The purpose of this visual is to share current timelines and the proposed, high-level scope for CDISC Foundational Standards in development. The timelines and scope below are updated at the start of each quarter as standards progress through the CDISC Standards Development Process described in COP-001. Please note that published standards are not presented in this timeline. A fullscreen version is available here.
The proposed scope for each standard is described below with both perceived impacts and benefits. Scope, impacts, and benefits are subject to change based on feedback received during the various review periods and are not final until publication.
| Proposed Scope/Change | Proposed Scope/Change Description | Impacts | Benefits |
|---|---|---|---|
| Genetic Toxicology - In Vivo (GV) | Domain for subject-level genetic toxicology data (e.g., micronucleus data and comet data), includes updates to align with SDTM metadata restructure and included new SDTM variables. | Included from SENDIG-Genetox v1.0 | Allows the SENDIG-Genetox 1.0 to be “sunset” after allowing industry to get a 2-year head start on submitting this data |
| Cell Phenotyping (CP) | Domain to support tests associated with a cell phenotyping component based on the use of markers for use with disseminated tissue specimens (e.g., blood and other body fluids, bone marrow aspirates) and cell suspensions. | New domain to SENDIG | Supports submission of cell phenotyping data, including data collection/extraction tools and controlled terms |
| Immunogenicity Specimen Assessments (IS) | Domain for assessments of antigen induced humoral or cell-mediated immune response in the subject. | New domain to SENDIG | Supports submission of antigen induced humoral or cell-mediated immune response data |
| Ophthalmic Examinations (OE) | Domain for qualitative findings and quantitative measurements related to the eye. | New domain to SENDIG | Moves targeted eye exam data from CL Domain into the OE domain which supports the inclusion of numeric data. Addition of this domain addresses the request for inclusion of eye irritation studies in SEND |
| Nervous System Test Results (NV) | Domain for findings related to the nervous system, including motor activity, behavioral changes, coordination, and sensory/motor reflex. (e.g., functional observational batteries (FOBs), passive/active avoidance, mazes, rotarod performance, gait analyses, auditory startle response, and electroretinography). | New domain to SENDIG | Supports submission of nervous system data. Addition of this domain addresses the request for inclusion of FOB data in SEND |
| Skin Test Results (SK) | Domain for quantitative and qualitative results related to dermal measurements or evaluations. | New domain | Moves targeted skin exam data from CL Domain into the SK domain which supports the inclusion of scored data. Addition of this domain addresses the request for inclusion of skin irritation studies in SEND |
| Pharmacokinetic Input (PI) | Domain for concentrations of therapeutics, therapeutic components, or metabolites used to calculate the pharmacokinetic parameters (input to PP). | New domain | Allows for presentation of concentration data as used to calculate the pharmacokinetic parameters. (e.g., value for BLQ, exclusion from analysis, extrapolated concentration) |
| Scoring Scales (SX) | Reference domain that describes the scoring scales used to collect data. | New domain | Presents the complete scoring scale used for a given test. Eliminates the need to include in nSDRG and define.xml. |
| Non-Standard Variables (NS--) | Replaces SUPP-- datasets with horizontal NS-- datasets that do not have to be transposed before appending to parent dataset. | New domain | NSVs are represented vertically rather than horizontally, requiring less processing to join on the data to the parent. Metadata for NSVs is populated in same way as parent domain. Each NSV can have either Char or Num datatype, previously only Char was allowed and conversion was needed for Num values. |
| --RESMOD | New standard variable for use in MI and MA. There will be Controlled Terminology for MIRESMOD. | New variable for SDTM (elevated from NSV) Will alleviate the need for Supp/NSV records | Will significantly reduce the need to create NS-- domains. |
| MASSID | A sequence of characters used to uniquely identify a mass within a subject identified during a test or examination. | New variable for SDTM Will replace the current usage of --SPID. | Allows mass observations from multiple domains to be cross-referenced using a dedicated identifier and without the need for RELREC. |
| --CALCN | The associated numeric value for the result to be used for the interpretation for calculations. Promoted to a standard variable from a nonstandard variable name in SUPPQUAL. | New variable for SDTM (elevated from NSV) Will alleviate the need for Supp/NSV records | Will significantly reduce the need to create NS-- domains. |
| –LOBXFL | Provides an unambiguous way to communicate which data are the last observed before first treatment. | New to SEND | Changes communication of baseline data; clarifies ambiguity present with current --BLFL variable. |
| --ROEBE, --ROELNM, --ROETYP | Adds the ability to communicate baseline measurements in Latin Square, Modified Parallel (split dose) and Rising Dose study designs. | New Variables for SDTM | Changes communication of baseline data; clarifies ambiguity present with current --BLFL variable and addresses the differences between study designs. |
| --REPNUM | Provides ability to indicate multiple observations for the same test that occur within a single timepoint | New to SEND | Allows additional granularity of a particular test when that isn’t possible with --TPT on its own. |
| --RSCNT | First identified need is for count of the number of arrhythmias observed. | New Variable for SDTM | Allows inclusion of arrhythmia data in the EG domain as the data can be fully qualified |
| RCAT | The category of the test code from the related domain associated with the scoring scale. This is the category (--CAT) of --TEST in the RDOMAIN that is associated with the scoring scale. | New Variable for SDTM | Provides appropriate link to parent domain |
| RELSCAT | The subcategory of the test code from the related domain associated with the scoring scale. This is the Subcategory (--SCAT) of --CAT in the RDOMAIN that is associated with the scoring scale. | New Variable for SDTM | Provides appropriate link to parent domain |
| RTESTCD | The test code from the related domain associated with the scoring scale. This is the --TESTCD in the RDOMAIN that is associated with the scoring scale. | New Variable for SDTM | Provides appropriate link to parent domain |
| RMETHOD | The method of the test from the related domain associated with the scoring scale. This is the --METHOD in the RDOMAIN that is associated with the scoring scale. | New Variable for SDTM | Provides appropriate link to parent domain |
| RVAR | The variable in the related domain that is populated with the score from the scoring scale. Populate with the name of the related variable in the RDOMAIN that is associated with the score. For numeric scoring scales the related variable must be --STRESC. | New Variable for SDTM | Provides appropriate link to parent domain |
| SCALENAM | Name of the scoring scale from the related domain. The name of the scale should be meaningful and should provide traceability to the study plan and/or report if possible. | New Variable for SDTM | Provides name of scoring scale |
| SCORE | A valid value for a score from the scoring scale. The scoring scale is described in SCALENAM. | New Variable for SDTM | Provides the value of the score |
| SCRDSC | The description of a score from the scoring scale. This is the description of the value in SCORE. Must be populated for scores that are codes or abbreviations. The score description variable is limited to 200 characters. Score descriptions over 200 characters must be presented by adding additional columns in the dataset labeled SCORDSC1-SCORDSCn each containing no more than 200 characters of the score description. | New Variable for SDTM | Provides a text description of a particular score |
| DISPORD | The display order of the scores from the scoring scale. A number that gives the display order of the SCORE/SCOREDSC combination within SCALENAM. Display order must be used if the scale has a ranking order. | New Variable for SDTM | Provides the order a score should be displayed in relation to other scores within a scale |
| AGERHI, AGERLO | Removed AGETXT from DM and uses AGERHI and AGERLO to define a range of age values when the exact age of an animal is not known. | New Variables for SDTM | The values used in the new variables will be numeric instead of the free text. This will ensure consistent population of this data. |
| TXGRPID | Added GRPID to TX domain (A sequence of characters used to uniquely identify related records for a subject within a domain, or related parameters) | Automated analysis tools that read in SEND datasets will need to be updated to accommodate this change. New rules for population of TX parameters. | Allows for multiple values associated with a single TX parameter value to be populated as single records in the TX, with appropriate grouping. |
| SDTM Metadata Restructure to Align with SDTM v2.0 | Restructuring the metadata tables in the SENDIG will be done in order to match the metadata structure in SDTM v2.0. | The specification tables format is different from previous IGs | There will be more informative and better structured metadata in the SENDIG specification tables. |
| Creation of Define Appendix | All references to a define file or the use of the Define specification have been revised for clarity and consolidated into an appendix. | Minimal information related to define.xml remains in the main IG sections. New appendix added to IG. | Consolidation into an appendix and updates for clarity should allow for more consistent production of define.xml for SEND datasets |
| Creation of Trial Summary and Trial Set Codes Appendix | A new appendix that includes a reorganization of previous information and expanded metadata about usage of parameter codes in TS and TX domains. | Individual TX and TS parameters sections removed from IG. New appendix added to IG. | Allows one to determine, from one table, appropriate usage of these parameters in either the TS or TX domains |
| Creation of SEND Scope Appendix | Statement of the confidently modeled study types/designs and endpoints of SENDIGv4.0. | New appendix added to IG. | Allows the CDISC SEND team to positively assert what has been confidently modelled in SENDIG v4.0. |
| Timing Variable clarifications to guidance | Clarifications to many timing variables to provide more consistent guidance. This includes clarification of --NOMDY/--NOMLBL usage, expectancy of at least one of --DY/--DTC value, clarification and additional examples for data based on a reference time, and many other minor clarity updates. | Some reordering of sections. | Will give users of the IG clearer guidance on how to handle different timing scenarios. |
| Sexual Maturity, Reproductive Cycle Phase, Targeted Staining, Macroscopic Examination Follow-up | Modeled new tests to accommodate requested endpoints in the MI domain. | New assumptions and examples were added. | Will allow additional data to be represented in the MI domain. |
| MIDETECT | Variable added to the MI domain and will be populated in identical fashion as TFDETECT was in SENDIG v3.1.1 and before. | New variable for domain | Supports the deprecation of the TF domain. |
| MICAT, MISCAT | Variables added to the MI domain and will be populated with information related to staining. | New variables for domain | Supports the addition of Immunohistochemistry data and the presentation of relevant staining information. |
| Organ Measurements | Variables OMTSTDTL, OMMETHOD are included in the domain specification. New tests were added for Femur Length and Testicular Volume (in-life measurements). | OMTSTDTL is new to SEND. OMMETHOD is new for the domain. | Supports the addition of morphology measurements. |
| Replacing (supp--.xpt) with Non-Standard Variable Domain (NS--.xpt) | The Non-Standard Variables (NS--) relationship dataset model is used to capture non-standard variables (NSVs) and their association to parent records in general-observation class datasets (Events, Findings, Interventions) and Demographics (DM). NSVs are to be represented in separate NS-- datasets for each parent dataset with related non-standard variables. | Removal of SUPP—guidance and domain. | Supports inclusion of non-standard variables in a vertical format instead of a horizontal one. |
| The following will be deprecated from SEND: Domains: TF, BG, SUPP-- Variables: --BLFL, VISITDY, SEUPDES | These have been deprecated or removed from this version of the SENDIG | Indicated domains and variables removed from IG | Allows removal of unused or redundant guidance, or allows data to be presented in a more efficient and relevant fashion |
| Document | Proposed Scope/Change | Proposed Scope/Change Description | Impacts | Benefits |
|---|---|---|---|---|
| CDASH v2.0, CDASHIG v3.0 | Metadata Tables | Restructure the metadata tables to align with the upcoming versions of the SDTMIG (v4.0) & SDTM (v3.0) | Restructured metadata tables | Decreased discrepancies between CDASH and SDTM |
| CDASH v2.0, CDASHIG v3.0 | SDTMIG v4.0/SDTM v3.0 Alignment | Update all domains based on new metadata and alignment with SDTM IG v4.0. Align NSV with NSV registry. Incorporate new SDTMIG domains | Additional content in the CDASH Model & IG | Decreased discrepancies between CDASH and SDTM |
| CDASH v2.0, CDASHIG v3.0 | CDASH Controlled Terminology (CT) | Replace CDASH CT with SDTM terminology where applicable | Updated CT | Streamlined CT lists. Reduced CT maintenance. |
| CDASH v2.0, CDASHIG v3.0 | Sexual Orientation & Gender Identity (SOGI) | Incorporate the SOGI CRF | Additional content in the CDASH Model & IG | Consolidated CDASH content |
| CDASH v2.0, CDASHIG v3.0 | SAE Supplement | Incorporate the latest SAE Supplement | Additional content in the CDASH Model & IG | Consolidated CDASH content |
| CDASHIG v3.0 | eCRF Portal | Update example eCRFs. Base SDTM targets on MSG v2.0. Move from the CDASHIG to the eCRF Portal | Additional content in the eCRF Portal | Increased usability of the eCRF Portal (eCRF portal as single point for example CRFs) |
| Document | Proposed Scope/Change | Proposed Scope/Change Description | Impacts | Benefits |
|---|---|---|---|---|
| SDTMIG v4.0 | SUPP to NSV (NS—domain) | Replaces SUPP datasets with horizontal NSV datasets that do not have to be transposed before appending to parent dataset. | Industry will need to update tools and rules to handle NSV rather than SUPP datasets. | Easier for reviewers to join the data back to the parent NSV variable-level metadata - For example, data type or length vs only having 'text' for SUPP.QVAL, you can have numeric values and additional qualifiers. It aligns visually with the TAUG representations. Many sponsors already store their SDTM datasets in a structure that appends the NSVs to the parent domains. |
| SDTMIG v4.0 | Multiple Subject Instances - DC domain | Expands on minimal guidance currently provided for handling of data in studies where subjects can re-screen or participate in the same study more than once. There are also use cases that can be applied for SEND. | New Domain | Facilitates review through a standardized approach for submitting data for multiple subject instances. |
| SDTMIG v4.0 | Metadata Restructuring | Restructuring the metadata tables in the SDTMIG will be done in order to match the metadata structure in SDTM v2.0. | Additional metadata columns in the domain specifications. | The organization will be better, the overloaded columns of codelists and formats would be split out and easier to read. There will be better informative labels in the SDTMIG. |
| SDTMIG v4.0 | Variable Groups | "Variable Groups" column added to specifications tables. | Informative, formalizes terms already in common use like "visit variables", "coding variables". | Assist users in understanding variables and using them properly. |
| SDTMIG v4.0 | Protocol Deviations | Updating of the DV domain to support new regulatory guidance documents including ICH E6 R3. Provides a new variable, Classification of Protocol Deviation (DVCLASI) which can capture values e.g. Important vs Non-Important. | DVCLASI can allow sponsors to use DVCAT/DVSCAT for other purposes. | Improve SDTM alignment with regulatory guidance document and supports BIMO submissions. |
| SDTMIG v4.0 | Event Adjudication (EA) domain | A Findings-About structured domain for the submission of event adjudication data. | Users will have to create an EA domain and may have to modify their existing forms for adjudication data. Sponsors would need to implement the applicable CT for this domain. | Provides a standard domain that expands on the PHUSE approach, which is also the approach described in the FDA "Technical Specification for Submitting Clinical Trial Data Sets for treatment of Noncirrhotic Nonalcoholic Steatohepatitus (NASH)" |
| SDTMIG v4.0 | Gastrointestinal System Findings (GI) domain | A findings domain that contains physiological and morphological findings related to the gastrointestinal system, including the esophagus, stomach, small and large intestine, anus, liver, biliary tract and pancreas. | New Domain | Provides a findings domain that contains physiological and morphological findings related to the gastrointestinal system. |
| SDTMIG v4.0 | Deprecation of Baseline Flag (--BLFL) | --BLFL will be deprecated and removed. | Deprecation of an existing variable. The 'Core' of --BLFL was already changed from 'Expected' to 'Permissible' in preparation for deprecation and --LOBXFL has been added as 'Expected' to all domain tables for Findings domains. No real impact except that --BLFL can no longer be used in SDTM, as baseline flags are derived in ADaM datasets. | (--LOBXFL) will take its place as it provides a more defined algorithm for derivation. |
| SDTMIG v4.0 | Reorganization / rewrite of Sections 1-4 | Related to restructuring of the metadata; sections 1-4 revised to add clarity, better organization, and to ensure that general assumptions are consistent and in one place rather than scattered through CDISC notes. | Sponsors are going to have to learn where to find new information (sections renumbered, content moved, etc). | Clearer and better-organized text within the SDTMIG. |
| Document | Proposed Scope/Change | Proposed Scope/Change Description | Impacts | Benefits |
|---|---|---|---|---|
| SDTMIG-MD v2.0 | Merging the DO (Device Properties) and DU (Device In-Use) domains | Combine Device Properties (DO) and Device in-Use (DU) into a Single (DU) Domain | Merging 2 domains into 1 such that whether a given property changes during a study or not, the same domain is used. | Simplifies the representation of device property data by removing the need to split properties into different domains based on whether they change during a study. |
| SDTMIG-MD v2.0 | Relating One AE to Multiple Devices | If a subject has multiple devices, each AE experienced by the subject must be assessed for their relationship and action taken relative to the AE. Examples demonstrating how to use Findings About to do this are being added, as well as representing them in the AE domain. | No new datasets or variables. Potential programming changes to model relationship and action taken in either AE or FA. | Provides examples of 2 approaches to modeling one-to-many relationships current modelling and examples do not cover. |
| SDTMIG-MD v2.0 | Clarifying AERLDEV, DERLDEV and others | Adding clarification to the use of selected variable fragments when applied in different domains. | None. | Clarifying existing variable fragments when used in different domains. |
| SDTMIG-MD v2.0 | Handling Exposure for Ancillary Devices | Inclusion of ancillary devices in DX domain. | None. | Provides clarity about where to put data related to devices used in studies but that are not under study. |
| SDTMIG-MD v2.0 | Composite Devices & Components | Devices may be treated as a single unit for tracking and exposure purposes, or as a series of components, depending upon regulatory and sponsor needs. This change provides a means of identifying and connecting components with their parent device and can support component replacements over time while retaining the ability to analyze the device as a whole. | Uses RELDEV, a relationship dataset that will be published in the associated version of the SDTM, to represent relationships among the devices and their components. | Provides new modeling for representing relationships that must be reflected in the data, but for which there is no mechanism described in the IG. |
| SDTMIG-MD v2.0 | New variables --RLDEV, --SINTV, --RLPRT, --RLPRC, --UNANT, RDEVID (in Associated Persons- there don't appear to be rules for AP) | Materials needed in IG to support the new device-related variables that were published in SDTM v2.0 and SDTMIG v3.4. | None assuming sponsors implemented the variables when SDTM v2.0 and SDTMIG v3.4 were published. | Provides examples in the MDIG of the previously published variables, and includes additional examples showing more use cases. |
| SDTMIG-MD v2.0 | Relating Devices and Components (RELDEV) dataset | A relationship table that allows devices and their components to be related to each other. | New dataset | The RELDEV structure permits the relating of multiple components to one parent device. Components can also have components, meaning that a component can also function as a parent. There is theoretically no limit to the number of levels of components associated with a given parent. |
| SDTMIG-MD v2.0 | Adding examples from TAUGs | Updating and adding select examples of device data from the Therapeutic Area User Guides. | None - examples only | Updates use cases shown in TAUGs to conform to MDIG v2.0 practices. Makes the device use cases easier to find. |
| SDTMIG-MD v2.0 | Adding CDASH to some existing SDTM examples | For a subset of existing SDTM examples in the MDIG, adding CDASH data collection aCRFs. | None - examples only | Data collection examples integrated with the SDTM datasets help to show where the data comes from and how they are transformed into SDTM format. |
| SDTMIG-MD Conformance Rules v1.0 | Conformance Rules | Conformance rules are being developed for the new materials in the device IG. | New rules around RELDEV, the revised DU, and some of the device variables published in SDTM v2.0. | Assist the user community to understand the design intent of the IG. |
| Document | Proposed Scope/Change | Proposed Scope/Change Description | Impacts | Benefits |
|---|---|---|---|---|
| ADaM and Implementation Guide v3.0 | Consolidated model and implementation guides with conformance rules | Consolidation of the ADaM model (v2.1) and implementation guides (ADaMIG v1.3, OCCDS v1.1, NCA v1.0) into an overarching ADaM Model & IG. | Updated model, implementation guides, and conformance rules | Assist industry with implementing compatible versions of the ADaM documents. |
| ADaM Implementation Guide for Anti-Drug Antibody Data v1 | Implementation guide with conformance rules | Implementation guide for analysis datasets of anti-drug antibody (ADA) data with conformance rules. | New implementation guide and conformance rules. | Provide sponsors with a standardized approach for using ADaM for anti-drug antibody (ADA) data. |
| ADaM Examples for Pharmacokinetic Parameters (PP) v1 | Examples document | An examples document to detail the process starting from the creation of the non-compartmental Analysis (NCA) file to ADPP. | New examples | Provide sponsors with a standardized approach for using ADaM for pharmacokinetic parameter data. |
| ADaM Oncology Examples v1 | Examples document | An examples document to support analyses for clinical trials focused on oncology therapies. | New examples | Provide sponsors with a standardized approach for using ADaM for the oncology therapeutic area. |
| ADAM Example Datasets for Lab Displays v1 | Examples document | An examples document containing ADaM-conformant datasets to support some of the lab displays included in the draft Safety Tables and Figures Integrated Guide published by the FDA. | New examples | Provide sponsors with ADaM-conformant datasets for lab displays. |
| Document | Proposed Scope/Change | Proposed Scope/ Change Description | Impacts | Benefits |
|---|---|---|---|---|
| Analysis Results Standard v1 | Model and accompanying user guide | Development of a model and accompanying user guide to support automation, consistency, traceability, and reuse of results data. | New model and user guide | Provide sponsors with a standardized approach for using ADaM for results data. |
| Document | Proposed Scope/ Change | Proposed Scope/Change Description | Impacts | Benefits |
|---|---|---|---|---|
| Tobacco Implementation Guide v1.0 | Hybrid implementation guide | A foundational standard that is a single, stand-alone, comprehensive implementation guide for tobacco product data submissions. | New hybrid implementation guide. | An implementation guide to address concepts and endpoints for studies of tobacco products to improve semantic understanding, support data sharing, and facilitate global regulatory applications. |