This action might not be possible to undo. Are you sure you want to continue?
Release Notes Release 4.6.2
E18815-01 April 2011
Overview | References | Media | Installation | Enhancements | Problems Addressed | Known Issues | Revision History | Documentation Accessibility
Oracle 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.
Priority Problem type(s) Patch component(s) Version Platforms Normal Enhancements and bug fixes Application Server, Reports Server, Database Server, Database This is the first version. All
Refer to the following documents for more information.
White Papers and Technical Notes
The 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
6.6.0 Summary of Patches Available 883213.2 Administrator's Guide In addition.6.oracle. Oracle Clinical customers can request a copy of the Oracle Clinical Stable Interface Technical Reference Manual from Oracle Support. 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.1: Desupport of PDF Data Entry in Oracle Clinical Remote Data Capture In addition. To download the media pack from eDelivery: 1.2 Conducting a Study Oracle Clinical Release 4.oracle.6. select Health Sciences.2 Media Pack includes the Oracle Clinical and Oracle Clinical Remote Data Capture (RDC) user guides on disk V25150-01.6. 4. To receive a physical media pack with all the required DVDs.2 is available on the Oracle Clinical 4.1: Oracle Clinical Versions 4.1: Cloning Databases in Oracle Clinical and TMS 4.2 is available on the Oracle Health Sciences documentation page at: http://www.6.2 User's Guide Oracle RDC Onsite Release 4. Go to http://edelivery.6. the Oracle Clinical Remote Data Capture Release Content Document Release 4. The user documentation includes: ■ ■ ■ ■ ■ ■ Oracle Clinical Release 4.6.com/technetwork/documentation/hsgbu-154445.6.2 Getting Started Oracle Clinical Release 4.121863.5 and 4.6.com and log on.6.6. Media Oracle Clinical 126.96.36.199 Media Pack.2 and Oracle Thesaurus Management System 4. From the Select a Product Pack drop-down list. 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.html User Documentation The Oracle Clinical and Oracle Thesaurus Management System 4.oracle.2 User's Guide Oracle RDC Onsite Release 4.x 467823.2 Creating a Study Oracle Clinical Release 188.8.131.52 Installation Guide Oracle Clinical Release 4. 2.com/technetwork/documentation/hsgbu-154445.2 Application Programming Interface Guide Oracle Remote Data Capture (RDC): ■ ■ ■ Oracle RDC Classic Release 4. 2 .html Note: Always check the Oracle Health Sciences Documentation page to ensure you have the latest updates to the documentation.2 Administrator's Guide Oracle Clinical Release 4.
(Release 4.6) Data-driven branching within a CRF is also supported in RDC Onsite. Installation For complete installation instructions. which supports multiple branches and multiple target question locations in the CRF. ■ ■ ■ ■ ■ ■ ■ ■ 3 .2) Integration with Siebel Clinical or another clinical trial management system with Oracle Clinical is supported. ■ (Release 4. Select Oracle Clinical and Oracle Thesaurus Management System 4. minimizing conflicts and record locking in environments where data entry is performed on a 24x7 basis.6.6. Note: If this media pack is the only one available in Health Sciences for the platform you selected.1 for known installation issues.6.html. select the appropriate database tier operating system. and handling intermittent connectivity loss that allows the application to continue with minimum disruption to the users.6 feature Indicator Branching and by the more flexible 4. refer to the Oracle Clinical Remote Data Capture Release Content Document for Release 4.2) This release includes an upgraded technology stack. (Release 4. Download the software.000 characters.6.2 Media Pack forYour_Operating_ System and click Continue.6 feature Conditional Branching. see the Oracle Clinical Release 4.3. The full responses to these fields are displayed in an auxiliary page for the CRF in the patient data report. (Release 4. (Release 4. 6.com/technetwork/documentation/hsgbu-154445. based on an earlier response. 4.6 at http://www.2 and Release 4.6) Scalability and performance enhancements include improved handling for simultaneous background processing and data capture activities. (Release 4. From the Platform drop-down list. (Release 4.2) RDC Onsite data entry text fields defined as "extended text" fields can hold up to 10. Check My Oracle Support document number 386941.6.2 Installation Guide. the system takes you immediately to the media pack page from which you can download the software disk by disk. Release 4. Click Go.6. (Release 4.6.6) To address the growing number of studies with multi-arm and other complex trial designs.oracle. 5. study definition features support defining rules for data-driven events that determine or change a subject's schedule or expected assessments. users’ access to specified DCIs can be restricted by their role.6 also included a number of minor usability enhancements in RDC Onsite. optimization of middle tier resources. Enhancements For more details on the following enhancements.6) In RDC Onsite. both by the pre-4. Both types of branching disable fields that should not be entered.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.
6 Patches Problems Addressed in Oracle Clinical and RDC 4.5. the audit trigger on the CLINICAL_STUDY_STATES table is missing. Problems Addressed in Oracle Clinical 4. Bug 10359851 Before After changing a prompt position and regenerating a character layout from the DCM Question Groups form.1.6.6 without having applied 4.6 Problems Addressed in Oracle Clinical and RDC 4. the form displays correctly.6. Spell check works properly in the DCI/DCM Layout Editor.6.1. Bug 11723663 Before Performing an Out of Study Load on the Linux platform resulted in failure.5 and 4. (Auditing of this table was introduced in patch 4.52. 184.108.40.206.2 Problems Addressed in RDC Onsite 4. After Out of Study Loads execute successfully on the Linux platform.0 Summary of Patches Available.3 Patches Problems Addressed in Oracle Clinical and RDC 4.1 Patches For a complete list of patches available. As a result. Oracle Clinical Versions 4.5. After In the above scenario.) After In the above installation and upgrade scenarios. 4 .2 Problems Addressed in Oracle Clinical and RDC 4. Bug 11799141 Before When upgrading to 4.6. including: ■ ■ ■ ■ ■ ■ Problems Addressed in Oracle Clinical 4.6.2 This section lists the problems addressed in Oracle Clinical 4.Problems Addressed This section lists the problems fixed in Oracle Clinical 4. Security. Conduct.1.2.52 or performing a new installation of 4.6. the form did not refresh correctly if the generation failed due to the unavailability of PSUB.5.2. After The latest version of Jspell is supported in OC 4.6. Clinical Study States) are not audited. the audit trigger on the CLINICAL_STUDY_STATES table is correctly installed. see My Oracle Support article 121863. updates to settings in the Clinical Study States form (Oracle Clinical. with their primary bug numbers. Bug 10381793 Before Spell check did not work properly in the DCI/DCM Layout Editor.
After If a user role is deleted from the DCI Access form. 5 . Problems Due to Release 4. data is replicated from all locations for the specified study. journal records were created at the target location. the same validation is applied as when this flag is updated at the study-owning location. Bug 11697096 Before When performing Disconnected Replication on tables with journal triggers that contained pre-existing replication check logic. the deleted user role for the study was not included in the audit table for the Delete operation. Disconnected Replication successfully executes at the target location. These problems have all been addressed in Oracle Clinical 4. They all involve values’ not being displayed properly. Disconnected Replication failed at the target location.0 with the migration from Forms 6i to Forms 10g.6.2: Bug 11902867 In the Single view of the Investigator Assignments window. the Investigator Name was not displayed. 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. the deleted user role for the study is included in the audit table for the Delete operation. the replication job is successful. the current flag value is preserved. Bug 11696740 Before When a received DCI at the source location was updated through key changes and the study had page tracking enabled. After When a received DCI at the source location is updated through key changes and the study has page tracking enabled. an alert is displayed: "You have updated the 'Flex Study Enabled?' flag. After Now when performing Disconnected Replication on tables with journal triggers that have pre-existing replication check logic. If the user selects Yes. Security. the replication job ended in failure if there was more than one location from which to pull data.Bug 11067471 Before When a user role was deleted from DCI Access.6. which owns this study. You must ensure this setting matches the setting specified at location owning_location. After When data replication is performed with Data Location Code = ‘%’. 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.6 Technology Stack Upgrade Addressed The following bugs were introduced in Oracle Clinical 4. Do you wish to continue? YES/NO" If the user selects No. Bug 7391963 Before When data replication was performed with Data Location Code = ‘%’.
2. Single mode of History: Event Type description and interval were not displayed. (Note: These are display-only fields. 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. 2. Bug 11899023 Single mode of Study Statuses: Descriptions for the Randomization and Study Status were not displayed. Treatment Regimen name is blank.Bug 11900342 Create Patient Positions and Change Owning Location for Patient Positions: After changing the Location to own Patients.6. Bug 11900603 The Effective Start and End dates of lab ranges were not displayed. add Regimen to Treatement Pattern.2 This section lists the problems addressed in RDC Onsite 4. Bug 11899057 Single mode of Study Versions: Descriptions for the Replacement Rule and Time Unit Code were not displayed. Bug 11902867 Single mode of Clinical Studies: ■ ■ Descriptions of Study Status and Random Access in single view were not visible. Bug 11900342 Upon changing the 'Location to own Patients' field in the 'Create Patient Positions' and the 'Change Owning Location for Patient Positions' screens. under Study Intervals assigned to regimen.) Bug 11901691 The regimen name was not displayed in drill-down to Procedures. 6 . User can select it if they know what the name is and click Assign Regimen to Intervals. the 'Current Number Of Screening/Normal/Replacement Patients' fields were not updated to reflect the corresponding values for the new location.6. the 'Assigned' checkbox was not checked. Bug 11901027 This bug had two issues: 1. study status code and description. the fields Current Number of Screening/Normal/Replacement Patients were not updated to reflect the new location.) Under Assigning regimens to interval screen. When creating a new study. For selected Drug and Regimen for this drug. Factor Code was not updatable from LOV. ■ Single mode of Enrollment: ■ ■ Factor Code description was not visible. random access code and description were not defaulted.) Label Code and Treatment Regimen Name were shown as blank while adding Regimen to Treatment Pattern. Study status type code and random access type code were not modifiable from this screen. column "Assigned?" was always unchecked. treatment pattern: ■ ■ For selected regimen. Bug 11901027 For a selected study. Problems Addressed in RDC Onsite 4.
id' is null or not an object". The native.lastNavigatedField. The Data Entry window became inactive and had to be forcibly closed using Task Manager. After In the above scenario. positioned the cursor in a response field. 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. "’this.sizeOfDesktopInKB parameter in the dcapi. the discrepancy highlight color did not change to the required color. . ■ After Bug 11723264 Before When using RDC Onsite with Internet Explorer 7. The Data Entry window became inactive and had to be forcibly closed using Task Manager. or of type that does not accept the focus". This could happen in two ways: ■ The user entered only header fields. The CRF is automatically marked blank.properties controls the size of the desktop heap in kilobytes of the non-interactive desktop which is created programmatically by RDC Onsite Java code. >. the application displayed an error message. 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. The user positioned the cursor in a response field and used the blank flag tool to mark the CRF blank. No errors occur in the scenarios described above. Bug 11062292 Before In an RDC Onsite Data Entry window. no errors occur.6. By default. and saved Complete. 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.2 supports Windows Server 2008 R2.Bug 11062829 Before If a CRF was marked blank when the cursor was in a response field. not enabled. “. the subsequent Save action resulted in the error "Can't Move focus to the control because it is invisible. the size is 48 MB. if a response field was highlighted with a discrepancy in the Data Entry window and the discrepancy was routed.). 7 . 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 10366222 Before RDC Onsite did not support middle tier Windows Server 2008 R2. 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 RDC Onsite 4. No blank flag check box was displayed in the CRF.
5.6. 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.6.5.6. the Siebel Clinical integration patches OC_4.Problems Addressed in Oracle Clinical and RDC 4.html Problems Addressed in Oracle Clinical and RDC 220.127.116.11 and even-numbered patches up to and including OC_4.76.2 restores standard.0. these issues do not occur.6 are included in Oracle Clinical Release 4.oracle.2 includes the fixes in all Release 4.6. Refer to the release notes for these patches on My Oracle Support to review the problems addressed.74. These issues do not apply to disconnected or symmetric replication.6. that is.5.0.2 includes the fixes in all Release 4. Replication Issues Replication of patient data and study definition metadata from one location to another was not supported in Oracle Clinical 4.3 Patches Oracle Clinical/RDC 4. ■ ■ ■ 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. In addition.51 and OC_4. odd-numbered patches up to and including OC_4.6 patches that were current as of the final development stage for Release 4.1 patches that were current as of the final development stage for Release 4.0.6.com/technetwork/documentation/hsgbu-154418.104.22.168 Patches Oracle Clinical/RDC 4.6. For details about these bugs. including replication of tables introduced in Oracle Clinical 4.1. odd-numbered patches up to and including OC_4. which was not released and is not included in 4.22. up to and including OC_4. and symmetric replication.5. Release 4. 8 .6 All bug fixes included in Oracle Clinical 4.com.2.15 and even-numbered patches up to and including OC_4.6.5. except for OC_4. If you always use full study definition replication and study data replication with Refresh All set to Yes. disconnected.3.52 are included. Most of these issues are resolved by subsequent replication.2.2.5. Refer to the release notes for these patches on My Oracle Support to review the problems addressed.2 includes the fixes in all Release 4.0. see the Oracle Clinical 4.6 to support flexible studies. Problems Addressed in Oracle Clinical and RDC 4.3 patches that were current as of the final development stage for Release 4. Problems Addressed in Oracle Clinical and RDC 4.1. that is. Refer to the release notes for these patches on My Oracle Support to review the problems addressed. Known Issues This section lists selected issues that remain unresolved with this patch.6 Patches Oracle Clinical/RDC 22.214.171.124.oracle.126.96.36.199 Release Notes at http://www.5. that is.6.
Workaround 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. Therefore. 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. extra records are found for a discrepancy that no longer exists. Workaround Bug 11842256 Issue (Study Data Replication) When (Un)Verify and (Un)Approve actions are the only updates performed since the last incremental replication. 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.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. Workaround To correct data. 9 . Workaround To correct data. To correct data. To correct data. execute replication with Refresh All = Y. 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. execute replication with Refresh All = Y. execute replication with Refresh All = Y. subsequent replication with Refresh All = N does not include that update. after deleting a CRF via key changes and performing incremental replication. replication deletes the discrepancy at the target location but not corresponding history and VRV records. deletions are not reflected at the slave site. Workaround Bug 11682124 Issue (Study Data Replication) After updating only the Tracking Status Comment for a CRF at the source Database. To correct data. Workaround Bug 6857694 Issue (Study Data Replication) In studies with page tracking enabled. To correct data. verification and approval records are not replicated. execute replication with Refresh All = Y. the history entry for the delete is not replicated from source to target.
) Incremental replication replicates the deletion of a patient. 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. however. Workaround Users with query-only access must request the information from the Global Library. Bug 11659401 Issue (Study Definition Replication) In a replicated environment.) Incremental replication fails to replicate the deletion of a CRF (Delete Study Information). Make another definitional update to the study (if necessary. then Default DCI Access by Role). 10 . 2. the following queries may be used.Bug 2068367 Issues (Study Data Replication) This bug has two issues: 1. Workaround Other Oracle Clinical Issues This section lists known Oracle Clinical issues that are not related to replication. simply reverse the same update and redo it) and rerun incremental replication. then Users and Roles. Changes to the global default DCI Access table will be replicated. incremental study definition replication does not replicate updates to the global default DCI Access table (in the Oracle Clinical menu path Admin. Note In order to verify DCI Access has replicated properly. or run full replication. Workaround To correct data. when updates since the last replication are restricted to this table. CRFs for the patient are not deleted at the target site. execute with Refresh All = Y. Workaround Make an update to a different table and repeat incremental replication. or run full replication.and study-owning site as appropriate. 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. Bug 11656503 Issue (Study Definition Replication) Oracle Clinical does not provide any query-only menu options for the DCI Access definition forms.
it must be saved after it has been renamed. Bug 8602512 Issue When a DCI Book is copied in the Maintain Enhanced DCI Books form. Workaround Make the active Book provisional and re-activate it. No workaround is required for a retired DCI Book. None. then delete it. 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. OLSA Supported Technology Stacks. Workaround Bug 8815823 Issue If a Save is performed for an active or retired DCI Book in the Maintain Enhanced DCI Books. so that Validation Status is SUCCESS or WARNING.Bug 10354514 Issue Due to a regression in Report Server 10.2. Workaround 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. Workaround Refer to document number 180430.3.1. DCI Book Pages window. 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. causing the CRF to span pages. Check My Oracle Support article number 180430. and that row contains a field with text that wraps. None. if one of the Books fails validation. Then run 'Calc Expectedness in Test' and 'Calc Expectedness in Prod'. A similar failure can occur when the Clinical Study ID or Investigator ID exceeds 7 digits.1. Workaround 11 . the Validation Status of the Book changes to PENDING. Windows 7 does not support Adobe 8. Save the renamed copied Book. and Oracle has not yet certified the Oracle Clinical Adobe Plug-in with Adobe 9. Bug 11822055 Issue The Annotated Layouts feature cannot be used on Windows 7. If the Exit button is selected after the copied Book has been renamed there is no option to discard changes.1. OLSA Supported Technology Stacks for certification of Adobe 9. 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. for availability of a report server patch to address this issue. and then activate the Books.
after making definition changes. 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. If patients are assigned to the Book. The problem occurs if a study definition changes while a CRF is open in Oracle Clinical or RDC. These are the steps to reproduce: Modify a document in RDC Classic. Subsequent batch validation runs should not fail. 12 . Workaround Change the status of the DCI Book to Provisional and re-activate." If Calculate Expectedness in Test and Calculate Expectedness in Prod are not run for that book. In most cases. Normally the batch validation failure doesn't happen during production data entry. then run Calculate Expectedness in Test and Calculate Expectedness in Prod from the Special menu in the Maintain Enhanced DCI Books form. 2. you must set it to Provisional and reactivate. 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. We do not support uninstalling database server code. it will appear in RDC Onsite that no CRFs are expected for any patients assigned to that Book. Workaround Select Clear Form (Shift + F7). run batch validation once when users are not entering data. the editor does not support the Symbol font. There is no workaround. When creating a DCI Rule in a study which has only one DCI. skipping the locked CRFs. General Workaround Known Case 1. Select a valid font. For example. which returns the focus to the main menu. if you select an invalid font. you must manually calculate expectedness.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. Create a length discrepancy and leave the document open. no Intervals are available in the Select Target Interval pop-up window. or where every DCI is the target of a DCI Rule in the current DCI Book. a warning appears about using the DCI Book in RDC "To use the Book in RDC. Bug 8797582 Issue The Installer appears to allow uninstalling database server code. for some text. An open RDC document (or possibly an HTML Data Entry document). the layout editor displays square boxes (  ). Workaround Bug 8295370 Issue There are some rare cases where batch validation or online validation can fail to complete. Workaround Bug 8474089 Issue In the Oracle Clinical Layout Editor. These are exceptions to Oracle Clinical's new support for executing batch jobs at any time. causes Batch Validation to fail to complete. If the Select? box is checked it is not possible to exit this pop-up window using the Back button.
Workaround Rename the file yiesrvc. then Manage Add-ons. and then completes to SUCCESS. when you select the magnifying glass icon for the patient from field. run batch validation once when users are not entering data. In Manage Add-ons disable all the Yahoo toolbar options. Subsequent batch validation runs should not fail. 3.3. Batch validation fails to finish. batch validation continues and finishes with a warning.dll located in C:\Program Files\Yahoo!\Common. 2. after making definition changes. Update a value of a question that is used in online derivation procedure. Run batch validation. and at the same time another Oracle Clinical user updates the field that raised this discrepancy via Data Entry. then Enable or Disable Add-ons. Bug 6503931 Issue When the Google pop-up blocker is installed in the end user's browser. Batch validation fails to finish. If you close the Data Entry window. skipping the locked CRFs. Make the derivation procedure Provisional. Leave the CRF open. 4. 13 . the second attempt to open the patient LOV fails. in the browser window navigate to Tools. make the procedure Offline while a CRF is open. In RDC (or possibly in HTML Data Entry): Workaround Known Case 1. In RDC (or possibly in HTML Data Entry): Workaround Known Case 1. Disable the Google pop-up blocker. For example. Run batch validation. the application fails to respond at some point after closing a data entry window. 3. 4. Batch validation fails to complete when it tries to obsolete the discrepancy that is in the open and locked RDC document. General Workaround In most cases. Run batch validation. Increase DCM Question length in Oracle Clinical. Batch validation for the second user waits for the first user to either save the changes or exit the discrepancy window. 2. Alternatively. It appears that Yahoo services continue to run after renaming this file. batch validation continues and finishes. From Oracle Clinical. the LOV is retrieved successfully but when you then select the magnifying glass icon for the patient to field. the LOV is not retrieved. saves the changes and then runs batch validation. Workaround Bug 6277447 Issue For users running Yahoo! services. Update a value of a question that is used in a derivation procedure. If you close CRF. Update. Close the CRF. Workaround Known Case (Bug 8490277) An Oracle Clinical user is updating the discrepancy status for any document through the discrepancy database.
0. a user can change the Document Mode setting such that RDC Onsite does not work properly. unverified or have discrepancies updated.0. or temporarily grant the user Privileged Update in Oracle Clinical. then Enhanced DCI Books. It appears correctly in the layout editor itself. RDC Onsite users restricted to APPROVE. and discrepancy update actions against locked CRFs. Internet Explorer 8. select DCI Book Pages to display the DCIs for the selected visit. Select Developer Tools F12 from the Tools menu. unapproved. 'Delete Book Pages for CPE' fails for a Provisional DCI Book if production data has been entered. Select the Tools menu in the current tab. Internet Explorer 8 comes with Developer Tools.Bug 11869431 Issue Preview in the Graphic Layout Editor incorrectly displays an apostrophe (’) as &apos. Workaround Bug 10327441 Issue In Oracle Clinical. ensure the browser has the setting: Document Mode: Quirks Mode (Page Default) Alt+Q To check this setting: 1. as it is targeted at Web developers. then selecting Delete Record the Data menu. View the layout from RDC Onsite or in the Patient Data Report. Remote Data Capture Issues This section lists known issues in Oracle Clinical Remote Data Capture.0. verify. and in the Patient Data Report. It is not anticipated that RDC Onsite users will change this setting. when the apostrophe is part of a question prompt. Bug 8482879 Issue If you set RSTRCT LCKD = Y in the OC OCL_DE_CONFIG codelist.6. verified. Select the Document Mode: option in the Developer Tools menu and set to Quirks Mode (Page Default) Alt+Q. Launch Internet Explorer 8. or unverify CRFs or update discrepancies. select the visit with pages to be deleted and then. 3. click Navigator. from the Special menu select Delete Book Pages for CPE). VERIFY. enabling Web site developers to prototype and test Web sites that they develop. and/or UPD_DISCREP privileges cannot be granted a temporary unlock in order to approve. With the de-support of PDF data entry in 4. locked CRFs cannot be approved. Workaround Either set RSTRCT LCKD CRF = N. (To reach this option. Delete each DCI individually by selecting each DCI in turn. 14 . Workaround For RDC Onsite. unapprove. approve. in the HTML data entry window. Bug 8588321 Issue Although RDC Onsite can be accessed from a Web client with Internet Explorer 8. Workaround In the Enhanced DCI Book Navigator.0. navigate to DCIs in the Definition menu. which allows verify. 2. 4.
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. Commit. you can deduce the next expected visit. Run the following at the SQL prompt: update ocl_doc_index set oc_doc_name='/rdc/footprint/wwhelp/wwhimpl/api. Timeout occurred while waiting for a request. However. By looking at visits for which data has been entered so far for the patient. The next visit may depend upon the data entered for that patient. Workaround Bug 8783072 Issue The Next Visit field in the Patient Summary Report may be incorrect in a Flex Study. Bug 12352802 Issue The online help link from the Special Listings page no longer works. 15 . Exit. Log on to the database as RXC and start a SQL session. Workaround Navigate to the Patient Casebooks page and query such that the patient of interest is retrieved. Error 404 .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. the data entry window shuts down with the message "This application has encountered a fatal error and will shut down. set the focus to the patient of interest and review the list of visits in the visit drop-down. Bug 8801316 Issue When data entry for a CRF is completed and you return to the Patient Casebooks page. 4. it refreshes the surround and renders the whole page. To fix this problem: Workaround 1.htm?context%'. Under these conditions and when the network drop occurs during specific user scenarios. There is no workaround. This problem is not consistently reproducible. This functionality works inconsistently when the session is running on Internet Explorer 6. Under Set Visit Focus. The window may be suspended with a Processing message for some time before the error message appears.Page Not Found appears. 3." Workaround There is no workaround. The field displays the next visit defined in the DCI Book. the next defined visit is not necessarily the next visit expected for a given patient. perhaps only when the network connection has pronounced latency. But the progress bar continues to show progress even after the page is rendered. 2. in a flexible study. This is the set of expected visits for this patient.
or services. This software and related documentation are provided under a license agreement containing restrictions on use and disclosure and are protected by intellectual property laws. Accessibility standards will continue to evolve over time. GOVERNMENT RIGHTS Programs.2 E18815-01 Copyright © 2011. and other measures to ensure the safe use of this software. duplication. Other names may be trademarks of their respective owners. This software and documentation may provide access to or information on content. broadcast. If you use this software in dangerous applications. Reverse engineering. redundancy.oracle. distribute. backup.6. Government or anyone licensing it on behalf of the U. products. Oracle Clinical and Oracle Clinical Remote Data Capture Release 4. Accessibility of Links to External Web Sites in Documentation This documentation may contain links to Web sites of other companies or organizations that Oracle does not own or control. and supporting documentation accessible to all users. the use. disassembly. For more information. license. costs. This software is developed for general use in a variety of information management applications. you may not use.html or visit http://www. disclosure. and related documentation and technical data delivered to U. This documentation is available in HTML format.S. reproduce. Oracle is a registered trademark of Oracle Corporation and/or its affiliates. perform. The conventions for writing code require that closing braces should appear on an otherwise empty line.. publish. is prohibited. products. Except as expressly permitted in your license agreement or allowed by law. modify. If this software or related documentation is delivered to the U. products. To that end.html if you are hearing impaired. the following notice is applicable: U. Accessibility of Code Examples in Documentation Screen readers may not always correctly read the code examples in this document. some screen readers may not always read a line of text that consists solely of a bracket or brace. and contains markup to facilitate access by the disabled community.com/accessibility/. Oracle Corporation and its affiliates will not be responsible for any loss.com/us/corporate/accessibility/support/index. Oracle Corporation and its affiliates are not responsible for and expressly disclaim all warranties of any kind with respect to third-party content.S. visit the Oracle Accessibility Program Web site at http://www.oracle. our documentation includes features that make information available to users of assistive technology. software. Commercial Computer Software License (December 2007). modification. please report them to us in writing. As such. services. copy. Government customers are "commercial computer software" or "commercial technical data" pursuant to the applicable Federal Acquisition Regulation and agency-specific supplemental regulations. Government. and services. All rights reserved. Access to Oracle Support Oracle customers have access to electronic support through My Oracle Support. The information contained herein is subject to change without notice and is not warranted to be error-free.S. Oracle neither evaluates nor makes any representations regarding the accessibility of these Web sites. visit http://www. Redwood City. in any form.com/us/support/contact-068555. including users that are disabled. or decompilation of this software. Inc. databases. and services from third parties. or by any means. including applications which may create a risk of personal injury.S. CA 94065. For information. then you shall be responsible to take all appropriate fail-safe. If you find any errors. however. exhibit. Oracle and/or its affiliates. Oracle Corporation and its affiliates disclaim any liability for any damages caused by use of this software in dangerous applications. It is not developed or intended for use in any inherently dangerous applications. or display any part. and. Oracle USA. unless required by law for interoperability. transmit. 16 . to the extent applicable by the terms of the Government contract.227-19. or damages incurred due to your access to or use of third-party content. 500 Oracle Parkway.Revision History 25 April 2011 This is the first version of these release notes.oracle. and adaptation shall be subject to the restrictions and license terms set forth in the applicable Government contract. Documentation Accessibility Our goal is to make Oracle products. translate. and Oracle is actively engaged with other market-leading technology vendors to address technical obstacles so that our documentation can be accessible to all of our customers. the additional rights set forth in FAR 52.