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Oracle® ClinicalRelease Notes

Release 4.6.2

E18815-01

April 2011

Contents Overview | References | Media | Installation | Enhancements | Problems Addressed | Known Issues | Revision History | Documentation Accessibility

OverviewOracle Clinical 4.6.2 is a complete release that includes upgrades to the technology stack, enhancements, and bug fixes. You can install Release 4.6.2 as a new installation or upgrade directly from 4.5.1, 4.5.2, 4.5.3 or 4.6.0.

Release 4.6.2 includes enhancements and bug fixes, and carries forward all the enhancements and fixes of Release 4.6 and previous releases.

ReferencesRefer to the following documents for more information.

White Papers and Technical NotesThe following documents are available on My Oracle Support at https://support.oracle.com:

386941.1: OLSA 4.6.x and 4.7.x Known Install and Configuration Issues

180430.1: OLSA Supported Technology Stacks

1300836.1: Oracle Clinical, Oracle Clinical Remote Data Capture Onsite, and Oracle Thesaurus Management System Security Configuration Guide

1300850.1: Configuring Oracle Clinical Remote Data Capture Onsite 4.6.2 for Performance and Scalability

1300847.1: Oracle Clinical and Oracle Clinical Remote Data Capture Onsite 4.6.2 Performance Behavior and System Recommendations

Priority Normal

Problem type(s) Enhancements and bug fixes

Patch component(s) Application Server, Reports Server, Database Server, Database

Version This is the first version.

Platforms All

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121863.1: Oracle Clinical Versions 4.6, 4.5 and 4.0 Summary of Patches Available

883213.1: Cloning Databases in Oracle Clinical and TMS 4.6.x

467823.1: Desupport of PDF Data Entry in Oracle Clinical Remote Data Capture

In addition, the Oracle Clinical Remote Data Capture Release Content Document Release 4.6.2 is available on the Oracle Health Sciences documentation page at:

http://www.oracle.com/technetwork/documentation/hsgbu-154445.html

User DocumentationThe Oracle Clinical and Oracle Thesaurus Management System 4.6.2 Media Pack includes the Oracle Clinical and Oracle Clinical Remote Data Capture (RDC) user guides on disk V25150-01.

You can download the most current versions of the user documentation in PDF and HTML format from the Oracle Health Sciences documentation page at:

http://www.oracle.com/technetwork/documentation/hsgbu-154445.html

The user documentation includes:

■ Oracle Clinical Release 4.6.2 Installation Guide

■ Oracle Clinical Release 4.6.2 Getting Started

■ Oracle Clinical Release 4.6.2 Creating a Study

■ Oracle Clinical Release 4.6.2 Conducting a Study

■ Oracle Clinical Release 4.6.2 Administrator's Guide

■ Oracle Clinical Release 4.6.2 Application Programming Interface Guide

Oracle Remote Data Capture (RDC):

■ Oracle RDC Classic Release 4.6.2 User's Guide

■ Oracle RDC Onsite Release 4.6.2 User's Guide

■ Oracle RDC Onsite Release 4.6.2 Administrator's Guide

In addition, Oracle Clinical customers can request a copy of the Oracle Clinical Stable Interface Technical Reference Manual from Oracle Support.

MediaOracle Clinical 4.6.2 is available on the Oracle Clinical 4.6.2 and Oracle Thesaurus Management System 4.6.2 Media Pack.

To receive a physical media pack with all the required DVDs, contact Oracle Support. To expedite your request you can either call Oracle Support directly or open a Service Request (SR) selecting problem category: Version Update Request.

To download the media pack from eDelivery:

1. Go to http://edelivery.oracle.com and log on.

2. From the Select a Product Pack drop-down list, select Health Sciences.

Note: Always check the Oracle Health Sciences Documentation page to ensure you have the latest updates to the documentation.

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3. From the Platform drop-down list, select the appropriate database tier operating system.

4. Click Go.

5. Select Oracle Clinical and Oracle Thesaurus Management System 4.6.2 Media Pack forYour_Operating_System and click Continue.

6. Download the software.

InstallationFor complete installation instructions, see the Oracle Clinical Release 4.6.2 Installation Guide. Check My Oracle Support document number 386941.1 for known installation issues.

EnhancementsFor more details on the following enhancements, refer to the Oracle Clinical Remote Data Capture Release Content Document for Release 4.6.2 and Release 4.6 at http://www.oracle.com/technetwork/documentation/hsgbu-154445.html.

■ (Release 4.6.2) The list of values available to an RDC Onsite user can be restricted by the user’s current study and site context when the list of values is based on a thesaurus DVG.

■ (Release 4.6.2) Integration with Siebel Clinical or another clinical trial management system with Oracle Clinical is supported.

■ (Release 4.6.2) RDC Onsite data entry text fields defined as "extended text" fields can hold up to 10,000 characters. The full responses to these fields are displayed in an auxiliary page for the CRF in the patient data report.

■ (Release 4.6.2) This release includes an upgraded technology stack.

■ (Release 4.6) To address the growing number of studies with multi-arm and other complex trial designs, study definition features support defining rules for data-driven events that determine or change a subject's schedule or expected assessments.

■ (Release 4.6) Data-driven branching within a CRF is also supported in RDC Onsite, both by the pre-4.6 feature Indicator Branching and by the more flexible 4.6 feature Conditional Branching, which supports multiple branches and multiple target question locations in the CRF. Both types of branching disable fields that should not be entered, based on an earlier response.

■ (Release 4.6) In RDC Onsite, users’ access to specified DCIs can be restricted by their role.

■ (Release 4.6) Scalability and performance enhancements include improved handling for simultaneous background processing and data capture activities, minimizing conflicts and record locking in environments where data entry is performed on a 24x7 basis; optimization of middle tier resources; and handling intermittent connectivity loss that allows the application to continue with minimum disruption to the users.

■ Release 4.6 also included a number of minor usability enhancements in RDC Onsite.

Note: If this media pack is the only one available in Health Sciences for the platform you selected, the system takes you immediately to the media pack page from which you can download the software disk by disk.

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Problems AddressedThis section lists the problems fixed in Oracle Clinical 4.6.2, including:

■ Problems Addressed in Oracle Clinical 4.6.2

■ Problems Addressed in RDC Onsite 4.6.2

■ Problems Addressed in Oracle Clinical and RDC 4.6

■ Problems Addressed in Oracle Clinical and RDC 4.6 Patches

■ Problems Addressed in Oracle Clinical and RDC 4.5.3 Patches

■ Problems Addressed in Oracle Clinical and RDC 4.5.1 Patches

For a complete list of patches available, with their primary bug numbers, see My Oracle Support article 121863.1, Oracle Clinical Versions 4.6, 4.5 and 4.0 Summary of Patches Available.

Problems Addressed in Oracle Clinical 4.6.2This section lists the problems addressed in Oracle Clinical 4.6.2.

Bug 10359851

Before After changing a prompt position and regenerating a character layout from the DCM Question Groups form, the form did not refresh correctly if the generation failed due to the unavailability of PSUB.

After In the above scenario, the form displays correctly.

Bug 11723663

Before Performing an Out of Study Load on the Linux platform resulted in failure.

After Out of Study Loads execute successfully on the Linux platform.

Bug 11799141

Before When upgrading to 4.6 without having applied 4.5.1.52 or performing a new installation of 4.6, the audit trigger on the CLINICAL_STUDY_STATES table is missing. As a result, updates to settings in the Clinical Study States form (Oracle Clinical, Conduct, Security, Clinical Study States) are not audited. (Auditing of this table was introduced in patch 4.5.1.52.)

After In the above installation and upgrade scenarios, the audit trigger on the CLINICAL_STUDY_STATES table is correctly installed.

Bug 10381793

Before Spell check did not work properly in the DCI/DCM Layout Editor.

After The latest version of Jspell is supported in OC 4.6.2. Spell check works properly in the DCI/DCM Layout Editor.

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Bug 11067471

Before When a user role was deleted from DCI Access, the deleted user role for the study was not included in the audit table for the Delete operation.

After If a user role is deleted from the DCI Access form, the deleted user role for the study is included in the audit table for the Delete operation.

Bug 11696740

Before When a received DCI at the source location was updated through key changes and the study had page tracking enabled, Disconnected Replication failed at the target location.

After When a received DCI at the source location is updated through key changes and the study has page tracking enabled, Disconnected Replication successfully executes at the target location.

Bug 7391963

Before When data replication was performed with Data Location Code = ‘%’, the replication job ended in failure if there was more than one location from which to pull data.

After When data replication is performed with Data Location Code = ‘%’, the replication job is successful; data is replicated from all locations for the specified study.

Bug 11697096

Before When performing Disconnected Replication on tables with journal triggers that contained pre-existing replication check logic, journal records were created at the target location.

After Now when performing Disconnected Replication on tables with journal triggers that have pre-existing replication check logic, the journal records are not created at the target location.

Bug 10399045

Before No warning was displayed when the 'Flex Study Enabled?' flag was updated (Conduct, Security, Clinical Study States) for a study at a non-study owning location.

After When the 'Flex Study Enabled?' flag is updated for a study at a non-study owning location, an alert is displayed: "You have updated the 'Flex Study Enabled?' flag. You must ensure this setting matches the setting specified at location owning_location, which owns this study. Do you wish to continue? YES/NO" If the user selects No, the current flag value is preserved. If the user selects Yes, the same validation is applied as when this flag is updated at the study-owning location.

Problems Due to Release 4.6 Technology Stack Upgrade Addressed The following bugs were introduced in Oracle Clinical 4.6.0 with the migration from Forms 6i to Forms 10g. They all involve values’ not being displayed properly. These problems have all been addressed in Oracle Clinical 4.6.2:

Bug 11902867 In the Single view of the Investigator Assignments window, the Investigator Name was not displayed.

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Bug 11900342 Create Patient Positions and Change Owning Location for Patient Positions: After changing the Location to own Patients, the fields Current Number of Screening/Normal/Replacement Patients were not updated to reflect the new location. (Note: These are display-only fields.)

Bug 11901691 The regimen name was not displayed in drill-down to Procedures.

Bug 11900603 The Effective Start and End dates of lab ranges were not displayed.

Bug 11902867 Single mode of Clinical Studies:

■ Descriptions of Study Status and Random Access in single view were not visible.

■ When creating a new study, study status code and description, random access code and description were not defaulted.

■ Study status type code and random access type code were not modifiable from this screen.

Single mode of Enrollment:

■ Factor Code description was not visible.

■ Factor Code was not updatable from LOV.

Single mode of History: Event Type description and interval were not displayed.

Bug 11899023 Single mode of Study Statuses: Descriptions for the Randomization and Study Status were not displayed.

Bug 11899057 Single mode of Study Versions: Descriptions for the Replacement Rule and Time Unit Code were not displayed.

Bug 11901027 For a selected study, treatment pattern:

■ For selected regimen, under Study Intervals assigned to regimen, the 'Assigned' checkbox was not checked.

■ For selected Drug and Regimen for this drug, add Regimen to Treatement Pattern, Treatment Regimen name is blank. User can select it if they know what the name is and click Assign Regimen to Intervals.

Bug 11900342 Upon changing the 'Location to own Patients' field in the 'Create Patient Positions' and the 'Change Owning Location for Patient Positions' screens, the 'Current Number Of Screening/Normal/Replacement Patients' fields were not updated to reflect the corresponding values for the new location.

Bug 11901027 This bug had two issues: 1.) Label Code and Treatment Regimen Name were shown as blank while adding Regimen to Treatment Pattern. 2.) Under Assigning regimens to interval screen, column "Assigned?" was always unchecked.

Problems Addressed in RDC Onsite 4.6.2This section lists the problems addressed in RDC Onsite 4.6.2.

Bug 10075092

Before A Help button was not present in the Extended Text dialog box

After A Help button is present in the Extended Text dialog box and on-line help is displayed when the button is clicked.

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Bug 11062829

Before If a CRF was marked blank when the cursor was in a response field, the subsequent Save action resulted in the error "Can't Move focus to the control because it is invisible, not enabled, or of type that does not accept the focus". The Data Entry window became inactive and had to be forcibly closed using Task Manager. This could happen in two ways:

■ The user entered only header fields, positioned the cursor in a response field, and saved Complete. The CRF is automatically marked blank.

■ No blank flag check box was displayed in the CRF. The user positioned the cursor in a response field and used the blank flag tool to mark the CRF blank.

After No errors occur in the scenarios described above.

Bug 11723264

Before When using RDC Onsite with Internet Explorer 7, if a response field was highlighted with a discrepancy in the Data Entry window and the discrepancy was routed, the discrepancy highlight color did not change to the required color.

After When a response field has a discrepancy highlighted in the Data Entry window and the discrepancy is routed then the highlight color changes to the required color.

Bug 11062292

Before In an RDC Onsite Data Entry window, when you routed a discrepancy from the Navigator and immediately saved the CRF without re-positioning the cursor on a response field in the CRF, the application displayed an error message, "’this.lastNavigatedField.id' is null or not an object". The Data Entry window became inactive and had to be forcibly closed using Task Manager.

After In the above scenario, no errors occur.

Bug 10366222

Before RDC Onsite did not support middle tier Windows Server 2008 R2.

After RDC Onsite 4.6.2 supports Windows Server 2008 R2. This allows the specification of the desktop heap size so that the number of Data Entry sessions can scale properly and match the middle tier with the database hardware capabilities. The native.sizeOfDesktopInKB parameter in the dcapi.properties controls the size of the desktop heap in kilobytes of the non-interactive desktop which is created programmatically by RDC Onsite Java code. By default, the size is 48 MB.

Bug 11718512

Before The patient data report failed to generate when the ‘Bookmark Title for Ancillary Data Section’ in the DCI Form Local Database Settings – Patient Data Report Setting included special characters (<, >, “, ,).

After The patient data report generates successfully with special characters in the ‘Bookmark Title for Ancillary Data Section’ in the DCI Form Local Database Settings – Patient Data Report Setting.

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Problems Addressed in Oracle Clinical and RDC 4.6All bug fixes included in Oracle Clinical 4.6 are included in Oracle Clinical Release 4.6.2. For details about these bugs, see the Oracle Clinical 4.6 Release Notes at http://www.oracle.com/technetwork/documentation/hsgbu-154445.html

Problems Addressed in Oracle Clinical and RDC 4.6 PatchesOracle Clinical/RDC 4.6.2 includes the fixes in all Release 4.6 patches that were current as of the final development stage for Release 4.6.2; that is, odd-numbered patches up to and including OC_4.6.0.15 and even-numbered patches up to and including OC_4.6.0.8. In addition, the Siebel Clinical integration patches OC_4.6.0.51 and OC_4.6.0.52 are included.

Refer to the release notes for these patches on My Oracle Support to review the problems addressed.

Problems Addressed in Oracle Clinical and RDC 4.5.3 PatchesOracle Clinical/RDC 4.6.2 includes the fixes in all Release 4.5.3 patches that were current as of the final development stage for Release 4.6.2; that is, odd-numbered patches up to and including OC_4.5.3.25 and even-numbered patches up to and including OC_4.5.3.22.

Refer to the release notes for these patches on My Oracle Support to review the problems addressed.

Problems Addressed in Oracle Clinical and RDC 4.5.1 PatchesOracle Clinical/RDC 4.6.2 includes the fixes in all Release 4.5.1 patches that were current as of the final development stage for Release 4.6.2; that is, up to and including OC_4.5.1.76, except for OC_4.5.1.74, which was not released and is not included in 4.6.2.

Refer to the release notes for these patches on My Oracle Support to review the problems addressed.

Known IssuesThis section lists selected issues that remain unresolved with this patch.

■ Replication Issues

■ Other Oracle Clinical Issues

■ Remote Data Capture Issues

You can view the complete set of open bugs on My Oracle Support at https://support.oracle.com.

Replication IssuesReplication of patient data and study definition metadata from one location to another was not supported in Oracle Clinical 4.6. Release 4.6.2 restores standard, disconnected, and symmetric replication, including replication of tables introduced in Oracle Clinical 4.6 to support flexible studies.

There are a number of issues related to the use of incremental replication—both incremental study definition replication and study data replication with Refresh All set to No. Most of these issues are resolved by subsequent replication. If you always use full study definition replication and study data replication with Refresh All set to Yes, these issues do not occur.

These issues do not apply to disconnected or symmetric replication.

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Bug 11675366

Issue (Study Data Replication) If replication is performed between the time a user opens a data entry window and the time the user makes a data update, subsequent replication with Refresh All = N does not include that update.

Workaround To correct data, execute replication with Refresh All = Y.

Bug 6857694

Issue (Study Data Replication) In studies with page tracking enabled, after deleting a CRF via key changes and performing incremental replication, deletions are not reflected at the slave site.

Workaround To correct data, execute replication with Refresh All = Y.

Bug 6852468

Issue (Study Data Replication) When a DCF that has already been replicated is deleted at the source location and incremental replication is performed, the history entry for the delete is not replicated from source to target.

Workaround To correct data, execute replication with Refresh All = Y.

Bug 11842256

Issue (Study Data Replication) When (Un)Verify and (Un)Approve actions are the only updates performed since the last incremental replication, verification and approval records are not replicated.

Workaround To correct data, either execute replication with Refresh All = Y or perform an update in any other CRF for the same patient and run replication with Refresh All = N again.

Bug 11695597

Issue (Study Data Replication) When a multivariate discrepancy is deleted (system-closed) at the source location, replication deletes the discrepancy at the target location but not corresponding history and VRV records. Therefore, extra records are found for a discrepancy that no longer exists.

Workaround To correct data, execute replication with Refresh All = Y.

Bug 11682124

Issue (Study Data Replication) After updating only the Tracking Status Comment for a CRF at the source Database, subsequent data replication to a target database with Refresh All = N does not copy the new entries into RECEIVED_PAGES and RECEIVED_PAGE_HISTORY tables.

Workaround To correct data, either execute replication with Refresh All = Y or perform a different update (not in the Tracking Status Comment) in any CRF for the same patient and run replication with Refresh All = N again.

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Bug 2068367

Issues (Study Data Replication) This bug has two issues: 1.) Incremental replication fails to replicate the deletion of a CRF (Delete Study Information); 2.) Incremental replication replicates the deletion of a patient; however, CRFs for the patient are not deleted at the target site.

Workaround To correct data, execute with Refresh All = Y.

Bug 11659401

Issue (Study Definition Replication) In a replicated environment, incremental study definition replication does not replicate updates to the global default DCI Access table (in the Oracle Clinical menu path Admin, then Users and Roles, then Default DCI Access by Role), when updates since the last replication are restricted to this table.

Workaround Make an update to a different table and repeat incremental replication, or run full replication. Changes to the global default DCI Access table will be replicated.

Bug 11656503

Issue (Study Definition Replication) Oracle Clinical does not provide any query-only menu options for the DCI Access definition forms. In a replicated environment, this means that users at non-Global Library-owning sites cannot view default DCI Access definitions and users at non-study-owning sites cannot view study-specific DCI Access definitions.

Workaround Users with query-only access must request the information from the Global Library- and study-owning site as appropriate.

Note In order to verify DCI Access has replicated properly, the following queries may be used, running as the RXC user and entering the study name when prompted:

select * from DCI_USER_ROLE_PRIVS where clinical_study_id in (select clinical_study_id from clinical_studies where upper(study) like upper('&StudyName'))

and

select * from DCI_USER_ROLE_PRIVS_DCIS where PRIVILEGE_ID in (select PRIVILEGE_ID from DCI_USER_ROLE_PRIVS where clinical_study_id in (select clinical_study_id from linical_studies where upper(study) like upper('&StudyName')))

Bug 10434366

Issue (Study Definition Replication) Incremental replication of the study definition will not replicate an update to the target site if it is the only update that has been made since the last replication.

Workaround Make another definitional update to the study (if necessary, simply reverse the same update and redo it) and rerun incremental replication, or run full replication.

Other Oracle Clinical IssuesThis section lists known Oracle Clinical issues that are not related to replication.

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Bug 10354514

Issue Due to a regression in Report Server 10.1.2.3, the character-based Patient Data Report may drop text when the last line in the CRF is the last row in a repeating question group, and that row contains a field with text that wraps, causing the CRF to span pages.

Workaround Refer to document number 180430.1, OLSA Supported Technology Stacks, for availability of a report server patch to address this issue.

Bug 11822055

Issue The Annotated Layouts feature cannot be used on Windows 7. Windows 7 does not support Adobe 8, and Oracle has not yet certified the Oracle Clinical Adobe Plug-in with Adobe 9.

Workaround None. Check My Oracle Support article number 180430.1, OLSA Supported Technology Stacks for certification of Adobe 9.

Bug 11709987

Issue Subject flow in the CTMS integration fails with error message " Required Protocol Site Id is not present in the message" when the Site ID is greater than 7 digits. A similar failure can occur when the Clinical Study ID or Investigator ID exceeds 7 digits.

Workaround None.

Bug 8815823

Issue If a Save is performed for an active or retired DCI Book in the Maintain Enhanced DCI Books, DCI Book Pages window, the Validation Status of the Book changes to PENDING.

Workaround Make the active Book provisional and re-activate it. Then run 'Calc Expectedness in Test' and 'Calc Expectedness in Prod'. No workaround is required for a retired DCI Book.

Bug 8802768

Issue When changes are made to several DCI Books that impact their rules and the Books are all activated simultaneously without prior validation, if one of the Books fails validation, then the Expectedness calculation for any of the modified Books can fail with the following error:

1212500: An error occurred while performing expectedness 1212600: ORA:20000

Workaround Run Validate DCI Book for each book, so that Validation Status is SUCCESS or WARNING, and then activate the Books.

Bug 8602512

Issue When a DCI Book is copied in the Maintain Enhanced DCI Books form, it must be saved after it has been renamed. If the Exit button is selected after the copied Book has been renamed there is no option to discard changes.

Workaround Save the renamed copied Book, then delete it.

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Bug 8719791

Issue When the "Flex Study Enabled?" box is checked in Maintain Clinical Study States for a non-flexible study and active DCI Books exist, a warning appears about using the DCI Book in RDC "To use the Book in RDC, you must set it to Provisional and reactivate. If patients are assigned to the Book, you must manually calculate expectedness." If Calculate Expectedness in Test and Calculate Expectedness in Prod are not run for that book, it will appear in RDC Onsite that no CRFs are expected for any patients assigned to that Book.

Workaround Change the status of the DCI Book to Provisional and re-activate, then run Calculate Expectedness in Test and Calculate Expectedness in Prod from the Special menu in the Maintain Enhanced DCI Books form.

Bug 8766369

Issue In the Maintain Enhanced DCI Books form when creating an Interval Rule with Action = 'BypassTo' in a study which has only one Interval, no Intervals are available in the Select Target Interval pop-up window. If the Select? box is checked it is not possible to exit this pop-up window using the Back button.

When creating a DCI Rule in a study which has only one DCI, or where every DCI is the target of a DCI Rule in the current DCI Book, no DCIs are available in the Select Target DCI pop-up window. If the Select? box is checked it is not possible to exit this pop-up window using the Back button.

Workaround Select Clear Form (Shift + F7), which returns the focus to the main menu.

Bug 8797582

Issue The Installer appears to allow uninstalling database server code. We do not support uninstalling database server code.

Workaround There is no workaround.

Bug 8474089

Issue In the Oracle Clinical Layout Editor, if you select an invalid font, the layout editor displays square boxes ([] [] []), for some text. For example, the editor does not support the Symbol font.

Workaround Select a valid font.

Bug 8295370

Issue There are some rare cases where batch validation or online validation can fail to complete. These are exceptions to Oracle Clinical's new support for executing batch jobs at any time. The problem occurs if a study definition changes while a CRF is open in Oracle Clinical or RDC. Normally the batch validation failure doesn't happen during production data entry.

General Workaround In most cases, after making definition changes, run batch validation once when users are not entering data. Subsequent batch validation runs should not fail, skipping the locked CRFs.

Known Case An open RDC document (or possibly an HTML Data Entry document), causes Batch Validation to fail to complete. These are the steps to reproduce:

1. Modify a document in RDC Classic.

2. Create a length discrepancy and leave the document open.

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3. Increase DCM Question length in Oracle Clinical.

4. Run batch validation. Batch validation fails to complete when it tries to obsolete the discrepancy that is in the open and locked RDC document.

Workaround If you close the Data Entry window, batch validation continues and finishes with a warning.

Known Case In RDC (or possibly in HTML Data Entry):

1. Update a value of a question that is used in a derivation procedure.

2. Leave the CRF open.

3. Make the derivation procedure Provisional.

4. Run batch validation. Batch validation fails to finish.

Workaround If you close CRF, batch validation continues and finishes.

Known Case In RDC (or possibly in HTML Data Entry):

1. Update a value of a question that is used in online derivation procedure.

2. From Oracle Clinical, make the procedure Offline while a CRF is open.

3. Run batch validation. Batch validation fails to finish.

Workaround Close the CRF.

Known Case (Bug 8490277) An Oracle Clinical user is updating the discrepancy status for any document through the discrepancy database, and at the same time another Oracle Clinical user updates the field that raised this discrepancy via Data Entry, Update, saves the changes and then runs batch validation. Batch validation for the second user waits for the first user to either save the changes or exit the discrepancy window, and then completes to SUCCESS.

General Workaround In most cases, after making definition changes, run batch validation once when users are not entering data. Subsequent batch validation runs should not fail, skipping the locked CRFs.

Bug 6503931

Issue When the Google pop-up blocker is installed in the end user's browser, the second attempt to open the patient LOV fails. For example, when you select the magnifying glass icon for the patient from field, the LOV is retrieved successfully but when you then select the magnifying glass icon for the patient to field, the LOV is not retrieved.

Workaround Disable the Google pop-up blocker.

Bug 6277447

Issue For users running Yahoo! services, the application fails to respond at some point after closing a data entry window.

Workaround Rename the file yiesrvc.dll located in C:\Program Files\Yahoo!\Common. It appears that Yahoo services continue to run after renaming this file. Alternatively, in the browser window navigate to Tools, then Manage Add-ons, then Enable or Disable Add-ons. In Manage Add-ons disable all the Yahoo toolbar options.

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Bug 11869431

Issue Preview in the Graphic Layout Editor incorrectly displays an apostrophe (’) as &apos; when the apostrophe is part of a question prompt. It appears correctly in the layout editor itself, in the HTML data entry window, and in the Patient Data Report.

Workaround View the layout from RDC Onsite or in the Patient Data Report.

Bug 10327441

Issue In Oracle Clinical, 'Delete Book Pages for CPE' fails for a Provisional DCI Book if production data has been entered. (To reach this option, navigate to DCIs in the Definition menu, then Enhanced DCI Books, click Navigator, select the visit with pages to be deleted and then, from the Special menu select Delete Book Pages for CPE).

Workaround In the Enhanced DCI Book Navigator, select DCI Book Pages to display the DCIs for the selected visit. Delete each DCI individually by selecting each DCI in turn, then selecting Delete Record the Data menu.

Remote Data Capture IssuesThis section lists known issues in Oracle Clinical Remote Data Capture.

Bug 8482879

Issue If you set RSTRCT LCKD = Y in the OC OCL_DE_CONFIG codelist, locked CRFs cannot be approved, unapproved, verified, unverified or have discrepancies updated. With the de-support of PDF data entry in 4.6.0, RDC Onsite users restricted to APPROVE, VERIFY, and/or UPD_DISCREP privileges cannot be granted a temporary unlock in order to approve, unapprove, verify, or unverify CRFs or update discrepancies.

Workaround Either set RSTRCT LCKD CRF = N, which allows verify, approve, and discrepancy update actions against locked CRFs, or temporarily grant the user Privileged Update in Oracle Clinical.

Bug 8588321

Issue Although RDC Onsite can be accessed from a Web client with Internet Explorer 8.0, a user can change the Document Mode setting such that RDC Onsite does not work properly. It is not anticipated that RDC Onsite users will change this setting, as it is targeted at Web developers. Internet Explorer 8 comes with Developer Tools, enabling Web site developers to prototype and test Web sites that they develop.

Workaround For RDC Onsite, Internet Explorer 8.0, ensure the browser has the setting: Document Mode: Quirks Mode (Page Default) Alt+Q

To check this setting:

1. Launch Internet Explorer 8.0.

2. Select the Tools menu in the current tab.

3. Select Developer Tools F12 from the Tools menu.

4. Select the Document Mode: option in the Developer Tools menu and set to Quirks Mode (Page Default) Alt+Q.

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Bug 8628351

Issue Refer to enhancement bug 7243863 for RDC Onsite: The data entry window was modified to detect and attempt recovery from momentary drops in network connectivity. This functionality works inconsistently when the session is running on Internet Explorer 6, perhaps only when the network connection has pronounced latency. Under these conditions and when the network drop occurs during specific user scenarios, the data entry window shuts down with the message "This application has encountered a fatal error and will shut down. Timeout occurred while waiting for a request."

Workaround There is no workaround. The window may be suspended with a Processing message for some time before the error message appears.

Bug 8801316

Issue When data entry for a CRF is completed and you return to the Patient Casebooks page, it refreshes the surround and renders the whole page. But the progress bar continues to show progress even after the page is rendered. This problem is not consistently reproducible.

Workaround There is no workaround.

Bug 8783072

Issue The Next Visit field in the Patient Summary Report may be incorrect in a Flex Study. The field displays the next visit defined in the DCI Book. However, in a flexible study, the next defined visit is not necessarily the next visit expected for a given patient. The next visit may depend upon the data entered for that patient.

Workaround Navigate to the Patient Casebooks page and query such that the patient of interest is retrieved. Under Set Visit Focus, set the focus to the patient of interest and review the list of visits in the visit drop-down. This is the set of expected visits for this patient. By looking at visits for which data has been entered so far for the patient, you can deduce the next expected visit.

Bug 12352802

Issue The online help link from the Special Listings page no longer works. Error 404 - Page Not Found appears.

Workaround To fix this problem:

1. Log on to the database as RXC and start a SQL session.

2. Run the following at the SQL prompt:

update ocl_doc_indexset oc_doc_name='/rdc/footprint/wwhelp/wwhimpl/api.htm?context=footprint'||CHR(38)||'topic=special_listings'||CHR(38)||'single=true'where PRODUCT_CODE = 'RDC' and TASK = 'RDC_HTML' and BLOCK_NAME = 'DEFAULT' and MODULE_NAME = 'SPECIAL_LISTINGS'and oc_doc_name like '%/footprint/default.htm?context%';

3. Commit.

4. Exit.

16

Revision History

25 April 2011This is the first version of these release notes.

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