| Oracle® Clinical Remote Data Capture Classic Data Entry User's Guide Release 4.6 B13921-03 |
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PDF · Mobi · ePub |
| Oracle® Clinical Remote Data Capture Classic Data Entry User's Guide Release 4.6 B13921-03 |
|
|
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 Classic 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.
An item in the Task Pane of the Activity List Window. Each activity is related to the node that is in focus in the Navigation Pane and functions as a link that creates a workset and loads the associated patients and CRFs in the RDC Classic Spreadsheet.
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. In RDC Classic, there are four approval statuses:
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 Classic, an approval is equivalent to an electronic signature.
Any field in the CRF that has an ATTACHMENT prefix represents an extended text field that supports 10,000 characters instead of the normal maximum of 200 characters. You can enter and update data in these fields only in Oracle Clinical Remote Data Capture Onsite (RDC Onsite).
The set of all audit records for a given datapoint.
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 datapoint
Previous value of the datapoint
Username that changed the datapoint
Timestamp the data update occurred
Change reason
Optional comment
A feature of RDC Classic 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 via a user performing data entry.
An RDC Classic 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.
A check box GUI component used in the Data Entry window. 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 Data Entry window and may also be present in the CRF section, especially in multi-section CRFs.
See case book.
In RDC Classic, a statement that uses a Boolean operator to construct a search string by combining two or more search strings.
A key word that is used to logically join two search strings in a Boolean expression. RDC Classic accepts the following Boolean operators:
AND
OR
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 Classic users must be assigned this privilege or a higher-level privilege that incorporates it.
A privilege, specific to batch loaded CRFs, that provides the user with the ability to view existing data, but not to add new or update existing data in CRFs. This is the minimum privilege required for a user to view batch loaded CRFs.
A user action that halts the current process or action and reverts to the state of the application that immediately preceded the process or action, without changing the status of the system or data.
In a dialogue or pop-up window, a Cancel button causes the application to dismiss the window, disregard changes made in the window, and revert to conditions that existed before the window opened.
The set of CRFs that are used to collect data for a patient over the course of the study. Each patient is assigned to a particular case 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 Classic, 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 timestamp and the username of the person who made the change are recorded. In RDC Classic, a change history can be associated with the following:
A constituent of an audit record. A standardized entry that explains why a datapoint changed. The change reason can be supplied either automatically (system provided) or manually (user provided).
In RDC Classic, a user-supplied change reason is required when patient data changes after the CRF reaches entry complete data entry status.
An occurrence, usually a visit, that is scheduled as part of a protocol to collect clinical data for a patient. In RDC Classic, 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 acronym for contract research associate.
In Oracle Clinical and RDC Classic, a defined role that can be assigned to a user for the purpose of discrepancy management.
An RDC Classic entry status designation that is assigned to a CRF when all required CRF header data has been entered and saved, and no other data, that is, 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.
In reference to the RDC Classic Search window, one of the components that can be altered so that a certain set of study data is retrieved to the Spreadsheet. Each criterion is comprised of a set of parameters that allow you to make choices about the data you wish to retrieve.
The Search Window is comprised of seven criteria:
Each criterion is comprised of a certain number of parameters. With the exception of the book criterion, all Search window criteria have a default setting that retrieves the maximum amount of data. (The default for the Site criterion, for example, is "All Sites.")
You modify a criterion from its default by changing one or more of the parameters that comprise it.
The Book and Site criteria each have a single parameter, which you access and modify from the Search window.
All other criteria have multiple parameters, which you access and modify in the Subsearch window that is specific to each criterion.
An area of a CRF which consists of information that identifies that the CRF and the data that it collects. The information pertains to the patient, visit, investigator, and site.
In the Data Entry windows, certain fields in the CRF header are required, that is, you must record that information before the system allows you to save the CRF.
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. There is one header for each CRF.
RDC Classic will not save a CRF to the study database until all required CRF header and CRF section header fields are collected.
In RDC Classic, 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 data set that is active in RDC Classic. The name of the current study is displayed in the title bar of the Main Application Window.
data collection instrument (DCI)
(General) The Oracle Clinical term that correlates to an RDC Classic CRF. A DCI is composed of one or more DCMs.
See also case report form, data collection module (DCM), CRF.
(General) 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 method that is used to enter data into a CRF and save it to the study database.
A designation that describes the current state of data entry for a CRF. In RDC Classic, 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.
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.
Either of two RDC Classic components that allow you to specify the patient data you want to include in a workset. The Search Window, which is available to all users, provides the capability to specify parameters that can result in narrowly defined worksets. The Activity List Window, which is made available in the RDC Classic session by the administrator through a setting in the RDC Classic Configurator, defines the workset indirectly, based on the activity the user selects.
In RDC Classic, 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).
The saved search that is designated to be used as the default search criteria for the Search window and the default filter for the Activity List window.
The preferred study associated with your username. RDC Classic 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 logon, 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. The specific components of the discrepancy change history that are available to RDC Classic users are:
Timestamp of update
Error text
Discrepancy comment
Current status
Resolution
Resolution comment
Change by
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.
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.
A mode of the Data Entry window that is accessible from the Individual Discrepancy Tab of a multivariate discrepancy. The system uses the window to display the data field of a discrepancy variable that is not in the currently open CRF. In this mode, the title bar is highlighted in red and the words "Discrepancy Review" are appended to the normal title bar information.
The highest level designation of a discrepancy. A discrepancy can be in one of two states:
A designation that describes a current discrepancy.
A designation that describes the current state of a CRF with regard to discrepancies. In RDC Classic there are four discrepancy statuses:
(Oracle Clinical) 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. It may also allow the same question to be used in multiple instances.
It is also possible for one DVG to be a subset of another DVG. In this case, the child DVG is made up of responses that are part of the parent.
In RDC Classic, the equivalent of a CRF.
(Oracle Clinical) An acronym for discrete value group.
An acronym for electronic data capture.
A method of data collection for clinical trials that uses computers at investigator sites as a mechanism to submit patient data and information to a centralized study database.
Remote Data Capture is an electronic data capture application.
See also EDC.
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, delineated in Oracle Clinical and RDC Classic, that track the progression of a CRF from no data entered ("Created") through entry complete.
See also blank, created, entry started, entry complete.
A saved search that is applied to the Activity List window to limit the scope of the Navigation pane and/or the activities that are available in the Task pane. It allows you to generate a more discrete and focused workset that is still based on an activity.
In RDC Classic, 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, or visit.
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 may either be 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 Classic only.
See also required field.
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 Classic 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.
installation reference codelist
(Oracle Clinical) A reference codelist that is defined and populated upon initial installation of the application.
See also reference codelist.
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 Classic provides visual cues to alert the user to the presence of an investigator comment associated with a datapoint:
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.
See also LOV, discrete value group.
1) A privilege that may be assigned that enables a user to lock a CRF or a set of CRFs
See also privilege.
2) 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.
See also patient data report, data entry status.
A designation that describes the current state of a CRF, with regard to whether or not it may be updated. In RDC Classic, there are two lock statuses:
An acronym for list of values.
A response field in the question area of 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.
See also required 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 a data point value. In RDC Classic, 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.
The section of the Main Application window that provides access to RDC Classic commands.
Refer to "Main Application Window" and "Menu Bar" for further information.
See also menu command, menu item.
Each menu command is displayed in either black or grey font. If the command is displayed in black font, it is available and may be invoked under the current application conditions. If the command is displayed in grey font, it is not available under the current application conditions. If you attempt to use a menu command that is displayed in grey font, the system does not respond.
Each label (for example, "File" or "Insert") used to categorize commands that are available from the menu bar. When a menu is accessed, either by clicking the label or using its access key, it drops down to display the list of menu commands that are associated with it.
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. 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.
See also discrepancy, discrepancy management, manual discrepancy.
In the Activity List Window, the section, or frame, that comprises the left-hand portion of the window and presents a hierarchical listing of the current study, the sites to which you have access. When you click a Site node the patients assigned to each site to which you have access are displayed under the site name.
A message that is communicated by the study sponsor to some portion of its RDC Classic users. News items are displayed in the News Window.
An item in the hierarchical tree in the Navigation pane of 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 username, there may be more than one Site node displayed under the Study node, and generally many Patient nodes listed under each Site node.
See also scope.
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.
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 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 discrepancy status, discrepancy, active, other, closed.
In reference to the Search Window, a component of a criterion that you use to define a specific property of the data you wish to comprise the workset. A parameter may be comprised of settings that represent a value or range of values that, when combined with any other parameters in the same criterion, define specific data.
See also criterion, setting, search phrase, workset.
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.
A human participant in a clinical study. Each patient in a study is assigned a unique patient number that is associated with a particular site. In addition, the patient number is also assigned to a particular case book.
See also case book.
The data that is collected about a participant in a clinical study. This includes demographic information and clinical results.
See also freezing, locking, subject.
In Oracle Clinical or RDC Classic, a generated PDF document that is a compilation of data collected about a patient. There are two basic types of PDR: reports that contain blank CRFs and reports that contain response data, audit history records, and/or discrepancy data.
PDRs that include response data provide a snapshot of a dataset that you specify. This type of PDR includes investigator comments and long data values, notes deleted CRFs, and provides the option for you to specify an extensive set of parameters that control the data that is included in the report.
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.
An acronym for Portable Document Format.
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 attribute 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 Classic Spreadsheet to view CRFs by phases. To do this, select the Phase Spreadsheet view from the Spreadsheet View drop-down list box.
A type of file format.
Portable Document Format is a universal file format published by Adobe Systems, Inc., that preserves all of the fonts, formatting, graphics, and color of a source document that is generated on with any application on any operating system.
See also PDF.
The ability for an RDC Classic user to perform a certain task. In RDC Classic, privileges are granted to users in the RDC Classic 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 following privileges may be assigned to RDC Classic users:
The order that RDC Classic uses to navigate to and open CRFs. There are three different modes available in RDC Classic:
By patient
By patient, within Spreadsheet view
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. The system uses the progression sequence when other progression settings are selected.
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.
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 user who able to set or modify the privileges associated with other RDC users, either via Oracle Clinical or the RDC Admin application. Within the RDC application, a user who is an RDC administrator is able to maintain saved searches for any RDC user.
A user is designated as RDC administrator through any one of these actions:
Selecting the Admin? check box in the Study Security or Site Security windows
Assigning the user one of these database roles:
RXC_ADMIN
RXC_SUPER
RXC_SUPER_NOGL
Refer to the Oracle Clinical Administrator's Guide for additional information.
A question that usually consists of more than one response. The responses are generally situated in a single row and are referred to as a "repeating question row". For each response, there may be a default value, which is a system-provided value that entered automatically when you open the CRF. A repeating question is usually one of a set, each of which are distinguished by the initial response or by a question label.
An example is a question group titled, "Body Systems". Each repeating question row collects data about a different body system with three response values. The first response in each row identifies the part of the body, for example, chest or head. The next response in each row requires one of three values: "Normal", "Abnormal", or "Not Done". If the response to this question is "Abnormal", the third response, "Explanation", is required.
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.
An RDC Classic designation for a CRF datapoint that indicates data must be collected for that field before the system will save the CRF. In RDC Classic, required fields occur in
A type of discrepancy action that 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 datapoint. This term usually refers to fields in the Question area of a CRF.
See also CRF, data point.
The order in which the system expects data entry to proceed, from one field to the next. Also termed tab order, this is determined for each question during the CRF design phase of study setup. It is used when you use the Tab key to navigate from one field to another. The system also uses it to facilitate the Auto Skip and Auto Fill features of the Data Entry window.
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.
An action that commits pending data changes to the study database.
In RDC Classic, there are two modes of save action: explicit and implicit. The former is a result of user action, for example, clicking the Save button. The latter is the result of a system action.
A set of search criteria that have been saved to the study database, which can be re-used at a later time to quickly and consistently generate a workset.
See also search criteria, workset, RDC administrator.
In the Activity List Window, a category or classification of a set of tasks; there are three scope levels that are available in the Activity List window:
Study
Site
Patient
These are listed and identified in the Navigation Pane. When you select an item in the Navigation pane, the activities that are associated with its scope are listed in the Task Pane. Because only one study can be active in RDC Classic 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.
The settings that determine the CRFs that comprise the workset. These settings can be defined directly, through the Search window, or indirectly, through the Activity List window.
The group of settings that, when taken together, define a searchable property. An example is, "search all CRFs named 'Vitals' for systolic BP values that are greater than or equal to 120." You use several drop-down lists in the Subsearch window to construct the search phrase.
A GUI component in RDC Classic that allows a user to define directly the search criteria that is displayed in the RDC Classic Spreadsheet. The Search window provides access to seven criteria, which are can be modified from default values, that the system combines to retrieves CRFs from the study database.
1) In RDC Classic, 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).
2) In the Graphical User Interface - a part of a window or other informational feature that contains related information and/or data fields. It is often delineated by a descriptive label and a border that surrounds its related components.
For example, the different views that are available in the Summary Task tab are differentiated by the sections that comprise each view. In some cases, the sections are used in more than one view. Refer to "Summary Task Tab" for examples of sections.
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.
The system displays "<Oper>" as an indication of the presence of a section discrepancy in the title bar of the Data Entry window when focus is in the discrepant CRF section.
See also discrepancy, CRF section.
The period that starts when you successfully log in to RDC Classic and ends when you exit RDC Classic. This is also referred to as an RDC Classic session. It is constricted by limitations that are imposed by the following conditions:
Only one username is granted access to a session.
The role and privileges assigned to the username determine the patient data and functionality that is available within a session.
Only one database can be accessed during a given session – if you want to access a different database, you must initiate a new RDC Classic session.
Only one study can be open at a time during a session, however, unlike the restriction on the active database, you can change to another study within an RDC Classic session – if you want to access a different study you must close the current study and select another.
Only one book can be active at a given time, however, you can change to another book within an RDC Classic session.
One or more sites can be active during a given session and the privileges assigned to the username may vary from site to site.
The value of a parameter in the Search Window, which is a contributor to a the value of a criterion. Usually, the default setting for a parameter is "ALL", which means that the parameter does not limit the data that is retrieved. When the value of a parameter is set to something other than "ALL", it generally limits the number of CRFs that are retrieved.
In the Discrepancy Task Tab, the ordering number that is assigned to each discrepancy associated with the current CRF or CRF section (if the current CRF is multi-section). Discrepancies are listed in the List of Discrepancies Tab 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 timestamp, 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.
1) A criterion that contributes to the generation of search criteria based on the sites to which the user has access. The criterion can have a value of either:
<ALL> – includes all sites to which the user has access
Single site – limits search criteria to one site to which the user has access
2) A clinical location that participates in a study.
The first place that patient data is recorded. This may be in a hospital chart or a paper CRF at an investigative site. Alternatively, it may be collected in an electronic CRF via RDC Classic data entry.
In RDC Classic, the verification process entails source data verification. That is, ensuring that the source data matches what has been collected in RDC Classic.
In the RDC Classic Spreadsheet, these determine how the system displays the workset data. There are three different tabs that each provide a different view of the workset:
Study
Phase
Visit
You select the type with the Spreadsheet view drop-down list that is located above the patient listings in the Spreadsheet. (Note that the presence of this component is dependent on a sponsor-specified configuration.)
A window that is accessed from the Search window that allows a user to change the values of parameters. Changes in the subsearch window affect a Search window criterion.
In the Activity List Window, the section, or frame, that comprises the right-hand portion of the window and presents a listing of activities, or tasks, associated with the currently selected node in the Navigation pane. When you click a task, RDC Classic retrieves the data necessary to complete the task from the study database and displays it in the RDC Classic Spreadsheet.
See also node, scope, Navigation pane.
A method of using RDC Classic during study design, prior to the initiation of the protocol. Under normal circumstances, RDC Classic runs with Production mode active. This 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 datapoint that provides a chronology for significant events during a study. Such events include the date/time when a value was created and the date/time when a value was updated.
An Internet address that points to a specific resource on the World Wide Web by its location. The address is described in combinations of syntax and special characters that, when combined, represent a unique string. In general, URLs make up a subset of URIs. Common URLs are those that point to Web pages or to FTP sites. The former are identified by an "http:" prefix string, the latter are identified by an "ftp:" prefix string.
A discrepancy that is dependent on the value of a single data point. This type of discrepancy is usually when the value recorded for a response does not meet certain criteria that is deemed acceptable by the study sponsor.
See also discrepancy, discrepancy management, manual discrepancy, multivariate discrepancy.
1) A privilege that is assigned to a user to unlock a CRF. The privilege can only be assigned at the site level.
2) 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 which 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.
1) A process or condition in which CRF data or information, which has previously been saved, is changed.
2) A privilege that allows a user to initiate data entry, update data, initiate discrepancies, and update discrepancies.
A privilege that allows a user to initiate or update a discrepancy in CRFs that are batch-loaded.
A privilege that allows a user to initiate or update a discrepancy in CRFs that are no batch-loaded.
An acronym for Uniform Resource Locator.
In RDC Classic, a set of users that are assigned to the same user role.
A database role that is granted to a user or user group. In RDC Classic, there are five default user roles, however, any given study database may include some or all of these, and may include sponsor-specific roles. RDC Classic allows privileges to be assigned independently of user role assignment.
RDC Classic ships with the following roles:
Super User (SU)
Data Manager (DM)
Clinical Research Associate (CRA)
Site Coordinator (SITE)
Site Investigator (INV)
See also privilege, user group.
Note:
The RDC Classic documentation uses this default set of user roles to describe various functionality that is dependent on certain sets of privileges.An action that entails the initiation and processing of sponsor-defined procedures, in the case of multiple datapoints, or edit checks, in the case of a single datapoint, that analyze collected data and return an query, or discrepancy, for each datapoint that does not meet the criteria defined in the procedure. Such a data-generated discrepancy is also referred to as a validation error.
A condition associated with one or more datapoints 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.
A designation that describes if a CRF has been verified. In RDC Classic, there are four verification statuses:
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.
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.
A clinical event, which generally denotes the occurrence of a meeting between a patient and clinical staff at a study site. In the course of a visit, data related to the study is collected, which at some point is recorded and saved to the study database.
In RDC Classic, a visit consists of one or more CRFs. By default, the system displays Spreadsheet Visit view in the RDC Classic Workspace, which displays, for the current patient list, all of the CRFs collected for a single visit.
The collection of patient data that is currently displayed in the RDC Classic Spreadsheet. You use either the Search Window or the "Activity List Window" to select the data that you want to view in the Spreadsheet. This may include, but is not limited to, the following:
Patients
CRFs, including entry, approval, verification, and lock statuses
Response data
Investigator comments
Discrepancies
Audit trail history
This term may also be called a dataset.
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