A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder who Have had an Inadequate Response to Antidepressants Alone

Source: Publicly Available
Added: 16 Jun 2026
Contributor: System
Produced by: USDM Template v12 12.0.0

Phase III Trial Interventional Study v1.0 USDM v4.0.0

Sponsor: Sponsor Organization
Protocol ID: 3111-302-001
Identifier: NCT03739203

SynopsisSynopsis
Objectives and endpointsObjectives
EligibilityEligibility not in this file
Study designDesign
InterventionsInterventions
Schedule of ActivitiesSchedule
Protocol documentDocument not in this file
ConformanceConformance

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Synopsis

A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder who Have had an Inadequate Response to Antidepressants Alone

Study

Study type: Interventional Study
Phase: Phase III Trial
Therapeutic area: Psychiatry/Psychology
Protocol version: 1.0

Design

Design: Not stated
Model: Single Group Study
Blinding: Open Label Study
Intent: Treatment Study
Arms: 1
Epochs: 3

Participants

Population: Study population
Planned enrolment: 750
Sex: Both
Age: 18 Year to 65 Year
Healthy participants: Patients only

Key dates

Protocol Approval: 01 Jan 2024

Objectives and endpoints

Primary

To evaluate the efficacy of cariprazine 1.5 mg/day and 3 mg/day compared with placebo as an adjunctive treatment to ADT in patients with MDD who have had an inadequate response to antidepressants alone.

Primary
Change from baseline to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Primary
Change from baseline in the CGI-S score.
Primary
Analysis of CGI-I score.
Primary
CGI-I response (CGI-I score ≤ 2).
Primary
MADRS response (≥ 50% reduction from baseline in MADRS total score).
Primary
MADRS remission (MADRS total score ≤ 10).
Primary
Change from baseline in the HAMD-17 total score.
Primary
Change from baseline in the HAM-A total score.

Secondary

To evaluate the safety and tolerability of cariprazine 1.5 mg/day and 3 mg/day compared with placebo as an adjunctive treatment to ADT in patients with MDD who have had an inadequate response to antidepressants alone.

Secondary
The safety parameters will include AEs, clinical laboratory parameters, vital signs, ECG parameters, EPS scales, the C-SSRS and the YMRS..

Study design

What each arm receives in each epoch of the study.
Arm	Screening	Treatment	Follow Up
Main Protocol Treatment Arm	—	—	—

Interventions

VRAYLAR®

Cariprazine 1.5mg (Route: Oral)

VRAYLAR®

Cariprazine 3mg (Route: Oral)

Placebo

Placebo (Route: Oral)

Schedule of Activities

7 visits 55 activities Entry: Subject enrolled in study arm

Schedule of Activities — 7 visits

Activities by visit. A dot marks a visit at which the activity takes place.
Activity	Screening	Treatment					Follow Up
Visit	1 Main Day 42	1 Main Day 29	8 Main Day 8	15 Main Day 1	29 Main Day 1	42 Main Day 28	28 Main Day 15
From previous visit	◆ Treatment Day 1.0		+1 day	+1 day	+1 day	+1 day	+1 day
Structured Clinical Interview for DSM-5 Axis I Disorders (SCID-5)	Structured Clinical Interview for DSM-5 Axis I Disorders (SCID-5) at 1
Inclusion/Exclusion Criteria	Inclusion/Exclusion Criteria at 1
Abnormal Involuntary Movement Scale (AIMS)		Abnormal Involuntary Movement Scale (AIMS) at 1	Abnormal Involuntary Movement Scale (AIMS) at 8	Abnormal Involuntary Movement Scale (AIMS) at 15	Abnormal Involuntary Movement Scale (AIMS) at 29	Abnormal Involuntary Movement Scale (AIMS) at 42
Medical History, Relevant	Medical History, Relevant at 1
IRT-Randomization		IRT-Randomization at 1
CBC W Differential Panel (Automated), Bld	CBC W Differential Panel (Automated), Bld at 1					CBC W Differential Panel (Automated), Bld at 42
SAFER Score Evaluation	SAFER Score Evaluation at 1	SAFER Score Evaluation at 1
Complete Physical Exam	Complete Physical Exam at 1					Complete Physical Exam at 42
Adverse Events	Adverse Events at 1	Adverse Events at 1	Adverse Events at 8	Adverse Events at 15	Adverse Events at 29	Adverse Events at 42	Adverse Events at 28
Prolactin [Mass/Vol]	Prolactin [Mass/Vol] at 1					Prolactin [Mass/Vol] at 42
Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS)		Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS) at 1	Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS) at 8	Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS) at 15	Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS) at 29	Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS) at 42	Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS) at 28
Verified Clinical Trials (VCT) Check	Verified Clinical Trials (VCT) Check at 1
Magnesium [Mass/Vol]	Magnesium [Mass/Vol] at 1					Magnesium [Mass/Vol] at 42
Urinalysis Dipstick w Reflex Microscopic Panel	Urinalysis Dipstick w Reflex Microscopic Panel at 1					Urinalysis Dipstick w Reflex Microscopic Panel at 42
Hamilton Anxiety Rating Scale (HAM-A)		Hamilton Anxiety Rating Scale (HAM-A) at 1		Hamilton Anxiety Rating Scale (HAM-A) at 15		Hamilton Anxiety Rating Scale (HAM-A) at 42
12 Lead ECG	12 Lead ECG at 1					12 Lead ECG at 42
Chemistry Panel (CHEM-20), Ser/Plas	Chemistry Panel (CHEM-20), Ser/Plas at 1					Chemistry Panel (CHEM-20), Ser/Plas at 42
Medication Compliance Assessment		Medication Compliance Assessment at 1	Medication Compliance Assessment at 8	Medication Compliance Assessment at 15	Medication Compliance Assessment at 29	Medication Compliance Assessment at 42
Investigational Product Compliance Assessment			Investigational Product Compliance Assessment at 8	Investigational Product Compliance Assessment at 15	Investigational Product Compliance Assessment at 29	Investigational Product Compliance Assessment at 42
Investigational Product Return			Investigational Product Return at 8	Investigational Product Return at 15	Investigational Product Return at 29	Investigational Product Return at 42
Medical History, General (Lifetime)	Medical History, General (Lifetime) at 1
Simpson Angus Scale (SAS)		Simpson Angus Scale (SAS) at 1	Simpson Angus Scale (SAS) at 8	Simpson Angus Scale (SAS) at 15	Simpson Angus Scale (SAS) at 29	Simpson Angus Scale (SAS) at 42
IP Administration - Oral Capsule		IP Administration - Oral Capsule at 1	IP Administration - Oral Capsule at 8	IP Administration - Oral Capsule at 15	IP Administration - Oral Capsule at 29	IP Administration - Oral Capsule at 42
Prior Medications	Prior Medications at 1
Bilirubin Direct [Mass/Vol]	Bilirubin Direct [Mass/Vol] at 1					Bilirubin Direct [Mass/Vol] at 42
Clinical Global Impression of Improvement (CGI-I)			Clinical Global Impression of Improvement (CGI-I) at 8	Clinical Global Impression of Improvement (CGI-I) at 15	Clinical Global Impression of Improvement (CGI-I) at 29	Clinical Global Impression of Improvement (CGI-I) at 42
Lipid Panel, Ser/Plas	Lipid Panel, Ser/Plas at 1					Lipid Panel, Ser/Plas at 42
Insulin [Mass/Vol]	Insulin [Mass/Vol] at 1					Insulin [Mass/Vol] at 42
Columbia-Suicide Severity Rating Scale, Lifetime (C-SSRS)	Columbia-Suicide Severity Rating Scale, Lifetime (C-SSRS) at 1
Montgomery-Asberg Depression Rating Scale (MADRS)	Montgomery-Asberg Depression Rating Scale (MADRS) at 1	Montgomery-Asberg Depression Rating Scale (MADRS) at 1	Montgomery-Asberg Depression Rating Scale (MADRS) at 8	Montgomery-Asberg Depression Rating Scale (MADRS) at 15	Montgomery-Asberg Depression Rating Scale (MADRS) at 29
Pharmacogenetic DNA Analysis Panel, Bld/Tiss		Pharmacogenetic DNA Analysis Panel, Bld/Tiss at 1	Pharmacogenetic DNA Analysis Panel, Bld/Tiss at 8	Pharmacogenetic DNA Analysis Panel, Bld/Tiss at 15	Pharmacogenetic DNA Analysis Panel, Bld/Tiss at 29	Pharmacogenetic DNA Analysis Panel, Bld/Tiss at 42
Antidepressant Treatment Response Questionnaire (ATRQ), ClinRO	Antidepressant Treatment Response Questionnaire (ATRQ), ClinRO at 1
Investigational Product Dispensation		Investigational Product Dispensation at 1	Investigational Product Dispensation at 8	Investigational Product Dispensation at 15	Investigational Product Dispensation at 29
Informed Consent Obtained	Informed Consent Obtained at 1	Informed Consent Obtained at 1
Vital Signs	Vital Signs at 1	Vital Signs at 1	Vital Signs at 8	Vital Signs at 15	Vital Signs at 29	Vital Signs at 42	Vital Signs at 28
SAFER Criteria Inventory	SAFER Criteria Inventory at 1
Young Mania Rating Scale (YMRS)	Young Mania Rating Scale (YMRS) at 1	Young Mania Rating Scale (YMRS) at 1	Young Mania Rating Scale (YMRS) at 8
Barnes Akathisia Rating Scale (BARS)		Barnes Akathisia Rating Scale (BARS) at 1	Barnes Akathisia Rating Scale (BARS) at 8	Barnes Akathisia Rating Scale (BARS) at 15	Barnes Akathisia Rating Scale (BARS) at 29	Barnes Akathisia Rating Scale (BARS) at 42
Hemoglobin A1c (HbA1c) [Mass/Vol], Bld	Hemoglobin A1c (HbA1c) [Mass/Vol], Bld at 1
Concomitant Medications	Concomitant Medications at 1	Concomitant Medications at 1	Concomitant Medications at 8	Concomitant Medications at 15	Concomitant Medications at 29	Concomitant Medications at 42	Concomitant Medications at 28
PK Sampling, Bld				PK Sampling, Bld at 15	PK Sampling, Bld at 29	PK Sampling, Bld at 42
Clinical Global Impression of Severity (CGI-S)	Clinical Global Impression of Severity (CGI-S) at 1	Clinical Global Impression of Severity (CGI-S) at 1	Clinical Global Impression of Severity (CGI-S) at 8	Clinical Global Impression of Severity (CGI-S) at 15	Clinical Global Impression of Severity (CGI-S) at 29	Clinical Global Impression of Severity (CGI-S) at 42
Lactate Dehydrogenase [Act/Vol]	Lactate Dehydrogenase [Act/Vol] at 1					Lactate Dehydrogenase [Act/Vol] at 42
Drug Identification by Screen Method, Urine	Drug Identification by Screen Method, Urine at 1
Informed Consent, Optional Sample Collection (Pharmacogenetic)	Informed Consent, Optional Sample Collection (Pharmacogenetic) at 1	Informed Consent, Optional Sample Collection (Pharmacogenetic) at 1	Informed Consent, Optional Sample Collection (Pharmacogenetic) at 8	Informed Consent, Optional Sample Collection (Pharmacogenetic) at 15	Informed Consent, Optional Sample Collection (Pharmacogenetic) at 29	Informed Consent, Optional Sample Collection (Pharmacogenetic) at 42
Myoglobin [Presence], Urine	Myoglobin [Presence], Urine at 1
Human Chorionic Gonadotropin (HCG) Beta Subunit (Pregnancy Test) [Presence]	Human Chorionic Gonadotropin (HCG) Beta Subunit (Pregnancy Test) [Presence] at 1					Human Chorionic Gonadotropin (HCG) Beta Subunit (Pregnancy Test) [Presence] at 42	Human Chorionic Gonadotropin (HCG) Beta Subunit (Pregnancy Test) [Presence] at 28
Thyroid Function Panel (TSH/FT3/FT4), Ser/Plas	Thyroid Function Panel (TSH/FT3/FT4), Ser/Plas at 1					Thyroid Function Panel (TSH/FT3/FT4), Ser/Plas at 42
Hamilton Depression Rating Scale (HDRS-17)	Hamilton Depression Rating Scale (HDRS-17) at 1	Hamilton Depression Rating Scale (HDRS-17) at 1				Hamilton Depression Rating Scale (HDRS-17) at 42
Alcohol Breath Test	Alcohol Breath Test at 1
12-Item Short Form Survey (SF-12)		12-Item Short Form Survey (SF-12) at 1				12-Item Short Form Survey (SF-12) at 42
HBV and HCV Screening and Diagnosis, Ser/Plas	HBV and HCV Screening and Diagnosis, Ser/Plas at 1
Bilirubin Indirect [Mass/Vol]	Bilirubin Indirect [Mass/Vol] at 1					Bilirubin Indirect [Mass/Vol] at 42
Creatine Kinase [Act/Vol]	Creatine Kinase [Act/Vol] at 1					Creatine Kinase [Act/Vol] at 42
Non-IP Administration - Oral Capsule		Non-IP Administration - Oral Capsule at 1	Non-IP Administration - Oral Capsule at 8	Non-IP Administration - Oral Capsule at 15	Non-IP Administration - Oral Capsule at 29	Non-IP Administration - Oral Capsule at 42

◆ marks the fixed reference the other visits are timed from. Study days are not shown: the timings in this schedule do not connect every visit to it.

No entry point is declared, which USDM requires. The first visit is inferred as the only one nothing else leads to.

Conformance CDISC CORE CDISC Open Rules Engine 21 rules reported issues 207 rules 128 passed 16 with errors 4 with warnings 1 unrated 58 not evaluated 458 issues, most against Activity, Estimand and Location Engine 0.15.0 USDM v4.0 rules Run 16 Jun 2026

CDISC CORE

CDISC Open Rules Engine

21 rules reported issues 207 rules 128 passed 16 with errors 4 with warnings 1 unrated 58 not evaluated 458 issues, most against Activity, Estimand and Location Engine 0.15.0 USDM v4.0 rules Run 16 Jun 2026

JSON report

Partially executable: CDISC notes this rule may report issues that are not present. Engine wording: “partially executable - possible overreporting”.

In this document

Object	Location in the file	Values
Code Code_501	/study/versions/0/studyDesigns/0/objectives/0/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Objective
Code Code_601	/study/versions/0/studyDesigns/0/objectives/0/endpoints/0/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Endpoint
Code Code_602	/study/versions/0/studyDesigns/0/objectives/0/endpoints/1/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Endpoint
Code Code_603	/study/versions/0/studyDesigns/0/objectives/0/endpoints/2/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Endpoint
Code Code_604	/study/versions/0/studyDesigns/0/objectives/0/endpoints/3/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Endpoint
Code Code_605	/study/versions/0/studyDesigns/0/objectives/0/endpoints/4/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Endpoint
Code Code_606	/study/versions/0/studyDesigns/0/objectives/0/endpoints/5/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Endpoint
Code Code_607	/study/versions/0/studyDesigns/0/objectives/0/endpoints/6/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Endpoint
Code Code_608	/study/versions/0/studyDesigns/0/objectives/0/endpoints/7/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98772 decode Primary Endpoint
Code Code_502	/study/versions/0/studyDesigns/0/objectives/1/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Objective
Code Code_601	/study/versions/0/studyDesigns/0/objectives/1/endpoints/0/level	codeSystem http://www.cdisc.org codeSystemVersion 2025-09-26 code C98781 decode Secondary Endpoint

Not evaluated 58

53 skipped · 5 engine errors 58 rules

DDF00084 Engine error There is not exactly one objective with a level of 'Primary Objective' within the study design. Failed to execute rule operation. Operation: distinct, Target: text, Domain: Objective, Error: 'Column not found: text'
DDF00107 Engine error The scheduled activity instance has a sub-timeline that is not defined within the same study design. Failed to execute rule operation. Operation: distinct, Target: parent_id, Domain: ScheduleTimeline, Error: 'timelineId'
DDF00114 Engine error The specified context of the condition is not a valid instance of either the Activity or ScheduledActivityInstance class (the value of the condition's contextIds attribute either matches the id of an instance that is not an Activity or ScheduledActivityInstance, or it does not match the id of any class instance). Failed to execute rule operation. Operation: record_count, Target: None, Domain: Condition, Error: Failed to execute rule operation. Domain Condition does not exist. Operation: record_count, Target: None, Core ID: CORE-000878
DDF00181 Engine error The study definition document version has more than one governance date with the same type and geographic scope. Cannot perform 'rand_' with a dtyped [float64] array and scalar of type [bool]
DDF00247 Engine error The text attribute contains non-conformant XHTML. Failed to execute rule operation. Operation: get_xhtml_errors, Target: text, Domain: Objective, Error: 'text'
DDF00006 Skipped One or more of the window attributes (windowLabel, windowLower, windowUpper) is missing.
DDF00013 Skipped A required biomedical concept property (isRequired=true) is not enabled (isEnabled is not true), or a disabled biomedical concept property (isEnabled=false) is required (isRequired is not false).
DDF00014 Skipped The biomedical concept category does not have any members or children.
DDF00020 Skipped Population of otherReason is not consistent with code - code.code is C17649 ('Other') but otherReason is blank, or otherReason is present but code.code is not C17649 ('Other').
DDF00021 Skipped An instance of a class is referencing itself as its previous instance.
DDF00022 Skipped An instance of a class is referencing itself as its next instance.
DDF00023 Skipped The next and previous relationships are not reciprocal - the instance is the "previous" instance (parent_rel is "previousId") for an instance that is not its "next" instance (nextId is not the same as parent_id), or vice versa.
DDF00024 Skipped The epoch references a previous or next epoch that is not specified within the same study design.
DDF00025 Skipped One or more of the window attributes (windowLabel, windowLower, windowUpper) contains a value for a Fixed Reference timing (type.code=C201358).
DDF00026 Skipped The scheduled activity instance is referencing its parent timeline as its sub-timeline.
DDF00027 Skipped The same instance is referenced more than once as previous or next - nextId or previousId values are not unique.
DDF00028 Skipped The activity references a previous or next activity that is not specified within the same study design.
DDF00029 Skipped The encounter references a previous or next encounter that is not specified within the same study design.
DDF00034 Skipped The duration will vary (durationWillVary is not 'false' or reasonDurationWillVary is populated), but it is not fully defined (durationWillVary is not 'true' or reasonDurationWillVary is missing).
DDF00038 Skipped The scheduled decision instance does not refer to a default condition.
DDF00040 Skipped The study element is not referenced by any study cell.
DDF00044 Skipped The condition assignment's target is the same as its parent.
DDF00047 Skipped The study element is referenced by a study cell but was not defined within the same study design as the study cell: the parent_id of the study element ($parent_of_study_element) is not the same as parent_id of the study cell (parent_id.StudyCell).
DDF00061 Skipped The lower limit of the timing window (windowLower) is not a non-negative duration in ISO 8601 format.
DDF00062 Skipped The upper limit of the timing window (windowUpper) is not a non-negative duration in ISO 8601 format.
DDF00071 Skipped The study cell references an arm that is not defined within the same study design as the study cell.
DDF00072 Skipped The study cell references an epoch that is not defined within the same study design as the study cell.
DDF00090 Skipped The biomedical concept category is referenced more than once from the same activity.
DDF00102 Skipped The scheduled activity instance references a timeline exit that is not defined within the same schedule timeline as the scheduled activity instance.
DDF00110 Skipped The eligibility criterion's category is not specified using the Category of Inclusion/Exclusion (C66797) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.
DDF00112 Skipped The study intervention's role is not specified using the study intervention role (C207417) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.
DDF00128 Skipped The study intervention's type is not specified using the Intervention Type Response (C99078) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.
DDF00137 Skipped The reference is not a fixed value (it contains "usdm:ref") but it is not specified in the correct format.
DDF00143 Skipped The study amendment reason is not coded using the study amendment reason (C207415) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00152 Skipped The activity references a timeline that is not specified within the same study design.
DDF00175 Skipped The administration's frequency is not specified according to the extensible Frequency (C71113) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00176 Skipped The administration's route is not specified according to the extensible Route of Administration Response (C66729) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00179 Skipped The administrable dose form is not specified according to the extensible Pharmaceutical Dosage Form (C66726) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00180 Skipped The administrable product property type is not specified according to the extensible administrable product property type (C215479) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00183 Skipped The reference identifier type is not specified according to the extensible reference identifier type (C215478) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00187 Skipped The narrative content item text contains non-conformant XHTML.
DDF00199 Skipped The study impact type is not specified according to the extensible study amendment impact type (C215481) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00207 Skipped The medical device identifier type is not specified according to the extensible medical device identifier type (C215484) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00208 Skipped The administrable product sourcing is not specified according to the extensible administrable product sourcing (C215483) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00209 Skipped The medical device sourcing is not specified according to the extensible medical device sourcing (C215482) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00210 Skipped The administrable product's product designation is not specified using the product designation (C207418) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.
DDF00214 Skipped The interventional study design's intent type is not specified according to the extensible Trial Intent Type Response (C66736) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00215 Skipped The interventional study design's sub type is not specified according to the extensible Trial Type Response (C66739) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00216 Skipped The study design's intervention model is not specified according to the extensible Intervention Model Response (C99076) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00217 Skipped The study design's blinding schema is not specified according to the extensible Trial Blinding Schema Response (C66735) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00218 Skipped The study design's characteristic is not specified according to the extensible study design characteristics (C207416) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00223 Skipped The study design's observational model is not specified according to the extensible Observational Study Model (C127259) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00224 Skipped The observational study design's time perspective is not specified according to the extensible Observational Study Time Perspective (C127261) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00225 Skipped The observational study design's sampling method is not specified according to the extensible Observational Study Sampling Method (C127260) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00226 Skipped The observational study design's sub type is not specified according to the extensible observational study design subtype (C215486) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00229 Skipped The study design's study phase is not specified according to the extensible Trial Phase Response (C66737) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).
DDF00230 Skipped The study design's study type is not specified using the Study Type Response (C99077) SDTM codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive), and/or neither code nor decode is found in the codelist.
DDF00259 Skipped The study role code is not specified using to the extensible study role code (C215480) DDF codelist - codeSystem is not "http://www.cdisc.org", codeSystemVersion is not a valid terminology package date, and/or the code or decode (either as preferred term or as submission value) is found in the codelist (case insensitive) but the corresponding decode or code does not match the codelist value (case sensitive).

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