Diagnostic Catalog
This page lists the Diagnostics available, their purpose and settings. Diagnostics are divided into a number of categories.
Build Quality
TrialGrid recommends running on all studies and libraries
ID |
Name |
Description |
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0004 |
CheckBoxes all have format of 1 |
Ensure all Checkbox Fields have a format of 1. Fix will set format of Field to 1.
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0005 |
FormOIDs reserved by Windows / DOS |
Ensure that Form OIDs do not use Windows/DOS reserved words. See Reserved Words List in Rave
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0006 |
Field OIDs Reserved for Lab View Columns |
The Rave Lab View reserves some Field names, these should not be used as Field OIDs. See Reserved Words List in Rave
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0007 |
FormOIDs use only valid characters |
Ensure that FormOIDs are defined with only A-Z, 0-9 and \_ character
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0008 |
Field OIDs Reserved for Clinical View Header Columns |
Ensure Field OIDs do not use names reserved for Clinical View Header Columns. See Reserved Words List in Rave
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0009 |
Field OIDs Reserved By SQL |
Ensure Field OIDs do not use names reserved for SQL. See Reserved Words List in Rave
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0010 |
FieldOIDs use only valid characters |
Ensure that FieldOIDs are defined with only A-Z, 0-9 and \_ character
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0014 |
Labels do not have data entry Field settings |
Label Fields do not have data entry field settings (VisualVerify, SourceDocument, ReviewGroup, LowerRange, UpperRange, NCLowerRange, NCUpperRange)
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0016 |
Bypass during migration should be set |
These Edit Checks should not be run during migrations
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0017 |
Identify incomplete or invalid Edit Checks |
Rave allows incomplete or invalid Edit Checks to be created and saved. This Diagnostic identifies them.
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0020 |
Check text strings for possible spelling mistakes |
Compares all text in the Draft against a list of more than 4,000 commonly misspelled US English words and a comprehensive US-language dictionary including medical terms. Misspellings are highlighted and correct spelling suggested.
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0022 |
FormOIDs should not start with numbers |
Forms starting with numbers 123AE get turned into \_123AE in SAS extracts/CV names. Best practice is not to use OIDs starting with numbers.
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0026 |
Active Checks and Derivations should not reference inactive Forms or Fields |
Active Checks and Derivations that reference inactive Forms or Fields will not run and cannot be published to a Version in Architect. Fix will set Checks and Derivations Inactive.
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0027 |
Record Position should be set to 0 for Standard Fields in Edit Checks and Derivations |
Standard Fields should only be referenced with RecordPosition 0 in Check Steps, Check Actions and Derivation Steps. Referencing Standard Fields without setting RecordPosition = 0 in a Check or Derivation which also references Log Fields may lead to unexpected results. Note: Rave 2018.1.0 will not allow Edit Checks and Derivations to be created or saved without RecordPosition 0 for standard Fields.
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0031 |
Edit Check SYS_ prefix |
Rave reserves the SYS\_ prefix for Edit Checks that it creates for Field range checks and IsRequired. Rave will not export any Edit Check with the prefix SYS\_ to the Architect Loader Spreadsheet so it is best practice to avoid the SYS\_ prefix in user-defined Edit Checks.
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0032 |
QueryFutureDate should be set for Date and DateTime Fields |
Generally, date and datetime Fields should not allow future dates. Identifies Fields with ControlType set to Date or DateTime. This Diagnostic ignores Derived Fields. The Fix will set QueryFutureDate to True.
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0033 |
Numeric fields should have query non-conformance set |
Numeric Fields in Rave are represented as text Fields and users are able to enter values which do not match the format. If an entry is non-conformant then it should be queried.
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0034 |
Fields which require translation should not also be marked as required |
Fields which require translation should not also be marked as required. The Fix will set IsRequired to False.
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0039 |
All question Fields should have a pre-text label |
Question Fields should have a pre-text label describing their purpose.
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0046 |
Place Sticky Check Action should not contain HTML tags |
The message for a Place Sticky Check Action cannot contain HTML tags. Such tags will appear escaped in Rave (i.e. will not display as expected). This Diagnostic can identify and automatically remove HTML tags without changing the contained text.
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0047 |
Data Dictionaries should not have duplicate Coded Values or User Values |
Check that there are no duplicate Code or Decode values within a Data Dictionary.
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0049 |
Data format must be valid for Field control type |
Data format must be valid for Field control type.
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0050 |
Data format must be valid for associated Data Dictionary |
Data format of Field must be valid for the associated Data Dictionary. For example if the longest Coded Value in a Data Dictionary has 10 characters then the Field DataFormat should be at least $10. If a Field has a numeric DataFormat then Coded Values in the Data Dictionary should be able to fit into that Format.
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0052 |
Where SAS Format is set, it should be valid for the Rave Field Data Format |
If a Field has a SAS Format set then that format should be compatible with the Data Format of the Field. For example, Rave fields with Date formats such as "dd/mm/yyyy" should have a SAS Format set such as DTDATE9. or DATETIME22.3 a SAS Format of 1. would not be appropriate. Note that this Diagnostic does not determine if a SAS Date/Time format is appropriate for the display of time precision. Rave stores and outputs all date/times with both date and time parts - even if the Rave Data Format only contains time parts (e.g. hours, minutes and seconds)
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0053 |
Variables should have consistent properties |
A variable should have consistent properties across all Fields in which it is used, i.e. the same DataFormat, Data Dictionary (if set) and Unit Dictionary (if set)
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0055 |
Empty objects (Forms, Data Dictionaries, Unit Dictionaries, Custom Functions, Matrices) |
Empty objects may indicate an issue in the study build. Note that Fix will delete the unused object from the Draft.
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0056 |
Fields associated with Coder Dictionaries should have an OID of less than 20 characters length |
Fields associated with Coder Dictionaries should have an OID of less than 20 characters length.
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0057 |
Fields associated with Coder Dictionaries should have string formats |
Fields associated with Coder Dictionaries should have string formats. Associated Fields means Fields related to Coder Configuration, Coder Supplemental Term or Coder Component Term.
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0058 |
Check Actions should have a matching Check Step |
Check Actions should have a matching Check Step. Per Medidata: Check Actions should have a matching Check Step. When there is none available, Rave will not wildcard properly. This means that you may see previously submitted forms or log lines causing an edit to fire incorrectly on the current form or log line being submitted. By having a DataPoint in an action that is not referenced in one of the steps you run the risk of submitting all of the DataPoints in the step, but not the action if it is on a separate form.
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0061 |
Valid HTML tags |
Check that HTML tags used in Field strings and Folder Names are supported by Rave (b, i, u, li, ul, ol, sup, br, font, small, h1, h2, h3, h4, p, a). See HTML Tags in Rave Note that Rave will accept other HTML tags but the output of PDFs may be affected.
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0063 |
Variables targeted by Set DSL Actions are referenced by Check Steps |
Each unique Variable that appears in a Set Dynamic Search List Check action, must be referenced in the Check Steps of at least one Edit Check with a Set Dynamic Search List Check action against that Variable. If condition is not met then the Draft cannot be published and a warning "An invalid Edit Check setup was detected for the Dynamic SearchList field" is shown. |
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0064 |
Edit Check Coded Value steps should be compared against valid Data Dictionary Entries |
Edit Check Coded Value steps should be compared against valid Data Dictionary Entries
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0065 |
Fields which are not Date or Time Fields should not have date related properties set |
Fields which are not Date or Time Fields should not have date related properties set, i.e. should not have QueryFutureDate, CanSetRecordDate, CanSetDataPageDate, CanSetInstanceDate or CanSetSubjectDate set to True (checked)
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0066 |
Checkbox Fields should not have an IsEmpty or IsNotEmpty step in Edit Checks |
Checkbox Fields should not have an IsEmpty or IsNotEmpty step in Edit Checks
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0067 |
Forms should have unique names |
Forms should have unique names
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0068 |
Date Fields should have at least one check associated with them |
Date Fields (Date/Time fields with a Year component) which are Visible and Active and appear on an active Form should have at least one Edit Check that creates a query on them. Dates with no Query Actions may not be adequately checked. Derived Fields are excluded from the Diagnostic results. This Diagnostic ensures VariableOID only Checks are identified as well as Checks specific to a Form/Field combination. Note that this Diagnostic \*does not\* search Custom Functions for Query Actions and it ignores Field-level settings such as QueryFutureDate.
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0069 |
Identify Forms not included in a Matrix or in an AddForm Check Action |
Forms may be added via inclusion in a Matrix or via an AddForm Check Action on an Active Check. This Diagnostic identifies Forms which are not added to the study via either method i.e. It identifies Forms which are not used. This Diagnostic will indicate if a Form might be added via a Custom Function.
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0070 |
Check text strings for non-ASCII characters |
Checks the draft for instances of non-ASCII characters which may render poorly in PDF copies of CRFs.
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0071 |
Find Required Fields which are View/Entry Restricted from Site Users |
Checks Draft for Fields which are View or Entry Restricted at the Field or Form level for EDC Site Roles.
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0072 |
Find duplicate edit checks |
Checks the draft for duplicate Edit Checks, and optionally Edit Checks which have the same logic or actions but not both the same. When Edit Checks have the same logic but different actions, you may wish to consolidate them into a single Check.
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0073 |
Dictionary Field default values |
When a Field is related to a Dictionary, any default value(s) set for that Field should be found in the Dictionary. Note that for log field defaults Rave will stop adding default log lines as soon as it reaches a value that is not in the dictionary. So if an invalid value is found in the |middle|of|a|list then the invalid value and all the values after it will not be created even if the ones after are valid.
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0076 |
Non-Zero Recordposition for Log Fields in Edit Checks and Derivations |
Log Fields should never be referenced with RecordPosition 0 in Check and Derivation Steps and in Check Actions. Unlike Standard Fields which have "shadow values" copied to all Log Records, Log Fields have no valid value on the Record with RecordPosition 0.
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0078 |
Data Status should not be used in Edit Check steps |
Rave Architect has a Data Value of 'Data Status' which can be selected when creating Edit Checks steps but is: 'not currently in use' according to Medidata documentation. The Fix will change 'Data Status' to 'DataPoint'.
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0080 |
Medical Coded Fields may not have Data or Unit Dictionaries or Lab Analytes associated with them |
Fields which will be Coded cannot have values which come from Dictionaries or Labs. This Diagnostic checks only the information from the Fields tab of the Architect Loader Spreadsheet (ALS). It does not look at data from the CoderConfiguration, CoderSupplementalTerms or CoderComponentTerms tabs of the ALS. See Diagnostic 0057 for checks on that data.
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0081 |
Check text strings for trailing whitespace |
Whitespace (spaces, tabs t, carriage returns r, line-feeds r and printer form-feeds f) at the end of text strings are generally unwanted and can affect the display of questions and other output in PDFs Note that fix will remove whitespace characters at the end of the text. This diagnostic checks: Draft Confirmation message and Signature Prompt; Draft Form Name and Help Text in Forms; Pre Text, Header Text, Draft Field Number and Help Text in Fields; Matrix Names; Data Dictionary and Unit Dictionary Names and Unit Strings; Edit Check steps static values and Actions; Custom Function Names; Body and Subject of email alerts
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0082 |
Medical Coded Fields must have a text format |
Fields which will be Coded must have a text ($) format. See also Diagnostic 0057 for checks on Coder related Fields.
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0085 |
Check Appropriateness of Form-level SignatureRequired = No setting |
Checks the appropriateness of Signature Required setting for Forms where Signature Required=No (unchecked) but at least one Field Participates in Signature (at least one Field has DoesNotParticipateInSignature unchecked). Where Form Signature Required=No but there are fields which Participate In Signature then the Fields may not be able to be locked because they have not been signed.
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0086 |
Static Value Check Step Length |
Checks that Static Values in Check Steps have appropriate length set. e.g. a value of "MALE" with a format of $2 is compared as "MA". Only $ format Static Values are checked by this Diagnostic. Fix will set the format for the Static Value to ${length of value}
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0087 |
Check Appropriateness of Form-level SignatureRequired = Yes setting |
Checks the appropriateness of Signature Required setting for Forms where Signature Required=Yes (checked) but no Fields Participate in Signature (all Fields have DoesNotParticipateInSignature unchecked). Where Form Signature Required=Yes but there are no fields which Participate In Signature then there is nothing to sign.
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0088 |
Data entry Fields should Participate in Signature |
Checks that Fields entered by data entry users participate in Signature. A Field is considered a data entry field if: \* it is not a Derived Field \* AND it is not View Restricted to ALL of the data entry roles (i.e. all these users can see the data) \* AND it is not Entry Restricted to ALL of the data entry roles (i.e. all these users can enter the data) Fix will set this field DoesNotParticipatesInSignature=False (i.e. Does participate in signature)
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0089 |
Data entry Fields should Require Source Document Verification |
Checks that Fields entered by data entry users require Source Document Verification. A Field is considered a data entry field if: \* it is not a Derived Field \* AND it is not View Restricted to ALL of the data entry roles (i.e. all these users can see the data) \* AND it is not Entry Restricted to ALL of the data entry roles (i.e. all these users can enter the data) Fix will set this field Requires Source Document Verification=True
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0090 |
Data entry Fields should be Visible |
Checks that Fields entered by data entry users are Visible. A Field is considered a data entry field if: \* it is not a Derived Field \* AND it is not View Restricted to ALL of the data entry roles (i.e. all these users can see the data) \* AND it is not Entry Restricted to ALL of the data entry roles (i.e. all these users can enter the data) Fix will set this field Visible=True
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0091 |
Non-Data entry Fields should not Participate in Signature |
Checks that Fields which cannot be entered by data entry users do not participate in signature. A Field should not break or require signature if it cannot be seen or entered by a data-entry user. A Field is considered a non-data entry field if: \* it is a Derived Field \* OR it is View Restricted to ALL of the data entry roles (i.e. none of these users can see the data) \* OR it is Entry Restricted to ALL of the data entry roles (i.e. nobody can enter the data) Fix will set this field DoesNotParticipatesInSignature=True (i.e. Does not participate in signature)
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0092 |
Non-Data entry Fields should not Require Source Document Verification |
Checks that Fields which cannot be entered by data entry users do not need to be Verified. A Field should not require Source Document verification if it cannot be seen or entered by any data-entry user. A Field is considered a non-data entry field if: \* it is a Derived Field \* OR it is View Restricted to ALL of the data entry roles (i.e. none of these users can see the data) \* OR it is Entry Restricted to ALL of the data entry roles (i.e. none of these users can enter the data) Fix will set this field Requires Source Document Verification=False (i.e. Does not require Source Document Verification)
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0093 |
Non-Data entry Fields should not be Required |
Checks that Fields which cannot be entered by data entry users are not Required. A Field should not be Required if it cannot be seen or entered by any data-entry user. A Field is considered a non-data entry field if: \* it is a Derived Field \* OR it is View Restricted to ALL of the data entry roles (i.e. none of these users can see the data) \* OR it is Entry Restricted to ALL of the data entry roles (i.e. none of these users can enter the data) Fix will set this field Required=False (i.e. is not Required)
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0094 |
Non-Data entry Fields should not have Edit Check Query Actions |
Checks that Fields which cannot be entered by data entry users should not have Edit Check queries raised on them since the data entry users will not be able to change data values in response. A Field is considered a non-data entry field if: \* it is a Derived Field \* OR it is View Restricted to ALL of the data entry roles (i.e. none of these users can see the data) \* OR it is Entry Restricted to ALL of the data entry roles (i.e. none of these users can enter the data)
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0095 |
Lab Analyte Names should be unique within a form |
Lab Anaylte Names should be unique within a Form, there should not be more than one Field on a Form with the same Analyte Name. |
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0099 |
Repeat Numbers in Check Steps and Actions with no OID |
Rave allows Check Steps, Check Actions and Derivation Steps to have a Folder or Form repeat number but without entering a Folder or Form OID. Setting up a Step or Action this way may be a mistake of the editing process and not intended. This Diagnostic finds Check Steps and Actions with Folder or Form repeats and missing identifier OIDs. |
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0101 |
Static values in Check and Derivation Steps should be valid |
Rave does not perform checks on Static Values entered in Check and Derivation steps. This Diagnostic checks Static Value formats and values for correctness.
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0102 |
Check that URLs in text strings are valid |
Finds URLs in text strings and checks if the URLs can be reached, i.e. that the URL address is correct
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0103 |
Default value of =NOW should only be used with Date/Time fields |
Checking the "Use Current Date Time" checkbox sets the default value for the field to =NOW. Setting this value for any field type other than date/time types will cause Subject PDF generation to fail. This Diagnostic ignores Inactive Fields and Fields on Inactive Forms. Fix will remove this default value. |
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0104 |
Verify Form Help Text matches link to help resource |
Form help text that starts with %% (two percent signs) is treated by Rave as a hyperlink to a help resource document. Instead of opening a pop-up page with this help content, Rave navigates the current page to this help web page or resource (e.g. a PDF document). Resources may be hosted as part of the Rave URL by arrangement with Medidata or on any other accessible web server. If you use hosted help resources, this diagnostic will check that Form help is set to reference this global resource.
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0105 |
Verify Form is not set for Double Data Entry (DDE) |
The Double Data Entry (DDE) features of Medidata Rave are not frequently used and some organizations never use these features. This diagnostic identifies Forms where DDE is not set to "Never". The fix will change the Form DDE setting to "Never".
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0106 |
IsTemplate is set to False for all Forms |
If you do not wish to use Template Forms in your study this Diagnostic can be used to enforce that Forms are not set to be Template Forms.
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0107 |
Verify that a Matrix designed to contain all forms does contain all Forms. |
An All Forms Matrix is often used in conjunction with the Medidata Rave PDF generator to create PDFs of Forms for review. All Forms are listed as part of the SUBJECT folder. As new Forms are added to the study this Matrix must be updated. This Diagnostic checks that the identified all forms Matrix contains all Forms defined in the draft in the SUBJECT Folder. The Fix will add missing Forms.
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0108 |
Verify that PDF/All Visits Matrix is a superset of all other Matrices |
A PDF/All Visits Matrix is often used to show the complete set of Folder/Form combinations possible in a study. This Diagnostic checks that the named Matrix contains all Folder/Forms from the other Matrices in the study. The Fix will add missing Forms / Folder combinations and will remove Folder / Form combinations which do not exist in other Matrices.
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0124 |
Checkbox Fields should not have Default Values |
If a Checkbox Field has a Default Value then pdf generation will fail. Fix will remove the Default Value.
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0125 |
Edit Check Open Query Actions which Require Response must also have Require Manual Close |
When an Edit Check Open Query Action is set to Require Response it must also have Required Manual Close set. Fix will set Require Manual Close = True. This Diagnostic ignores inactive and invalid Edit Checks. |
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0126 |
Edit Check Open Query Actions must have Require Response and Require Manual Close set to True |
Use this Diagnostic if your organization has a standard of requiring both Response and Manual Close of Queries. This Diagnostic ignores inactive and invalid Edit Checks. Fix will set Open Query Check Action to RequiresResponse and Requires Manual Close
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0129 |
Find Fields which are enterable by Site Users and do not have a missing data check |
Checks Draft for Fields which can be entered by Site users and which do not have a Field level Required check or an Edit Check which opens a Query and has an 'IsEmpty' check step on the Field. The fix will set the Field level Required property. Derived Fields, Label Fields, Checkbox Fields, inactive Fields, Fields on inactive Forms and Fields with a Data Dictionary with 0 or 1 values are not included.
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0142 |
Pipe delimiters should not appear in non-log default values |
Pipe delimiters in standard fields may prevent data being saved to the form after a migration.
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0164 |
Ensure that log fields with default values have the full list of values from the data dictionary |
Designed to be used where you have a Log Field that has default values set to all the entries of a Data Dictionary in Entry Ordinal order with a closing | to prevent further entries. Typically used for Inclusion/Exclusion criteria or lab tests where log lines are used to record both the data and the question identifier from the Data Dictionary.
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0165 |
Check text strings for unbalanced quotes |
Finds unbalanced quotation marks in text strings, excluding contractions, e.g. subject's. Double-quote marks will be higlighted in yellow. Single quote marks will be highlighted in blue. Other unicode quote marks (smart quotes, etc) will be highlighted in red, and are not included in working out whether quotation marks are balanced. This diagnostic checks: Draft Confirmation message and Signature Prompt; Help Text in Forms; Pre Text and Help Text in Fields; Data Dictionary strings; Edit Check Actions strings (including query messages); Subject of email alerts |
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0166 |
Find Edit Check query actions which do not use the standard Marking Group |
Finds Edit Check query actions which use a Marking Group different from the standard Marking Group specified in the diagnostic configuration. Autofix will set the marking group to the standard one.
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0167 |
Find Log Forms which have Lab Analyte Fields |
Log Forms which have Lab Analyte Fields can cause slow performance in Rave because the lab range calculation will be repeated for each log record.
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Rave EDC (RaveX)
TrialGrid recommends running on studies and libraries which will be used with Rave EDC (RaveX), and as a Diagnostic to assess the impact of upgrading existing studies and libraries
ID |
Name |
Description |
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0059 |
Custom Functions used in Rave EDC (RaveX) should not use blacklisted methods |
Blacklisted methods will not work in future versions of Rave, including Rave EDC (RaveX). This Diagnostic uses a simple string search to identify these method and so may flag false positives where the method has been already commented out.
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0060 |
IsPresent Check Action |
Rave 2016.4 introduced the IsPresent Check Action which is used to verify if a data point was submitted. Previously an 'always true' Custom Function Check Action was required. The IsPresent Check Action MUST be used for Rave EDC (RaveX) studies. This Diagnostic will find Custom Functions where the only C# code is 'return true;'. The Fix will replace the Custom Function Check Action with an IsPresent Check Action
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0074 |
Rave EDC (RaveX) Supports only "NoLink" Form Redirect |
Rave EDC (RaveX) does not support Form Redirect of Link Next or Link Custom. This Diagnostic identifies Forms which cannot be published to a Rave EDC (RaveX) study due to invalid Form Redirect. Fix sets the Redirect of the Form to "No Link".
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0077 |
Rave EDC (RaveX) does not support the File Upload control |
Rave EDC (RaveX) does not support the File Upload control. Drafts with Fields using this control cannot be published for Rave EDC (RaveX). |
Naming
Diagnostics to check compliance with naming conventions
ID |
Name |
Description |
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0013 |
Labels should have a consistent naming prefix or suffix |
Label Fields are named according to naming convention starting with a prefix (e.g. LBL\_) or a suffix ( e.g. \_LBL). Denoting Label fields with a naming convention makes the purpose of label fields clearer. A value should be provided either for the prefix or the suffix, if both are present then both are applied i.e. the Field would have to be named [prefix\_]label[\_suffix]. If neither are present then no check is performed.
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0023 |
Date Fields should have a consistent naming suffix or prefix |
Ensures that Fields with a ControlType of DateTime which are full or partial dates (i.e. with no time component) are named according to naming convention. The convention may enforce ending with a suffix (default DAT for compliance with CDASH), containing characters (e.g. must contain "DT") or must have a prefix. Leave the suffix/prefix/contains settings empty to ignore that rule. Note that if the Field OID is the same as the Variable OID then changing the Field OID also changes the Variable OID. If the Field and Variable OIDs were different before the change they are not made the same.
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0024 |
Time Fields should have a consistent naming suffix |
Time Fields are named according to naming convention ending with a suffix (default TIM for compliance with CDASH)
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0025 |
Date/Time Fields should have a consistent naming suffix |
Date/Time Fields are named according to naming convention ending with a suffix (default DTC for compliance with CDASH)
|
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0048 |
Derived Fields should have a standard prefix |
When a Field is calculated by a Derivation there is no way to tell that this is the case from the Field. It is good practice to have a unique prefix (default DER\_) to identify these Fields in the Architect Form editor.
|
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0075 |
Enforce Data Dictionary naming convention |
This Diagnostics allows a naming convention for Data Dictionaries to be enforced by using a regular expression that the Dictionary Name must match.
|
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0096 |
VariableOID should match FieldOID |
Rave does not require that Fields have matching VariableOID and FieldOID properties. However, some organizations enforce this.
|
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0098 |
Maximum SAS Label Length |
Rave allows SAS Labels to be up to 256 characters but some organizations have stricter limits. This diagnostic will find SAS Labels greater than the length specified.
|
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0128 |
FieldOID should match FieldName |
Rave does not require that Fields have matching FieldOID and FieldName properties. However, some organizations enforce this. Fix will set FieldName to be the same as FieldOID.
|
Best Practice
Diagnostics to check conformance with guidelines and best practices
ID |
Name |
Description |
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---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
0001 |
Text/LongText Field Length |
Compare Text and LongText Fields against a length threshold value. Fields with lengths below the threshold should be Text Fields, those equal or above the threshold should be LongText. Note: Fix will reset the control type of the Field to Text or LongText as appropriate.
|
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0002 |
Text Fields Length Limit |
Check that all text format Fields are less than a threshold length
|
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0003 |
Field OID Length Limit |
Check that all Field OIDs are less than a threshold length
|
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0011 |
Fields using the same Data Dictionary have identical format |
Ensure that all Fields referencing a Data Dictionary use the same format
|
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0012 |
Fields using the same Unit Dictionary have identical format |
Ensure that all Fields referencing a Unit Dictionary use the same format
|
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0015 |
Dictionary Fields are of appropriate display type |
Ensure that Dictionary Fields use appropriate RadioButton vs DropDownList vs SearchList. For example, it is considered good practice when a Dictionary has only a few options to use a horizontal radio-button group. For longer Dictionaries a set of vertical radiobuttons or a DropDownList may be more appropriate.
|
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0028 |
Data Dictionary CodedData should not contain double backslash. |
Prior to Rave 2018.1.0 commas (,) and semicolons (;) in Data Dictionary Coded Fields are not permitted since Rave uses these to indicate specify values on Data Dictionaries which use the specify feature. From Rave 2018.1.0 onward commas and semicolons are permitted but double backslash (\) is no longer permitted.
|
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0030 |
Custom Function length |
Custom Functions cannot be longer than 8000 characters. Custom Functions approaching that limit may be difficult to change in future. Note that each line break counts as 2 characters in Rave.
|
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0035 |
Data entry Fields should have a SAS Label |
Data entry fields should have a SAS label set. If a SAS label is not set it will default to the Field Name.
|
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0036 |
Fields with default values should not have SDV set |
When a Field has a default value, it should not require Source Document Verification (SDV). Fix will remove SDV setting.
|
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0037 |
Fields with default values should not be set as Required |
When a Field has a default value it should not be set as a required. Ignores inactive and invisible fields and fields on inactive forms. Field.
|
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0038 |
Checkbox, Data Dictionary and Time Fields should not be set to Query for Non-Conformance |
Checkboxes cannot have data entered which is non-conformant so setting this attribute has no meaning. Data Dictionary Fields can only be non-conformant if the Specify option is set on a Data Dictionary Entry. This Diagnostic flags Fields which use Data Dictionaries which do not have a Specify option set.
|
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0041 |
Data Dictionaries should not have a coded value of 0 (Zero) |
Best practice is not to have a coded value of 0 (Zero) in a Data Dictionary. Fields which use a Data Dictionary with a 0 value will need to have IsNotEmpty checked with an Edit Check because Rave treats a 0 value as no data/not done (i.e. when no data is entered CodedValue = 0). The Fix action for this Diagnostic is to prompt the user for a new Coded Value for the Data Dictionary Entry with Coded Value of 0. Note that the Fix does NOT identify or change Edit Checks which compare against this value.
|
||||||||||||||||||||||||||||||||||||||||||||
0042 |
Consider setting QueryNonConformance for Fields related to Data Dictionaries with a Specify option |
When a Data Dictionary has a Specify option the user may enter non-conformant data in the specify field. Consider setting QueryNonConformance check for these Fields.
|
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0043 |
Data Dictionaries should be unique |
Check that there are no duplicate Data Dictionaries. A duplicate is the same Coded and User Values / Specify options regardless of ordering of the entries.
|
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0051 |
Fields should have a SAS Format specified |
Fields should have a SAS Format specified.
|
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0054 |
Unused objects (Data Dictionaries, Unit Dictionaries, Custom Functions) |
Unused objects may indicate an issue in the study build. The Diagnostic message will indicate if a Custom Function is called by another Custom Function. NOTE: Fixing this result will delete the unused object.
|
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0062 |
Default values in Log Fields in a Form are consistent |
Rave allows Log Fields to have default values specified. This has the effect of automatically creating log line records with those default values entered. e.g. a default value of A|B|C will cause 3 log lines to be created, one for each value in this Field. The default delimiter is the | symbol. If this symbol appears at the end of a value list e.g. A|B|C| then the effect is to prevent further log lines from being added by the user. This Diagnostic detects the situation where one log fields entries clash with another. e.g. If default value for Field1 is A|B| and for Field2 is C|D|E then Rave will adopt the shortest list (A|B|) and the log line E for Field2 will not be created.
|
||||||||||||||||||||||||||||||||||||||||||||
0097 |
Fields of ControlType Signature should not be used |
Since Rave 2015.1.0 loading an ALS or publishing a Draft containing Fields with control type Signature causes a warning. Medidata Recommends using Form level signatures instead. |
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0100 |
Clinical views can have a maximum of 144 Fields |
Clinical Views are constructed one View per Form. A maximum of 144 Fields can be included in a Clinical View across all published Versions. Label fields are not counted. Inactivated and Deleted fields count toward this number if they are active in an expecting published version. Fields after the 144th Field in a Form are NOT INCLUDED in Clinical Views. This diagnostic identifies Forms which have more Fields than the threshold. Forms which are close to the 144 Field limit should be carefully managed to avoid going over the limit.
|
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0109 |
Fields should NOT have a SAS Format specified |
Fields should NOT have a SAS Format specified. This allows SAS On Demand to choose an appropriate SAS Format which is generally what you want. This Diagnostic is the opposite of Diagnostic 51. Use when you do not wish fields to have SAS Formats specified. This Diagnostic excludes Inactive Fields and Fields on Inactive Forms.
|
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0110 |
ePRO Forms should not require signature |
ePRO Forms should not be set to Signature Required. Fix will remove Requires Signature setting.
|
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0111 |
Ensure a set of Custom Functions exist in a Draft |
This Diagnostic checks that a set of named Custom Functions, or at least 1 Custom Function matching a pattern, exists in the Draft. Multiple Custom Function names/patterns to find may be entered.
|
||||||||||||||||||||||||||||||||||||||||||||
0112 |
Variables which are targets of Set Dynamic Search List Check Actions should have a Control Type of DynamicSearchList. |
Rave Architect will allow some Variables which are targeted by a Set Dynamic Search List Check Action to have a Control Type other than DynamicSearchList. Fix will make the ControlType of the Field DynamicSearchList. This Diagnostic ignores Inactive Checks. |
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0113 |
Primary Form may not have DynamicSearchList controls. |
A Primary Form which has Fields with ControlType set to DynamicSearchList cannot be published. This Diagnostic detects DynamicSearchList controls on the Primary Form. |
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0114 |
Forms should have Confirm Save set. |
Rave has 4 settings for Save Confirmation - No Confirmation (Save Confirm checkbox unchecked), No Link, Link Next and Link Custom. This Diagnostic checks that it is not set to "No Confirmation". To Enforce a particular Confirmation Style see Diagnostic 74. To enforce that the Save Confirm checkbox is unchecked (No Confirmation) see Diagnostic 176.
|
||||||||||||||||||||||||||||||||||||||||||||
0115 |
Ensure specific Forms/Folder/Matrix combinations exist |
This Diagnostic checks that specific Form/Folder combinations exist in either specific Matrices or in Any Matrix. If a combination exists but the Form is inactive then a warning is given.
|
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0116 |
Ensure specific Forms/Fields have Set Folder Observation Date checked in order to support studies which use the Subject Calendar |
This Diagnostic checks that specific Form OID/Field OID combinations have Set Folder Observation Date set. If a combination exists but the Form or Field is inactive or the Field is not a Date then a warning is given. Fix will set the "Set Folder Observation Date" flag to True.
|
||||||||||||||||||||||||||||||||||||||||||||
0117 |
Check the name of the Primary Form |
This Diagnostic checks that the Primary Form for the Draft has a specific name or matches a specific pattern (e.g. contains the word "Subject")
|
||||||||||||||||||||||||||||||||||||||||||||
0118 |
Check Draft Confirmation Message and Signature Prompts match expected text |
This Diagnostic checks that the Save Confirmation Message and Signature Prompt text for the Draft exactly match the values provided. This allows organizations to ensure that their legal wording is being reproduced precisely in study designs.
|
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0119 |
Fields of ControlType CheckBox should not be used except on a specific set of Forms or Fields |
Some organizations do not use CheckBox controls except in specific circumstances. Checkboxes have a value of Checked (1) or Unchecked (0) which makes it impossible to know if a user deliberately chose not to check a box or overlooked the question.
|
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0120 |
No Form should have an OID starting with ECOA or EPRO |
Prefixing a Form OID with ECOA or EPRO will force the Form to appear in the ePRO application regardless of any other settings. Use the Patient Cloud Form setting instead. This diagnostic is only applicable to studies using Medidata Patient Cloud.
|
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0121 |
Fields on ePRO Forms should use only supported Control Types |
Fields on ePRO forms should use only Control Types supported by Patient Cloud. These are: Checkbox DateTime DropDownList LongText RadioButton RadioButton (Vertical) Text Other control types may cause unexpected results with the device. Note that ePRO forms are those with a FormOID prefix of ECOA or EPRO and/or the Patient Cloud Setting.
|
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0122 |
DateTime Fields on ePRO Forms should use only supported Data Formats |
ePRO does not support seconds (ss) in data formats, partial dates (dd- MMM- yyyy), or dashes (-) in Date Formats. Dates should only be specified in Day / Month / Year format (dd MMM yyyy or dd/MMM/yyyy) since other formats are only supported in Rave EDC not in ePRO.
|
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0123 |
Fields on ePRO Forms do not support Default Values, Unit Dictionaries and Dictionaries with Specify Options |
ePRO does not support Default Value, Unit Dictionary selection or Data Dictionaries with a Specify option set. These should not be used since they do not display in the ePRO app as defined.
|
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0127 |
Fields should not have SDV set |
This Diagnostic is appropriate where SDV will not be used in a study or where SDV is set only with Targeted SDV (TSDV) and no base set of fields is marked for SDV. Fix will remove the SDV flag from Fields. Inactive Fields and Fields on inactive Forms are ignored.
|
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0130 |
Analyte Fields should have Clinical Significance set |
Fields which have an Analyte Name should also have Prompt for Clinical Significance set. Note: Fix will set Prompt for Clinical Significance = True. See Diagnostic 171 for a version of this diagnostic which checks that Prompt for Clinical Significance is NOT set for Analyte fields.
|
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0131 |
Rave Project Names length and characters |
Project Names in Rave should not be longer than 30 characters and should not include special characters, otherwise the Rave Project might not be accessible from J-Review or Business Objects. See Creating Projects in Rave
|
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0132 |
Forms and Fields should not be View or Entry restricted to certain EDC Roles |
Forms and Fields should not be View or Entry restricted to certain EDC Roles
|
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0133 |
Forms and Fields should not be View restricted to certain EDC Roles |
Forms and Fields should not be View restricted to certain EDC Roles. Entry restrictions are allowed.
|
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0134 |
Text Fields with format of 200 or more characters should have query non-conformance set |
If a Text Field has a format of 200 or more characters, if data longer than the format is entered then Rave will truncate the data, and so query non-conformance should be set
|
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0135 |
Forms should not be set to EPRO |
EPRO Forms should not be set
|
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0136 |
Fields should not use more than the maximum number of Review Groups |
Fields should not use more than the maximum number of Review Groups, otherwise the Rave Core Configuration will need to be changed.
|
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0137 |
Edit Checks should not use more than the maximum number of Marking Groups |
Edit Checks should not use more than the maximum number of Marking Groups, otherwise the Rave Core Configuration will need to be changed.
|
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0138 |
Fields OIDs should not start with a number |
Fields OIDs should not start with a number
|
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0139 |
Forms with Lab Analyte fields should have a Field to set the Observation (record or datapage) date |
Forms with Lab Analyte fields should have a Field to set the Observation (record or datapage) date
|
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0140 |
Standard Fields should be before Log Fields |
Standard Fields should be before Log Fields. Derived Fields and Labels are excluded from findings.
|
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0141 |
Inactive Forms |
Inactive Forms. Fix will delete the Form.
|
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0143 |
Data Dictionary Entries should not have Specify set |
If "Other, Specify" is needed create separate field to capture the "Specify" information. The built in "Specify" capability should not be used because it can lead to data truncation if the "other" value entered is long. Note that the fix will set Specify = False
|
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0144 |
Data Dictionary Entries should not have HTML tags or <string> content |
Do not use HTML tags or "<string>" in dictionaries because this causes inability to render eCRF within Rave EDC and PDF Generator module. Note that fix will remove all tags
|
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0145 |
Form Names should not contain words greater than 25 characters in length |
A single word within FormName should not exceed 25 characters to ensure it correctly displays in Rave. This is for Classic Rave only.
|
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0146 |
Matrices should not have overlapping Folder/Form combinations |
When a Folder/Form combination is included in more than one Matrix the Form may be merged by one Matrix and unmerged by another.
|
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0147 |
Identify Folder/Form combinations included in a Matrix and in an AddForm Check Action |
When a Folder/Form combination is included in a Matrix and an AddForm Check Action, it may be merged by the Matrix and removed by the Check Action, or vice versa. Wilcard Folders in Check Actions are excluded.
|
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0148 |
Identify Matrices which are added or merged by more than one Check Action |
When more than one edit check can merge the same matrix there exists a risk that a matrix can be merged by one edit check that passes and unmerged by an edit check that fails.
|
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0149 |
Identify Checks which have more than one Add or Merge Matrix Check Actions |
Having AddMatrix and MergeMatrix actions in the same edit check risks matrix replication during migrations.
|
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0150 |
Identify Checks which have an Add or Merge Matrix Check Action on a Log Field |
If the site inactivates any of the loglines or changes the condition of the edit to be false the matrix added by the edit will be removed. This can cause folders/forms to be removed incorrectly because of data being entered or loglines being inactivated. Instead use a custom function to determine if any of the log lines meet the condition, not just the one submitted.
|
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0151 |
Overlapping Add Form Edit Checks |
There should be no "overlapping/clashing" AddForm Check Actions. Checks if a form is being added to the same folder (or wildcarded) via multiple Edit Checks.
|
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0152 |
Approved Data Formats for Date and Time Fields |
Data Formats for Date and Time Fields should conform to one of the formats specified in this diagnostic
|
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0153 |
Matrices with Allow Add set and no Maximum specified |
Matrices which have Allow Add set should also have a Maximum specified
|
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0154 |
Checkbox Fields should not have IsRequired set |
Checkbox Fields should not have IsRequired set
|
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0155 |
ePRO controls have valid settings |
ePRO controls should be configured correctly. The list of rules this diagnostic applies can be found here
|
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0156 |
ePRO Forms should be configured correctly. |
ePRO Forms should be configured correctly. This linter checks that ePRO Forms have: \* One Timestamp control \* One or zero Form Settings controls \* Text format Fields have a maximum length of 254 \* The Form has View and/or Entry restrictions \* Fields on Anytime Enabled ePRO Forms should be Log Fields (excluding Form Availability, Calendar and NoCloudDisplay controls) \* Old controls ("Pre 2016/7") should not be used
|
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0157 |
All Visible=False fields should have an edit check that makes them visible. |
This Diagnostic ignores inactive Fields and Fields on inactive Forms. If a Field is set to be invisible then there should be an Active Edit Check which sets this Field or Variable to Visible with a SetDataPointVisible (TRUE) Check Action. If there is no Check Action this Diagnostic tries to identify Custom Functions that reference the Field or Variable and modify IsVisible attributes but this is not 100% reliable.
|
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0158 |
Inactive Derivations |
Inactive Derivations. Fix will delete the Derivation.
|
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0159 |
Inactive Checks |
Inactive Checks. Fix will delete the Check.
|
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0160 |
Inactive Fields |
Inactive Fields. Fix will delete the Field.
|
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0161 |
Static values in Check Steps cannot be longer than 50 characters |
If the number of characters in a Static Value in a Check Step exceeds 50 characters then Rave Architect will show an error, regardless of the DataFormat. |
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0162 |
Static values in Derivation Steps cannot be longer than 256 characters |
If the number of characters in a Static Value in a Derivation Step exceeds 256 characters then Rave Architect will show an error, regardless of the DataFormat. |
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0163 |
Defaulted Fields should be Entry Restricted to a set of EDC Roles |
When a Field is defaulted it should be Entry Restricted to all Roles in this set of EDC Roles - either by Form Entry Restriction or Field Entry Restriction or a combination of the two. If no Roles are selected then this Diagnostic does nothing.
|
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0168 |
Limit the number of fields on a form |
Medidata best practice is to have less than 60 fields on a Form to reduce user scrolling and the number of possible edit checks on a form which could impact performance. See Medidata online help.
|
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0169 |
Fields which have lab analytes assigned should have a numeric format |
Typically analyte fields have a set format unless they are related to dictionary fields. If the format is too short then entered data will be non-conformant. If data formats are set as text then ranges cannot work. Note that this diagnostic ignores fields with an associated Data Dictionary.
|
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0170 |
Find placeholders in Field PreText Values |
It is common to include placeholder text in Field PreTexts which should be substituted in a study. This diagnostic helps you find Fields with those placeholder values
|
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0171 |
Analyte Fields should have Clinical Significance set |
Fields which have an Analyte Name should NOT have Prompt for Clinical Significance set. Note: Fix will set Prompt for Clinical Significance = False. See Diagnostic 130 for a version of this diagnostic which checks that Prompt for Clinical Significance is set for Analyte fields.
|
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0172 |
Analyte Fields should have Clinical Significance set |
Fields which have an Analyte name may only have a Control Type of Text or DropDownList
|
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0173 |
Analyte Fields should have Clinical Significance set |
Fields which have an Analyte name must not have a fixed unit specified. Fix will remove the fixed unit.
|
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0174 |
Analyte Fields should not use Data Dictionaries with Specify options |
A Data Dictionary mapped to an analyte field must not use the Specify option since this is not supported functionality
|
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0175 |
Analyte Fields should not appear on mixed Forms with log and non-log fields |
Analyte Fields should not appear on mixed Forms with log and non-log fields
|
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0176 |
Forms should not have Confirm Save set. |
Rave has 4 settings for Save Confirmation - No Confirmation (Save Confirm checkbox unchecked), No Link, Link Next and Link Custom. This Diagnostic checks that it is set to "No Confirmation". Fixing a deviation will set to the Form to "No Confirmation" To Enforce a particular Confirmation Style see Diagnostic 74. To enforce that the Save Confirm checkbox is checked see Diagnostic 114.
|
Substitution
Diagnostics to substitute placeholder text with study-specific values
ID |
Name |
Description |
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0029 |
List of words to be substituted with another word in Draft text strings |
List of words to be substituted with another word in Draft text strings
|
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0044 |
List of keywords to be substituted in Data Dictionary Entries |
List of words to be substituted in Data Dictionary Entries
|
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0045 |
List of words to be substituted in Draft Field Default Value |
If a Field definition has been imported from a Global Library then it may contain text which should be substituted for Therapeutic Area or Project specific text. This Diagnostic finds identifier text strings in Field default values and substitutes them for new values.
|
TrialGrid
Diagnostics to help manage Core Configuration settings
ID |
Name |
Description |
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0018 |
Review Groups in a Draft should appear in the URL Configuration Review Groups |
Review Group names should exist in the URL Configuration for use in Edit Check Actions. Fix will be available for users with Manage Configuration URL permission. The Fix will create the Review Group in the TrialGrid URL Configuration, or activate it if it exists but is inactive.
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0019 |
Marking Groups in a Draft should appear in the URL Configuration Marking Groups |
Marking Groups referenced in active Edit Checks should exist in the URL configuration for use in Edit Check Actions. Fix will be available for users with Manage Configuration URL permission. The Fix will create the Marking Group in the TrialGrid URL Configuration, or activate it if it exists but is inactive.
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0021 |
EDC Roles in Form or Field Entry or View Restrictions should appear in the URL configuration |
EDC Roles in Form or Field Entry or View Restrictions in a Draft should appear in the URL configuration. The Fix will create the EDC Role in the TrialGrid URL Configuration, or activate it if it exists but is inactive.
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0040 |
Field OIDs should be unique |
Some organizations ensure that all Field OIDs in a study are unique across all Forms. This Diagnostic identifies Field OIDs which are not unique in the Draft. Note: Rave does not require Field OIDs to be unique across Forms.
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0079 |
Identify Checks with SendMessage Check Actions |
Rave issue DEV-3145 means that an Edit Check with Check Action of SendMessage cannot be loaded into Rave if it is sent to a specific user or user group. If such as Check Action exists, the Upload will fail. Also note that the "Confirmation" check option is not exported from Rave into the ALS. The setting for Confirmation should be checked in Rave after ALS upload. This Diagnostic identifies checks with the SendMessage Check Action so that they can be reviewed in Rave once uploaded via ALS.
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0083 |
Find Forms which do not have Custom Properties set |
This Diagnostic finds Forms which do not have the named Custom Properties set. Fix provides an opportunity to set a value for these missing Properties. Note that property names that do not exist in this URL are ignored.
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0084 |
Find Fields which do not have Custom Properties set |
This Diagnostic finds Fields which do not have the named Custom Properties set. Fix provides an opportunity to set a value for these missing Properties. Note that property names that do not exist in this URL are ignored.
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