| Oracle® Clinical Administrator's Guide Release 5.1 E53556-02 |
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PDF · Mobi · ePub |
| Oracle® Clinical Administrator's Guide Release 5.1 E53556-02 |
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PDF · Mobi · ePub |
A property of a user name which denotes that certain privileges have been granted to that user. The term is used in RDC documentation as a means to convey that a set of privileges have or have not been granted to a particular user. An example of typical usage is:
The keyboard key corresponds to the letter that is underlined in an item's on-screen title. The access key may be activated either singly or in combination with the ALT key.
See also: shortcut key
A discrepancy status that indicates the relevant discrepancy is actionable by members of your user group.
A record, or set of records, associated with a CRF that lists each change in approval status starting with the initial approval action.
A designation that describes the current state of approval for a CRF.
See also: discrepancy status, entry status, verification status
An approval status that indicates a user with the approve privilege has removed the approved status of a CRF via the Undo Approval action.
A privilege assigned to a user name that allows the user to alter the approval status of a CRF or a group of CRFs. The privilege is assigned at the site level only.
An approval status assigned to a CRF that indicates a user with the approve privilege certifies that the CRF is an accurate representation of the source data. In RDC, an approval is equivalent to an electronic signature.
The set of all audit records for a given data point.
See also: audit record, data point
A set of information that describes an instance of data update. Each audit record includes the following information:
Current value of the data point
Previous value of the data point
User name that changed the data point
Time stamp the data update occurred
Change reason
Optional comment
A feature of RDC that enhances user data entry, monitor verification, and investigator approval sessions. When automatic progression is enabled, as you complete work on the current CRF focus moves to the next CRF in a sequence specified by the settings in the Preferences window. The next CRF may be: within the current patient record, across Spreadsheet tabs; within the current patient, within the current event tab; or within the current CRF column.
Note that, based on system administrator settings, the Preferences window may not be available in your session.
This is a system-generated approval status that indicates the CRF is approved, but that one or more response values were updated. A CRF in this approval status can be re-approved or the approval can be undone.
The CRF changes that cause the change in approval status include:
response value update
update to an investigator comment
initiation of a new investigator comment
update to a discrepancy
initiation of a new discrepancy
This is a system-generated verification status that indicates the CRF is verified, but that one or more response values were updated. A CRF in this verification status can be re-verified or the verification can be undone.
The CRF changes that cause the change in verification status include:
response value update
update to an investigator comment
initiation of a new investigator comment
update to a discrepancy
initiation of a new discrepancy
A designation that specifies response values were entered into a CRF by electronic means, as opposed to manually entered by a user performing data entry.
An RDC entry status designation that is assigned to a CRF a user has defined as blank. A Blank CRF does not contain data, nor can data be collected while it is marked as blank.
The Blank Flag, or check box, is used to designate a CRF as blank. It is a standard item in the CRF Header area of a DE window and may also be present in the CRF Section, especially in multi-section CRFs.
1) A user action that entails reviewing existing data without adding new data or changing existing data.
2) A privilege, specific to manually entered CRFs, that provides the user with the ability to view existing data, but not to add new data or update existing data in CRFs. All RDC users must be assigned this privilege or a higher-level privilege that incorporates it.
See book.
A paper or electronic record associated with a patient in a clinical study. Its purpose is to facilitate accurate collection of clinical data. In RDC, CRFs are depicted electronically through the data entry window.
See also: CRF
A listing of the values that have been assigned to data or information. Each list item includes information that uniquely identifies it. Specifically, a time stamp and the user name of the person who made the change are recorded. In RDC, a change history can be associated with the following:
A constituent of an audit record. A standardized entry that explains why a data point changed. The change reason can be supplied either automatically (system-provided) or manually (user-provided).
(CPE) An occurrence, usually a visit, that is scheduled as part of a protocol to collect clinical data for a patient. In RDC, visits appear in the context of a case book.
A discrepancy status that indicates the relevant discrepancy is not actionable by any user group. The discrepancy has been resolved, either by a user or the system.
See also: discrepancy status, user group, active, other, obsolete, discrepancy state
An acronym for clinical planned event.
An RDC entry status designation that is assigned to a CRF when all required CRF header data has been entered and saved, and no other data, i.e., response data, has been entered.
This is used when your internal process involves an administration person who logs the paper as received in-house, but the data have not yet been entered by the data entry staff.
See case report form
A component of a CRF as it is displayed in the data entry window. It consists of one or more header fields, in which you collect information that uniquely describes and defines the current CRF.
RDC will not save a CRF to the study database until all required CRF header and CRF section header fields are collected.
In RDC, a constituent of a CRF that is comprised of a set of related questions. Each CRF contains at least one section and may contain more than one. In Oracle Clinical terms, a section equates to a data collection module (DCM).
A discrepancy state that indicates action can be taken on the discrepancy – either by a user or by the system. It has not been made obsolete by the system.
See also: discrepancy state, obsolete, open, active, other, closed
The study data set that is active in RDC. The name of the current study is displayed in the title bar of the main application window.
data collection instrument (DCI)
The Oracle Clinical term for a CRF. A DCI is composed of one or more DCMs.
See also: case report form, data collection module (DCM), CRF
The Oracle Clinical term for a CRF section.
(Oracle Clinical) A set of one or more related groups of questions that pertain to a single clinical study visit.
See also: section
A designation that describes the current state of data entry for a CRF. In RDC, there are four data entry statuses:
A location in the Question area of the Data Entry window in which you type a value that is the response to a CRF question.
1) A single piece of clinical data collected during a trial. In most cases, the response to a single question for a patient during a visit.
2) A location in a form where a data value may be entered. In most cases, a data point corresponds to a field in the data entry window.
The process of changing a CRF that has been created and saved to the database by altering a data point and saving the new version of the CRF to the database.
see also: created, data point, CRF, initial data entry
An acronym for data collection module (DCM).
In RDC, the preferred study associated with your user name. RDC automatically selects the default study when you initiate a session.
If you have access to one study, that is your default study.
If you have access to more than one study, the study that was active when you closed the previous session is the default study.
If you have access to more than study, but have not initiated a previous session in the current database, the system administrator can specify a default study.
If the a default study is not specified, the system presents the Change Study window when you log in, which allows you to choose a study from among those to which you have access.
Data that falls outside of an expected range of values or is otherwise 'flagged' during the edit check process.
See also: discrepancy management, manual discrepancy, multivariate discrepancy, univariate discrepancy
A process that changes the status of a discrepancy. There are two types of actions:
Routing
Resolution
The listing associated with a discrepancy that provides details of each update that was made it.
1. A process that systematically addresses discrepancies generated within a study. Discrepancy management attempts to identify the cause and assess the implications of each discrepancy and determine an appropriate action for the discrepancy. Its goal is to satisfactorily resolve all discrepancies associated with each CRF.
2. A subsystem of Oracle Clinical and RDC that supports managing discrepancies.
See also: discrepancy, multivariate discrepancy, univariate discrepancy, manual discrepancy
An entry which is part of the study database that defines the pertinent aspects of a discrepancy, from its initial occurrence and through each action that is taken on it.
The highest level designation of a discrepancy. A discrepancy can be in one of two states:
1) A designation that describes a current discrepancy
2) A designation that describes the current state of a CRF with regard to discrepancies. In RDC there are four discrepancy statuses:
(DVG) A set of responses that are acceptable for a given question. A DVG constrains the responses to a question to a distinct set of values.
A DVG subset contains a subset of the responses of another DVG.
The equivalent of a CRF.
An acronym for discrete value group.
An entry status that is assigned to a CRF in which all required fields have been entered, including CRF header fields and Question area response data points.
An entry status that is assigned to a CRF in which data entry has been initiated but is not complete. CRFs that are assigned this entry status, some required data fields are complete, while some are not; the document has been saved in an incomplete status.
Formal stages of data entry in Oracle Clinical and RDC, that track the progression of a CRF from no data entered ("Created") through entry complete, to approved.
See also: blank, created, entry started, entry complete
Where the cursor is currently active. Focus may change from window to window, as when the cursor moves from the main application window to the first data field in the Data Entry window when you click a CRF cell.
How focus changes is a consideration when you are modifying the settings on the Preferences window to enhance the efficiency of your data entry or verification/approval sessions.
A designation that is applied to a patient which indicates that all data has been received, entered, reviewed, and cleaned for the patient, CRF, visit, or study.
(GUI) The screen representation of a software application that uses graphical components, such as windows, icons, and menus, to effect user interaction, rather than typing command line entries.
An acronym for Graphical User Interface.
A location in the CRF Header or the CRF Section Header in which you collect values that provide information about the CRF. A header field is either required or optional. All required header fields must be collected before the system permits a CRF to be saved to the study database.
In the CRF Header, the following header fields are available:
visit date
visit time
comment
In CRF Section Headers, the following fields are available:
date
time
lab
Note: The preceding lists are specific to RDC only.
A question used with certain question groups that allows "branching" during data entry based on the response.
For example, in a Drug Allergy question group, an indicator question could be, "Allergic to any drug?"
If the response is "Yes", the remaining questions in the question group, such as "Drug Name" and "Type of Reaction", require responses.
If the response is "No", the rest of the question group is not collected.
The step in the RDC workflow during which the CRF is initially opened and created. During this process all required CRF and CRF section header information is collected. Response data may or may not be collected.
A discrepancy status that can be assigned to a section discrepancy through a routing action. This type of discrepancy can be configured so that it is "hidden" from one or more user groups.
A textual explanation that is written by the investigator. It provides the investigator with the opportunity to include additional information with a response value. Each investigator comment is saved as part of the response with which it is associated.
RDC provides visual cues to alert the user to the presence of an investigator comment associated with a data point:
the response field is displayed with a yellow background color
the data value is displayed in a green font
when focus is in the relevant response field, the Data Entry window header includes an entry: <Inv>, to indicate the presence of the investigator comment.
A set of possible values for a data field. The list of values can generally be displayed by either clicking the button that is associated with list of value fields, pressing the List button or by pressing the F9 key.
Values that are defined for a discrete value group are displayed in a list of values.
See also: discrete value group
A process that prevents subsequent update of a CRF. Under most circumstances, a locked CRF cannot be 'unlocked,' although administrators may permit, on a limited basis, a user to unlock a single CRF so that data may be updated.
A status assigned to a CRF that indicates all data has been collected, approved, and verified. A locked CRF may be viewed in browse mode and may be included in PDRs, however, its data may not be updated under normal circumstances.
A designation that describes the current state of a CRF, with regard to whether or not it may be updated. In RDC, there are two lock statuses:
A response field in the question area of a CRF section that should be completed before the CRF is saved in the Entry Complete status. Failure to do so results in the generation of a discrepancy, which is associated with the relevant response field.
A discrepancy associated with a mandatory response field that is generated by the system when a CRF is saved. The discrepancy triggers when data for the field is not collected.
A discrepancy that is generated by a user rather than the action of a validation procedure on a data point value. In RDC, a manual discrepancy may be associated with an entire CRF, a CRF section header or a specific response in the question area of a CRF.
See also: discrepancy, discrepancy management, section discrepancy
A discrepancy that is dependent on two or more data point values, which can be within a single CRF or across multiple CRFs and/or visits. In RDC, a multivariate discrepancy is generated when a CRF is saved, which causes the system to run the validation procedures that locate this type of discrepancy. In Oracle Clinical, the Batch Validation process runs all validation procedures.
See also: discrepancy, discrepancy management, manual discrepancy
A message that is communicated by the study sponsor to some portion of its RDC users. News items are displayed in the News window.
An item in the hierarchical tree in the Activity List window. When you select a node, the tasks that are associated with it are displayed in the Task pane.
Each node represents one of three scopes: Study, Site, or Patient. Within the Navigation pane, there is only one Study node displayed. However, depending on the security settings associated with your user name, there may be more than one Site node displayed under the Study node, and generally many Patient nodes listed under each Site node.
A set of questions that are related, but for which there is not a single set of possible answers.
See also: question group, repeating question group
An approval status assigned to a CRF that indicates the CRF has never been approved.
See also: approval status, approved, not approved, awaiting re-approval
A verification status that indicates the CRF has not yet been verified.
See also: verification status, verified, not verified, awaiting re-verification
A system-generated discrepancy state assigned to a discrepancy that is associated with a response that is a constituent of a:
repeating question group row that was deleted
a question that was deleted
a CRF section that was deleted
a CRF that was deleted.
A section discrepancy is made obsolete when its parent CRF is deleted or made blank. A data discrepancy is also made obsolete if the validation procedure upon which it is based is retired.
1) A designation for a discrepancy that indicates it is either in the active or other discrepancy status; that is, it is actionable by a user group.
2) A designation for a CRF that indicates it contains at least one active or other discrepancy.
A CRF that is planned in a visit, but which the protocol does not require to be collected. Optional CRFs are not included when the system determines whether there are missing pages. The information in the CRF Column Header of optional CRFs is displayed in italic font to distinguish each from required CRFs.
A discrepancy status that indicates the discrepancy is actionable by a user group other than yours.
See also:
A data entry status that assigned to CRFs that originate in the Oracle Clinical data entry system. It indicates that the first pass is complete.
A data entry status that assigned to CRFs that originate in the Oracle Clinical data entry system. It indicates that at least one response field has been recorded in the first pass.
A data entry status that assigned to CRFs that originate in the Oracle Clinical data entry system. It indicates that two-pass data entry was required for the CRF and that the second pass is complete.
A data entry status that assigned to CRFs that originate in the Oracle Clinical data entry system. It indicates that two-pass data entry was required for the CRF and that at least one response field has been recorded in the second pass.
The data that represents a participant in a clinical study. This includes demographic information and clinical results.
In Oracle Clinical or RDC, a patient data report (PDR) includes all study data for a single patient in a PDF document.
A designation for a a set of patient data that is unique across a given study. Patient numbers are assigned to a study as part of the Oracle Clinical Design process. Alternative terms include: enrollment number, allocation number, and randomization number.
The following rules apply to all patient numbers:
Each patient number must always be assigned to a site.
Each patient number may not be assigned to more than one site at a time.
The first character in the patient number string may be a non-zero numeric or an alphabetic character.
If the first character in the patient number string is alphabetic, the second character must be a non-zero numeric character.
Only the first character may be alphabetic.
Changes that are made to a CRF that have not yet been committed to the study database. The changes that may be pending are response value, investigator comments, or discrepancies. The Save action commits pending changes to the database.
An attibute of a book that denotes a stage of a study. Phases are used to divide the study into logical groupings of visits. Examples of phases include: Screening, Dosing, and Follow-up.
You can use the RDC Spreadsheet to view CRFs by phases. To do this, select the Phase Spreadsheet view from the Spreadsheet View drop-down list box.
The ability for an RDC user to perform a certain task. Privileges are granted to users in the RDC Administration study and site maintenance windows by administrators. In general, users within a user group, that is, those that are given the same role, are assigned the same set of privileges.
The order that RDC uses to navigate to and open CRFs. There are three different modes available in RDC:
By patient
By CRF column
The specific sequence that is employed at any time is defined by the Progression to next CRF setting in the Preferences window. In PDF mode, the browse sequence is invoked when you use the Previous and Next buttons.
A question that differentiates between sets of identical questions. In a multi-section CRF, where the same section, containing the same set of questions, is collected more than once, a qualifying question is used in each such section. The purpose of the qualifying question is to elicit a unique response, called a qualifying value, which allows differentiation of the responses in the sections.
When you respond to a qualifying value question, you select from a discrete set of values that are specified in the question definition.
An example of a qualifying question is a multi-section CRF that collects vital sign data multiple times in a single visit. Each set of vital sign data comprises a section. Each section is differentiated by "time post dose" question. The result is a set of vital signs collected at specific times.
The value assigned to a qualifying value question that is associated with a CRF section. For multi-section CRFs, where each section includes a qualifying question, the qualifying value is used to differentiate between the sections.
1) A procedure that is run against a database with the goal of returning a subset of a data that satisfy the query criteria.
2) An industry term that is a synonym for the Oracle Clinical term, discrepancy.
The set of information that delineates what data a question collects. Among the information is:
question name
data type
length
lower bound
upper bound
A set of questions in a CRF that are related due to similarity or study protocol considerations.
An example of a question group is Demographics, which collects such data as: sex, race, and date of birth.
See also: non-repeating question group, repeating question group
The label that describes a question. It may be in the form of a question or it may simply be a word or phrase that serves as the prompt for a response.
A question group that is collected more than once in the same CRF section (or Oracle Clinical DCM).
In some cases each data point is preceded by a prompt that distinguishes the response required from the other questions in the group, which are often displayed on subsequent rows. For example, a question group may collect findings for several organs. The prompt in each row is automatically populated to identify one organ, and the data point field collects the finding for that organ. The organ names are defined as Default Repeat Values in Oracle Clinical.
See also: question group, non-repeating question group
A CRF that the protocol specifies as a planned CRF in a visit, for which data must be collected. Planned CRFs are analyzed when the system determines whether there are missing pages. The information in the CRF Column Header of optional CRFs is displayed in regular font to distinguish each from optional CRFs.
See also: CRF, optional CRF.
A type of discrepancy action that resolves the discrepancy and causes the status of the discrepancy to change from active to closed.
See also: discrepancy, discrepancy status, discrepancy action, routing, user role
A parameter associated with a discrepancy action that provides a sponsor-defined reason when a user closes a discrepancy.
The value that is assigned to a data point. This term usually refers to fields in the Question area of a CRF.
See also: CRF, data point
See user role
A type of discrepancy action that causes the status of the discrepancy to change from active to other for your user group and from other to active for a different user group.
See also: discrepancy, discrepancy status, discrepancy action, resolution, user role
In the RDC Activity List window, a category or classification of a set of tasks: study, site, or patient.
These are listed and identified in the Navigation pane. When you select an item in the Navigation pane, the tasks that are associated with its scope are listed in the Task pane. Because only one study can be active in RDC at any given time, the study scope is listed once. The site scope is listed once for each site to which you have access for the current study. The patient scope is listed once for each patient to which you have access for the site.
In RDC, a constituent of a CRF that is comprised of a set of related questions. Each CRF contains at least one section and may contain more than one. In Oracle Clinical terms, a section equates to a data collection module (DCM) (DCM).
A user-generated discrepancy that is associated with a CRF section. There can be multiple discrepancies associated with a CRF section. This is the only type of discrepancy can be routed as an internal discrepancy.
See also: discrepancy, CRF section
The period that starts when a single user successfully logs in to an application and ends when the user exits the application. In RDC, it is also referred to as an RDC session.
In the RDC Discrepancy task tab, the ordering number that is assigned to each discrepancy associated with the current CRF or CRF section (if the CRF has multiple sections). Discrepancies are listed in numerical order, according to the sequence number. The number assigned to each discrepancy is not static. It is based on the following parameters: the current status, the time stamp, and the location of the response field within the CRF or section.
A key or key combination that allows you to implement a function in the application by using the keyboard.
See also: access key
A method of using RDC during study design, prior to the initiation of the protocol. Under normal circumstances, RDC runs in Production mode. Test mode mirrors the look and feel of production mode but uses a separate set of tables to store the data.
A significant event in the history of a CRF. Used as criterion when viewing the Audit Trail tab. Examples of timepoints include:
creation date
verification dates
approval dates.
A value assigned to a data point that provides a chronology for significant events during a study. Such events include: the date/time when a value was created, the date/time when a value was updated, etc.
A discrepancy that is dependent on the value of a single data point. This type of discrepancy usually occurs when the value recorded for a response does not meet criteria defined by the study sponsor.
See also: discrepancy, discrepancy management, manual discrepancy, multivariate discrepancy
A process that allows a user with unlock privilege to assign to another user the capability to update a CRF that is in the locked status.
A lock status that indicates a CRF may be updated.
A designation attributed to any event or CRF that was not part of the protocol schedule or that occurs at a time other than was originally specified in the protocol schedule.
See also: unplanned CRF, unplanned visit
A CRF collected at a visit at which it was not planned, that is, it is not part of the case book.
A set of users that are assigned to the same user role (RDC).
A database role that is granted to a user or user group.
In RDC, there are several default user roles. However, any given study database may include some or all of these, and may include sponsor-specific roles. RDC allows privileges to be assigned independently of user role assignment.
An action that entails the initiation and processing of sponsor-defined procedures, or edit checks, on multiple data points, or other checks on a single data point, that returns a discrepancy for each data point that does not meet the defined criteria. Such a data-generated discrepancy is also referred to as a validation error.
A condition associated with one or more data points that indicates the value does not meet the criteria defined in a question definition or validation procedure. It is equivalent to a data-generated discrepancy.
When used in the context of criteria and parameters, the choice that you assign to a parameter, which was chosen from a list of possible values.
A record, or set of records, associated with a CRF that lists each change in verification status starting with the initial verification action.
In RDC, a designation that describes if a CRF has been verified, including: not verified, verified, awaiting re-verification, verification undone.
A verification status that indicates the CRF was verified but subsequently the verification was undone. This status is equivalent to the not verified status, with the exception that a verification history exists for a CRF in verification undone status.
A verification status that indicates the CRF has been verified by a user with the verify privilege.
1) Check a data point or CRF against the collected source data.
2) A privilege assigned to a user name that allows the user to alter the verification status of a CRF or a group of CRFs. The privilege can be assigned at the study level or the site level.
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