Phase 3, GGG Approval Release

Post public review release. Comments from the public review have been incorporated. This is the version ready for GGG approval.

The release includes (DDF-RA issues) JIRA ticket references:

• Precise definition of the parameter maps (#327, #328, #329, #339, #344) JIRA-496, JIRA-508
• Further flexibility for codes within the route of, frequency and units of administrations (#325, #326, #346) JIRA-514, JIRA-517
• Consistency with names, description and labels for ScheduleInstances (#317, #318, #319, #320) JIRA-520
• Clarity around structured text syntax (#312) JIRA-520
• Controlled terminology and consistent approach wrt subject / participant in definitions (#301) JIRA-503
• Controlled terminology and updates to objective definitions (#310) JIRA-520
• Controlled terminology fixes and tweaks (#302, #338) JIRA-489, JIRA-490, JIRA-491, JIRA-492, JIRA-501, JIRA-506
• Fix relationship cardinality for Interventions (Quantity class) (#303, #304, #347) JIRA-519
• Fix planned sex relationship to optional in Study Population (#340, #341, #342)
• Add model version, system name and system version to API (#313, #349) JIRA-498, JIRA-520
• Update IG to define minimum API content (#315) JIRA-499, JIRA-500, JIRA-520
• Update IG to clarify Syntax Template syntax (#260) and JIRA-509
• Update IG to clarify Timing relationships JIRA-487
• Update CT to clarify Timing description attribute definition JIRA-492
• Update IG to clarify BC enabled and required attribute use JIRA-493
• Update IG to clarify use of the Timeline Exit class JIRA-507
• Update IG with small wording changes and typographical errors JIRA-511, JIRA-512, JIRA-513

The following changes were made as a result of internal team testing undertaken during the public review comment resolution process:

• Fix objective level (#321, #322, #323)
• Narrative Content improvements(#335, #336, #337, #345)
• Timing value attribute improvements (#331, #332, #333, #343)

Phase 3, Public Review Release, Release 2.10.0

Release for public review following internal team review and GGG approval.

Phase 3, Release 2.9.0

This release contain the following changes:

• Renamed attribute type in studyVersion class to studyType (#257)
• Renamed attribute type in organization class to organizationType (#258) to avoid confusion. (also raised a new ticket as there are still concerns in the team regarding organizations – for public review)
• Renamed class EligibilityCriteria to EligibilityCriterion #279
• Renamed relationship from estimand to intervention class to ‘intervention’ (instead of treatment) #279
• Remove relationship from StudyDesign to Site. Make the relationship go from StudyDesign to ResearchOrganization. The new relationship name is now ‘organizations’ #262
• From API perspective: StudySites are now nested in researchOrganization
• Only for API: changed childrenIds to childIds #279
• Move relationship "timings" from ScheduledInstance to ScheduleTimeline. #263
• Allow for multiple options for environmental setting #244 – multiplicity changed to 0..*

Phase 3, Release 2.8.1

API bug fixes. Correct two issues found during testing

• Update SubjectEnrollment, quantity attribute type from string -> Quantity
• Update StudyIntervention, administrations to a list

Phase 3, Release 2.8.0

This release contain the following changes:

• Better condition handling: #231, #105, #220, #221, #223
• SDTM TS Domain support: #246, #245, #247, #175
• Interventions: #250, #249, #251
• Study Titles: #170, #217, #224
• CT.gov Support: #238, #239, #240, #241
• Multi centre support: #234, #233, #235, #236
• Model refactoring with Quantity, Range: #213, #213, #226

API updates: #255
IG updates: #150, #188, #178, #181, #177, #112, #211

Phase 3, Release 2.7.1

This release contains API fixes contained within ticket #219. Note that one example file has been updated as part of this release

Phase 3, Release Version 2.7.0

This release contain the following major changes:

• Cohorts #185, #186, #187

Note that the examples and the Implementation Guide have NOT been updated.

Phase 3, Release Version 2.6.0

This release contain the following major changes:

• Intervention Dose and Administration #171 , #172 , #173

This release contains content from the following PBIs:

#179
#180
#184
#191
#193
#201
#202
#203

Note that the examples and the Implementation Guide have NOT been updated.

Phase 3, Release Version 2.5.0

This release contain the following major changes:

• Documents & Amendments incorporating #137, #95, #118

This release contains content from the following PBIs:

#145
#154
#156
#157
#158
#167
#168
#174
#182

Note that the examples and the Implementation Guide have NOT been updated.

Phase 3, Release 2.4.1

This release introduces a new UML artefact built directly from Enterprise Architect. In addition the release includes an API bug fix #167