USDM4_Excel Package

Library for import and export of USDM Version 4 via MS Excel

Implementation Status

This README documents the target sheet formats. Not every documented sheet is implemented yet — the table below is the source of truth (last audited 2026-07-30, see docs/completion_plan.md for the completion plan).

Sheet	Import	Export
configuration	yes	yes
study, studyIdentifiers, studyOrganizations	yes	yes
studyReferences (reference identifiers)	yes	yes
dates (separate sheet + legacy table on study sheet)	yes	yes (both)
roles, extensions	yes	yes
documents, documentVersions, document content/templates	yes	yes
studyAmendments, amendmentChanges, amendmentImpact	yes	yes
abbreviations	yes	yes
notes	yes	yes
dictionaries	yes	yes
people (assigned persons)	yes	yes
studyDesignSites	yes	yes
studyDesign, arms, epochs, elements, encounters, timing, activities	yes	yes
SoA / timelines	yes (multiple per design)	yes
studyDesignPopulations	yes	yes
studyDesignOE (objectives & endpoints)	yes	yes
eligibility criteria (legacy one-sheet)	yes (fallback)	yes
eligibilityCriteria + eligibilityCriteriaItems (split)	yes (preferred)	yes (both dialects)
studyDesignConditions, interventions	yes	yes
studyDesignProcedures (definitions, referenced from SoA rows)	yes	yes
studyDesignEstimands	yes	yes
studyDesignIndications	yes	yes
studyDesignCharacteristics (cohort characteristic definitions)	yes	yes
studyDesignSpecimen (definitions, referenced from studyDesign sheet)	yes	yes
studyProducts, studyProductOrganizationRoles	yes	yes
studyDevices	yes	yes

A JSON → Excel → JSON round-trip test (tests/usdm4_excel/test_round_trip.py) guards the import/export pairing. No known import/export asymmetries remain. Note: CommentAnnotation stores no name, so exported notes carry synthesised names (NOTE_1, NOTE_2, ...) on the notes sheet, referenced from each sheet's notes column — the original workbook's note names are import keys only and are not preserved.

Workbook Formats

The package reads and writes two formats:

Legacy single workbook. Every sheet in one file, compatible with workbooks written for the old usdm / usdm4_legacy_excel packages. Unmodified legacy workbooks import directly: the study sheet's dates table, protocolVersion/protocolStatus keys and configuration TEMPLATE mappings (from which the study definition documents are synthesised), legacy column names (siteName, studyEpochType, encounterType, …) and xref reference columns are all understood. Export in this format (to_excel(..., format="legacy") or to_legacy_excel) writes both dialects where they differ (legacy dates table + dates sheet; legacy one-sheet eligibility + split sheets) so the file is readable by both old and new importers.

Multi-workbook. One main workbook plus one workbook per study design, for complex multi-design studies (to_excel(..., format="multi")):

• The main workbook holds the study/version-level sheets: study, dates, identifiers, organizations, roles, extensions, people, sites, documents and content, amendments, abbreviations, dictionaries, eligibilityCriteriaItems, conditions, interventions, products, devices, product organization roles, configuration.
• The study sheet's studyDesigns row lists the design workbook file names, comma-separated, relative to the main workbook (export names them <main-stem>_<design-name>.xlsx).
• Each design workbook holds that design's sheets: studyDesign, arms, epochs, elements, encounters, activities, timing, populations, objectives & endpoints, eligibilityCriteria, indications, estimands, procedures, characteristics, specimen retentions, and the timeline (SoA) sheets.
• The main workbook must NOT also contain an embedded studyDesign sheet when studyDesigns lists files — the import rejects this as ambiguous.
• On import the format is auto-detected from the studyDesigns row; no flag is needed.

Name uniqueness rule. Cross-references are resolved by name in a single study-wide namespace: populations, cohorts, arms, epochs, elements, encounters, activities, timings, procedures, characteristics, criterion items, etc. must have names that are unique across the WHOLE study, including across design workbooks. Two designs may not both define, say, a population named POP1 — the second is dropped with an error.

Table of Contents

• Export
• Import
  • General Sheets
    • Configuration Sheet
    • Dates Sheet
    • Dictionaries Sheet
    • Notes Sheet
  • Study Sheets
    • Study Sheet
    • Study Organizations Sheet
    • Study Identifiers Sheet
    • Study References Sheet
    • Documents Sheet
    • Document Versions Sheet
    • Abbreviation Sheet
    • Amendment Sheet
    • Amendment Changes Sheet
    • Amendment Impact Sheet
    • Assigned Person Sheet
    • Roles Sheet
    • Document Content Sheet
    • Document Template Sheets
    • Eligibility Criteria Items Sheet
    • Extensions Sheet
    • Sites Sheet
  • Study Design Sheets
    • Study Design Sheet
    • Study Design Arms Sheet
    • Study Design Characteristics Sheet
    • Study Design Encounters Sheet
    • Study Design Epochs Sheet
    • Study Design Elements Sheet
    • Study Design Activities Sheet
    • Study Design Timing Sheet
    • Timeline (SoA) Sheets
    • Study Design Populations Sheet
    • Study Design Objectives and Endpoints Sheet
    • Eligibility Criteria Sheet
    • Study Design Eligibility Criteria Sheet (Legacy)
    • Study Design Conditions Sheet
    • Study Design Interventions Sheet
    • Study Design Procedures Sheet
    • Study Design Estimands Sheet
    • Study Design Indications Sheet
    • Study Design Specimen Sheet
    • Study Products Sheet
    • Study Product Organization Roles Sheet
    • Study Devices Sheet
  • Data Format Guidelines
  • CDISC CT Code Lists

Export

A simple export mechanism is in place to export a USDM file to the v4 CDISC Excel format

Import

General

This section describes all the columns used within the Excel sheets for USDM4 data import/export, along with the expected formats and values for each column. This format is an updated version of the CDISC v4 Excel format that allows for multiple study designs (one workbook per design) and a few other improvements. See the Implementation Status table above for what is currently wired in.

General Sheets

Configuration Sheet

Sheet Name: configuration

This sheet configures CDISC CT (Controlled Terminology) versions for the import process.

Column	Format	Description	Example
Name (Column A)	Text	Configuration parameter name (case-insensitive)	CT VERSION
Value (Column B)	Text	Configuration parameter value	SDTMCT = 2025-03-28

Supported Configuration Parameters:

• CT VERSION: Specifies CDISC CT version in format <CT name> = <version>
  • Valid CT names: SDTMCT, PROTOCOLCT, DDFCT
  • Version format: YYYY-MM-DD
• TEMPLATE (legacy): maps a document template to the sheet holding its narrative content, in format <template name> = <sheet name>. The default mapping SPONSOR = document always applies.
• The legacy options EMPTY NONE, USE TEMPLATE, USDM VERSION, SDR PREV NEXT, SDR ROOT and SDR DESCRIPTION are accepted with a deprecation warning and their values ignored.

Examples:

CT VERSION | SDTMCT = 2025-03-28
CT VERSION | PROTOCOLCT = 2025-03-28
CT VERSION | DDFCT = 2025-03-28
TEMPLATE   | M11 = m11Template

Dates Sheet

Sheet Name: dates

Defines governance dates for the study version, amendments and document versions. This is the preferred dialect; the legacy dates table on the study sheet is still read when this sheet is absent.

Column	Format	Description	Required	CDISC CT Code List	Example
name	Text	Date name (reference key)	Yes	-	Approval Date 1
description	Text	Date description	Yes	-	Date of protocol approval
label	Text	Date label	Yes	-	Approval
type	CDISC CT	Type of governance date	Yes	C207413	Approval Date
dateValue	Date	Date value	Yes	-	2024-01-15
geographicScopes	Geographic Scopes	Comma-separated scopes: Global, Region: <name>, Country: <name or code>	No (defaults to Global)	C207412	Global
category	Text	study_version (default), protocol_document or amendment. Only study_version dates attach to the study version; the others are referenced by name from the documentVersions / studyAmendments sheets	No	-	study_version

Dictionaries Sheet

Sheet Name: dictionaries

This sheet defines syntax template dictionaries for parameterized text.

Column	Format	Description	Required	Example
name	Text	Dictionary name	Yes	Treatment Duration
description	Text	Dictionary description	Yes	Template for treatment duration text
label	Text	Dictionary label	Yes	Duration Template
key	Text	Parameter key/tag	Yes	duration
class	Text	API class name for cross-reference	No	Duration
reference / xref	Text	Referenced object's name (xref is the legacy heading)	No	Treatment Duration
attribute / path	Text	Attribute path for cross-reference	No	quantity.value
value	Text	Static value (when not using cross-reference)	No	12 weeks

Notes:

• Multiple parameter maps can be defined for the same dictionary
• Either use class/reference/attribute for dynamic references or value for static text
• Cross-references link to other API objects created in the system

Notes Sheet

Sheet Name: notes

This sheet defines comment annotations that can be referenced by other sheets.

Column	Format	Description	Required	Example
name	Text	Note identifier/name	Yes	Safety Note 1
text	Text	Note content/description	Yes	Monitor for adverse events
codes	CDISC CT Codes	Comma-separated list of codes	No	C49667:Safety Study, C25256:Adverse Event

Code Format:

• Format: <code>:<preferred_term> or <system>:<code>=<preferred_term>
• Multiple codes separated by commas
• Example: C49667:Safety Study, LOINC:LA6115-6=Mild

Study Sheets

Study Sheet

Sheet Name: study

This sheet defines the main study information using a key-value format (Column A = Parameter Name, Column B = Value).

Parameter Name	Format	Description	Required	CDISC CT Code List	Example
name	Text	Study name	Yes	-	Phase III Efficacy Study
description	Text	Study description	Yes	-	A randomized controlled trial
label	Text	Study label	Yes	-	Study ABC-123
studyVersion	Text	Study version identifier	Yes	-	1.0
studyAcronym	Text	Study acronym	No	-	EFFICACY-III
studyRationale	Text	Study rationale	No	-	To evaluate efficacy and safety
businessTherapeuticAreas	CDISC CT Codes	Therapeutic areas (multiple)	No	-	C3262:Oncology, C3263:Cardiology
briefTitle	Text	Brief study title	No	-	Efficacy Study of Drug X
officialTitle	Text	Official study title	No	-	A Phase III Study of Drug X
publicTitle	Text	Public study title	No	-	Drug X Study for Cancer
scientificTitle	Text	Scientific study title	No	-	Efficacy of Drug X in Advanced Cancer
studyDesigns	File References	Study design file names (multiple)	No	-	design1.xlsx, design2.xlsx
notes	Note References	Comma-separated note names	No	-	Version Note
protocolVersion	Text	Protocol version (legacy; drives document synthesis when the documents sheets are absent)	No	-	2.1
protocolStatus	CDISC CT	Protocol status (legacy)	No	C188723	Final

The legacy keys studyType, studyPhase (moved to the studyDesign sheet) and studyTitle (deprecated) are recognised but ignored with a warning.

Governance Dates Section (legacy dialect): A blank key row ends the key/value block; the row after next starts a dates table with the following fixed column order (only read when the separate dates sheet is absent):

Column	Format	Description	Required	CDISC CT Code List	Example
category	Text	Date category	Yes	-	study_version, protocol_document, amendment
name	Text	Date name	Yes	-	Study Start Date
description	Text	Date description	Yes	-	Date when study enrollment begins
label	Text	Date label	Yes	-	Start Date
type	CDISC CT	Type of governance date	Yes	C207413	Effective Date
date	Date	Date value	Yes	-	2024-01-15
scopes	Geographic Scopes	Comma-separated scopes: Global, Region: <name>, Country: <name or code>	No (defaults to Global)	-	Global

Valid protocolStatus values (C188723):

• Approved (C25425)
• Draft (C85255)
• Final (C25508)
• Obsolete (C63553)
• Pending Review (C188862)

Valid governance date type values (C207413):

• Approval Date (C71476)
• Effective Date (C215663)
• Issued Date (C215664)

Study Organizations Sheet

Sheet Name: studyOrganizations

Defines organizations involved in the study.

Column	Format	Description	Required	CDISC CT Code List	Example
organisationName / organizationName / name	Text	Organization name	Yes	-	ABC Pharmaceutical
label	Text	Organization label	No	-	ABC Pharma
organisationType / organizationType / type	CDISC CT	Type of organization	Yes	C188724	Pharmaceutical Company
organisationIdentifierScheme / organizationIdentifierScheme / identifierScheme	Text	Identifier scheme	Yes	-	DUNS
organisationIdentifier / organizationIdentifier / identifier	Text	Organization identifier	Yes	-	123456789
organisationAddress / organizationAddress / address	Address	Organization address	No	-	123 Main St, City, State, 12345, USA

Valid organizationType values (C188724):

• Clinical Study Registry (C93453)
• Regulatory Agency (C188863)
• Healthcare Facility (C21541)
• Pharmaceutical Company (C54149)
• Laboratory (C37984)
• Contract Research Organization (C54148)
• Government Institute (C199144)
• Academic Institution (C18240)
• Medical Device Company (C215661)

Address Format:

• Format: <street>, <city>, <state>, <postal_code>, <country>
• Can also use pipe separator: <street> | <city> | <state> | <postal_code> | <country>
• Example: 123 Main Street, Boston, MA, 02101, USA

Study Identifiers Sheet

Sheet Name: studyIdentifiers

Defines study identifiers assigned by different organizations.

Column	Format	Description	Required	Example
studyIdentifier / identifier	Text	Study identifier value	Yes	ABC-123-2024
organization	Organization Reference	Organization name that assigned the identifier	Yes	ABC Pharmaceutical

Notes:

• The organization must exist in the Study Organizations sheet
• Multiple identifiers can be assigned by different organizations

Study References Sheet

Sheet Name: studyReferences

Defines reference identifiers: identifiers of related documents/plans held by an organization (StudyVersion.referenceIdentifiers).

Column	Format	Description	Required	CDISC CT Code List	Example
studyIdentifier / identifier	Text	Reference identifier value	Yes	-	LZZT CD Plan 1
organization	Organization Reference	Organization name holding the reference	Yes	-	ABC Pharmaceutical
referenceType	CDISC CT decode	Type of reference	Yes	C215478	Clinical Development Plan

Notes:

• The organization must exist in the Study Organizations sheet

Documents Sheet

Sheet Name: documents

Defines study definition documents (protocols, etc.).

Column	Format	Description	Required	CDISC CT Code List	Example
name	Text	Document name	Yes	-	Study Protocol v2.1
label	Text	Document label	Yes	-	Protocol
description	Text	Document description	Yes	-	Main study protocol document
type	CDISC CT	Type of document	Yes	C215477	Protocol
templateName	Text	Template name	Yes	-	Standard Protocol Template
language	ISO 639 Code	Document language	Yes	-	en
documentVersion	Document Version Reference	Name of the document version (documentVersions sheet) attached to this document	Yes	-	PROTOCOL_V2
notes	Note References	Comma-separated note names	No	-	Protocol Note

Valid type values (C215477):

• Protocol (C70817)

Document Versions Sheet

Sheet Name: documentVersions

Defines versions of the study definition documents, referenced by name from the documents sheet's documentVersion column.

Column	Format	Description	Required	CDISC CT Code List	Example
name	Text	Document version name (reference key)	Yes	-	PROTOCOL_V2
version	Text	Version identifier	Yes	-	2.1
date	Date Reference	Name of a governance date (dates sheet); the cell may be left empty	Yes	-	Approval Date 1
status	CDISC CT	Document version status	Yes	C188723	Final
sheetName	Text	Name of the sheet holding the document version's narrative structure (see Document Template Sheets)	Yes	-	m11Template
notes	Note References	Comma-separated note names	No	-	Protocol Note

Abbreviation Sheet

Sheet Name: abbreviations

Defines abbreviations and acronyms used in the study.

Column	Format	Description	Required	Example
abbreviatedText	Text	Abbreviation/acronym (reference key for the document abbreviations macro)	Yes	AE
expandedText	Text	Full definition	Yes	Adverse Event
notes	Note References	Comma-separated note names	No	Definition Note

Amendment Sheet

Sheet Name: studyAmendments

Defines study amendments.

Column	Format	Description	Required	Example
name	Text	Amendment name	Yes	Amendment 1
description	Text	Amendment description	No	Protocol amendment to modify inclusion criteria
label	Text	Amendment label	No	Amend-1
number	Text	Amendment number	Yes	01
summary	Text	Amendment summary	Yes	Modified inclusion criteria for better enrollment
date	Date Reference	Name of a governance date (dates sheet, category amendment)	No	Amendment 1 Approval
primaryReason	CDISC CT / Other	Primary reason: CDISC CT value (C207415) or Other = <text>	Yes	New Safety Information Available
secondaryReasons	CDISC CT / Other	Comma-separated secondary reasons, same format as primaryReason; may be empty	Yes	Protocol Design Error
enrollment	Enrollment Values	Comma-separated: GLOBAL: <n>, COUNTRY: <name>=<n>, REGION: <name>=<n>, COHORT: <cohort name>=<n>, SITE: <site name>=<n> (cohort/site referenced by name, resolved once the designs are built)	Yes	GLOBAL: 300, COHORT: T1DM=40
geographicScope	Geographic Scopes	Comma-separated scopes: Global, Region: <name>, Country: <name or code>	No (defaults to Global)	Global
template	Text	Document template this amendment's changed sections apply to (case-insensitive match on the document's template name; defaults to SPONSOR)	No	lilly
notes	Note References	Comma-separated note names	No	Amendment Note

Amendment Changes Sheet

Sheet Name: amendmentChanges

Defines specific changes made in amendments.

Column	Format	Description	Required	Example
amendment	Amendment Reference	Name (or legacy number) of the amendment the change belongs to	Yes	Amendment 1
name	Text	Change name	Yes	Inclusion Criteria Change
description	Text	Change description	Yes	Modified age range from 18-65 to 18-75
label	Text	Change label	No	Age Change
rationale	Text	Rationale for the change	Yes	Improve enrollment
summary	Text	Change summary	Yes	Age range widened to 18-75
sections	Section References	Comma-separated <section number>: <section title> pairs of the changed document sections	Yes	5.1: Inclusion Criteria

Amendment Impact Sheet

Sheet Name: amendmentImpact

Defines the impact of amendments.

Column	Format	Description	Required	CDISC CT Code List	Example
amendment	Amendment Reference	Name (or legacy number) of the amendment the impact belongs to	Yes	-	Amendment 1
text	Text	Impact description	Yes	-	Assessment of safety implications
substantial	Boolean	Substantial impact flag	Yes	-	true
type	CDISC CT	Type of impact	Yes	C215481	Study Subject Safety
notes	Note References	Comma-separated note names	No	-	Impact Note

Valid type values (C215481):

• Study Subject Safety (C215665)
• Study Subject Rights (C215666)
• Study Data Reliability (C215667)
• Study Data Robustness (C215668)

Assigned Person Sheet

Sheet Name: people

Defines persons assigned to study roles (referenced by name from the roles sheet's people column).

Column	Format	Description	Required	Example
name	Text	Person name (reference key)	Yes	PERSON_1
description	Text	Person description	No	Principal Investigator
label	Text	Person label	No	PI Smith
personName	Text	Structured name, two forms (see below)	No	Dr, Fred, Smith, MD
jobTitle	Text	Job title	Yes	Principal Investigator
organization	Organization Reference	Organization name	No	Site Hospital

personName forms:

• Comma form (prefixes, givenName..., familyName, suffixes, at least 4 comma-separated parts): prefixes and suffixes are space-separated within their part and may be empty, e.g. Dr, Fred, Smith, MD or , Fred, Smith,. This is the legacy dialect; the exporter uses it whenever prefixes or suffixes are present.
• Simple form (First [Middle...] Last): last word is the family name, the rest are given names.

Roles Sheet

Sheet Name: roles

Defines study roles, linking organizations and assigned persons to a role code.

Column	Format	Description	Required	Example
name	Text	Role name	Yes	ROLE_1
description	Text	Role description	No	Sponsor role
label	Text	Role label	No	Sponsor
role	CDISC CT	Role code	Yes	Sponsor
organizations	Organization References	Comma-separated organization names (studyOrganizations sheet)	No	ABC Pharmaceutical
people	Person References	Comma-separated assigned person names (people sheet)	No	PERSON_1
masking	Text	Masking description; the role is marked as masked when non-empty	No	Blinded to treatment
notes	Note References	Comma-separated note names	No	Role Note

Document Content Sheet

Sheet Name: documentContent

Defines content sections within documents.

Column	Format	Description	Required	Example
name	Text	Content item name (referenced from the template sheets' content column)	Yes	Inclusion Criteria
text	HTML/Text	Content text	Yes	<div>Patients must be 18-75 years old</div>

Notes:

• Text content is automatically wrapped in <div> tags if not already HTML
• Supports HTML formatting for rich content
• Text is sanitised to valid XHTML on import (CDISC CORE rules CORE-001069 / CORE-000945): disallowed elements (<style>, <script>, <meta>, <link>) and attributes (e.g. type on <ol>/<ul>/<li>) are removed and malformed tags repaired, each fix logged as a warning
• <usdm:macro/> tags in the text are expanded after the full study is assembled. Supported macro ids: xref (reference to a named object's attribute, path syntax supported), element (study elements such as study_full_title, study_identifier, study_phase), section (generated sections title_page, inclusion, exclusion, objective_endpoints with template="m11" or "plain", plus soa / timeline for the plain template), image (file inlined as base64 from the workbook's folder), note, bc and abbreviations. Expanded content carries <usdm:ref/> references, matching the legacy usdm package

Document Template Sheets

Sheet Name: not fixed — one sheet per document template. The sheet name is given by the sheetName column of the documentVersions sheet or, for legacy workbooks, by a TEMPLATE <name> = <sheet name> mapping on the configuration sheet (the legacy default maps the SPONSOR template to a sheet named document).

Defines the section structure (table of contents) of a document version, each row referencing a content item from the documentContent sheet.

Column	Format	Description	Required	Example
name	Text	Section name (defaults to SECTION <number> when empty)	Yes	Introduction
sectionNumber	Text	Dotted section number; the dot depth defines the section level	Yes	1.2
sectionTitle	Text	Section title	Yes	Trial Design
displaySectionNumber	Boolean	Display the section number	Yes	true
displaySectionTitle	Boolean	Display the section title	Yes	true
content	Content Reference	Name of the narrative content item (documentContent sheet)	Yes	Inclusion Criteria

Eligibility Criteria Items Sheet

Sheet Name: eligibilityCriteriaItems

Defines individual eligibility criteria items.

Column	Format	Description	Required	Example
name	Text	Criteria item name	Yes	Age Range
description	Text	Criteria description	Yes	Patient age must be within specified range
label	Text	Criteria label	Yes	Age
text	Text	Criteria text	Yes	Age 18-75 years inclusive
dictionary	Dictionary Reference	Dictionary name for parameterized text; may be empty	Yes	Age Template

Extensions Sheet

Sheet Name: extensions

Defines USDM extension attributes attached to the study version or to a study identifier, using a two-column name/value format.

Column	Format	Description	Required	Example
name	Text	<parent>: <url> where <parent> is StudyVersion or StudyIdentifier=<identifier text> and <url> is the extension URL	Yes	StudyVersion: http://example.com/ext/sponsor-flag
value	Text	<type>: <payload> where <type> is string, boolean, integer, id or code (code payload: <code>, system: <s>, version: <v>, decode: <d>); empty for a valueless attribute	No	string: some value

Sites Sheet

Sheet Name: studyDesignSites

Defines study sites, each managed by an organization from the studyOrganizations sheet.

Column	Format	Description	Required	Example
siteName / name	Text	Site name	Yes	Memorial Hospital
siteDescription / description	Text	Site description	Yes	Primary research site
siteLabel / label	Text	Site label	Yes	Site 001
siteCountry / country	ISO 3166 Code	Site country (code or name)	Yes	USA
organization	Organization Reference	Managing organization name	Yes	Site Hospital

Study Design Sheets

Study Design Sheet

Sheet Name: studyDesign

Defines a study design using a key-value format (Column A = key, Column B = value), followed by the arm/epoch design matrix. In the multi-workbook format this sheet lives in each design workbook; in the legacy format it is embedded in the main workbook.

Key	Format	Description	Required	CDISC CT Code List	Example
studyDesignName / name	Text	Study design name	Yes	-	Study Design 1
studyDesignDescription / description	Text	Study design description	Yes	-	The main study design
label	Text	Study design label	No	-	Main Design
studyDesignType / studyType	CDISC CT	Study type; Observational Study switches the design (and the sub type / time perspective / sampling method codelists) to observational	Yes	C99077	Interventional Study
studyDesignPhase / studyPhase	CDISC CT	Trial phase	Yes	C66737	Phase III Trial
studyDesignRationale	Text	Design rationale	Yes	-	Randomized to remove bias
therapeuticAreas	Codes	Comma-separated therapeutic area codes	No	-	SPONSOR: A1=Diabetes
studyDesignBlindingScheme	CDISC CT	Blinding schema (interventional)	No	C66735	Double Blind Study
trialIntentTypes	CDISC CT	Comma-separated intent types (interventional)	No	C66736	Treatment Study
trialSubTypes	CDISC CT	Comma-separated trial sub types	No	C66739 / C215486	Efficacy Study
interventionModel / model	CDISC CT	Intervention model	Yes	C99076	Parallel Study
mainTimeline	Sheet Reference	Sheet name of the main timeline (SoA) sheet	Yes	-	mainTimeline
otherTimelines	Sheet References	Comma-separated sheet names of additional timeline sheets	No	-	adverseEvents, followUp
specimenRetentions	Specimen References	Comma-separated names from the studyDesignSpecimen sheet	No	-	SPECIMEN_1
timePerspective	CDISC CT	Time perspective (observational)	No	C127261	Prospective
samplingMethod	CDISC CT	Sampling method (observational)	No	C127260	Probability Sampling
characteristics	CDISC CT	Comma-separated design characteristics	No	C207416	Randomized

The legacy masking key is recognised but ignored with a warning (masking moved to the roles sheet).

Design matrix: a blank key row ends the key/value block. The next row is a header row listing epoch names (studyDesignEpochs sheet) from column B onwards; each following row starts with an arm name (studyDesignArms sheet) in column A, and each body cell holds a comma-separated list of element names (studyDesignElements sheet) for that arm/epoch combination.

Study Design Arms Sheet

Sheet Name: studyDesignArms

Defines study arms/groups for the clinical trial.

Column	Format	Description	Required	CDISC CT Code List	Example
studyArmName / name	Text	Study arm name	Yes	-	Treatment Arm A
studyArmDescription / description	Text	Study arm description	Yes	-	Active treatment with Drug X
label	Text	Study arm label	No	-	Arm A
studyArmType / type	CDISC CT	Type of study arm	Yes	C174222	Investigational Arm
studyArmDataOriginDescription / dataOriginDescription	Text	Data origin description	Yes	-	Data collected during study
studyArmDataOriginType / dataOriginType	CDISC CT	Type of data origin	Yes	C188727	Data Generated Within Study
notes	Note References	Comma-separated note names	No	-	Safety Note 1, Efficacy Note

Valid studyArmType values (C174222):

• Investigational Arm (C174266)
• Active Comparator Arm (C174267)
• Placebo Control Arm (C174268)
• Protocol Treatment Arm (C15538)
• Sham Comparator Arm (C174269)
• No Intervention Arm (C174270)
• Control Arm (C174226)

Valid studyArmDataOriginType values (C188727):

• Historical Data (C188864)
• Data Generated Within Study (C188866)
• Real-world Data (C165830)
• Synthetic Data (C176263)
• Virtual Data (C188865)

Study Design Characteristics Sheet

Sheet Name: studyDesignCharacteristics

Defines study design characteristics.

Column	Format	Description	Required	Example
name	Text	Characteristic name	Yes	Randomization
description	Text	Characteristic description	Yes	Study uses randomization
label	Text	Characteristic label	Yes	Randomized
text	Text	Characteristic text/details	Yes	Subjects randomized 1:1
dictionary	Dictionary Reference	Dictionary name for parameterized text; may be empty	Yes	Randomization Template
notes	Note References	Comma-separated note names	No	Randomization Note

Study Design Encounters Sheet

Sheet Name: studyDesignEncounters

Defines study encounters/visits.

Column	Format	Description	Required	CDISC CT Code List	Example
encounterName / name	Text	Encounter name	Yes	-	Screening Visit
encounterDescription / description	Text	Encounter description	Yes	-	Initial screening procedures
label	Text	Encounter label	No	-	Visit 1
encounterType / type	CDISC CT	Type of encounter; may be empty	Yes	C188728	Visit
encounterEnvironmentalSetting / environmentalSettings / environmentalSetting	CDISC CT	Environmental settings (multiple)	Yes	C127262	Clinic, Hospital
encounterContactModes / contactModes	CDISC CT	Contact modes (multiple)	Yes	C171445	In Person, Telephone Call
transitionStartRule	Text	Start transition rule	No	-	After consent signed
transitionEndRule	Text	End transition rule	No	-	All procedures completed
window	Timing Reference	Name of the timing (studyDesignTiming sheet) the encounter is scheduled at	No	-	T1

Valid type values (C188728):

• Visit (C25716)

Valid environmentalSettings values (C127262):

• Household Environment (C102647)
• Childcare Center (C127785)
• Ambulatory Care Facility (C16281)
• Hospital (C16696)
• Healthcare Facility (C21541)
• Clinic (C211570)
• Home (C18002)
• And many more...

Valid contactModes values (C171445):

• Text Message (C157352)
• Audio-Videoconferencing (C171525)
• In Person (C175574)
• E-mail (C25170)
• Telephone Call (C171537)
• And more...

Study Design Epochs Sheet

Sheet Name: studyDesignEpochs

Defines study epochs/periods.

Column	Format	Description	Required	CDISC CT Code List	Example
studyEpochName / name	Text	Epoch name	Yes	-	Treatment Period
studyEpochDescription / description	Text	Epoch description	Yes	-	Active treatment phase
label	Text	Epoch label	No	-	Treatment
studyEpochType / type	CDISC CT	Type of epoch	Yes	C99079	Treatment Epoch
notes	Note References	Comma-separated note names	No	-	Treatment Note

Valid type values (C99079):

• Open Label Treatment Epoch (C102256)
• Product Exposure Epoch (C210380)
• Screening Epoch (C202487)
• Treatment Epoch (C101526)
• Follow-Up Epoch (C202578)
• Baseline Epoch (C125938)
• Washout Period (C42872)
• And more...

Study Design Elements Sheet

Sheet Name: studyDesignElements

Defines study elements, referenced from the studyDesign sheet's design matrix.

Column	Format	Description	Required	Example
studyElementName / name	Text	Element name	Yes	Screening
studyElementDescription / description	Text	Element description	Yes	Subject screening element
label	Text	Element label	No	Screen
transitionStartRule	Text	Start transition rule	No	After consent signed
transitionEndRule	Text	End transition rule	No	All procedures completed
notes	Note References	Comma-separated note names	No	Element Note

Study Design Activities Sheet

Sheet Name: studyDesignActivities

Defines study activities, referenced by name from the timeline (SoA) sheets.

Column	Format	Description	Required	Example
activityName / name	Text	Activity name	Yes	Blood Sample
activityDescription / description	Text	Activity description	Yes	Collect blood sample
label	Text	Activity label	No	Blood
notes	Note References	Comma-separated note names	No	Activity Note

Study Design Timing Sheet

Sheet Name: studyDesignTiming

Defines timings between the timepoints of the timeline (SoA) sheets.

Column	Format	Description	Required	CDISC CT Code List	Example
name	Text	Timing name	Yes	-	T1
description	Text	Timing description	Yes	-	Screening to dosing
label	Text	Timing label	Yes	-	Dose timing
type	Text	Fixed, After or Before	Yes	C201264	After
timingValue	Duration	Value and units, encoded as an ISO 8601 duration	Yes	-	7 days
toFrom	Text	Relative to/from: S2S, S2E, E2S or E2E (defaults to S2S)	Yes	C201265	S2S
from	Timepoint Reference	Name of the timepoint the timing is relative from	Yes	-	V1
to	Timepoint Reference	Name of the timepoint the timing is relative to	Yes	-	V2
window	Window	Timing window as <lower>..<upper> <units>; may be empty	Yes	-	-1..1 days

Timeline (SoA) Sheets

Sheet Name: not fixed — one sheet per timeline, named by the studyDesign sheet's mainTimeline and otherTimelines rows.

Each timeline sheet uses a fixed grid layout rather than a named-column table.

Timeline metadata (column B, rows 1-6):

Row	Content	Example
1	Timeline name	MAIN_TIMELINE
2	Timeline description	Main study schedule
3	Entry condition	Subject consented
4	Planned duration (quantity)	26 weeks
5	Reason duration will vary (empty when it will not)	Response dependent
6	Duration description	Around 26 weeks

Timepoint columns (column D onwards, rows 1-8): each column defines a scheduled instance:

Row	Content	Example
1	Timepoint name (reference key for timings and defaults)	V1
2	Timepoint description	Visit 1
3	Timepoint label	Visit 1
4	Instance type: Activity or Decision	Activity
5	Default reference: name of the next timepoint, or (EXIT) for a timeline exit; may be empty	V2
6	Condition assignments (decision instances)	if positive: V3
7	Epoch name (studyDesignEpochs sheet)	Treatment Period
8	Encounter name (studyDesignEncounters sheet)	Screening Visit

Optional timeline row (row 9): when the cell in column C of row 9 reads timeline, the row carries per-column timeline references (ScheduledActivityInstance.timelineId, resolved by timeline name with a legacy sheet-name fallback) and the header row and activity rows sit one row lower. The exporter always writes this row; legacy workbooks may omit it.

Activity rows (from row 10, or row 11 when the timeline row is present, below a header row): column A holds the parent activity name, column B the (child) activity name (studyDesignActivities sheet), column C comma-separated biomedical concept / procedure / timeline references for the activity, and each timepoint column an X marking the activity as performed at that timepoint.

Study Design Populations Sheet

Sheet Name: studyDesignPopulations

Defines the study design population and its cohorts. Exactly one row must have level MAIN; the remaining rows define cohorts.

Column	Format	Description	Required	Example
level	Text	MAIN for the design population, COHORT (anything else) for a cohort	Yes	MAIN
name	Text	Population/cohort name	Yes	POP1
description	Text	Population/cohort description	Yes	Full study population
label	Text	Population/cohort label	Yes	Population
plannedEnrollmentNumber	Quantity / Range	Planned enrollment, quantity or <low>..<high> range	Yes	300
plannedCompletionNumber	Quantity / Range	Planned completion, quantity or <low>..<high> range	Yes	250..280
plannedAge	Range	Planned age range with units; may be empty	Yes	18..75 years
plannedSexOfParticipants	CDISC CT	Up to two comma-separated values (C66732); may be empty	Yes	Female, Male
includesHealthySubjects	Boolean	Healthy subjects included flag	No	true
characteristics	Characteristic References	Comma-separated names (studyDesignCharacteristics sheet, cohorts only)	No	Randomization
indications	Indication References	Comma-separated names (studyDesignIndications sheet, cohorts only)	No	Diabetes

Study Design Objectives and Endpoints Sheet

Sheet Name: studyDesignOE

Defines objectives and their endpoints, one row per endpoint. A row with a non-empty objectiveText starts a new objective; following rows attach further endpoints to it. Rows with no endpoint content are objective-only.

Column	Format	Description	Required	CDISC CT Code List	Example
objectiveXref / objectiveName	Text	Objective name	Yes	-	OBJ1
objectiveDescription	Text	Objective description	No	-	Primary efficacy objective
objectiveLabel	Text	Objective label	No	-	Primary Objective
objectiveText	Text	Objective text; non-empty starts a new objective	No	-	To assess the efficacy of Drug X
objectiveLevel	CDISC CT	Objective level	Yes	C188725	Trial Primary Objective
objectiveDictionary	Dictionary Reference	Dictionary name for parameterized text	No	-	Objective Template
endpointXref / endpointName	Text	Endpoint name	No	-	EP1
endpointDescription	Text	Endpoint description	No	-	Change from baseline
endpointLabel	Text	Endpoint label	No	-	Primary Endpoint
endpointText	Text	Endpoint text	No	-	Change from baseline in HbA1c at week 26
endpointPurposeDescription / endpointPurpose	Text	Endpoint purpose (defaults to None provided)	No	-	Efficacy
endpointLevel	CDISC CT	Endpoint level	Yes	C188726	Primary Endpoint
endpointDictionary	Dictionary Reference	Dictionary name for parameterized text	No	-	Endpoint Template

Eligibility Criteria Sheet

Sheet Name: eligibilityCriteria

Defines the design-level eligibility criteria (preferred split dialect), each referencing a criterion item from the eligibilityCriteriaItems sheet.

Column	Format	Description	Required	CDISC CT Code List	Example
category	CDISC CT	Inclusion/exclusion category	Yes	C66797	Inclusion Criteria
identifier	Text	Criterion identifier	Yes	-	IE01
name	Text	Criterion name	Yes	-	Age Range
description	Text	Criterion description	Yes	-	Patient age must be within range
label	Text	Criterion label	Yes	-	Age
item	Item Reference	Name of the criterion item (eligibilityCriteriaItems sheet)	Yes	-	Age Range Item

Study Design Eligibility Criteria Sheet (Legacy)

Sheet Name: studyDesignEligibilityCriteria

The legacy one-sheet eligibility form: one row per criterion carrying both the criterion fields and the item text. Each row creates a criterion item (named <name>-ITEM) and a criterion referencing it. Read as a fallback when the split eligibilityCriteria / eligibilityCriteriaItems sheets are absent.

Column	Format	Description	Required	CDISC CT Code List	Example
category	CDISC CT	Inclusion/exclusion category	Yes	C66797	Exclusion Criteria
identifier	Text	Criterion identifier	Yes	-	IE01
name	Text	Criterion name	Yes	-	Age Range
description	Text	Criterion description	No	-	Patient age must be within range
label	Text	Criterion label	No	-	Age
text	Text	Criterion text	Yes	-	Age 18-75 years inclusive
dictionary	Dictionary Reference	Dictionary name for parameterized text	No	-	Age Template

Study Design Conditions Sheet

Sheet Name: studyDesignConditions

Defines conditions applying to activities, procedures or biomedical concepts.

Column	Format	Description	Required	Example
name	Text	Condition name	Yes	COND1
description	Text	Condition description	Yes	Only if clinically indicated
label	Text	Condition label	Yes	Clinically indicated
text	Text	Condition text	Yes	Perform only if clinically indicated
context	References	Comma-separated names of scheduled activity instances or activities the condition applies within; may be empty	Yes	V1, Blood Sample
appliesTo	References	Comma-separated names of procedures, activities or biomedical concepts the condition applies to; may be empty when a context is given	Yes	Blood Sample

Study Design Interventions Sheet

Sheet Name: studyDesignInterventions

Defines study interventions and their administrations.

Column	Format	Description	Required	CDISC CT Code List	Example
name	Text	Intervention name	Yes	-	Drug X Treatment
description	Text	Intervention description	No	-	Active treatment with Drug X
label	Text	Intervention label	No	-	Drug X
type	CDISC CT	Type of intervention	Yes	C99078	Pharmacologic Substance
role	CDISC CT	Role of intervention; may be empty	Yes	C207417	Experimental Intervention
codes	Codes	Additional codes; may be empty	Yes	-	C1909:Pharmacologic Substance
minimumResponseDuration	Quantity	Minimum response duration; may be empty	Yes	-	4 weeks
administrationName	Text	Administration name; empty when the row carries no administration	Yes	-	Daily Oral Dose
administrationDescription	Text	Administration description	No	-	Once daily oral administration
administrationLabel	Text	Administration label	No	-	QD PO
administrationDose	Quantity	Administration dose; may be empty	Yes	-	10 mg
administrationRoute	CDISC CT	Route of administration; may be empty	Yes	C66729	Oral
administrationFrequency	CDISC CT	Frequency of administration; may be empty	Yes	C71113	Once Daily
product	Product Reference	Product name (studyProducts sheet)	No	-	Drug X Tablet
administrationDurationDescription	Text	Duration description	No	-	Treatment continues for 12 weeks
administrationDurationWillVary	Boolean	Duration will vary flag	Yes	-	false
administrationDurationWillVaryReason	Text	Reason duration varies; may be empty	Yes	-	Based on response
administrationDurationQuantity	Quantity	Duration quantity; may be empty	Yes	-	12 weeks

Valid type values (C99078):

• Gene Therapy (C15238)
• Biological Agent (C307)
• Radiation Therapy (C15313)
• Medical Device (C16830)
• Diagnostic Procedure (C18020)
• Pharmacologic Substance (C1909)
• Combination Product (C54696)
• Dietary Supplement (C1505)
• Behavioral Intervention (C15184)
• Physical Medical Procedure (C98769)

Valid role values (C207417):

• Additional Required Treatment (C207614)
• Background Treatment (C165822)
• Challenge Agent (C158128)
• Diagnostic (C18020)
• Experimental Intervention (C41161)
• Placebo (C753)
• Rescue Medicine (C165835)
• Active Comparator (C68609)

Study Design Procedures Sheet

Sheet Name: studyDesignProcedures

Defines procedures, referenced from the timeline (SoA) sheets' activity rows.

Column	Format	Description	Required	Example
procedureName / name	Text	Procedure name	Yes	Blood Draw
procedureDescription / description	Text	Procedure description	Yes	Venous blood draw
label	Text	Procedure label	No	Blood Draw
procedureType	Text	Procedure type	Yes	Diagnostic
procedureCode / code	Code	Procedure code; may be empty	Yes	SPONSOR: BD1=Blood Draw

Study Design Estimands Sheet

Sheet Name: studyDesignEstimands

Defines estimands, one row per intercurrent event. A row with a non-empty summaryMeasure starts a new estimand; following rows attach further intercurrent events to it (empty event name/description repeat the previous row's values).

Column	Format	Description	Required	Example
name / xref	Text	Estimand name (xref is the legacy heading)	Yes	ESTIMAND1
summaryMeasure	Text	Population summary measure; non-empty starts a new estimand	Yes	Difference in mean change from baseline
populationDescription	Text	Analysis population description	Yes	All randomized subjects
populationSubset	Population Reference	Name of the population or cohort (studyDesignPopulations sheet) the analysis population subsets	Yes	POP1
intercurrentEventName	Text	Intercurrent event name	Yes	ICE1
intercurrentEventDescription / description	Text	Intercurrent event description	Yes	Discontinuation of treatment
label	Text	Intercurrent event label	No	Discontinuation
intercurrentEventStrategy	Text	Intercurrent event strategy	Yes	Treatment policy
intercurrentEventText	Text	Intercurrent event text	Yes	Subjects discontinuing treatment
treatment / treatmentXref	Intervention Reference	Name of the intervention (studyDesignInterventions sheet)	Yes	Drug X Treatment
endpoint / endpointXref	Endpoint Reference	Name of the endpoint (studyDesignOE sheet)	Yes	EP1

Study Design Indications Sheet

Sheet Name: studyDesignIndications

Defines study indications.

Column	Format	Description	Required	Example
name	Text	Indication name	Yes	IND1
description	Text	Indication description	Yes	Type 2 diabetes mellitus
label	Text	Indication label	No	T2DM
isRareDisease	Boolean	Rare disease flag	No	false
codes	Codes	Comma-separated codes; may be empty	Yes	SNOMED: 44054006=Diabetes mellitus type 2
notes	Note References	Comma-separated note names	No	Indication Note

Study Design Specimen Sheet

Sheet Name: studyDesignSpecimen

Defines biospecimen retentions, referenced from the studyDesign sheet's specimenRetentions row.

Column	Format	Description	Required	Example
name	Text	Specimen retention name (reference key)	Yes	SPECIMEN_1
description	Text	Specimen retention description	No	Serum samples retained
label	Text	Specimen retention label	No	Serum
retained	Boolean	Specimen is retained	Yes	true
includesDNA	Boolean	Retention includes DNA	Yes	false

Study Products Sheet

Sheet Name: studyProducts

Defines administrable products with their ingredients, substances and strengths. A row with a non-empty name starts a new product; following rows add further ingredients/strengths to it. Reference substance columns describe the substance a strength is expressed relative to.

Column	Format	Description	Required	CDISC CT Code List	Example
name	Text	Product name; empty continues the previous product	Yes	-	Drug X Tablet
description	Text	Product description	No	-	Drug X 10 mg film-coated tablet
label	Text	Product label	No	-	Drug X
administrableDoseForm	CDISC CT	Dose form	Yes	C66726	Tablet
productDesignation	CDISC CT	Product designation	Yes	C207418	Investigational Product
pharmacologicClass	Code	Pharmacologic class code; may be empty	Yes	-	MED-RT: N0000175565=Kinase Inhibitor
productSourcing	CDISC CT	Product sourcing; may be empty	Yes	-	Centrally Sourced
substanceName	Text	Ingredient substance name; empty when the row carries no ingredient	Yes	-	Substance X
substanceDescription	Text	Substance description	No	-	Active substance
substanceLabel	Text	Substance label	No	-	Substance X
substanceCode	Code	Substance code; may be empty	Yes	-	UNII: ABC123=Substance X
ingredientRole	Code	Ingredient role code; may be empty	Yes	-	SPONSOR: A=Active Ingredient
strengthName	Text	Strength name; empty when the row carries no strength	Yes	-	STRENGTH_1
strengthdescription	Text	Strength description (note the lowercase d)	No	-	10 mg per tablet
strengthLabel	Text	Strength label	No	-	10 mg
strengthNumerator	Quantity / Range	Strength numerator, quantity or <low>..<high> range	Yes	-	10 mg
strengthDenominator	Quantity	Strength denominator	Yes	-	1 tablet
referenceSubstanceName	Text	Reference substance name; empty when none	Yes	-	Substance X Base
referenceSubstanceDescription	Text	Reference substance description	No	-	Base form
referenceSubstanceLabel	Text	Reference substance label	No	-	Base
referenceSubstanceCode	Code	Reference substance code; may be empty	Yes	-	UNII: DEF456=Substance X Base
referenceSubstanceStrengthName	Text	Reference substance strength name; empty when none	Yes	-	REF_STRENGTH_1
referenceSubstanceStrengthdescription	Text	Reference substance strength description (note the lowercase d)	No	-	9 mg base per tablet
referenceSubstanceStrengthLabel	Text	Reference substance strength label	No	-	9 mg
referenceSubstanceStrengthNumerator	Quantity / Range	Reference strength numerator, quantity or range	Yes	-	9 mg
referenceSubstanceStrengthDenominator	Quantity	Reference strength denominator	Yes	-	1 tablet

Study Product Organization Roles Sheet

Sheet Name: studyProductOrganizationRoles

Defines organization roles for products and devices.

Column	Format	Description	Required	Example
name	Text	Role name	Yes	PROD_ROLE_1
description	Text	Role description	No	Manufacturer of Drug X
label	Text	Role label	No	Manufacturer
organization	Organization Reference	Organization name (studyOrganizations sheet)	Yes	ABC Pharmaceutical
role	CDISC CT	Organization role code	Yes	Manufacturer
appliesTo	References	Comma-separated product or device names (studyProducts / studyDevices sheets)	No	Drug X Tablet

Study Devices Sheet

Sheet Name: studyDevices

Defines medical devices, each embedding a product from the studyProducts sheet.

Column	Format	Description	Required	Example
name	Text	Device name	Yes	Injection Pen
description	Text	Device description	Yes	Pre-filled injection pen
label	Text	Device label	Yes	Pen
hardwareVersion	Text	Hardware version	Yes	2.0
softwareVersion	Text	Software version	Yes	1.4.2
sourcing	CDISC CT	Device sourcing	Yes	Centrally Sourced
product	Product Reference	Name of the embedded administrable product (studyProducts sheet)	Yes	Drug X Tablet
notes	Note References	Comma-separated note names	No	Device Note

Data Format Guidelines

Text Fields

• Standard text fields accept any string value
• Leading and trailing whitespace is automatically trimmed
• Empty strings are treated as null/missing values

CDISC CT Fields

• Use preferred terms (human-readable text) rather than C-codes
• System automatically looks up corresponding C-codes
• Case-sensitive matching
• Examples: Investigational Arm, Treatment Epoch, Oral

Multiple Values

• Separate multiple values with commas
• Example: In Person, Telephone Call
• Whitespace around commas is automatically trimmed

Quantity Fields

• Format: <value> <unit>
• Examples: 10 mg, 4 weeks, 2.5 hours
• Units must be valid CDISC CT terms from C71620

Boolean Fields

• Accepted true values: true, TRUE, yes, YES, 1
• Accepted false values: false, FALSE, no, NO, 0
• Empty values default to false

Reference Fields

• Reference other objects by their name field
• Must match exactly (case-sensitive)
• Referenced objects must exist in the system

Note References

• Reference notes defined in the Notes sheet
• Multiple notes separated by commas
• Example: Safety Note 1, Efficacy Note

CDISC CT Code Lists

The following CDISC CT code lists are used throughout the system:

Code List	Description	Used For
C66726	CDISC SDTM Dosage Form Terminology	AdministrableProduct.administrableDoseForm
C66729	CDISC SDTM Route of Administration Terminology	Administration.route
C66732	CDISC SDTM Sex of Study Group Terminology	StudyDesignPopulation.plannedSex
C66735	CDISC SDTM Trial Blinding Schema Terminology	InterventionalStudyDesign.blindingSchema
C66736	CDISC SDTM Trial Indication Type Terminology	InterventionalStudyDesign.intentTypes
C66737	CDISC SDTM Trial Phase Terminology	StudyDesign.studyPhase
C66739	CDISC SDTM Trial Type Terminology	InterventionalStudyDesign.subTypes
C66797	CDISC SDTM Category for Inclusion And Or Exclusion Terminology	EligibilityCriteria.category
C71113	CDISC SDTM Frequency Terminology	Administration.frequency
C71620	CDISC SDTM Unit of Measure Terminology	Quantity.unit
C99076	CDISC SDTM Intervention Model Terminology	StudyDesign.interventionModel
C99077	CDISC SDTM Study Type Terminology	StudyDesign.studyType
C99078	CDISC SDTM Intervention Type Terminology	StudyIntervention.type
C99079	CDISC SDTM Epoch Terminology	StudyEpoch.type
C127260	CDISC SDTM Observational Study Sampling Method Terminology	ObservationalStudyDesign.samplingMethod
C127261	CDISC SDTM Observational Study Time Perspective Terminology	ObservationalStudyDesign.timePerspective
C127262	CDISC SDTM Environmental Setting Terminology	Encounter.environmentalSettings
C171445	CDISC SDTM Mode of Subject Contact Terminology	Encounter.contactModes
C174222	CDISC Protocol Study Arm Type Value Set Terminology	StudyArm.type
C188723	CDISC DDF Protocol Status Value Set Terminology	StudyProtocolVersion.protocolStatus
C188724	CDISC DDF Organization Type Value Set Terminology	Organization.type
C188725	CDISC DDF Objective Level Value Set Terminology	Objective.level
C188726	CDISC DDF Endpoint Level Value Set Terminology	Endpoint.level
C188727	CDISC DDF Study Arm Data Origin Type Value Set Terminology	StudyArm.dataOriginType
C188728	CDISC DDF Encounter Type Value Set Terminology	Encounter.type
C201264	CDISC DDF Timing Type Value Set Terminology	Timing.type
C201265	CDISC DDF Timing Relative To From Value Set Terminology	Timing.relativeToFrom
C207412	CDISC DDF Geographic Scope Type Value Set Terminology	GeographicScope.type
C207413	CDISC DDF Governance Date Type Value Set Terminology	GovernanceDate.type
C207415	CDISC DDF Study Amendment Reason Code Value Set Terminology	StudyAmendmentReason.code
C207416	CDISC DDF Study Design Characteristics Value Set Terminology	StudyDesign.characteristics
C207417	CDISC DDF Study Intervention Role Value Set Terminology	StudyIntervention.role
C207418	CDISC DDF Study Intervention Product Designation Value Set Terminology	AdministrableProduct.productDesignation
C207419	CDISC DDF Study Title Type Value Set Terminology	StudyTitle.type

For complete lists of valid values, refer to the CDISC CT Excel file at /Users/daveih/Documents/github/infographics/usdm_ct_infographic/ct.xlsx.

Notes

1. Optional vs Required Sheets: Most sheets are optional. If a sheet is not present, the system will continue processing other sheets.

2. Error Handling: The system provides detailed error messages with cell locations when validation fails.

3. Cross-References: Many fields reference objects defined in other sheets. Ensure referenced objects are created before they are referenced.

4. CDISC CT Updates: CDISC CT versions can be configured in the Configuration sheet. The system will use the specified versions for code validation.

5. Extensibility: Most CDISC CT code lists are extensible, meaning custom codes can be added beyond the standard terminology.

6. Case Sensitivity: CDISC CT preferred terms are case-sensitive and must match exactly as defined in the terminology.

Building the Package

Build steps for deployment to pypi.org

• Build with python3 -m build --sdist --wheel
• Upload to pypi.org using twine upload dist/*