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.
| Document | Proposed Scope/Change | Proposed Scope/Change Description | Impacts | Benefits |
|---|---|---|---|---|
| SENDIG v4.0 | 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. | New appendix | Reduces redundancy with existing CDISC specifications and provides clarity for SEND user community. |
| SENDIG v4.0 | Cell Phenotyping | 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 | First standardization of cell phenotyping data, including data collection/extraction tools, controlled terms, and revision of standard operating procedures for compliance. |
| SENDIG v4.0 | Immunogenicity Specimen Assessments (IS) | Domain for assessments of antigen induced humoral or cell-mediated immune response in the subject. | New Domain to SENDIG | First inclusion of these data in SEND scope. |
| SENDIG v4.0 | Ophthalmic Examinations (OE) | Domain for qualitative findings and quantitative measurements related to the eye. | New Domain to SENDIG | Moves eye exams from CL into the OE domain. Adds numeric eye examination findings to SEND scope. |
| SENDIG v4.0 | Pharmacokinetic Input (PI) | Domain for concentrations of therapeutics, therapeutic components, or metabolites used to calculate the pharmacokinetic parameters (input to PP). | New Domain to SENDIG | First inclusion of these data in SEND scope. |
| SENDIG v4.0 | Scoring Scales (SX) | Reference domain that describes the scoring scales used to collect data. | New Domain to SENDIG | Provides the ability to communicate complete scoring scales used on study in a complete, unambiguous, standardized presentation. |
| SENDIG v4.0 | 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 | First inclusion of these data in SEND scope. |
| SENDIG v4.0 | Skin Test Results (SK) | Domain for quantitative and qualitative results related to dermal measurements or evaluations. | New Domain to SENDIG | Moves skin evaluations from CL into the SK domain. Adds numeric skin examination findings to SEND scope. |
| SENDIG v4.0 | 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 | Inclusion into parent IG to accommodate GV endpoints on in-scope study types. |
| SENDIG v4.0 | 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. There will be better informative labels in the SENDIG. | Removed and added metadata columns in the domain specifications | CDISC notes are jumbled with definitions and rules right now - that will be clearer with the added variable definition column and the rules will be split out and put into assumptions. 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 SENDIG and notes and examples columns will be added. |
| SENDIG v4.0 | Creation of SEND Scope Appendix | Clarification of the confidently modeled studies and endpoints of SENDIG. | New | The scope of the IG is included in the IG instead of in a separate document (e.g. the CoDEX). |
| SENDIG v4.0 | Sexual Maturity, Reproductive Cycle Phase, Targeted Staining, Macroscopic Examination Follow-up | Modeled new tests to accommodate requested endpoints in the MI domain. | New to MI | Increased the scope of data to be submitted in MI. |
| SENDIG v4.0 | Timing Variable clarifications to guidance | Clarifications to many timing variables to provide more consistent guidance. | Updated | The goal is to improve consistency in implementation of these variables. |
| SENDIG v4.0 | Trial Summary and Trial Set Domain enhancements and clarifications | A new appendix that includes a reorganization of previous information and expanded metadata about usage of parameter codes in TS and TX domains. | Updated | The goal is to improve consistency in implementation of the TS and TX domains. |
| SENDIG v4.0 | Adding --RESMOD to additional domains | Added to MI, MA Domains to standardize the result modifiers. | New variable added to MA, MI | Reduces nonstandard variable usage. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variable* --RSCNT | First identified need is for count of the number of arrhythmias observed. | New Variable | Adds ability to present arrythmia count data in EG. |
| SENDIG v4.0 | Adding --LOBXFL | Provides unambiguous way to communicate which data are the last observed before treatment. | New to SEND | Changes communication of baseline data; clarifies ambiguity present with current --BLFL variable and addresses the differences between study designs. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variables* --ETBLFL, --ETBLNM, --BLTYP | Adds the ability to communicate baseline measurements in latin square, modified parallel (split dose) and rising dose study designs. | New Variables | Changes communication of baseline data; clarifies ambiguity present with current --BLFL variable and addresses the differences between study designs. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variable* 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 | Provides the ability to communicate complete scoring scales used on study in a complete, unambiguous, standardized presentation. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variable* 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 | Provides the ability to communicate complete scoring scales used on study in a complete, unambiguous, standardized presentation. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variable* 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 | Provides the ability to communicate complete scoring scales used on study in a complete, unambiguous, standardized presentation. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variable* 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 | Provides the ability to communicate complete scoring scales used on study in a complete, unambiguous, standardized presentation. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variable* 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 | Provides the ability to communicate complete scoring scales used on study in a complete, unambiguous, standardized presentation. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variable* 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 | Provides the ability to communicate complete scoring scales used on study in a complete, unambiguous, standardized presentation. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variable* SCORE | A valid value for a score from the scoring scale. The scoring scale is described in SCALENAM. | New Variable | Provides the ability to communicate complete scoring scales used on study in a complete, unambiguous, standardized presentation. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variable* 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 | Provides the ability to communicate complete scoring scales used on study in a complete, unambiguous, standardized presentation. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variable* 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 | Provides the ability to communicate complete scoring scales used on study in a complete, unambiguous, standardized presentation. |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variable* --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 | Reduces nonstandard variable usage. |
| SENDIG v4.0 | Added GRPID to TX domain | Adding GRPID (A sequence of characters used to uniquely identify related records for a subject within a domain, or related parameters in the Trial Summary (TS) dataset) to TX domain. | Updated | Supports the ability to group dose records with units in the TX domain. |
| SENDIG v4.0 | MIDETECT, MIRESMOD (with CT), MICAT, MISCAT | Variables added to the MI domain to support modeling of new endpoints. | New to MI | Domain specification expanded to include new variables. |
| SENDIG v4.0 | Organ Measurements | Variables OMTSTDTL, OMMETHOD are included in the domain specification. New tests were added for Femur Length and Testicular Volume (in-life measurement). | Updated | Changes to tools to accommodate added variables and new tests |
| SENDIG v4.0 | SEND and SDTM Teams Approved New Variables* AGERHI, AGERLO | Removed AGETXT from DM and use AGERHI and AGERLO to define a range of age values when the exact age of an animal is not known. | New Variables | Enables the age definition of the subject to be represented as a range by animal (in DM domain). |
| Document | Proposed Scope/Change | Proposed Scope/Change Description | Impacts | Benefits |
|---|---|---|---|---|
| CDASHIG Model v3.0, CDASHIG v2.0 | Align with prior and upcoming SDTMIG publications | Increased alignment with SDTMIG v3.3 + SDTMIG v3.4 Domains, as well as with upcoming SDTMIG v4.0. | Additional SDTMIG Domains (e.g., Immunogenicity Specimen Assessments [IS Domain] in Findings Class Domains) | Advancing alignment & Decreasing discrepancies amongst CDASH and SDTM. |
| CDASHIG Model v3.0, CDASHIG v2.0 | Inclusion of SAE Supplement | Next release will merge the latest SAE Supplement v2.1 into the next iteration (i.e., CDASHIG v3.0 + Model v2.0). | Due to the structural changes of the model and metadata tables, the next release will be CDASHIG v3.0 and Model v2.0. | Streamlining SAE subject matter. |
| CDASHIG Model v3.0, CDASHIG v2.0 | Incorporation of Examples Collection into eCRF Portal | Additional content within the eCRF Portal. | Additional content within the eCRF Portal. | Increased user community awareness and usability of the eCRF Portal. |
| CDASHIG Model v3.0, CDASHIG v2.0 | Incorporation of SOGI CRF into eCRF Portal | Incorporation of work developed by the Sexual Orientation and Gender Identity (SOGI) Team. | Additional content within the eCRF Portal. | Increased user community awareness and usability of the eCRF Portal. |
| CDASHIG Model v3.0, CDASHIG v2.0 | Align CDASH Metadata to CDISC Library | The current CDASH Model represents Identifier, Timing, and Domain-specific variables in the metadata as an Observation Class. This does not align with the SDTM. This should be revised in a future version of the CDASH Model. | Proposal 1: Remove the Domain Specific Variables section and add to Model in the appropriate Class and add the column Usage Restrictions (to align with SDTMIG v3.4). Proposal 2: Revise Identifiers to All Observational Classes-Identifiers. | Improved interoperability of CDASH within CDISC Library. |
| Document | Proposed Scope/Change | Proposed Scope/Change Description | Impacts | Benefits |
|---|---|---|---|---|
| SDTMIG v4.0 | SUPP to NSV | 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 | Further standardization of the DV domain and related terminology in order to align with Transcelerate's Protocol Deviation Data Collection optimization initiative. Provides a new variable to capture DV classifications e.g. important vs non-important. | New variable with new controlled terminology. | Improve the industry standard for submitting protocol deviation data in SDTM for the support of BIMO. |
| SDTMIG v4.0 | Event Adjudication (EA) domain | A Findings-About structured domain for the submission of 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 Last Observation Before Exposure Flag (--LOBXFL) will take its place as it provides a more defined algorithm for derivation. This variable was introduced in SDTMIG v3.3 and it is already being implemented. | 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 | Deprecation of Pharmacokinetics Parameters (PP) domain | PP is a derived dataset that doesn't really belong in SDTM and should only reside in ADaM. There will be guidance for submitting this data in ADaM, e.g. ADPP. It is only being deprecated in the SDTMIG, not for SEND. | Deprecation of an existing domain. | Sponsors will no longer have to derive PP parameters and put them back into the SDTM tabulation data, in addition to including it with the ADaM datasets. |
| 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. |