provides guidance on implementing SDTM, SDTMIG and the medical device domains for studies where data about medical devices is captured. | ||
| MD-IG v2 | Adds new variables (related mostly to safety); provides CDASH data to complement existing MD-IG SDTM examples; includes a complete cardiovascular implant case with consistent data across multiple device and non-device domains; includes solution for relating one AE to multiple devices. Ongoing | 2017 |
| Analysis Data Model (ADaM) | ||
| Defines dataset and metadata standards that support efficient generation, replication, and review of clinical trial statistical analyses, and traceability between analysis results, analysis data, and data represented in the Study Data Tabulation Model (SDTM). | ||
| ADaMIG v1.2 | Adds new variables to ADaMIG v1.1 | 2017 |
| ADaMIG v? | Aligns ADaM Model v2.1 with ADaMIG v1.2 and Define v2.0 and incorporate ADaM appendices into a portfolio. Maybe a v3.0. | 2018 |
| ADaM IDS v1 | IDS v1 ADaM Data Structure for Integration: IADSL | 2017 |
| ADaM IDS v2 | IDS v2 ADaM Data Structure for Integration: OCCDS/BDS | 2018 |
| ADaM ADDL structure for Devices | ADDL structure for medical devices | 2018 |
| Compliance | ||
| XML Technology | ||
| Define-XML transmits metadata for SDTM, SEND and ADaM datasets; it is the metadata file sent with every study in each submission, which tells the FDA what datasets, variables, controlled terms, and other specified metadata were used. | ||
| Define-XML v2.1 | Update of Define-XML schema and specification. Public Review completed, now reviewing Public Review comments | Q4 2017 |
| Mobile Extension | Done. Presentation ODM extension that provides support for multiple devices, including smart phones. Extension library. https://www.cdisc.org/standards/foundational/odm/odm-xml-extension-library | Q1 2017 |
| ODMv2 | Major update of ODM to include an API, integrated SDM-XML + additional protocol elements, more formal semantic annotations, improved CRF representation, tabular operational datasets, multiple exchange formats, HL7 FHIR alignment, and other anticipated enhancements. Interim draft releases for testing will be made available prior to the final release in 2019. | 2019 |
| Controlled Terminology | ||
| Set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets. The CDISC Terminology Team, in collaboration with the National Cancer Institute's Enterprise Vocabulary Services (EVS), supports the controlled terminology needs of all CDISC Foundational Standards (SDTM (Drugs and Devices), CDASH, ADaM, SEND) and all CFAST disease/therapeutic area standards. | ||
| Package 29-32 | CV, Devices, ECG, General, Lab, Oncology, PGx, PK, Protocol Entities, SEND, Spectype/Speccond, Unit, Virology, QRS, flow cytometry | 2017 |
| Terminology Modernization |
| 2017 |
| Subsets | Create subsets that are clear and well defined in SHARE. Priorities to be determined.
| 2017 |
| Questionnaires, Ratings and Scales (QRS) | ||
| Define and support the Questionnaires, Ratings and Scales (QRS) needs of CDISC standards based on the SDTMIG. | ||
| QRS Supplements | New Supplements development based on user request and needs. | 2017 |
| QRS Process Update | Updating the QRS development process to align with the Foundational Standards development process to include both internal and public reviews of each supplement. | 2017 |
| SEND | ||
| SENDIG - DART v1.0 | Supports Developmental and Reproductive Toxicology (DART) Embryo and Fetal Development (EFD) study types | 2017 |
| SENDIG v3.0 Conformance Rules | Draft of first batch of data conformance rules for SENDIG v3.0 | 2017 |
| SEND Safety Pharmacology | Draft safety pharmacology (CNS) for public review | 2018 |
| SEND Genetic Toxicology | Draft Genetic toxicology for public review | 2018 |
| SEND Dermal / Ocular Toxicology | Draft dermal/ocular for public review | 2018 |
| Therapeutic Area User Guides (Extensions to the Standards project above) | ||
| Describe the most common biomedical concepts relevant to the indication, and the necessary metadata to represent such data consistent with CDISC standards. | ||
| Prostate Cancer v1 | Q1 2017 | |
| Colorectal Cancer v1 | Q2 2017 | |
| Vaccines v1 | Q2 2017 | |
| Duchenne Muscular Dystrophy v1 | Q3 2017 | |
| Nutritional Standards v1 | Q3 2017 | |
| Coronary Artery Disease v1 - TCM | Q3 2017 | |
| PTSD v1 | Q4 2017 | |
| Huntington's Disease v1 | Q4 2017 | |
| HIV v1 | 2018 | |
| Lung Cancer v1 | 2018 | |
| CDAD v1 | 2018 | |
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