Dimensional Warehouse Model Data Model

Entity

Entity Study Protocol Dimension

Description

A plan that, at a particular point in time, describes a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic.

Attributes
Accepts Healthy Volunteers Ind
Accrual Reporting Method Cd
Accrual Reporting Method Code Descr
Accrual Reporting Method Code Sk
Acronym Nm
Adaptive Design Ind
AE Coding System Cd
AE Coding System Code Descr
AE Coding System Code Sk
Allocation Cd
Allocation Code Descr
Allocation Code Sk
Amendment Grace Period Qty
AWM Load Info Sk
Blinded Role Cd
Blinded Role Code Descr
Blinded Role Code Sk
Blinding Schema Cd
Blinding Schema Code Descr
Blinding Schema Code Sk
Companion Cd
Companion Code Descr
Companion Code Sk
Condition Coding System Cd
Condition Coding System Code Descr
Condition Coding System Code Sk
Control Concurrency Type Cd
Control Concurrency Type Code Descr
Control Concurrency Type Code Sk
Control Type Cd
Control Type Code Descr
Control Type Code Sk
Current Ind
Data Monitoring Committee Ind
Delayed Registry Posting Ind
Design Configuration Cd
Design Configuration Code Descr
Design Configuration Code Sk
DWM Load Info Sk
Effective From Dt
Effective To Dt
Intervention Descr
Intervention Group Qty
Intervention Type Cd
Intervention Type Code Descr
Intervention Type Code Sk
Mandatory Ind
Multi Institution Ind
Participating Location Cd
Participating Location Code Descr
Participating Location Code Sk
Participating Organization Type Cd
Participating Organization Type Code Descr
Participating Organization Type Code Sk
Periodic Target Accrual Ratio
Phase Cd
Phase Code Descr
Phase Code Sk
Planned Duration Qty
Planned Site Number Range Qty
Planned Study Subject Experience Txt
Population Descr
Primary Purpose Type Cd
Primary Purpose Type Code Descr
Primary Purpose Type Code Sk
Purpose Statement Txt
Responsible Party Cd
Responsible Party Code Descr
Responsible Party Code Sk
Sampling Method Cd
Sampling Method Code Descr
Sampling Method Code Sk
Source Cd
Source Code Descr
Source Code Sk
Specimen Available For DNA Extraction Ind
Specimen Retention Ind
Study Agent Randomization Fraction
Study Protocol Bk
Study Protocol Dk
Study Protocol Sk
Study Schematic Descr
Study Subject Type Cd
Study Subject Type Code Descr
Study Subject Type Code Sk
Target Accrual Number Range Qty
Target Anatomic Site Cd
Target Anatomic Site Code Descr
Target Anatomic Site Code Sk
Tenant Sk
Therapeutic Area Cd
Therapeutic Area Code Descr
Therapeutic Area Code Sk
Time Perspective Cd
Time Perspective Code Descr
Time Perspective Code Sk
Type Cd
Type Code Descr
Type Code Sk
Valid From Ts
Valid To Ts

Primary Key
Study Protocol Dimension PK

Dependencies

Reverse Dependencies

Attribute Details

Accepts Healthy Volunteers Ind

Description	Specifies whether persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Accrual Reporting Method Cd

Description	The technique that is used for reporting study subject accrual data to the study sponsor. For example: Complete Abbreviated
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Accrual Reporting Method Code Descr

Description	The technique that is used for reporting study subject accrual data to the study sponsor. For example: Complete Abbreviated
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Accrual Reporting Method Code Sk

Description	The technique that is used for reporting study subject accrual data to the study sponsor. For example: Complete Abbreviated
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Acronym Nm

Description	The non-unique initials or abbreviated name used for identification of the study. For example: WHI for Women's Health Initiative
Data Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Adaptive Design Ind

Description	Specifies whether the design of the study is expected to evolve during the execution of the study.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

AE Coding System Cd

Description	The coding system used for recording adverse events for a study.
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

AE Coding System Code Descr

Description	The coding system used for recording adverse events for a study.
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

AE Coding System Code Sk

Description	The coding system used for recording adverse events for a study.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Allocation Cd

Description	Identifies the method of assigning experimental units to treatment or control groups. For example: n/a Randomized controlled study Non-randomized study
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Allocation Code Descr

Description	Identifies the method of assigning experimental units to treatment or control groups. For example: n/a Randomized controlled study Non-randomized study
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Allocation Code Sk

Description	Identifies the method of assigning experimental units to treatment or control groups. For example: n/a Randomized controlled study Non-randomized study
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Amendment Grace Period Qty

Description	The period of time during which sites can continue to accrue on an existing study version before they are required to switch to the new study version. For example: 90 days
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

AWM Load Info Sk

Description	The surrogate key of the load information entry describing the details regarding the loading of the row in the atomic data warehouse.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Blinded Role Cd

Description	Identifies the roles of individuals who are masked for single or double blind studies. For example: Subject Caregiver Investigator Outcomes assessor
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Blinded Role Code Descr

Description	Identifies the roles of individuals who are masked for single or double blind studies. For example: Subject Caregiver Investigator Outcomes assessor
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Blinded Role Code Sk

Description	Identifies the roles of individuals who are masked for single or double blind studies. For example: Subject Caregiver Investigator Outcomes assessor
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Blinding Schema Cd

Description	Specifies the type of masking used on a study protocol to ensure that the results are not biased by the study subjects or investigators. Double-blinded would indicate that both the investigator and the study subject would not know whether the intervention was a placebo or an active therapeutic intervention. For example: Open Label Double Blind Single Blind
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Blinding Schema Code Descr

Description	Specifies the type of masking used on a study protocol to ensure that the results are not biased by the study subjects or investigators. Double-blinded would indicate that both the investigator and the study subject would not know whether the intervention was a placebo or an active therapeutic intervention. For example: Open Label Double Blind Single Blind
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Blinding Schema Code Sk

Description	Specifies the type of masking used on a study protocol to ensure that the results are not biased by the study subjects or investigators. Double-blinded would indicate that both the investigator and the study subject would not know whether the intervention was a placebo or an active therapeutic intervention. For example: Open Label Double Blind Single Blind
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Companion Cd

Description	Specifies the type of ancillary study. For example: Embedded, Non-Stand-Alone Companion: This study is part of a master study and cannot be executed separately from it nor in association with another master study. The documentation for this kind of companion study is embedded in the protocol of the master study.
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Companion Code Descr

Description	Specifies the type of ancillary study. For example: Embedded, Non-Stand-Alone Companion: This study is part of a master study and cannot be executed separately from it nor in association with another master study. The documentation for this kind of companion study is embedded in the protocol of the master study.
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Companion Code Sk

Description	Specifies the type of ancillary study. For example: Embedded, Non-Stand-Alone Companion: This study is part of a master study and cannot be executed separately from it nor in association with another master study. The documentation for this kind of companion study is embedded in the protocol of the master study.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Condition Coding System Cd

Description	The coding system used for recording conditions that are the focus of a study.
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Condition Coding System Code Descr

Description	The coding system used for recording conditions that are the focus of a study.
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Condition Coding System Code Sk

Description	The coding system used for recording conditions that are the focus of a study.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Control Concurrency Type Cd

Description	Specifies the temporal relationships of the control to the study intervention. For example: Concurrent Historical Pre/post (patient owned control)
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Control Concurrency Type Code Descr

Description	Specifies the temporal relationships of the control to the study intervention. For example: Concurrent Historical Pre/post (patient owned control)
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Control Concurrency Type Code Sk

Description	Specifies the temporal relationships of the control to the study intervention. For example: Concurrent Historical Pre/post (patient owned control)
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Control Type Cd

Description	Specifies the kind of comparison or comparator against which the study treatment is evaluated. For example: Placebo Active Historical Uncontrolled Dose comparison
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Control Type Code Descr

Description	Specifies the kind of comparison or comparator against which the study treatment is evaluated. For example: Placebo Active Historical Uncontrolled Dose comparison
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Control Type Code Sk

Description	Specifies the kind of comparison or comparator against which the study treatment is evaluated. For example: Placebo Active Historical Uncontrolled Dose comparison
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Current Ind

Description	Set to 'Y' if this is the most recent row of a group having the same Surrogate Key.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Data Monitoring Committee Ind

Description	Specifies whether a data monitoring committee is appointed to the study.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Delayed Registry Posting Ind

Description	Specifies whether there is to be a delay in the public disclosure of the study, as permitted by relevant local legislation or regulation.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Design Configuration Cd

Description	Specifies how a subject or experimental unit exposures to treatment strategies (which may include controls such as no treatment) will be identified, for retrospective studies, or planned, for prospective studies, in order to characterize treatment effects and compare effects of different treatment strategies in a clinical or pre-clinical study. The configuration will specify whether a subject or experimental unit received or is to receive only one exposure or multiple exposures, and, if multiple exposures, whether those exposures were/are to be simultaneous or in series. The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment. For example: Parallel Group Design Crossover Design Factorial Designs Cohort Case-control Case-only Case-crossover Ecologic or Community Studies Family-based
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Design Configuration Code Descr

Description	Specifies how a subject or experimental unit exposures to treatment strategies (which may include controls such as no treatment) will be identified, for retrospective studies, or planned, for prospective studies, in order to characterize treatment effects and compare effects of different treatment strategies in a clinical or pre-clinical study. The configuration will specify whether a subject or experimental unit received or is to receive only one exposure or multiple exposures, and, if multiple exposures, whether those exposures were/are to be simultaneous or in series. The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment. For example: Parallel Group Design Crossover Design Factorial Designs Cohort Case-control Case-only Case-crossover Ecologic or Community Studies Family-based
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Design Configuration Code Sk

Description	Specifies how a subject or experimental unit exposures to treatment strategies (which may include controls such as no treatment) will be identified, for retrospective studies, or planned, for prospective studies, in order to characterize treatment effects and compare effects of different treatment strategies in a clinical or pre-clinical study. The configuration will specify whether a subject or experimental unit received or is to receive only one exposure or multiple exposures, and, if multiple exposures, whether those exposures were/are to be simultaneous or in series. The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment. For example: Parallel Group Design Crossover Design Factorial Designs Cohort Case-control Case-only Case-crossover Ecologic or Community Studies Family-based
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

DWM Load Info Sk

Description	The surrogate key of the load information entry describing the details regarding the loading of the row.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Effective From Dt

Description	Establishes a period where a set of attributes are true according to the business.
Data Type	Standards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Effective To Dt

Description	Ends a period of effectivity.
Data Type	Standards - Data Domains.ddm/Data Domains/Date [DATE]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Intervention Descr

Description	A character string that provides the key details of the intervention. For example: Interventions involving drugs may include dosage form, dosage, frequency and duration. (50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.)
Data Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Intervention Group Qty

Description	A character string that provides the key details of the intervention. For example: Interventions involving drugs may include dosage form, dosage, frequency and duration. (50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.)
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Intervention Type Cd

Description	A character string that provides the key details of the intervention. For example: Interventions involving drugs may include dosage form, dosage, frequency and duration. (50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.)
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Intervention Type Code Descr

Description	A character string that provides the key details of the intervention. For example: Interventions involving drugs may include dosage form, dosage, frequency and duration. (50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.)
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Intervention Type Code Sk

Description	A character string that provides the key details of the intervention. For example: Interventions involving drugs may include dosage form, dosage, frequency and duration. (50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.)
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Mandatory Ind

Description	Specifies whether the modifications contained in the study protocol version must be applied to all sites and subjects or study subjects that want to continue participating in the study.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Multi Institution Ind

Description	Specifies whether a study is designed to be conducted at more than one site concurrently. This could be conceived as derivable, but since it needs to be defined before study sites are associated with a study, it is needed here.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Participating Location Cd

Description	Specifies the locations from which participants will be, are intended to be, or have been recruited for the study.
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Participating Location Code Descr

Description	Specifies the locations from which participants will be, are intended to be, or have been recruited for the study.
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Participating Location Code Sk

Description	Specifies the locations from which participants will be, are intended to be, or have been recruited for the study.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Participating Organization Type Cd

Description	Specifies the kind of organizations planned to participate as study sites for this study. For example: Cancer Center Clinical Center Consortium Group Intergroup Multi-Center Network Single Institution
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Participating Organization Type Code Descr

Description	Specifies the kind of organizations planned to participate as study sites for this study. For example: Cancer Center Clinical Center Consortium Group Intergroup Multi-Center Network Single Institution
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Participating Organization Type Code Sk

Description	Specifies the kind of organizations planned to participate as study sites for this study. For example: Cancer Center Clinical Center Consortium Group Intergroup Multi-Center Network Single Institution
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Periodic Target Accrual Ratio

Description	A ratio representing the number of study subjects to be accrued per a specified amount of time. For example: For monthly target accrual, a given study may have a target accrual of 100 per 1 month meaning the numerator of the ratio is the integer 100 and the denominator is a PQ where the value is 1 and the unit is month.
Data Type	Standards - Data Domains.ddm/Data Domains/Ratio [FLOAT(5)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Phase Cd

Description	A coded value specifying a stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. For example: I I/II II III N/A
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Phase Code Descr

Description	A coded value specifying a stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. For example: I I/II II III N/A
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Phase Code Sk

Description	A coded value specifying a stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. For example: I I/II II III N/A
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Planned Duration Qty

Description	The intended period of time for the study.
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Planned Site Number Range Qty

Description	An integer falling within minimum and maximum bounds that specifies how many study sites are expected to participate in the conduction of the study. Relevant before specific sites have been selected. Can be derived once sites have been selected.
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Planned Study Subject Experience Txt

Description	A description of what the study subject can expect to experience over the course of the study, including the sequence and duration of activities. For example: The description, sequence and duration of study epochs, including pre-randomization and post-treatment epochs, therapy withdrawal epochs, and single- and double-blind treatment epochs.
Data Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Population Descr

Description	The textual representation of the characteristics, including inclusion and exclusion criteria that describes the population. This would include all subgroups as well.
Data Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Primary Purpose Type Cd

Description	Specifies the type of study based upon the intent of the study's activities. A classification of the intent of the study. For example: Treatment studies test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Primary Purpose Type Code Descr

Description	Specifies the type of study based upon the intent of the study's activities. A classification of the intent of the study. For example: Treatment studies test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Primary Purpose Type Code Sk

Description	Specifies the type of study based upon the intent of the study's activities. A classification of the intent of the study. For example: Treatment studies test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Purpose Statement Txt

Description	A statement describing the overall intent of the study. This field describes the contribution of this study to product development, treatment strategies, prevention approaches, diagnostic techniques, or patient quality of life, i.e., what knowledge is being contributed from the conduct of this study. For example: Test the efficacy of a particular cancer treatment
Data Type	Standards - Data Domains.ddm/Data Domains/Text Large [VARCHAR(1024)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Responsible Party Cd

Description	Specifies the type of entity who is legally responsible for the execution of the study. For example: Sponsor
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Responsible Party Code Descr

Description	Specifies the type of entity who is legally responsible for the execution of the study. For example: Sponsor
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Responsible Party Code Sk

Description	Specifies the type of entity who is legally responsible for the execution of the study. For example: Sponsor
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Sampling Method Cd

Description	Specifies the process used to define a representative set of a population for a study. For example: A Probability Sample: exclusively random process to guarantee that each participant or population has specified chance of selection, such as simple random sampling, systematic sampling, stratified random sampling, cluster sampling, and consecutive patient sampling. A Non-Probability Sample: any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer.
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Sampling Method Code Descr

Description	Specifies the process used to define a representative set of a population for a study. For example: A Probability Sample: exclusively random process to guarantee that each participant or population has specified chance of selection, such as simple random sampling, systematic sampling, stratified random sampling, cluster sampling, and consecutive patient sampling. A Non-Probability Sample: any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer.
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Sampling Method Code Sk

Description	Specifies the process used to define a representative set of a population for a study. For example: A Probability Sample: exclusively random process to guarantee that each participant or population has specified chance of selection, such as simple random sampling, systematic sampling, stratified random sampling, cluster sampling, and consecutive patient sampling. A Non-Probability Sample: any of a variety of other sampling processes, such as convenience sampling or invitation to volunteer.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Source Cd

Description	The code that corresponds to the Source Code Sk.
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Source Code Descr

Description	The description that corresponds to the Source Type Cd.
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Source Code Sk

Description	The origin of the data identifying the actual load source, vendor, manual key entry, or context of the data in a specific row in the database.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Specimen Available For DNA Extraction Ind

Description	Specifies whether any biological specimen has the potential for DNA extraction. Specimens with the potential for DNA extraction include frozen tissue and whole blood whereas specimens without the potential for DNA extraction include fixed tissue and plasma.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Specimen Retention Ind

Description	Specifies whether a biological specimen is retained beyond the duration of the study.
Data Type	Standards - Data Domains.ddm/Data Domains/Boolean Indicator [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Study Agent Randomization Fraction

Description	A number representing the quantity of study subjects in the overall study who receive at least one study agent (as opposed to placebo) divided by the quantity of subjects in the study overall - independent of dosage or other protocol variations.
Data Type	Standards - Data Domains.ddm/Data Domains/Percentage [FLOAT(2)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Study Protocol Bk

Description	Concatenated values of a set of business attributes that uniquely identify the row.
Data Type	Standards - Data Domains.ddm/Data Domains/Business Key [VARCHAR(255)]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Study Protocol Dk

Description	A numeric surrogate key used to uniquely identify entities in the dimensional model.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKey	true
Is Required	true
Is Derived	false
Is Surrogate Key	true

Study Protocol Sk

Description	A numeric surrogate key used to uniquely identify entities in the atomic model.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key Large [LONG]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Study Schematic Descr

Description	Diagram which outlines all study epochs, timing of randomization and duration of treatments.
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Study Subject Type Cd

Description	Specifies the kind of study subject involved in the study or investigation. This is explicitly not meant to represent parts of study subjects that may be studied, such as a human eye, or groups of study subjects such as a herd of cows. It is meant to represent the whole individual that is registered as a study subject. For example: Human Rat Mouse X-ray machine
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Study Subject Type Code Descr

Description	Specifies the kind of study subject involved in the study or investigation. This is explicitly not meant to represent parts of study subjects that may be studied, such as a human eye, or groups of study subjects such as a herd of cows. It is meant to represent the whole individual that is registered as a study subject. For example: Human Rat Mouse X-ray machine
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Study Subject Type Code Sk

Description	Specifies the kind of study subject involved in the study or investigation. This is explicitly not meant to represent parts of study subjects that may be studied, such as a human eye, or groups of study subjects such as a herd of cows. It is meant to represent the whole individual that is registered as a study subject. For example: Human Rat Mouse X-ray machine
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Target Accrual Number Range Qty

Description	An integer falling within minimum and maximum bounds that specifies how many study subjects are to be accrued for the study or study arm. This may represent the minimum number of study subjects needed to support data analysis and/or the maximum number of study subjects that may be accrued to the study or to the study arm.
Data Type	Standards - Data Domains.ddm/Data Domains/Quantity Integer [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Target Anatomic Site Cd

Description	Specifies the anatomic location that is the focus of the observation, procedure, study or result. The target site of an observation result may be different than the target site of the observation that generated it. For instance, the target site of the observation may be broad (for example, skin) while the target site of the observation result is specific (for example, skin on chest). Multiple contiguous sites within the same organ system may be referenced. For example: Lower intestine Arm Breast Ovary Kidney
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Target Anatomic Site Code Descr

Description	Specifies the anatomic location that is the focus of the observation, procedure, study or result. The target site of an observation result may be different than the target site of the observation that generated it. For instance, the target site of the observation may be broad (for example, skin) while the target site of the observation result is specific (for example, skin on chest). Multiple contiguous sites within the same organ system may be referenced. For example: Lower intestine Arm Breast Ovary Kidney
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Target Anatomic Site Code Sk

Description	Specifies the anatomic location that is the focus of the observation, procedure, study or result. The target site of an observation result may be different than the target site of the observation that generated it. For instance, the target site of the observation may be broad (for example, skin) while the target site of the observation result is specific (for example, skin on chest). Multiple contiguous sites within the same organ system may be referenced. For example: Lower intestine Arm Breast Ovary Kidney
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Tenant Sk

Description	The surrogate key of the entry identifying the legal owner of the data.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Therapeutic Area Cd

Description	A coded value specifying the field of knowledge that focuses on research and development of treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual. For Example: eye disease, nervous system disease
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Therapeutic Area Code Descr

Description	A coded value specifying the field of knowledge that focuses on research and development of treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual. For Example: eye disease, nervous system disease
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Therapeutic Area Code Sk

Description	Specifies the field of knowledge that focuses on research and development of treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual. For example: Eye disease Nervous system disease
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Time Perspective Cd

Description	Specifies the temporal relationship of observation period to time of subject enrollment. For example: Prospective Retrospective Cross-sectional
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Time Perspective Code Descr

Description	Specifies the temporal relationship of observation period to time of subject enrollment. For example: Prospective Retrospective Cross-sectional
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Time Perspective Code Sk

Description	Specifies the temporal relationship of observation period to time of subject enrollment. For example: Prospective Retrospective Cross-sectional
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Type Cd

Description	The code that corresponds to the Type Code Sk.
Data Type	Standards - Data Domains.ddm/Data Domains/Tenant Common Code [VARCHAR(80)]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Type Code Descr

Description	The description that corresponds to the Type Cd.
Data Type	Standards - Data Domains.ddm/Data Domains/Description [VARCHAR(250)]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Type Code Sk

Description	The code identifying the actual type of the entity as per the type hierarchy defined in the analysis data model.
Data Type	Standards - Data Domains.ddm/Data Domains/Surrogate Key [INTEGER]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Valid From Ts

Description	Establishes a period where a set of attributes are true in the source system. This would be populated with the transaction timestamp and would be used for the snapshot date.
Data Type	Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKey	false
Is Required	true
Is Derived	false
Is Surrogate Key	false

Valid To Ts

Description	Ends a period of validity.
Data Type	Standards - Data Domains.ddm/Data Domains/Timestamp [TIMESTAMP]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Primary Key Details

Study Protocol Dimension PK

Key Attribute

Study Protocol Dk

Overview

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Package

Entity

Dimensional Warehouse Model Data Model