| Oracle® Clinical Creating a Study Release 4.6.2 E18820-01 |
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PDF · Mobi · ePub |
| Oracle® Clinical Creating a Study Release 4.6.2 E18820-01 |
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PDF · Mobi · ePub |
This section contains the following topics:
Oracle Clinical can be integrated with a clinical trial management system (CTMS) to automatically pass certain data and metadata from one system to the other. There is an existing Oracle AIA process integration pack (PIP), that integrates Oracle Clinical with Siebel Clinical; see Oracle Study, Subject, and Visit Synchronization Integration Pack for Siebel Clinical and Oracle Clinical 3.1 Implementation Guide at: http://download.oracle.com/docs/cd/E21374_01/doc.31/e20497.pdf.
This integration:
Creates Oracle Clinical sites, Investigators and study sites based on Protocol site Information sent from Siebel Clinical
Passes information about patients and visits from Oracle Clinical to Siebel Clinical
Allows you to use the Oracle Clinical user interface to define Oracle Clinical/Remote Data Capture (RDC) data collection events that should be treated as visits/activities in Siebel Clinical and passes information o Siebel Clinical to signal the completion of visits/activities for patients
If you are using the Siebel Clinical integration, you must follow the instructions in this chapter.
You can use the same tools used to develop the Siebel Clinical integration to develop your own integration with a different system. New web services are available in Oracle Clinical to create and update sites, Investigators and study sites; see the Oracle Clinical Application Programming Interface Guide for further information. In addition, you must follow the instructions in this chapter to enable patient activity integration and define activities. Oracle Clinical writes information about patient visit/activity completion to the CLINICAL_STUDY_AQ activities queue in the database where a web service can pick it up and send it to another application.
This section contains the following topics:
You can make two types of Oracle Clinical information available to another application: Patient Positions and Subject Activities.
You set the default values for new studies at the database level and, if required, override the default values for individual studies.
Note:
Setting or changing these values does not affect existing studies.To set the default values at the database level:
Go to the Admin menu and then click Integration Database Settings. The Integration Database Settings window opens.
Click the Integration Settings node (+).
Enter values:
Enable Patient Integration? If set to Y, Patient Integration is enabled by default for new studies. Oracle Clinical writes information about a patient position to a queue, where it is available to send to other applications. For each patient position, this occurs for the first time when a patient is assigned to a patient position: when the enrollment date, informed consent signature date, or first CRF is entered for the patient position. Oracle Clinical also writes any subsequent updates for a patient position in the patient_positions table or patient_statuses table, or a change in the patient position's study site assignment, to the queue.
If set to N, Patient Integration for studies is not enabled by default. This is the shipped value. If set to Y, Patient Integration is enabled by default.
Enable Subject Activity Integration? If set to Y, Subject Activity integration is enabled by default for new studies. You can define completion criteria in Oracle Clinical so that patient data collected in Oracle Clinical or RDC can signal visit/activity completion in a clinical trial management system (CTMS); see "Setting Up and Using Activity Completion Integration".
If set to N, Subject Activity Integration is not enabled by default. This is the shipped value. If set to Y, Subject Activity Integration is enabled.
Note:
In order to use Subject Activity Integration in the Siebel Clinical integration, you must set both values to Y. It is possible to set Enable Subject Activity Integration? to Y and Enable Patient Integration? to N, but the integration will not work unless both values are set to Y.For each setting you can select Enforce Local DB Setting or not:
If selected, all new Studies are created with the value for the setting that you specify here and the value cannot be changed at the study level.
If unselected, all new Studies are created with the value for the setting that you specify here and the value can be changed at the study level.
Save.
To override the default values for a particular study:
Go to the Design menu and then click Integration Study Settings. The Integration Database Settings window opens.
Click the Integration Settings node (+).
Enter values:
Enable Patient Integration? If set to Y for this study, Oracle Clinical writes information about a patient position to a queue, where it is available to send to other applications. For each patient position, this occurs for the first time when a patient is assigned to a patient position: when the enrollment date, informed consent signature date, or first CRF is entered for the patient position. Oracle Clinical also writes any subsequent updates for a patient position in the patient_positions table or patient_statuses table, or a change in the patient position's study site assignment, to the queue.
If set to N, Patient Integration is not enabled for the study. If set to Y, Patient Integration is enabled for the study.
Enable Subject Activity Integration? If set to Y, you can define completion criteria in Oracle Clinical so that patient data collected in Oracle Clinical can signal visit/activity completion to a clinical trial management system (CTMS); see "Setting Up and Using Activity Completion Integration".
If set to N, Subject Activity Integration is not enabledfor the study.
Note:
In order to use Subject Activity Integration, you must set both values to Y.The Inherit from Local DB indicates whether or not the setting is inherited from the database level:
If selected, the setting is inherited. If you can deselect it, the setting is not enforced and you can change the value.
If unselected, the setting is not inherited. You can select it if you want to be sure you are using the default setting. You can change the setting as required for your study.
Save.
This section includes the following topics:
Clinical trial management systems and other applications may have a concept of an activity that, when completed, triggers action of some kind; for example, a change in status. Tracking activity completion may help to monitor the progress of a trial at each site.
For each study, you specify which Oracle Clinical events constitute an activity in the other application: visits or activities within a visit, and their completion criteria—data that, when entered for a patient, signals the completion of the activity to the other application. Completion criteria can include one or more CRFs (DCIs), one or more CRF sections (DCMs), or one or more Questions. You can even require a specific response to a Question; for example, a response of Yes to the Question "Was an MRI performed?" could trigger activity completion but a response of No would not.
The Track Activity batch job evaluates all active completion criteria and determines if patient data entered or updated since the last time the job ran causes the completion status or date of any activity to change; see "Running the Track Activities Batch Job"
To define an activity, navigate to Definition, then Activity Completion Criteria. The Activity Completion Criteria Summary window opens.
The first time you define an activity and its Completion Criteria you must select Insert Record from the Data menu in the Summary window, then navigate to the Details window to define the completion criteria details. After that, you can either create new activities the same way or entirely in the Details window, using the Add New Activity button.
Enter values as follows:
Activity Enter a name for the activity. You may want the name to correspond to the name of the activity in the other application.
Visit: A particular visit (Clinical Planned Event, or CPE) as a whole constitutes the activity.
Activity during a visit: One or more DCIs, DCMs, or Questions constitute the activity. You can either define the activity as occuring only during a particular visit, or each time the specified DCIs, DCMs, or Questions are collected for a patient at any visit.
P (Provisional) This is the default value. You can modify the Activity Completion Criteria only if its status is Provisional.
A (Active) The Track Activities job processes only active Completion Criteria. You can set the status to Active if:
At least one DCI, DCM or DCM Question have been specified in the Details section and there is a value for both Completion Date Level and Completion Date Source.
If Criteria Level is set to DCI, all specified DCIs are Active.
If Criteria Level is set to DCM, all specified DCMs are Active.
If Criteria Level is set to DCM Question, all specified DCMs that include the DCM Question are Active.
Note:
If you set an Activity Completion Criteria definition to Active, use it, and then set its status back to Provisional to modify it:Activities already completed are not affected.
Patient data entered while the status is Provisional does not trigger activity completion. However, when you set the status back to Active, the next time the Track Activity batch job runs it re-evaluates all patient data against this criteria and triggers activity completion for patients as appropriate.
R (Retired) If you no longer want to use an Activity Completion Criteria, set its status to Retired and specify a Retirement Reason. The Track Activity batch job no longer evaluates patient data against it. Changing the status to Retired does not affect patients' previously completed activities.
Visit Specific Criteria (Available only in the Details window.) Select this option if your activity is of type Visit, or if your activity is of type Activity Within a Visit and you want to specify a particular visit during which the completion criteria—DCI(s), DCM(s) or Questions—must be collected to trigger activity completion.
If the activity is of type Activity Within a Visit and you do not specify a particular visit, then each time the DCIs, DCMs, or Questions are collected for a patient in any visit, the activity is considered complete.
DCI Book (Optional) If you are using more than one DCI Book, select the relevant DCI Book. The system then allows you to select only DCIs, DCMs, and DCM Questions that are associated with the visit you specify, in the DCI Book you specify.
The list of DCI Books includes all DCI Books defined as either Active or Provisional for the current study.
Clinical Planned Event (CPE): If you want the activity to be considered complete if the specified DCI(s), DCM(s), or Question(s) are collected at a particular visit, select the name of the visit (CPE).
Completion Date Level Oracle Clinical sends the activity completion date to the other application. You may need to collect the completion date for different activities in a different manner, according to the requirements of the study and your business practices.
Select one value:
Select DCI to use a DCI header date as the completion date. Under Completion Date Source, you can then specify using the earliest or latest DCI (in case they are on different days) or a particular DCI.
Select DCM to use a DCM header date as the completion date. Under Completion Date Source, you can then specify using the earliest or latest DCM (in case they are on different days) or a particular DCM.
Select DCM Question if you have a DATE-type Question on the CRF for the purpose of collecting the date.
Completion Date Source If the Completion Date Level is DCI or DCM, choose how to determine the completion date at the specified level (in case the specified DCIs or DCMs are collected over more than one day):
Visit Start Date: The system uses the earliest visit date of all DCIs or DCMs listed in the Details section.
Visit End Date: The system uses the most recent visit date of all DCIs or DCMs listed in the Details section.
Specific Date: Rather than using the earliest or latest, you can specify a particular DCI or DCM whose value you want to use. If you choose Specific Date here, you must define the Criteria Level to be the same as the Completion Date Level: DCI, DCM, or DCM Question, and in the Criteria Details section you must specify the DCI, DCM, or Question you want to use.
If the Completion Date Level is DCM Question, Completion Date Source defaults to Specific Date and cannot be changed. In the Criteria Details section of the window you must check Use as Specific Date next to the DCM Question of data type DATE defined for the purpose of collecting the date.
Criteria Level Select the level of data—DCI, DCM, or DCM Question—that should be collected for a patient to signal the completion of the activity. If you selected Specific Date for the Completion Date Source, you must set Criteria Level to the same value as the Completion Date Level.
DCI: The system considers the activity complete when one or more DCIs are collected for the patient. You specify which DCIs under Criteria Details.
DCM: The system considers the activity complete when one or more DCMs are collected for the patient. You specify which DCMs under Criteria Details.
DCM Question: The system considers the activity complete when one or more DCM Questions in one or more DCMs are collected for the patient. You specify which DCM Questions under Criteria Details. The DCM Questions cannot be part of a DCM repeating Question Group.
You can require a particular response to one or more Questions as the completion criterion. For example, if you want the activity to be considered complete only if the Question "Was an MRI performed?" has a response value of Yes, select DCM Question here, and in the Details section select the name of the Question in the DCM Question field and enter Yes in the Response Value field in the Details section.
No. of Criteria (Available only in the Summary window.) The system provides high level information on how many Criteria Details must be completed for the activity to be considered complete.
Retirement Reason If you change the status to Retired, the system prompts you to enter a reason, which is then displayed in this field.
If you are working in the Summary window, you must save your work before clicking the Details button to complete the Activity Completion Criteria definition. See "Adding Activity Completion Criteria Details".
Select the particular DCI(s), DCM(s), or DCM Question(s) (depending on the Criteria Level you selected) required as completion criteria. You can do this in two ways:
Add criteria one at a time, using the list of values in the appropriate field.
Add more than one criterion at a time using the Add Multiple option. This is especially helpful if your Criteria Level is DCM or DCM Question since it allows you to narrow your search by first selecting the DCI, then the DCM, and then, if the Criteria Level is DCM Question, the Question(s).
If you selected a DCI Book, the system limits your choices to DCIs, DCMs, or DCM Questions associated with the visit in that DCI Book. Otherwise, the system allows you to select any DCI, DCM, or DCM Question included in the study.
The Criteria Level you specified determines which of the following fields are available:
Use as Specific Date If you defined the Completion Date Source as Use Specific Date, select this box for the DCI, DCM, or DCM Question whose date you want to use.
DCI Name If the Criteria Level is DCI you must select one or more DCIs that must be collected for the activity to be considered complete. If you did not specify a visit (CPE), the system considers the activity complete each time the specified DCIs are collected for a patient. For each DCI, the system displays the DCI name, type, and status in the list of values or after you click Add Multiple.
DCM Name If the Criteria Level is DCM you must specify one or more DCMs that must be collected for the activity to be considered complete. If you did not specify a visit, the system considers the activity complete each time the specified DCMs are collected for a patient. For each DCM, the system displays the DCM name, subset, qualifying value (if any), type, and description in the list of values or after you click Add Multiple. Using Add Multiple, you can drill down to the DCM from its DCI.
If the Criteria Level is DCM Question, select each DCM Question's DCM.
DCM Subset # When you select a DCM, you simultaneously select one of its subsets. The system enters the subset number in the next field as well as the name. You can select a different valid subset of the same DCM if there is one.
Qualifying Value If the same DCM exists in the visit more than once, you must select the qualifying value of the DCM(s) that must be collected for the activity to be considered complete. You must select a DCM name before you can enter a value in this field.
DCM Question If the Criteria Level is DCM Question, you must specify one or more DCM Questions. After you have selected the DCM (including the subset and qualifying value, if any) that contains the Question, select the Question Group and then the Question itself. Question Groups are displayed in the order in which they are defined in the DCM.
If you did not specify a visit, the system considers the activity complete each time the specified DCM Question(s) are collected for a patient in the context of the same DCM subset and qualifying value.
Occ # Select the Occurrence number of the DCM Question in the Question Group. If the Question is not included in the Question Group more than once, the value defaults to zero (0).
Response Value If a particular Question response is required to trigger the completion of the activity, enter it here. If the Question has a DVG, there is a list of values.
You must schedule the Track Activity batch job to run periodically to evaluate all active completion criteria and determine if patient data entered or updated since the last time the job ran causes the completion status or date of any Activity to change.
If new or modified Activity Completion Criteria have been set to Active since the last time the job was run, the job examines all existing patient data for the study. See "Completion Criteria Processing" for information on how the job works.
To set up the Track Activity process:
Navigate to Conduct, then Data Validation, then Track Activities. The system displays the Track Activity Completion window.
If your study is not already in context, select it using either the Change Study button or the Special menu.
The Track Activity process has no parameters. Submit or schedule the job.
Note:
The study must be enabled for Activity integration; see "Enabling Patient and Subject Activity Integration".This section includes the following topics:
In addition to the collection of the DCI(s), DCM(s), or DCM Question(s) defined as Activity Completion Criteria, activity completion logic requires that the Received DCI, Received DCM, or the Received DCM that contains the required DCM Question(s) meet the following criteria:
A received DCI or DCM that is marked as blank is not considered complete.
If the study requires two passes, only an RDCI or RDCM with the status PASS 2 COMPLETE or BATCH LOADED is considered complete.
If the study does not require two passes, only a Received DCI or DCM with the status PASS 1 COMPLETE, PASS 2 STARTED, PASS 2 PENDING, PASS 2 COMPLETE or BATCH LOADED is considered complete.
If the completion date for an activity changes, Oracle Clinical writes a message to the queue updating the completion date for the activity for the patient. The completion date can change if:
The source date value changes, in which case Oracle Clinical passes the new date to the queue.
The activity is no longer considered complete, in which case Oracle Clinical passes a blank date to the queue.
Activities previously considered complete may become incomplete due to the following kinds of changes:
If an RDCI or RDCM that was mapped to an activity is deleted, the activity is no longer considered complete.
If the blank flag is set to Y for an RDCI or RDCM that was mapped to a completed Activity, the Activity is no longer considered complete.
If a response value for a DCM Question that was mapped to an Activity is modified to a value other than the one defined in the mapping, the Activity is no longer considered complete.
If a response value for a DCM Question that was mapped to an Activity is removed leaving the response empty, the Activity is no longer considered complete.
Key changes: Changes to the following header (key) information for a received DCI or DCM make an Activity previously considered complete become incomplete.
Patient
DCI Book
Visit Number
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