The Standards Roadmap includes proposed start dates of Internal Review, Public Review, and Publication Date for several of the CDISC Foundational Standards. These timelines will be updated on a quarterly basis as the teams progress through the Standards Development Process outlined in COP-001. Please note that prior reviews or prior publications are not included on these timelines.
Below is a table which outlines the high-level scope for multiple CDISC Foundational Standards. For each standard and upcoming publication, the proposed scope/changes are described and impacts and benefits of each change are listed. The QRS tab lists supplements that are projected to be published within the next 6 months. Please note that the proposed scope/changes as well as the impact and benefits are subject to change based on feedback received during the various review periods and are not final until publication. The scoping tables will be updated on a quarterly basis.
| 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 Domain to SEND | 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 SEND | 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 SEND | 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 SEND | 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 SEND | 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 SDTM | 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 SEND | 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 SEND | 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). |
| * asterisk indicates variable(s) for which official approval is pending public review |
| Document | Proposed Scope/Change | Proposed Scope/Change Description | Impacts | Benefits |
|---|---|---|---|---|
| CDASH Model v2.0, CDASHIG v3.0 | 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. |
| CDASH Model v2.0, CDASHIG v3.0 | 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. |
| CDASH Model v2.0, CDASHIG v3.0 | 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. |
| CDASH Model v2.0, CDASHIG v3.0 | 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. |
| CDASH Model v2.0, CDASHIG v3.0 | 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. | 1: Proposal to remove the Domain Specific Variables section + 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 | Prior to SDTMIG v4.0, SUPP datasets need to be transposed before appending to the parent dataset. The proposed structure of the new NSV datasets is already horizontal which will make it much easier for reviewers to join the data back to the parent. NSVs can have defined variable level metadata in addition to value level metadata. | Sponsors and the industry at large will need to update their tools and conformance rules to handle the creation of NSV datasets rather than SUPPQUAL. Review and validation tools will need to be updated as well. The post-processing steps would be simplified, and it would make the merge easier. | 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 | QRS Instrument Reference (QX) domain | Allow sponsors to provide information about a QRS instrument in a structured format. Currently, this metadata is stored in SUPPQUAL at the subject-level and is the same for every subject. This can result in large file sizes for trial level information. The QX domain will be able to manage instrument-level metadata such as upper and lower ranges for Visual Analog Scales (VAS). | New Domain | Provide a solution for storing QRS instrument metadata at the instrument level rather than the subject-level for a trial. |
| SDTMIG v4.0 | Multiple Subject Instances - DC domain | Handling of data in studies where subjects can re-screen or participate in the same study more than once has been a longstanding issue. Guidance for how to handle the data is provided in the FDA sdTCG and the standards being developed will expand on the minimal guidance currently provided. There are also use cases that can be applied for SEND. | New Domain | Sponsors will have a standardized approach for submitting data for multiple subject instances that will facilitate review. SUBJID will be available in most domains where needed. Companies right now are handling it in an inconsistent manner - so everyone would need to adjust and handle it in a standardized manner using the new DC domain. |
| 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. There will be better informative labels in the SDTMIG, and the assumptions will be together instead of being separated from the examples. | Additional metadata columns in the domain specifications. | CDISC notes are jumbled with definitions and rules right now - that will be clearer with the real 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 SDTMIG. |
| 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 | There is no specific guidance for submission of adjudication data in SDTM. Developing a Findings About-structured standard domain, EA, will allow this data to be submitted in a separate domain from FA and not a split dataset of FA. People may not be using FA - there may be inconsistencies in the format of submission. CT may start to be developed for this domain. | 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 an industry standard for submitting adjudication data in SDTM. |
| SDTMIG v4.0 | Deprecation of Baseline Flag (--BLFL) | In SDTM, the baseline flag is an 'Expected' variable in Findings domains and is used to identify the record that contains the baseline value. However, there are many analysis situations where operationally, it is difficult for sponsors to accurately derive this flag variable. In these situations, sponsors may leave this flag variable blank or they may flag a record that contains an approximation for the true baseline value. Due to this, --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 |
|---|---|---|---|---|
| Medical Devices IG 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. |
| Medical Devices IG 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. |
| Medical Devices IG 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. |
| Medical Devices IG 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. | No new datasets or variables. Uses RELDEV, a published relationship dataset, to represent relationsips 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 mechnism described in the IG. |
| Medical Devices IG 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. |
| Medical Devices IG 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. |
| Medical Devices IG v2.0 | RELDEV | Materials in support of and for inclusion in the SDTM and SDTMIG-MD for the RELDEV dataset. | None, assuming sponsors implemented RELDEV after publication in SDTM v2.0. | Adds general description and supportive material about RELDEV to the MDIG. |
| Medical Devices IG 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. |
| Medical Devices IG 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. |
| Medical Devices IG v2.0 | Adding information about the extensive use of device domains in the Traditional Chinese Medicine TAUG. | Verbiage alerting users that device domains are applicable in broader circumstances than expected. | None. | Explicitly alerts users to the potential broader use of the device domains. |
| Medical Devices 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 v3 | 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. | Consolidated ADaMIG & Model document | Assist industry with implementing compatible versions of the ADaM documents. | |
| ADaM Oncology Examples v1 | ADaM examples for oncology data | Analysis of data for clinical trials used to support submissions for oncology therapies often requires some unique approaches in using the Analysis Data Model (ADaM). The purpose of this document is to provide descriptions and examples of how these approaches to ADaM can be applied in clinical trials. | New examples | Provide sponsors with a standardized approach for using ADaM for the oncology therapeutic area. |
| Anti-Drug Antibody (ADA) Dataset v1 | Guidance and/or examples for analysis datasets of anti-drug antibody (ADA) data. | New guidance or examples | Provide sponsors with a standardized approach for using ADaM for anti-drug antibody (ADA) data. | |
| ADAM Datasets for Lab Displays v1 | 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. | |
| 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. |
| List of Planned QRS Instruments for Publication |
|---|
| 4-Stair Ascend (4-STAIR ASCEND) |
| 4-Stair Descend (4-STAIR DESCEND) |
| 6-Minute Walk Test Expanded (SIX MINUTE WALK EXPANDED) |
| APACHE II (ADQRS) |
| Asthma Daytime Symptom Diary V1.0 (ADSD V1.0) |
| Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0) |
| BPRS 1988 (ADQRS) |
| HAMD-17 (ADQRS) |
| European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 Version 3.0 (EORTC QLQ-C30 V3.0) |
| Kurtzke Functional Systems Scores (KFSS) Supplement V2.1 |
| MINI Mini-Mental State Exam (MMSE) |
| Mini-Mental State Examination 2 Standard Version (MMSE-2 STANDARD VERSION) |
| Montreal Classification for Crohn's Disease (MONTREAL CROHN'S) |
| NEWS2 (ADQRS) |
| Non-Small Cell Lung Cancer Symptom Assessment Questionnaire V1.0 (NSCLC-SAQ V1.0) |
| Pain Intensity (ADQRS) |
| Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Item Library Version 1.0 (PRO-CTCAE V1.0) |
| Rising From Floor (RISING FROM FLOOR) |
| Rutgeerts Score (RUTGEERTS SCORE) |
| Sequential Organ Failure Assessment Score (SOFA Score) |
| Short Form 36 Health Survey Acute, US Version 2.0 (SF36 V2.0 ACUTE) |
| Short Form 36 Health Survey Standard, US Version 2.0 (SF36 V2.0 STANDARD) |
| NOTE: This is the proposed list of SDTMIG-QRS and ADQRS Supplements planned for publication within the next six months as of September 1, 2023. ADQRS Supplements are noted as such, all others listed are SDTMIG-QRS Supplements. |