A study within openCDMS represents the contents of the project/study/trial including the documents and their attributes and the properties necessary for the study to integrate with other openCDMS products for data entry and user managerment (ie. openCDMS Collect and openCDMS Control).
An document contains participant data and is part of a record. For example, PANSS and Baseline Audit Form are documents. Each document can be completed independently of other documents.
An entry is a particular field within a document that describes how the data should be entered and processed. Entries contain basic properties like name and help text for the entry and also more complex properties such as dependencies on other entries, validation rules and transformers. Specific properties of entries are details further below.
A centre represents a high-level geographical region within which the study will take place (e.g. North West-Lancashire Care Trust). A specification of centres depends on the particular study and its geographical reach. A centre contains one or more sites. The centre is composed of the hub and the trust codes, and identifies where the participant has been recruited.
Sites are contained within centres and describe a localised setting within which data will be entered and maintained (e.g. Springfield University Hospital). A specification of sites depends on the particular study and its geographical reach.
A study stage contains all document occurrences for grouping sets of document. In a longitudinal study, typical study stages might include baseline, 6 months, 12 months.
Where potentially identifiable data is entered into the database it is transformed such that it cannot be recovered. To preserve anonymity, entries may be designed to transform all participant's initials, postcodes and NHS numbers.
A unit is a precisely specified quantity in terms of which the magnitude of other quantities of the same kind can be stated (e.g. mg, days, weeks).
Validation rules specify particular constraints on the values that may be entered for particular entries within a study (e.g. validation rules may be set to ensure a date value entered is not set to a future date).
Roles are specified to define secure access control and permissions for users of the openCDMS study.
A status describes a particular state that a document occurrence may occupy. The status refers to the position of the record in the lifecycle of the project. In conjunction with state transitions, statuses are used to control the flow of data entry.
State transitions are used to control the flow of data entry (e.g. it may be desirable to ensure that data entry is completed for all documents in baseline before entry of data for the 6 month stage is completed). State transitions describe the allowed progressions over the lifetime of a record.
A consent form describes a set of questions that must be completed before access to data entry for documents may be granted.