Module : Standards

Issue

Type

TrialGrid Version

Description

3799

Bug

66.1

There was a javascript error if a user with no access to Request or Manage Standards expanded the explanation section for a row in the compare dialog. This has been corrected. The user would not have seen this javascript error.

3727

Feature

66

Custom objects now take part in standards compliance.

3728

Feature

66

It is now possible to switch off standards compliance reporting for custom object types from the URL editor page. Objects continue to have compliance calculated but excluded custom object types do not appear in compliance reports.

3753

Feature

65

The user listing of standards approvals for a particular user did not always report their role in the project correctly. This was corrected.

3698

Feature

64

The user-level standards request listings now show the role the user has in the project where the request was made. Listings can also be filtered by this value to help prioritize review based on role.

3699

Feature

64

Standards approval notification emails now include the name of the Project Role of the user receiving the email in the subject line and email body.

3662

Bug

61.2

When requesting approval for a set of object changes from an object listing the explanation was saved in a way that meant the explanation could not be updated from compare views. This was corrected and existing data was corrected.

3614

Feature

61

Compliance detail reports can now optionally include compliant entries such as Matched, Allowed Change and Rule Passed.

3535

Feature

58

Loading the Draft Home page when the Draft is a library Draft and has many linked objects was sometimes slow. Performance was improved by making the count of linked objects load asynchronously.

3507

Feature

56.1

Changing status in bulk from an object listing would do nothing for any object where there was already an explanation for a previous state of that missing object. This was corrected.

3432

Feature

56

It is now possible to filter standards requests lists by attribute name.

3431

Feature

56

In the project standards requests lists it is now possible to scan for obsolete standards requests.

3448

Feature

56

When an object not found in the library is approved, changing the object now makes the approval explanation no longer apply to the changed object unless it is changed back to the original attributes or the changes are only on Custom Properties which do not take part in compliance calculations. See help on standards compliance calculations for more details.

3473

Feature

56

If an object not found in the library has a conditional approval this means that any object of that type with that name that appears in any draft in the project has conditional approval. When one of those objects changes the conditional approval to some other state (say Approved) then the original conditional approval explanation is not changed. Instead, a copy of the conditional approval explanation made and changed to the new state so that previously conditionally approved objects maintain their compliance state.

3474

Feature

56

In standards management lists of explanations the calendar icon now shows the history of any explanation. This is helpful to view the workflow and previous states of this explanation (who requested, who approved etc).

3471

Feature

56

When an object is added to a draft but is not found in the library, any approval for that object now captures the state of the object (its attributes and values) at the time it was approved. This can be viewed from the approvals list.

3467

Feature

56

A new permission was added to allow users to see object fingerprints.

3468

Feature

56

It is now possible to delete standards requests, approvals, denials etc. This will have the effect of recalculating compliance for objects which might be using that request, approval or denial.

3479

Bug

56

When using compare dialog to copy attributes and child objects between objects, standards compliance was not recalculated. This was corrected.

3400

Bug

53

Standards Compliance Excel and PDF Reports show name of library object instead of the name of the study draft object. This was corrected.

3353

Feature

51

When an object has only allowed changes or changes which are allowed by rules then the status of the object is now reported as Compliant for standards purposes rather than Different but approved (the previous behaviour)

3360

Bug

50.1

Draft lists in library projects can be slow to display and can time out. Performance was improved by not counting as "related drafts" drafts which are not directly linked to the library draft but have objects (e.g. checks) which link to this library instead of to their default library. This means the listing can now show 0 related drafts when there are objects which use the library. In this case the library draft still cannot be deleted because it is still considered "in use".

3326

Bug

50

When explaining missing objects, request notification emails were not being sent. This was corrected.

3300

Bug

49.2

When importing test data to create test cases, fingerprints for test cases were not being set. This was corrected.

3301

Bug

49.2

On initial creation of a Matrix, setting custom property value did not update the fingerprint of the Matrix. This was corrected.

3303

Bug

49.2

On update of a Matrix, changing only custom property values did not update the fingerprint of the Matrix. This was corrected.

3304

Bug

49.2

On initial creation of a Folder, setting custom property value did not update the fingerprint of the Folder. This was corrected.

3312

Bug

49.2

Data Dictionary fingerprint calculations relied on the implicit sorting of the database which is system dependent. This did not affect users but was inconvenient when investigating production issues for developers. The issue was corrected.

2780

Feature

47

Allowed changes in Forms and Fields now includes the ability to select custom properties.

3148

Bug

47

Saving a test case in a library was triggering many database calls. Performance was improved.

3158

Bug

46

From object lists bulk approvals of MUST NOT EXIST rule failures for child objects (such as fields which should not exist) could not be performed. This was fixed.

3065

Feature

46

From object lists it is now possible to bulk approve all deviations for objects in the listing.

3133

Bug

45.1

Explanations in state Request Approval are removed when another draft in the same project does not require the explanation and has its status recalculated. This was corrected. Correct behaviour is that the explanation is removed if the explanation belongs to the object being recalculated only.

3004

Feature

45

When an object (or child object) is removed or an attribute changed, any outstanding requests for approval for that object are removed. Requests in other states (e.g. Approved, Denied) are not removed.

3095

Feature

45

It is now possible to switch off standards compliance reporting for draft object types from the URL editor page. When an object is excluded from standards compliance reporting it continues to have compliance calculated but this object type does not appear in compliance reports.

3086

Feature

45

When an added object object is conditionally approved, changing that object further does not remove conditional approval.

3109

Bug

44.2

In the situation where an object was created and had a state of not found in a library and this deviation was approved but then the object was deleted, if a new object of the same name was created again it would not recognize the previous approval. This was corrected.

3069

Bug

44

Denials for added child objects were being picked up at the parent object level causing incorrect status to show for the parent. For example, if a field was added and the reason for addition was denied and subsequently the form OID was changed so that the system believed this Form was "added" then any approval for adding the form was ignored because the system picked up the denial for the child field object. This was corrected.

3049

Feature

44

In a Library Draft a tab now appears with the count of drafts which use this draft as a library.

3051

Feature

44

In a Library Draft a tab now appears with the count of objects which use this draft as a library when the default for those objects would be some other library.

3035

Bug

42.3

System Monitoring reported a javascript error which was occurring on new Test Case pages. Users did not see the error and it did not affect functionality but it has been corrected.

3040

Bug

42.3

Copying an object from Library B into Library A when library B pointed to Library A would fail. This has been corrected.

3045

Bug

42.3

Explanations for Must Have Attribute rule deviations did not take into account the original value of the attribute which meant that a request for approval for the deviation could be denied, the value corrected and the denied request still shown for that value. Then approval would fail with an error because the value for the denied explanation did not match the value being approved. This was corrected.

2935

Feature

42

The compliance report is now available as a Microsoft Excel download as well as the PDF version.

2962

Feature

42

If objects are in a Compliance Calculating state then a warning is now shown on the Draft compliance summary page.

2912

Feature

41

Custom properties can now be excluded from standards compliance calculations.

2859

Feature

40

Projects now have an option to switch off all Standards Notification emails.

2854

Bug

40

When a draft object is linked to a library other than the default library and this other library is soft-deleted, the list of objects cannot be displayed. An error occurs.

2776

Feature

39

When entering a Standards Deviation explanation, a set of previously-used texts are shown, ranked by frequency. Clicking this hint text enters that text as the deviation reason. This is intended to improve the efficiency of the request/ approval workflow.

2670

Feature

39

Duplicate of #2776 above.

2330

Feature

39

Explanations and Approvals for Standard Deviations are now stored at the Project level and applied to all matching Draft objects within that Project. This means that deviations can be explained once in a Project and that explanation is applied to every instance of that deviation.

457

Feature

39

Duplicate of #2330 above.

2671

Feature

39

Duplicate of #2330 above.

2784

Feature

39

It is now possible to "Conditionally Approve" standards deviations. This is useful when you want to give a team permission to go ahead but want to re-assess an approval at a later date.

2794

Feature

39

If only change to an object is an "allowed change" then the status shows "Allowed Changes" for that object. An allowed change is one that is covered by the allowed adds/removals for Form Fields and Data Dictionary entries and allowed attribute change settings of Forms and Fields.

2799

Feature

39

In the standard comparison dialog I should be able to filter the list of differences so that I just see the lines which are Unexplained, Approved etc.

2800

Feature

39

When the only changes to an object meet the applicable standard rules the object status is shown as "Rules Passed".

2787

Feature

39

Standards comparison compares between two objects now show counts of explanation states for deviations - e.g. how many are unexplained, approved etc.

2788

Feature

39

Standards comparison compares between two objects now show each line difference with the ability to explain or approve each deviation on the line where it appears.

2669

Feature

39

It is now possible to bulk explain/approve/deny a set of deviations to an object in the compare view. For example, request approval for 10 unexplained deviations in a single operation.

2798

Feature

39

From the user-level standards deviation list or from the project-level listing users with Manage Approval permissions are able to select a set of explanations and bulk approve/conditionally approve or deny them.

2797

Feature

39

When objects with related standards deviations explanations are deleted from a draft, the explanations remain but no hyperlink to the object is be shown in standards lists.

2593

Bug

34

When an object had been approved by a standards manager, the approval was reverted if a user added a comment to the approved object. This was corrected so that adding a comment does not change the compliance approval.

2596

Bug

34

Standards compliance approval requests were being sent to users with inactive accounts. This was corrected.

2329

Feature

27

"Match to" identifier for objects compared against library objects is now included in the ALS export.

2337

Bug

27

Dates in Standards Approvals lists did not sort correctly. This was corrected.

2314

Feature

26

When creating a Draft from a Library, custom functions referenced in Check Actions are now included in the objects copied over if the check is otherwise valid

2042

Bug

26

The fingerprint for a newly created All Forms or Merged Matrix was not correct. This has been fixed.

2264

Bug

23

When viewing Standards Deviation Approval Requests for the user an error is shown if the related Draft has been deleted. This was corrected.

2261

Bug

23

Cloning a Draft now also copies Standard Rules (if a library) and Rule Activations (if linked to a library).

1930

Feature

23

Folders are now included in Standards Compliance and will be compared against Library Folders.

2043

Bug

23

Removing a Folder/Form from a Matrix will now update the Matrix fingerprint.

2192

Bug

23

Empty Metadata values were included in object fingerprints leading to reported differences. This was corrected.

2154

Bug

22

When creating Drafts from a Library the unique fingerprints of Forms were not properly updated. This was corrected.

1422

Feature

21

The Compare view for Edit Checks will now match Check Actions by Action Type alone if there is only one Action of that Type in the Edit Check.

2144

Bug

21

Custom Function Standard Comparisons would overflow the compare dialog. This was corrected.

2044

Bug

21

When a DataDictionary, Unit Dictionary, Form or Folder was renamed any Forms/Fields which used these objects would not have their compliance to libraries recalculated. This was corrected.

2068

Bug

21

The "used by" list of Drafts which are linked to a Library Draft showed Drafts that were once using this library but which no longer are. This was corrected.

2073

Feature

21

QuickEdit is shown in the Compare view for Edit Checks and Derivations. This also means that Edit Checks and Derivations which are copied from a library but which are not yet valid will be shown as "Modified" since they are not exactly the same as the library (they are invalid)

2100

Bug

21

If a Draft is deleted it is hidden from view and removed after 30 days. If a Draft was linked to a standard library and then the standard library was updated (e.g. a Form in the Library was changed) then the compliance of the matching Form in the deleted/hidden draft was recalculated but this caused an error because the deleted draft "was not found". This was corrected.

2045

Bug

21

When adding a new value to a Custom Property in a Field, the fingerprint and compliance status of the parent Form was not recalculated. This was corrected.

139

Feature

19

Last updated date/times on Compare views were only being shown after a 30 second delay. This was corrected.

2039

Feature

19

A Library Draft is now shown as "in use" when it contains any object (e.g. a Form) which is being used as a Standards Source by an object in a study draft.

2041

Feature

19

When an object in a Draft that is linked to a Standard Library points to a different Library, this is shown in the Object listing with a "Standard Library" icon in the Compliance state.

2049

Feature

19

The performance of uploading ALS files has been improved.

2038

Feature

19

A daily background process will check that all objects' standard compliance status is up to date.

1926

Feature

19

In the compare view the change highlighting showed a red/green character-by-character difference. This was changed for Yes/No and other fixed-value attributes to make the difference easier to read. Deletions are now also shown in strikethrough text.

1927

Feature

19

Compare view did not show comparison lines where both values were empty. This was changed to show all attributes including empty ones.

1932

Feature

19

Users can now navigate from a Field in a Form compare to that Field in the Form editor by clicking on the Field OID in the compare list.

1824

Feature

17

When a Library Test Case is deleted, all objects that rely on it as their standard object for comparisons change to "Not Found".

1830

Bug

16

Changing the draft standard library did not change the library associated with draft objects, this was corrected.

1795

Bug

16

The "Entries can be removed" and "Entries can be added" checkboxes on Data Dictionaries in Standard Libraries were not being displayed if checked. This has been corrected.

1780

Feature

16

When comparing two objects such as Forms the comparison view will now include text to indicate if the only change is in the ordinal of child objects such as Fields.

1729

Feature

16

When using Standards Compliance compare it was possible to set the compare to be against an object in the library with a different OID or Name. However, standards compare would still show that the OID or Name was different. This was corrected.

1756

Bug

16

When saving a Project, Activity Records were created for all Project Custom Properties even if they were not changed. This was corrected.

1774

Bug

16

Copying Edit Checks with Custom Function actions where the Custom Function called other Custom Functions using 'PerformCustomFunction' caused an error. This has been corrected.

1749

Bug

16

If a Form is compared against a different library than the Draft default then the Form listing will not display (introduced by changes from #1728). This was corrected.

1728

Bug

16

Under some conditions the PDF Compliance Report could not be created. This was corrected.

1709

Bug

16

The Allowed Changes list in the Form Editor was not being displayed correctly. This has been corrected.

1711

Bug

16

When copying a Data Dictionary or Unit Dictionary from a Standard Library the Compliance state of the Data Dictionary or Unit Dictionary would stay "Not Found" until a change was made to force recalculation of compliance. This was fixed.

1475

Feature

16

Test cases now have Standards Compliance comparisons against libraries.

1677

Feature

16

Compliance status of objects is now recorded with the object to enable data reporting and for performance reasons. This means that the change of an object causes compliance calculation for that object to be immediately performed. When a Draft is switched to a new or different standard library a mass calculation for objects in that Draft must be performed.

1485

Feature

16

The Test Case list has Standards Compliance information so it can be filtered for objects which are different from the library, not found or modified.

1666

Feature

16

For Standards Compliance it is now possible to explicitly set an OID/Name to match on in the associated Library. For example, you can set a Form with OID "VITALS1" in a Draft to match against a Form with OID "VITALS" in a Library.

1684

Feature

16

For Standards Compliance it is now possible to set the library to match against in the sidebar of the object Editor. This allows users to control on an object-by-object basis which library it should be compared against (e.g. a Therapeutic Area library vs a Core Library)

1588

Feature

16

The Edit Check editor now shows Standards Compliance information in the sidebar.

1587

Feature

16

The Derivation editor now shows Standards Compliance information in the sidebar.

1586

Feature

16

The Custom Function editor now shows Standards Compliance information in the sidebar.

1682

Feature

16

When compliance is being recalculated for a Draft it is not be possible to change the Draft Standards Parent. This block is removed when compliance has been recalculated for the Draft. This block is removed after 5 minutes so that if the compliance recalculation fails it can be changed again.

1640

Feature

16

Test Cases now have database fingerprints which will be used to add Standards Compliance for Test Cases. No changes are visible to users yet.

1543

Bug

16

When a Draft has a Standard Library and you save a Form with no changes a record was added to show that the Form standard library was changed. This was corrected.

1214

Feature

16

Standards compliance summary and PDF now show which standard library was effective at the time of comparison.

733

Feature

14

If a Draft object (Form, Edit Check, Folder, Custom Function, Dictionary or Test Case) is copied from a Library or another Draft then the sidebar will contain informaton about which object and Draft it was copied from. Standards Compliance information is now displayed in the object sidebar. Note that Derivations cannot be copied yet - this will be added in a future release (issue #1428).

1350

Feature

14

ALS exports now include standard-library related properties for Forms, Fields, Data Dictionaries and Data Dictionary Entries. This allows standard library related metadata to be exported from one TrialGrid environment (e.g. beta) to another (production) via ALS export/import.

1218

Bug

14

The Standard Compliance dropdown was not fully visible for rows at the bottom of object lists. This was corrected.

1116

Feature

13

Performance of draft import was slow on the production site. This has been improved.

1118

Bug

13

Matrix fingerprints were being calculated incorrectly on draft import. This has been corrected. There is no user impact since we do not apply standard compliance to matrices.

913

Bug

9

The 'fingerprints' of Check Actions and Derivations were not being calculated correctly on import of an ALS spreadsheet, leading to incorrect standards compliance comparisons. This has been corrected.

890

Bug

7

It was not possible to delete a Draft from a standard library even if it was not in use and the user had the correct permissions. This was corrected.

814

Bug

7

When importing an ALS if there are duplicate CodedData values in Data Dictionaries or duplicate CodedUnit values in Unit Dictionaries then the duplicate will not be imported and a warning will be displayed. Note that CodedData and CodedUnit values are case-sensitive in Rave, ie. 'M' and 'm' are different and can both be included in a Dictionary.

765

Bug

6

After copying a Data or Unit Dictionary from a Library, the standards compliance status was incorrectly being shown as 'Modified'. This has been corrected and the copy will now 'Match' the Library version.

592

Bug

4

On adding a new Form to a Draft that is linked to a standard library (and does not exist in the Standard), the compliance summary showed that Fields may not be added or deleted. These directions were not meaningful and are no longer shown.

541

Feature

2

In a library draft under the Field properties / Standards Tab a user can now select which Field properties (if any) should be ignored for standards compliance. This allows properties like Pre Text (label) and View / Entry Restrictions to be allowed to be changed.

543

Feature

2

Form Editor Standards tab now has an option to allow the addition of new Fields without invalidating Standards Compliance.

563

Feature

2

Compare View for Form objects now shows when a Field has been added or removed and whether that addition or removal is allowed by the standard.

564

Feature

2

In a library draft under the Form properties / Standards Tab a user can now select which Form properties (if any) should be ignored for standards compliance. This allows properties like Help text and View / Entry Restrictions to be allowed to be changed in Forms that are linked to this standard Form.

565

Feature

2

Form and Field properties which are allowed change due to Standards settings now have an icon next to their Labels in the Draft Form which shows which Form and Field properties are allowed to be changed by the Standard.

367

Feature

1

Users with standards approval permission should be able to view listings of current requests and past requests

420

Feature

1

At the Project Level provide listings of Standards Approval Requests, Approvals

343

Feature

1

The Standard Library associated with a Form can now be changed to any Standard Library to which the user has access. This will override the Standard Library associated with the Draft.

242

Feature

1

Users will receive alerts when Standards Compliance actions are taken, for example a user with Manage Approvals permissions will receive an alert when a request for approval is made. Users with Request Approval permission will receive an alert when a request is approved or denied. The number of new alerts will be displayed in the top menu bar. Users may also receive emails when Standards Compliance actions are taken. Users can choose whether or not to receive email notifications in their user profile.

337

Bug

1

When viewing a Data Dictionary which is linked to a Data Dictionary in a Standards Library, the 'Standard Required' column will display 'Not in Standard' if the Coded Data or User Data String do not match the Library version.

227

Feature

1

If an Edit Check has been copied from a Standard Library which is not the main Standard Library for the CRF Draft, then the Edit Check will be compared against its source Standard Library. If and Edit Check has been copied from another CRF Draft then the Edit Check will be compared against the main Standard Library associated with its CRF Draft for Standards Compliance.

306

Bug

1

The 'fingerprint' of Check Steps (used during Standards Compliance) were not being updated correctly when an Edit Check was saved. This has been fixed.

307

Bug

1

The 'Explain' button in the Form editor was not working. This has been fixed.

308

Bug

1

The 'Explain' button in the Custom Functions list was not working. This has been fixed.

311

Bug

1

Standards Compliance filters were not working in the Custom Functions list. This has been fixed.

197

Feature

1

Allow Fields to be Required / Not Required for standards compliance (work for Data Dictionaries already done)

197

Feature

1

Add 'required' entry to library properties for dictionaries and fields. In this release the work was done for Data Dictionaries with Unit Dictionaries and Fields to follow in a later release.

234

Feature

1

Exclude CopySource, Needs Restesting and Retesting Reason from fingerprints. "Fingerprints" are a way of taking the properties of an object (Form, Folder etc) and creating a unique identifier (a "hash") from it. When you want to compare two objects and see if they are the same you can compare the fingerprints instead of looking at every property. This change removed CopySource, NeedsRetesting and RetestingReason properties from Objects so that a change in those values is not reflected in the fingerprints since it is not important for "changes" as far as a user is concerned.

186

Feature

1

When an object with a standards deviation explanation was deleted, the standards explanations list would not load with an error. This was was corrected.

2791

Feature

1

Standards compliance information is shown in all object listings when a Draft is linked to a Standard Library. The listings can be filtered by Compliance status (e.g. matched / modified from library / not found).

2792

Feature

1

Deviations from the standard (i.e. modified from standard or not found in standard library) can now be explained by users that have appropriate permissions and these explanations can be approved or denied by users assigned to the project with a role that has Manage Standards Approval permission.

2921

Feature

1

Standards compliance is now calculated for objects in the system.

2922

Feature

1

It is now possible to perform visual comparisons between a draft object and its library counterpart.