Disclose Known Issues

By Gemma1 author143 articles

RRF Print Preview - Baseline Characteristics does not display Arm data, only Total data

Infrequent issue occurs where action history record is not displayed

ERF validation error message is displayed in error: Completed Must be greater than or equal to 1

Content of the field not reflected in ST submission ST XML

Users with the same name already exists

Import sync failure with message "Access to the path... is denied"

"An unexpected error has occurred" is displayed when checking out certain studies

Location Recruitment Status with underscore not recognized as a change

ERF Milestones Comments fields are not available in EudraCT Results

EudraCT Results website does not display "reason not completed" / "number of subjects" for Pre-assignment Period

Reasons Joined removed and Submission upload failure after AE imported to ERF with number of subjects joined

RRF Preview calculates Outcome Measure "Count of Participants"/"Number Analyzed" percentages incorrectly

Set assessments correctly to create CTIS Results Submission

ERF missing Validation Warning message when Endpoint is not reporting statistics for all arms in the Baseline period

ERF - UK subjects should not be counted in EEA total when global end of trial date is in the future

U.S. Trial Disclosures report "Corrections Expected" column displays the incorrect due date

Completing or Deleting study does not cancel Planned or In-Progress Tasks

Importing in ERF AE XML prevents CTIS ID fields to be updated and saved

Unable to reorder ERF Endpoints when there are many Endpoints

ERF import without an ageCategoricalCharacteristic element causes "Namespace Manager or XsltContext needed" error when editing the Age Categorical Baseline Characteristic.

Amendment which is manually completed before workflow is created, blocks subsequent Protocol Maintenance Events

Form comments bubble icon not displayed when Comments panel is collapsed and browser is refreshed

RRF: Quoted text in the "Measure Analysis Population Description" on a Baseline Characteristic on RRF prevents further edits

Disclose workflow tasks status may get out of sync due to network issues

Odata entity ComplianceEventSummary > Studies at risk incorrectly displaying "No" when CE completion date is NULL and CE due date is past

Deleted task assignees sent email notfication when the In-progress task duration is updated

Issues with Compliance Event comments

Importing in ERF AE XML removes CTIS fields

RRF Submission Preview: Incorrect (swapped) total displayed for Reasons not Completed

Time-out errors on the batch maintenance screen caused by slow loading performance

ERF Submission Preview - Endpoints display all Period Titles regardless of which Period Arm is being referenced

User removed from a task is assigned again when workflow is sent back to a previous step

Special Characters in Study fields cause study validation error and cannot be removed

EU Results Form - CTIS upload error messages are displayed when submitting results to EudraCT

ERF Missing Validation Error message: The end point values are incomplete. Values for the selected dispersion type must be provided for each category, for all selected reporting groups, and subject analysis sets

Administration > RuleSet Info does not display Compliance Rules when Auto-Assessment is disabled

Empty task details window caused by Workflow Service Timeout

ERF Submission upload failure when Endpoint Precision/Dispersion type is "N/A" and Category has a name

EudraCT Results Submission upload error message: Invalid content was found starting with element 'armComparisonGroupId'

Reassigning an In-Progress task (where there are multiple task assignees) will cancel the other tasks

Attachment upload fails when Attachment Type contains an extra space at the end of the Internal Value field

Study cannot be checked in and error message "Object reference not set to an instance of an object" is displayed when empty Secondary ID is added

ERF Validation error message displayed incorrectly on the Total # of Deaths Resulting From Adverse Events

ERF > Reporting Group > Number of Subjects displays a different number than Number Started

RRF Preview: Outcome Measure percentage calculated incorrectly when Measure Type is "Count of Participants"

RRF Preview displays Outcome Measure Anticipated Posting Date which cannot be removed via the UI

RRF to ERF sync: Baseline Characteristics with a single row don't sync total correctly

Expanded Access study - PRF Locations status displays options not applicable to study

ERF AE upload error message displayed "The Alternative Dictionary used is not consistent with the Dictionary Overriden section"

ERF validation message on Trial Information not intuitively located

ERF Validation error message incorrectly displayed for Measure Type Values

PRF error when trying to save a Condition which contains an apostrophe

RRF Print Preview - data is cut off when there are many Arms

EudraCT Results Submission upload failure due to white spaces in Reporting Group ID

After second import, RRF AEs may appear out of order

EudraCT Results upload error "EUTCT ID [100000167503] with version [16] is non current or has never been previously used"

ERF End Points with Precision/Dispersion type of "Not Applicable" and a single category causes upload errors on when submitting to EudraCT

ERF Validation missing when negative value entered for Endpoint Standard Deviation

CTA Version History View - field E.8.5.1 is displayed incorrectly

Compliance Event displays an error due to missing data even after the data has been entered and the study is checked in

ERF Submission Upload Error - "The value <> of element 'version' is not valid"

RRF Validation message: ERROR: An unnecessary explanation for Not Available data has been entered.

Invalid Validation Error displayed on RRF - "ERROR: The Protocol Enrollment is less than the number of participants Started. Revise or explain the inconsistency in Pre-assignment Details."

Uploading an attachment with special characters in the filename causes a TypeError

ERF Upload error when Statistical Analysis group is added before the Reporting Group - Invalid content was found starting with element 'armComparisonGroupId'

Last Uploaded Version = Never on create submission screen even though results were previously released from disclose

RRF: Validation message "Confidence Interval has not been correctly specified for a Statistical Analysis" is included in Validation Messages pop-up, but not on the form

ERF: Validation "The threshold for non-serious adverse event reporting must be an integer between 0 and 5" when a decimal is entered"

EudraCT Submission: Validation discrepancy - "The long-term follow up rationale(s) are missing..."

Overall Number of Baseline Participants in RRF is synced to Number of subjects in Reporting groups in the ERF

ERF Validation error: "Statistical Analysis confidence interval lower limits upload" and "Statistical Analysis confidence interval upper limits upload" errors displays incorrectly when the fields have 8 digits

RRF: NA Explanation field on Participant Flow disappears after entering data

ERF End Points: Changing Dispersion type from "Confidence Interval" to "Not Applicable" can cause upload errors

Product data is not saved on Study Properties for Products which contain special characters

The "Safety Issue" field is still available on Outcome Measures although it is no longer on PRS.

RRF: Outcome Measures: It's possible for users to delete all categories when an Outcome Measure has more than one row.

ERF imports with a non-current system organ class version number will cause ERF submissions to fail

ERF Missing Validation error when Endpoint has no Reporting Groups

ERF Reorder Arms feature: Adverse Event Arms do not reorder

Validation: "Field contains an invalid character at position: xx"

"Lookup Contact" dropdown menu includes inactive contacts.

ERF Validation in PharmaCM is not returned on EudraCT.

Default Roles changes aren't saving for all roles

ERF: Duplicate validation errors for "Public contact point" and "Scientific contact point"

ERF- Endpoint Percentage value if populated remains even if Precision Dispersion type is changed to NA

RRF Preview does not display the total number of participants at risk if the value is not entered and Adverse Events

In progress IRD CEs do not recalculate after DRP is released.

On the RRF Baseline Characteristics tab, Baseline Measure, if a value is not added to participants, than the view should show the default of overall number of baseline participants instead of "--".

CTGov Submission: Unapproved changes can be submitted via Batch Maintenance

Submission Uploads fail to release when study attachments are included in a submission and Board data is null - no error raised in PCM

Changes made to attachments are not considered changes to submission, which can cause an upload to be rejected

"Unique Study Id Changed" warning message doesn't display when study is saved before check in.

Imports: EudraCT and CTGov import generate a sync to Study Properties

CTA Submission: Error Conditions p:is_in_phase_one

Errors in Outcome Measure section of Expanded Access studies can create an invalid error message.

Scheduled Jobs: Results of Publication Report Process not displayed on Mailman tab

Validation "ERROR: Exceeds maximum length of 100" displays in Validation Messages pop-up, but not on form

ERF Validation error "The measure type value is not between the low and high values reported by the confidence interval." displays in the Validation Sidebar, but not on form.

ERF: Missing Validation "The Adverse event reporting group description is incomplete"

An error message displays when entering a comment on an intervention with more than 6 associated arms.

System exception occurs when Arm/Group Title or Description contains an apostrophe and changes are applied to Outcome Measures and Participant Flow

PRF: Incorrect validation: "ERROR: Actual Enrollment must be specified for a record that has Results Specified"

ERF: Upload Error Category Title- Content of field 'Title' may not be less than 2 characters and may not be larger than 50 characters raised incorrectly on the Baseline Characteristics Tab

ERF: Validation Error: "End Point Reporting Group: {value} The end point values are incomplete" raised as a result of invalid Precision/Dispersion Type

RRF: Comments on RRF are removed by another RRF Import

PRS Comment Status Page can't be filtered or sorted by Global Study Owner

EudraCT will reject Submissions with Arms having 0 number of Subjects started; validation error message is missing in Disclose

ERF: Missing validation for "Long term follow up planned"

ERF: Missing validation error message "The end point is incomplete. The end point must be in a state to indicate it is complete."

PRF: "Show only Locations with Errors" functionality does not display any locations

ERF: Studies with many AEs and OMs generate performance issues

CTA: "Show Changes Only" Link when comparing CTA to PRF is not functional.

ERF: Comment Fields in Subject Disposition tab are not included in Submission to EudraCT

PRF: Keywords are not submitted to PRS as individual keywords when using delimiters.

CTA: Missing validations in section D

ERF: Upload Error "Not a valid integer" for submission with a null country version node.

Action History: Blank popup displayed when viewing comments in Action History

ERF: Incorrect Validation Error for missing “Study continuous characteristic” values

RRF: Add scrolling capability for Reorder OM functionality

PRF: Cannot expand the columns of the Locations Grid

Submission: Validation Message: “ALERT: Outcome measures from protocol are not used when records include results”

Import: Cannot remove a user from a study role via XML import

Compliance: Reason for Cancellation comments are not saved when canceling a Compliance Event

PRF: Interventional fields (Design Tab) not removed when Study Type updated to Expanded Access

PRF Locations Tab: Locations are not marked as Submitted to CTgov

ERF: Incorrect Error message for “Age characteristics” under Baseline Characteristics tab.

ERF: Incorrect error message displayed for all "Study Categorical Characteristics" values under Baseline Characteristics tab

PRF "Human Subjects Protection Review" field displays as a dropdown; users are unable to populate the field

ERF: Upload error: "Trial Information: The global end of the trial data is not consistent with the global end of trial date reached selection."

ERF: Incorrect Validation: "Content of field ‘Dispersion Value (low)’ must be a decimal and must be in range .."

ERF: Validation error displayed onEudraCT - "Error: Reporting Group <XYZ> The adverse event reporting group is incomplete. Complete this field if relevant to the trial"

CTA: Validation missing on CTA F.1 Age Range fields when non-integer value entered

Admin: Unable to inactivate data that was loaded via master data script

Scheduled Jobs: Generate and send Publication Report failure notifications when process errs

PRF: Checkmark 'AllowImport" is removed from the locations grid

CTGov Submission Preview displays trailing comma when Postal Code is excluded from Submission

Comparison Functionality of Import records does not compare "Content" information

RRF: Serious Adverse Events not grouped by Organ System alphabetically on Preview

CTA: Missing Validation: If D.2.1 is answered "No" then D.2.1.2.1 should not be answered "No"

Compare: RRF Form Comparison does not include Adverse Events Data

Compare: Exception generated when attempting to compare two versions of an RRF

Import: Special characters imported into PharmaCM generates System Exception Error when editing/saving field