The personnel responsible for the setup and maintenance of the MACRO system, including user authentication and database control.
Application Programming Interface. This enables a user to access the functionality of MACRO via an external application.
See Archive Module (AR)
The optional MACRO module used to generate a fully compliant, archive-ready set of data including all study-related information, subject data and audit trails.
The decision support toolkit embedded in MACRO which handles expressions (such as question derivations), conditions (such as question validations) and eForm scheduling.
The application which displays the Arezzo representation of a MACRO study and allows the study designer to enter scheduling and additional task attributes.
A chronological record of the values and other attributes of a question, such as status and response value.
The personnel responsible for the checking and auditing of collected data.
A question whose value will not be accepted unless a user with the specified role supplies their username and password at the time of entering the data.
The personnel authorised to certify that data has been collected in accordance with regulations.
The MACRO module used to import study data that has been transferred from a remote site into a database on a central server. It is used in conjunction with the Data Transfer (DT) module as part of the optional remote data entry feature.
Automatically matching the response value of a thesaurus question to a decode from an associated medical dictionary.
The MACRO module used to import single question responses for multiple subjects from an external system such as a laboratory system, using csv or xml files.
Used in Batch Data Entry as the collective name for an individual study question, its response and the identity of the study subject to which it belongs.
The MACRO module used to revalidate one or more eForms for multiple subjects.
See Batch Data Loading module (BD)
See \"Data Browser\"
A question requiring a selection from a predefined list.
See Clinical Coding module (CC)
The standard created by the Clinical Data Interchange Standards Consortium (CDISC). Study/subject data can be exported to/imported as an xml file which is compatible with CDISC.
The site at which the central database is located for a study. Data is entered onto a local database at each remote site and transferred on a regular basis to the central database at the central site.
See Command Line (CL) module
The optional MACRO module used to code special thesaurus questions using a registered MedDRA dictionary in order to achieve consistency in describing symptoms.
A unique alphanumeric identifier for an item. Question, group, eForm and visit codes must all be unique within a study. Also refers to matching the response value of a thesaurus question to a decode from an associated medical dictionary.
Theaurus questions can have one of six special coding statuses applied in addition to the standard question statuses. Note that coding statuses do not have icons. The coding status of a question is displayed in the coding audit trail but not on the eForm.
An Arezzo condition attached to a question which determines whether the question is available for data entry. Also called a Skip condition. If the condition is not satisfied, the question is disabled and its status becomes 'Not Applicable' .
The module that provides you with a command line interface through which you can perform specific tasks without the need to open individual MACRO modules. You can script recurring tasks and schedule them to be performed automatically.
See \"Question Comment\" or \"eForm Comment\"
The criteria used for grading the toxicity of a laboratory test result. See \"Laboratory Definition\".
See 'Arezzo Composer'
An Arezzo expression that contains a comparison operator and evaluates to true or false. For example, a question's validation condition.
The term used for the scheduling of visits and the completion of eForms.
A printed, optical or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each study subject.
An individual form within the set of forms as described in CRF above. In MACRO a CRF Page is called an eForm.
Comma separated variable. A plain text format for data export or category question values import.
See Common Toxicity Criteria (CTC)
The repeat number of a repeating question, eForm or visit.
Gives an overview of all the subject data collected. The data browser includes a comprehensive set of filters to narrow the information displayed.
A printed version of a list of DCRs.
The personnel responsible for the entering of subject data.
The MACRO module used to enter, monitor and review subject data via a web interface.
A question used to collect a single piece of data. Each question in MACRO is mapped to a Data Item object in Arezzo.
The personnel responsible for the validation of data, as well as the routine administration of the trial.
The personnel responsible for ensuring that the study is conducted in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)and the applicable regulatory requirements.
The MACRO module used to transfer study data between a remote site and a central server. It is used in conjunction with the Auto Import (AI) module as part of the optional remote data entry feature.
Data tables containing information from the master database in a simpler format. These tables are created in the Data Views module.
The MACRO module used to transfer subject data into simplified data tables suitable for querying by external applications
Information stored in the database relating to the current user of a study, subject or eForm within a study. The storage of database locks prevents two users from simultaneously changing the same data.
The MACRO module used to upgrade a database either from MACRO v3 to the current version of MACRO v4, or from a previous version of MACRO v4 to the current version.
A question requiring the entry of a date and/or a time in a specified format.
See Data Clarification Form (DCF)
A Data Clarification Request is a query raised against an individual question by a Clinical Data Manager. The DCR must be responded to by the investigator site.
An item in a medical dictionary that is matched with a thesaurus question response via the clinical coding feature.
Questions whose responses are automatically calculated from the responses given to other questions. The data entry user cannot directly answer these questions.
A data entry form in MACRO (another name for an Electronic Case Report Form or eCRF).
A piece of text placed on an eForm to provide information to the data entry user.
An eForm may have a date and/or time associated with it known as its eForm date. This date can be entered by the user or be derived.
Certain questions require the entry of a username and password by a user with a specified role before the question response can be accepted. This authorisation is known as an electronic signature.
See Event Management module (EM)
The MACRO module used to record the occurrence of selected events such as data status changes and to perform actions such as sending an email when these events occur.
An Arezzo term specifying a question, a number, a date or time or a more complex formula from which a value may be calculated.
The window that helps the study designer create Arezzo expressions and conditions.
When the data entry user moves from field to field on the eForm, using the Tab key or the Return key, the \"field order\" is the order in which fields will be automatically highlighted.
A Data Manager can freeze data for a subject when data collection is complete. When a question, eForm or visit is frozen, the data cannot be changed. A user with the relevant permission can unfreeze data, but generally freezing should be thought of as irreversible. See also \"Locking\".
If an icon or menu option appears grey, instead of its normal colour, this means that the item cannot be changed. This can happen because: (1) the item has been locked or frozen. (2) you do not have the appropriate permissions to use it. (3) the functionality is not available in the module you are using. (4) the eForm or question has a condition which requires you to complete another eForm or question first.
A hidden question exists on an eForm but cannot be seen or answered by the data entry user.
A link on an eForm to another eForm. Hotlinks appear as underlined text on an eForm. Clicking on a Hotlink opens the target eForm.
See \"Subject ID\"
A greyed-out eForm which cannot be opened during data entry because it is dependent on scheduling constraints, preconditions or internal triggers which have not been satisfied.
A question status indicating that the data entered for this question has satisfied an 'Inform if' validation condition. This icon appears only to a data reviewer; other users will see the OK icon.
An Arezzo condition that may be attached to an eForm or visit which determines when the eForm or visit should be activated.
The personnel responsible for the conduct of the study at a site.
A location at which clinical tests are performed.
The definition of the normal ranges for clinical tests carried out at a particular laboratory.
A question requiring the entry of a laboratory test result.
The optional MACRO module used to translate individual study elements into a number of other languages and to specify which language should be used to display the study in the Web Data Entry/Review module for a particular study/site combination.
Click with the left mouse button (on a mouse which is configured for right-handed use). Normally used for selecting an object, clicking an on-screen button or following a hyperlink.
The MACRO module used to set up study parameters and predefined questions and eForms, including formats, question validation types and laboratory normal ranges.
See Library Management module (LM)
See \"Database Lock\"
A Data Manager can lock data for a subject when data collection is complete. When a question, eForm or visit is locked, the data cannot be changed. A user with the relevant permission can unlock data. See also \"Freeze\".
The modular clinical trial management system from Ennov.
See \"Web Data Management Module\".
A question that must be answered for the eForm in which it is located to be complete. See also \"Optional Question\".
The database containing study definitions and subject data. This database can be created in SQL Server or Oracle. See also \"Security Database\".
The Medical Dictionary for Regulatory Activities (MedDRA) was designed to regulate the terms used for patient symptoms. The terminology is updated twice a year.
A question or eForm status indicating that a question has not yet been answered or that an eForm has not been opened.
A study conducted according to a single protocol but at more than one site.
A question requiring the attachment of an electronic file.
Multi-User Study Definition. This allows more then one user to edit a study definition in SD at the same time.
The descriptive text for an item in MACRO. It does not have to be unique, unlike an item's code. See also \"Code\".
A set of values used to validate the result of a specific test within a particular laboratory. This range can have three bands; normal, feasible and absolute.
A question status indicating that a question cannot be answered as there are skip conditions assigned that have been satisfied. For example, if previous answers have identified the subject as male, any questions about pregnancy would automatically be made Not Applicable.
A question status indicating that a question has had its status manually changed from 'Missing' to 'Not Available', to show that it is not possible to obtain an answer for the question.
A piece of text, attached to an individual question in data entry and used as a method of communication between users. Notes can be public (viewable by all users) or private (viewable only by the user who created the note). See also \"Question Comment\".
A question requiring a numerical response in a particular format.
See \"Oracle Clinical\"
See \"Collect If Condition\"
A question status indicating that a question has been successfully answered and has not fired any attached validation conditions.
A quesion status indicating that the data entered for a question has satisfied a 'Warn if' validation condition and that this warning has been overruled by the user.
A question that is not required to be answered for the eForm to be complete. See also \"Mandatory\".
Determine what you can do and what information you have access to within each of the MACRO modules. A set of permissions together makes up a User Role. Permissions are also known as role functions.
See \"Study Phase\".
A Precondition can be attached to an Arezzo task and must be true for the task to be activated. See also \"Internal Trigger\".
Can be manually attached to a DCR at the time of printing a data clarification form. Can later be used as search criteria when searching for DCRs in the search panel.
A document that describes the objectives, design, methodology, statistical considerations and organisation of a study, including any amendments.
See Query Module (QM)
The MACRO module used to export subject data in a number of formats suitable for importing into external applications
The name given to a collectable data item on an eForm.
The name or title specified by the study designer for a question on an eForm. It may be set independently from the question name found in the question definition window.
The unique textual identifier for a question. Once a question has been created, its code cannot be changed.
A comment attached to a question response during data entry. See also \"Note\".
The descriptive name for a question. When a question is first created, its name is the same as the question code, but it can be changed within the question definition.
The menu that is displayed during data entry when right-clicking a question status icon or pressing the F10 key.
The process of allocating different treatments to subjects on a random basis.
A piece of text attached to a question in data entry explaining why the value has been changed. Setting the RFC flag for questions in the study definition ensures that data entry users will be prompted to supply a reason for change when they edit previously stored values. Predefined RFC text can be specified by the study designer.
A piece of text attached to a question in data entry explaining why a warning on the value has been overruled. Predefined RFO text can be specified by the study designer.
The process of assigning a unique identifier for a subject in a study, after optionally checking the subject's eligibility and uniqueness. Registration conditions are set up in the study definition. Registration normally occurs after some initial data has been entered for the subject.
A computer on which data is entered on a local database before being transferred to a central database on a server.
See Report Management module (REP)
An eForm for which multiple copies can be filled in during data entry. Once the first eForm has been completed by the Data Entry User, a new eForm is automatically generated, up to the maximum number specified by the study designer.
A group of questions which are displayed in a row on an eForm, for which there may be multiple copies filled in during data entry.
A visit for which multiple copies can be filled in during data entry. Once all the eForms in the first visit have been filled in, a new visit is automatically generated, containing new copies of all the eForms, up to the maximum number of cycles as specified by the study designer.
The MACRO module used to create customised reports and set up links to reports and files from the Home Page of the Data Management module.
An eForm status indicating that the eForm is active (available to open for data entry) but no data has been entered.
A group of words that cannot be entered as codes as they have specific internal meaning.
The data entered in answer to a question on an eForm.
The ability to manually run validation on all or selected eForms for a subject or group of subjects without having to open each individual subject.
See \"Reason for Change\"
See \"Reason for Overrule\"
Click with the right-hand mouse button (on a mouse which is configured for right-handed use). Often used to access a menu associated with a particular data item or icon.
Separate permissions that are grouped into user roles. These roles are then assigned to individual users according to the level of access that they should receive. See also \"Permissions\".
See \"Repeating Question Group\"
The arrangement of eForms in the visits for a study.
The sequencing of visits and of eForms within visits to force data entry users to enter data in a particular order. This is done by entering scheduling constraints or internal triggers in the Arezzo Composer.
See Study Definition module (SD)
See Study Data Diagnostic Utility (SDDU)
See \"Source Document Verification\"
The database containing user names, passwords and permissions plus a list of master databases. See also \"Master Database\".
A file containing values that control certain aspects of the behaviour of the modules. Some of these values an be edited.
A group of subjects whose data is collected into a single database. May also be (but does not have to be) associated with a single physical location. Each remote data entry machine will be associated with a single site. All sites are set up in the central database.
See \"Collect If Condition\"
See System Management module (SM)
A process carried out by a Data Monitor, consisting of cross checking the collected data with the original information source.
A set of symbols used to indicate the status of questions, eForms and subjects.
The process of assigning subjects into different treatment groups using randomisation conditions.
A clinical study protocol. See also \"Protocol\".
The MACRO module used to assess the integrity of subject and study data via a number of reports.
The definition of all the questions, eForms, visits and associated reference documents which comprise a study.
The MACRO module used to create and design study definitions.
The personnel responsible for the design of a study.
There are 4 distinct study phases, each corresponding to a different stage in the process of bringing a new drug to the market. Phase I studies test the new treatment in a very small group of subjects to determine the safety, appropriate dose, and best method of applying the treatment. Phase II studies test the treatment in a larger group of subjects to determine whether and how well the treatment works against the disease. Phase III studies compare the study treatment with the best standard treatment. Phase IIII studies occur after the treatment has been put on the market to monitor effects of long-term usage.
The class into which the study falls. For example, pre-clinical or clinical.
(1) An individual who participates in a study, either as a recipient of the investigational product(s) or as a control. (2) The collection of eForms for a study instantiated with data.
An integer identifier, unique within each site, automatically assigned to each subject. This ID can be used instead of the subject's name in all study related data. See also \"Subject Label\".
A subject identifier that is defined by the study designer as an Arezzo expression and automatically evaluated when the data entry user enters the necessary information. Subject labels are only unique if the study designer has created a unique specification. See also \"Subject ID\".
The MACRO module used to set up databases, user access rights, sites, studies and laboratories.
A question requiring a free text entry of a limited length and format.
The date and/or time at which an action is logged in the MACRO database. The 'Time Stamp' refers to the date/time that the response was saved to the local web server. The 'Database Time Stamp' refers to the date/time that the response was saved to the database server. If remote data entry is being used then both timestamps refer to the remote machine.
Consists of a group of permissions. The System Administrator assigns user roles to individual users according to the level of access that they need.
The checking of question responses against preset conditions. Validation conditions are defined by the Study Designer. If these conditions are satisfied during data entry, warning messages are displayed.
A set of eForms. A visit often corresponds to a patient's visit to a clinic, where several data entry forms are filled in.
A visit date is the eForm date of a special visit date eForm. The visit date is linked to a date question in the header of each eForm in the visit. Visit date eForms do not appear in the data entry schedule but the associated visit date field appears in the header of each eForm in the visit.
A display indicating the arrangement of eForms within visits.
A question status indicating that the data entered for this question has satisfied a 'warn if' validation condition.