SDTMIG V4.0前瞻

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.