Glossary
Glossary | Definition |
|---|---|
| Audit Log | System feature that maintains a historical record of key actions related to a Study Subject that have run on the CheckPad database (this is part of 21 CFR Part 11 compliance). |
| CRF (Case Report Form) | A form that collects and contains Visit information for a Study Subject. CRFs are defined using CRF Builder |
| Dataset Definition | Criteria (metadata) specified to create a dataset. |
| Dataset | A collection of data and metadata from records such as CRFs, Visits, etc. that matches a dataset definition and is exported to a file whose format can be selected, for use in other applications. |
| Delete | A delete action completely removes the information from the CheckPad system. Deleted information cannot be restored, although the audit log tracks the deletion action. Nearly all information in CheckPad is removed rather than deleted because removed information can be restored. |
| Discrepancy Notes | Means of communicating about CRF Items whose value, condition, level of detail, etc. are not as expected. |
| Enrollment | Adding a Subject to a Study. The CheckPad Enrollment Date is when the Subject is added to an CheckPad Study. |
| Item | Also known as a data Item. A single question in a CRF. Items have metadata attached to them. Each Item has an OID attached to it. Items can have multiple Edit Checks attached to them through either metadata or Rules |
| Item Group | A grouping of Items in a CRF. Item Groups can be repeating (for example, recording multiple Adverse Events on one form) or non-repeating. |
| Job | In CheckPad, you can schedule Export Data Job and Import Data Job to run automatically at a specified frequency. |
| Module | A group of related features in CheckPad, such as the Submit Data module. Access to a module is based on a user's Role. |
| OID (Object Identifier) | System-generated unique identifiers that CheckPad uses to directly reference key entities in a Study. OIDs are essential for importing data, creating Rules, and using data exported from CheckPad to certain formats. |
| Person ID | The unique identifier for a Subject that references the Subject across all Studies in the CheckPad system. It can be required or optional, depending on the way the Study is set up. |
| Freeze | An action prevent data from editing. |
| Lock | An action prevent data from editing, verifing... |
| Remove | A remove action makes the information unavailable in the CheckPad system. You can restore information that has been removed to make it available again. Most information in CheckPad is removed so that it can be restored, although in some cases, information can be deleted. See also the glossary description for Delete. |
| Restore | Restore information after remove if needed |
| Roles | Categories for users in CheckPad that determine the tasks available to them in the system. |
| Rules | Customized methods used to trigger actions on records such as the automatic generation of a Discrepancy Note, email, etc. Rules are stored in XML files. They can be built directly in an XML file and uploaded to CheckPad, or built in CheckPad using the Rule Designer feature. |
| Secondary ID | An optional identifier given to a Subject. It is often a legacy identifier like a patient record number that is used to link the Subject to another system or workflow, for example. |
| Sites | Locations where the Study is taking place, although they do not have to be physical locations. You can work with CheckPad at the Site level, which limits the view of the Study to a specified Site. |
| SDV (Source Data Verification) | A processs review data entry result with source data |
| Study | In CheckPad, a clinical trial or clinical research project, including all the metadata and data for it. |
| Study Subject | A person added to a Study in CheckPad. Also referred to as a Subject. |
| Subject Group Class | An optional feature used to categorize Subjects in a Study. Often, Subject Group Classes are used for different treatment options. |
| Study Subject ID | A unique identifier generated either manually or by the system when adding a Subject to a Study. |
| Subject | In CheckPad, a person who participates in Studies. |
| Subject Case Book | All CRFs for all Events for a Study Subject. |
| User | Person using the CheckPad software. A user can have one or more Roles in one or more Studies or Sites. For some automated processes, the user can be an automated system. |
| Visit | A visit or encounter in the Study where data is captured or created. A Study Visit packages one or more case report forms (CRFs). |
| Visit CRF | Visit CRF is used in visit to collect data. |
| Visit Definition | Information that describes a type of Visit, and includes specifying the CRFs to be used for it. |