Objective DescrStudy Objective Type
| Business Data Model Data Model |
| Description | A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study. For example: To extend the life of study participants by at least 3 years. To determine efficacy of Drug X dose 1, dose 2, and dose 3 as measured by the percentage of subjects experiencing headache relief. |
| Attributes | |
| Objective Descr |
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| Study Objective Type |
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| Dependencies | |
 NONE |
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| Reverse Dependencies | |
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| Attribute Details |
Objective Descr
| Description | The textual representation of the study objective. For example: The objective of the analysis is to evaluate the efficacy of study treatment versus placebo. The Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items [ADAS-Cog (11)] and the Video-referenced Clinician's Interview-based Impression of Change (CIBIC+) will serve as the primary efficacy instruments. Efficacy will be determined by testing for a statistically significant relationship between the change in both the ADAS-Cog (11) and CIBIC+ scores, and drug dose (0, low dose [54 mg], and high dose [81 mg]). |
| 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 Objective Type
| Description | Specifies the kind of study objective. The examples given are the only allowable concepts. For example: Primary Secondary Tertiary Exploratory |
| 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 |
| Business Data Model Data Model |