Glossary

action

A mechanism for moving a discrepancy from one state to another; may also apply a tag.

audit trail

A complete record of changes made to study data or study objects such as validation checks and tables.

blinding

Hiding data that might divulge which patients were receiving the study drug and which were not. An entire table may be blinded, in which case no data in the table is visible to users without special blinding-related privileges, or certain columns, rows, or cells may have mask values visible to users without special blinding-related privileges.

category

1. A metadata attribute equivalent to a label that can be applied to discrepancies—either by a validation check or by a user directly in the Discrepancies page—or to validation checks or flags. If a category is applied to a validation check, the validation check automatically applies the category to all discrepancies it creates. Users can filter discrepancies by category.

2. Companies must categorize, or group, studies in Oracle DMW to use a common library for the study group. The default categorization is by therapeutic area.

clinical data model

A reusable set of database tables and related objects including data transformation programs, validation checks, and security that are assembled to address a specific need during a trial. For example, an input model contains tables with exactly the same structure as the files loaded from external systems such as InForm or labs; a review model can contain tables with a structure suitable for review and analysis, plus the transformation programs required to put input source data into the review structure; and a reporting data model can contain tables in SDTM or ODM CDISC structure.

conformance check

Oracle SQL Loader checks incoming data against formatting requirements such as data type and code list values.

Data Management Workbench

See Oracle DMW.

discrepancy

Potential error detected either manually or programmatically in clinical data. Tied to a data point. Called a query in InForm.

edit check

See validation check.

flag

A review metadata attribute associated with a data record. Flags are applied to a data record, can have any number of states, and are local to Oracle DMW. They apply to the record only in the clinical data model in which they are applied.

File Watcher

A feature that checks for new data files in a location defined by an administrator at specified intervals and automatically loads the data into the system.

InForm

A clinical trial data collection and management application; full name Oracle Health Sciences InForm.

Listings

A page in the Oracle DMW user interfaces that displays data records in the current clinical data model. There are three Listings pages: Default Listings, which displays all records in the current model (dependent on the user's security privileges), Validation Check Listings, which displays records specified by a single validation check at a time; and Custom Listings, which displays records specified by a user's query.

manual discrepancy

A discrepancy that a user, usually a data manager, creates in Oracle DMW during the review process.

Oracle DMW

Oracle Health Sciences Data Management Workbench.

patient

See subject.

preferred path

If a data point has multiple source data points, one must be marked by a user or the transformation program that created the data point as the preferred source data point. If a target data point has only one source data point, the system automatically marks it as the preferred source. The upstream or downstream path from one preferred source data point to the next is called the preferred path.

The system associates any discrepancies with the preferred path when routing them to the source system.

For example, for a Body Mass Index (BMI) value one source value—either Weight or Height—must be designated the preferred source data point for the purpose of routing a discrepancy back to the source system. In InForm the system creates a query on the preferred source data point.

Query Builder

User interface feature to facilitate building valid PL/SQL queries.

staging table

A table created for use with a transformation program to hold data at an intermediate stage during transformation execution. Source and target data lineage displays may include staging tables, but they are not otherwise visible in the user interface.

subject

A candidate accepted into a study; sometimes called a patient.

surrogate key (SK)

System-generated record ID based on the primary key identifiers for the table. The first token in the Surrogate Key is the table instance ID (tableRef obj_id). This is followed by each value from the primary key columns, in column order. The tokens are separated by a tilde (~).

tag

A label for discrepancies that can be applied with an action and used for filtering discrepancy display, creating substates, or directing communication among teams while a discrepancy remains in a single state.

validation check

Program that can be executed to check data and create discrepancies; also called an edit check.