Business Data Model Data Model

Entity

Entity Study Protocol

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
Accrual Reporting Method
Acronym
Adaptive Design Ind
AE Coding System
Amendment Grace Period Qty
Companion Code
Condition Coding System
Delayed Registry Posting Ind
Intervention Descr
Mandatory Ind
Multi Institution Ind
Participating Location
Participating Organization Type
Periodic Target Accrual Ratio
Phase Code
Planned Duration Qty
Planned Site Number Range Qty
Planned Study Subject Experience Txt
Population Descr
Primary Purpose Type
Purpose Statement Txt
Study Design Configuration
Study Responsible Party
Study Schematic Descr
Study Subject Type
Target Accrual Number Range Qty
Target Anatomic Site
Therapeutic Area

Relationship
involvingStudyProtocol
subdividedStudyProtocol
referencingStudyReference
sponsoredStudyProtocol
describingStudyProtocol
subdividedStudyProtocol/1
evaluatingStudyProtocol

Dependencies
NONE

Reverse Dependencies

Attribute Details

Accrual Reporting Method

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/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Acronym

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

Description	The coding system used for recording adverse events for a study.
Data Type	Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)]
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

Companion Code

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/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Condition Coding System

Description	The coding system used for recording conditions that are the focus of a study.
Data Type	Standards - Data Domains.ddm/Data Domains/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Delayed Registry Posting Ind

Description	Specifies whether there will 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

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

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

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/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Participating Organization Type

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/Enumeration [VARCHAR(20)]
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 Code

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/Enumeration [VARCHAR(20)]
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

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/Enumeration [VARCHAR(20)]
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

Study Design Configuration

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/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Study Responsible Party

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/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
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

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/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Target Accrual Number Range Qty

Description	An integer that specifies the number of study subjects to be accrued for the study or study arm, and can represent the minimum number of study subjects needed to support data analysis and the maximum number of study subjects that can be accrued to the study or 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

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/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Therapeutic Area

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/Enumeration [VARCHAR(20)]
Is Part Of PrimaryKey	false
Is Required	false
Is Derived	false
Is Surrogate Key	false

Relationship Details

involvingStudyProtocol

Description	Each StudyObjective always is an aim of one StudyProtocol. Each StudyProtocol might aim to achieve one or more StudyObjective.
Is Identifying Relationship	false
Child Table	Study Protocol
Child Role Name	involvedStudyObjective
Child Multiplicity	ZERO_TO_MANY
Child Referential Integrity: On Delete	SET_NULL
Child Referential Integrity: On Insert	NONE
Child Referential Integrity: On Update	SET_NULL
Parent Table	Study Objective
Parent Role Name	involvingStudyProtocolVersion
Parent Multiplicity	ZERO_TO_ONE
Parent Referential Integrity: On Delete	NONE
Parent Referential Integrity: On Insert	SET_NULL
Parent Referential Integrity: On Update	SET_NULL

subdividedStudyProtocol

Description	Each Arm always is a division of one StudyProtocol. Each StudyProtocol might be divided into one or more Arm.
Is Identifying Relationship	false
Child Table	Study Protocol
Child Role Name	subdividingArm
Child Multiplicity	ZERO_TO_MANY
Child Referential Integrity: On Delete	SET_NULL
Child Referential Integrity: On Insert	NONE
Child Referential Integrity: On Update	SET_NULL
Parent Table	Arm
Parent Role Name	subdividedStudyProtocolVersion
Parent Multiplicity	ZERO_TO_ONE
Parent Referential Integrity: On Delete	NONE
Parent Referential Integrity: On Insert	SET_NULL
Parent Referential Integrity: On Update	SET_NULL

referencingStudyReference

Description	Each StudyReference always is referenced by one or more StudyProtocol. Each StudyProtocol might refer to one or more StudyReference.
Is Identifying Relationship	false
Child Table	Study Protocol
Child Role Name	referencingStudyReference
Child Multiplicity	ZERO_TO_MANY
Child Referential Integrity: On Delete	NONE
Child Referential Integrity: On Insert	NONE
Child Referential Integrity: On Update	NONE
Parent Table	Study Reference
Parent Role Name	referencedStudyProtocolVersion
Parent Multiplicity	ZERO_TO_MANY
Parent Referential Integrity: On Delete	NONE
Parent Referential Integrity: On Insert	NONE
Parent Referential Integrity: On Update	NONE

sponsoredStudyProtocol

Description	Each StudyLegalSponsor always is responsible for one StudyProtocol. Each StudyProtocol might be the responsibility of one or more StudyLegalSponsor.
Is Identifying Relationship	false
Child Table	Study Protocol
Child Role Name	sponsoringStudyLegalSponsor
Child Multiplicity	ZERO_TO_MANY
Child Referential Integrity: On Delete	SET_NULL
Child Referential Integrity: On Insert	NONE
Child Referential Integrity: On Update	SET_NULL
Parent Table	Study Legal Sponsor
Parent Role Name	sponsoredStudyProtocolVersion
Parent Multiplicity	ZERO_TO_ONE
Parent Referential Integrity: On Delete	NONE
Parent Referential Integrity: On Insert	SET_NULL
Parent Referential Integrity: On Update	SET_NULL

describingStudyProtocol

Description	Each StratumGroup always is defined by one StudyProtocol. Each StudyProtocol might define one or more StratumGroup.
Is Identifying Relationship	false
Child Table	Study Protocol
Child Role Name	describedStratumGroup
Child Multiplicity	ZERO_TO_MANY
Child Referential Integrity: On Delete	SET_NULL
Child Referential Integrity: On Insert	NONE
Child Referential Integrity: On Update	SET_NULL
Parent Table	Stratum Group
Parent Role Name	describingStudyProtocolVersion
Parent Multiplicity	ZERO_TO_ONE
Parent Referential Integrity: On Delete	NONE
Parent Referential Integrity: On Insert	SET_NULL
Parent Referential Integrity: On Update	SET_NULL

subdividedStudyProtocol/1

Description	Each Epoch always is a division of one StudyProtocol. Each StudyProtocol might be divided into one or more Epoch.
Is Identifying Relationship	false
Child Table	Study Protocol
Child Role Name	subdividingEpoch
Child Multiplicity	ZERO_TO_MANY
Child Referential Integrity: On Delete	SET_NULL
Child Referential Integrity: On Insert	NONE
Child Referential Integrity: On Update	SET_NULL
Parent Table	Epoch
Parent Role Name	subdividedStudyProtocolVersion
Parent Multiplicity	ZERO_TO_ONE
Parent Referential Integrity: On Delete	NONE
Parent Referential Integrity: On Insert	SET_NULL
Parent Referential Integrity: On Update	SET_NULL

evaluatingStudyProtocol

Description	Each StudyAgent always is evaluated by one StudyProtocol. Each StudyProtocol might be evaluating one or more StudyAgent.
Is Identifying Relationship	false
Child Table	Study Protocol
Child Role Name	evaluatedStudyAgent
Child Multiplicity	ZERO_TO_MANY
Child Referential Integrity: On Delete	SET_NULL
Child Referential Integrity: On Insert	NONE
Child Referential Integrity: On Update	SET_NULL
Parent Table	Study Agent
Parent Role Name	evaluatingStudyProtocolVersion
Parent Multiplicity	ZERO_TO_ONE
Parent Referential Integrity: On Delete	NONE
Parent Referential Integrity: On Insert	SET_NULL
Parent Referential Integrity: On Update	SET_NULL

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