A property of a user name that 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.
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. RDC has 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.
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:
The current value of the data point
The previous value of the data point
The user name that changed the data point
The time stamp the data update occurred
The change reason
An optional comment
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
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 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 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 casebook.
A user action that entails reviewing existing data without adding new data or changing existing data.
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 dialog box or window, the 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.
See 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).
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 casebook.
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 active; discrepancy state; discrepancy status; obsolete; other.
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 (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.
Case Report Form. A paper or an electronic record associated with a patient in a clinical study. Its purpose is to facilitate accurate collection of clinical data. RDC displays CRFs in the Data Entry window.
In reference to the RDC Search window, one of the components that can be altered so that a certain set of study data is retrieved. Each criterion is comprised of a set of parameters that allow you to make choices about the data you want to retrieve.
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 active; closed; discrepancy state; obsolete; open; other.
The 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)
See DCI.
See DCM.
In RDC, 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. RDC has four data entry statuses: created, blank, entry started, and entry complete.
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.
In RDC, 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 CRF; created; data point; initial data entry.
Data Collection Instrument. The term that Oracle Clinical uses for an RDC CRF. A DCI is composed of one or more DCMs.
Data Collection Module. The term that Oracle Clinical uses for a CRF section (CRF).
In Oracle Clinical, a DCM is a set of one or more related groups of questions that pertain to a single clinical study visit.
See also section (CRF).
The preferred study associated with your user name. RDC automatically selects the default study when you start 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 started 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 lets you select 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 users are:
Time stamp 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; manual discrepancy; multivariate discrepancy; univariate discrepancy.
An entry that 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: current or obsolete.
A designation that describes a current discrepancy or the current state of a CRF with regard to discrepancies. RDC has four discrepancy statuses: active, other, closed, and none.
See DVG.
In RDC, the equivalent of a CRF.
(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.
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 started 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, that track the progression of a CRF from no data entered (created) through entry complete, to approved.
See also blank; created; entry complete; entry started.
In RDC, where the cursor is currently active. Focus may change from window to window, as when the cursor moves from the application page to the first field in the Data Entry window.
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 and approval sessions.
A designation that is applied to a patient that indicates that all data has been received, entered, reviewed, and cleaned for the patient, CRF, or visit.
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
Blank flag
In CRF Section Headers, the following fields are available:
Date
Time
Blank flag
Clinical planned event
Lab
Qualifying value
Note: The preceding lists are specific to RDC only.
A question used with a question group 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.
installation reference codelist
(Oracle Clinical) A reference codelist that is defined and populated upon initial installation of the application.
An application server instance is the set of processes required to run the configured components within an application server installation. There can be only one application server instance per application server installation. The terms installation and instance are sometimes used interchangeably; however, it is important to remember that an installation is the set of files installed into an Oracle home and an instance is a set of processes associated with those files.
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 Data Entry window displays the response field with a yellow background.
The Data Entry window displays the data value in a green font.
When focus is in the relevant response field, the title in the Data Entry window includes an <Inv> entry 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 clicking the button that is associated with list of value fields, clicking the List button, or pressing the F9 key.
Values that are defined for a discrete value group are displayed as a list of valid 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.
See also browse mode; lock; PDR; status; update mode; unlock.
A designation that describes the current state of a CRF, with regard to whether or not it may be updated. RDC has two lock statuses: locked and unlocked.
See 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.
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, 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. 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.
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; awaiting re-approval; not approved.
A verification status that indicates the CRF has not yet been verified.
See also awaiting re-verification; not verified; verification status; verified.
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.
Refers to the folder location where the OC4J instance under which the RDC application is running is installed.
Oracle Application Server Containers for J2EE (OC4J) is a complete set of J2EE containers written entirely in Java that execute on the Java Virtual Machine (JVM) of the standard Java Development Kit (JDK).
RDC runs under a specific OC4J instance called rdc created under AS10g during installation. Restarting this OC4J involves going to the AS10g administrative console (Web or command prompt), locating this particular OC4J instance, and restarting it.
An environment variable (UNIX) or registry key (Windows) that indicates the directory where Oracle software is installed. For RDC, OPA_HOME refers to the location of the OLSA home folder, which includes subfolders containing binaries, logs, temporary files, and configurations.
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.
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 that 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.
In reference to the Search window, a component of a criterion that you use to define a specific property of the data you want 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; search phrase; setting.
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.
A generated compilation of data that is presented in a PDF document.
A designation for 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.
Portable Document Format. A universal file format published by Adobe Systems, Inc., that preserves all the fonts, formatting, graphics, and color of a source document that is generated with any application on any operating system.
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.
See PDF.
A privilege is the right to perform an action on the database. Privileges can either be general (system privileges) or specific to particular database objects (object privileges). They can also be grouped into roles.
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 following privileges may be assigned to RDC users:
Browse
Browse batch loaded data
Browse Source Data Verification Plan
Update data
Update batch data
Update discrepancies
Update Source Data Verification Plan
Administrate Source Data Verification Plan
Verify CRFs
Approve CRFs (on a site basis only)
Lock
Unlock (on a site basis only)
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.
A procedure that is run against a database with the goal of returning a subset of a data that satisfy the query criteria.
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 gender, race, and birth date.
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 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 instance, 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 non-repeating question group; 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 designation for a CRF data point that indicates data must be collected for that field before the system will save the CRF.
A type of discrepancy action that causes the status of the discrepancy to change from active to closed.
See also discrepancy; discrepancy action; discrepancy status; 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 action; discrepancy status; resolution; user role.
The settings that determine the CRFs that comprise the workset. These settings can be defined directly in the Search pane, or indirectly, through an Activities link.
The group of settings that, when taken together, define a searchable property. For example:
Search all CRFs named Vitals that have active discrepancies.
You use several drop-down lists in the Search window to construct the search phrase.
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).
section (Graphical User Interface)
In the user interface, a section is 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.
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 CRF section; discrepancy.
The period that starts when you successfully log in to RDC and ends when you exit RDC. This is also referred to as an RDC session. It is constricted by limitations that are imposed by the following conditions:
Only one user name is granted access to a session.
The role and privileges assigned to the user name 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 start a new RDC 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 session. If you want to access a different study, you must close the current study and select another one.
Only one book can be active at a given time, however, you can change to another book within an RDC session.
One or more sites can be active during a given session and the privileges assigned to the user name may vary from site to site.
The value of a parameter in the Search pane, 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.
A key or key combination that allows you to implement a function in the application by using the keyboard.
A method of using RDC during study design, prior to the start of the protocol. Under normal circumstances, RDC 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 time points 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, and so on.
See URI.
See URL.
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.
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 casebook.
A process or condition in which CRF data or information, which has previously been saved, is changed.
Uniform Resource Identifier. The generic term for all types of names and addresses that refer to objects on the World Wide Web. A URL is one kind of URI.
Uniform Resource Locator. 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 "https:" or "http:" prefix string, the latter are identified by an "ftp:" prefix string.
Uniform Resource Locator (URL), a form of URI, is a compact string representation of the location for a resource that is available via the Internet. It is also the text-string format Web clients use to encode requests to Oracle Application Server.
A role is a group of database privileges that can be granted and revoked as a unit. Specific privileges can be granted and revoked from the role dynamically, and the role can be enabled or disabled dynamically for specific users.
In RDC, 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 allows privileges to be assigned independently of user role assignment.
The roles that RDC ships with are:
Super User (SU)
Data Manager (DM)
Clinical Research Associate (CRA)
Site Coordinator (SITE)
Site Investigator (INV)
See also privilege.
Note:
The RDC 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 data points, or edit checks, in the case of a single data point, that analyze collected data and return an query, or discrepancy, for each data point 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 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.
A designation that describes if a CRF has been verified. RDC has four verification statuses: not verified, verified, verification undone, and awaiting re-verification.
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, a visit consists of one or more CRFs.