Data Validations(Edit Check)

Data validation is used to enter high-quality data. This ensures that the user does not violate any data entry rules while entering the data.

Data validation can be defined either at the system or CP levels. The data validations defined at the CP level take precedence over the system-level data validations.

1 What is Data Validation or Edit Check?
2 How to define data validation?
- 2.1 Example JSON
- 2.2 Attribute types and examples
  - 2.2.1 Participant page examples
  - 2.2.2 Visit page examples
  - 2.2.3 Primary specimen page examples
  - 2.2.4 Shipment page examples
  - 2.2.5 Order page examples
  - 2.2.6 Field Dictionary

Edit Check is a paid plugin; please get in touch with support@krishagni.com for further details.

What is Data Validation or Edit Check?

Data Validation is a series of constraints designed to check the validity of the input data.
Constraints can be made of variables of a single record or multiple records.
Data Validation is designed to ensure high-quality specimen data is collected.

Edit Check supported for below List of modules and level

Participant Fields, Custom Form, and Custom Fields
Visit Fields, Custom Form, and Custom Fields
Specimen Fields, Events, Custom Forms, and Custom Fields
Shipment
Order

How to define data validation?

Data validation has two attributes - records and rules

records - whenever any of the specified records are modified, the constraint rules should be evaluated/enforced
rules - a list of integrity rules that should be satisfied by the records.

A rule is made up of three attributes when, expr, and description.

When: The attribute 'when' is optional and specifies when the rule is applicable? For example, the rule is applicable only for primary specimens.

expr: The attribute 'expr' specifies the check constraint that should be satisfied.

description: The attribute 'description' describes the constraint in user-friendly language. This is also used in error messages when the rule is broken or not satisfied.

The aliases available in the rules are - “cpr, visit, primary Specimen, specimen”.

Example JSON

Visit date should be same or later than the registration date
The specimen collection date should be the same or later than the registration date
Specimen should be stored at room temperature
Specimen anatomic site should be Liver

{
  "name" : "editChecks",
  "data" : {
    "constraints" : [ 
      {
        "records" : [ "cpr", "visit" ],
        "rules" : [
          {
            "expr" : "#cpr.registrationDate != null && #visit.visitDate != null && !#cpr.registrationDate.after(#visit.visitDate)",
            "description" : "Visit date should be same or later than the registration date!"
          } 
        ]
      },
      {
        "records" : [ "cpr", "primarySpecimen" ],
        "rules" : [
          {
            "when" : "#specimen.status == 'Collected'",
            "expr" : "!#cpr.registrationDate.after(#specimen.collectionEvent.time)",
            "description" : "The specimen #specimen.label (#specimen.type) collection date should be same or later than the registration date!"
          },
          {
            "when" : "#specimen.status == 'Collected'",
            "expr" : "#cpr.participant.gender != 'Male Gender' || #specimen.extensionDetail?.getAttrsMap()?.get('DD6') == 'Room Temperature'",
            "description" : "Specimen #specimen.label should be stored at room temperature!"
          }
        ]
      },
      {
        "records" : [ "visit", "primarySpecimen" ],
        "rules" : [
          {
            "when" : "#primarySpecimen.status == 'Collected'",
            "expr" : "!#containsAny(#visit.clinicalDiagnoses, {'Liver regeneration (disorder)', 'Liver cell adenoma'}) || #primarySpecimen.anatomicSite == 'Liver'",
            "description" : "Specimen #specimen.label anatomic site should be Liver"
          }
        ]
      } 
    ]
  }
}

{
  "name" : "editChecks",
  "data" : {
    "constraints" : [ 
      {
        "records" : [ "cpr", "visit" ],
        "rules" : [
          {
            "expr" : "#cpr.registrationDate != null && #visit.visitDate != null && !#cpr.registrationDate.after(#visit.visitDate)",
            "description" : "Visit date should be same or later than the registration date!"
          } 
        ]
      },
      {
        "records" : [ "cpr", "primarySpecimen" ],
        "rules" : [
          {
            "when" : "#specimen.status == 'Collected'",
            "expr" : "!#cpr.registrationDate.after(#specimen.collectionEvent.time)",
            "description" : "The specimen #specimen.label (#specimen.type) collection date should be same or later than the registration date!"
          },
          {
            "when" : "#specimen.status == 'Collected'",
            "expr" : "#cpr.participant.gender != 'Male Gender' || #specimen.extensionDetail?.getAttrsMap()?.get('DD6') == 'Room Temperature'",
            "description" : "Specimen #specimen.label should be stored at room temperature!"
          }
        ]
      },
      {
        "records" : [ "visit", "primarySpecimen" ],
        "rules" : [
          {
            "when" : "#primarySpecimen.status == 'Collected'",
            "expr" : "!#containsAny(#visit.clinicalDiagnoses, {'Liver regeneration (disorder)', 'Liver cell adenoma'}) || #primarySpecimen.anatomicSite == 'Liver'",
            "description" : "Specimen #specimen.label anatomic site should be Liver"
          }
        ]
      } 
    ]
  }
}

Attribute types and examples

Attribute Type	Description	Example JSON

Attribute Type	Description	Example JSON
DropDown	Only male participant registrations are allowed If Race is one (White or Asian), then Ethnicity should be 'American.'	`{ "records" : [ "cpr" ], "rules" : [ { "expr" : "#cpr.participant.gender != null && !#containsAny(#cpr.participant.gender, {'Female', 'Unknown', 'Undifferentiated'})", "description" : "Only Male patient should be register" } ] }, { "records" : [ "cpr" ], "rules" : [ { "when" : "#containsAny(#cpr.participant.races, {'White', 'Asian'})", "expr" : "#containsAny(#cpr.participant.ethnicities, {'American'})", "description" : "For White/Asian races, Ethnicity should be American" } ] },`
Dropdown and Muliselect	If Registration Site='MCRI Repository', then Race values is one of 'White' or 'Asian' If the patient is ‘Alive’ then Ethnicity should be ‘African’ or 'American'
Calculated Field (Age)	Participant age at the time of registration should be more than 18 years
DropDown Custom Field	If the patient is ‘Dead’, enter the values for the 'Diagnosed With' field from the dropdown.
DropDown Multiselect (Custom Field)	If the patient is 'Alive', enter the values for the 'City lived In field from the dropdown.
Fancy Control-User	If the user (Surgeon) is 'Krishna W' then the user needs to provide the death cause value (Custom Field) for the patient.

Participant page examples

Attribute Type	Description	Example JSON

Attribute Type	Description	Example JSON
Text	Patient first name, last name should not be null.
Text	Allow only capital letters in the field first name
Text Custom Field	If the patient is ‘Dead’ then, specify the value ‘Cause of death.’
Custom Form Field	In the ‘Smoking History Form’ attached at the ‘Participant Forms’ level, if the value of ‘Have you ever smoked’ is ‘Yes’, the error ‘Smokers not allowed!’ should be thrown.
Custom Form Field	‘Male’ participants with the value of ‘Have you ever smoked?’ as ‘Yes’ are not allowed. Error ‘Male smokers not allowed!’ should be thrown.
Custom form Date Field	‘Date of participant signed' is a date type custom field. The date is valid if Valid Date = (Date signed ≤ Today’s Date) otherwise invalid

Visit page examples

Attribute Type	Description	Example JSON

Attribute Type	Description	Example JSON
Dropdown	Clinical diagnosis should be one of `'Cholera', 'Liver cell carcinoma'`
Dropdown custom field	If the clinical diagnosis is one of `'Cholera', 'Liver cell carcinoma', then the Diagnosis subtype ID 'Negative'`
Date	Participant/Visit fields: "Visit date should be the same or later than the registration date!"
Dropdown (Core fields)	If ‘Clinical Diagnoses’ is one of List a then acceptable ‘Anatomic Site’ values will be among List b. List a: '10 weeks gestation of pregnancy, '11 weeks gestation of pregnancy', '12 weeks gestation of pregnancy', '13 weeks gestation of pregnancy, '14 weeks gestation of pregnancy List b: Extrahepatic bile duct Intrahepatic bile duct Liver
Dropdown (Custom Form fields)	If the ‘Tumor Site/Anatomic site’ value from the custom form is ‘Extrahepatic bile duct', 'Intrahepatic bile duct', 'Liver', then the allowed values for the 'Tumor Morphology Diagnosis’ field from the custom form will be '10 weeks gestation of pregnancy', '11 weeks gestation of pregnancy', '12 weeks gestation of pregnancy, '13 weeks gestation of pregnancy, '14 weeks gestation of pregnancy'
Dropdown (Core and Custom Form)	If the 'Primary Site' values (Custom Form) are 'Extrahepatic bile duct', 'Intrahepatic bile duct', 'Liver', the allowed value for Clinical Diagnosis (Core) should be in {'10 weeks gestation of pregnancy', '11 weeks gestation of pregnancy', '12 weeks gestation of pregnancy', '13 weeks gestation of pregnancy', '14 weeks gestation of pregnancy'}
Dropdown (Core and Custom Form)	If the diagnosis field from the visit level form contains values from the below List, then the allowed value for Clinical Diagnosis (Core) should be '`Non-malignant`'. List: ‘8006/2 Observation for suspected malignant neoplasm’, '8009/1 Non-malignant diagnosis, no history of cancer (Other Medical Care)'. Why is RegEx used in the edit check? Providing these long multi-choice values in the edit check is not flexible, so RegEx checks for the statement and matches the values.

Primary specimen page examples

Attribute Type	Description	Example JSON

Attribute Type	Description	Example JSON
Date	Registration Date vs. Collection Date The specimen collection date should be the same or later than the registration date.
Dropdown custom	The anatomic site should be Brain NOS OR Abdomen NOS for tissue samples
Dropdown core	If the participant gender is ‘Male’, then the anatomic site cannot include 'Female genital tract, NOS', 'Overlapping lesion of female genital organs', 'Other specified parts of female genital organs', 'Breast, NOS'
Date field (core)	Specimen data should be the same or later than the Visit date! (Visit date allows only ‘Date' whereas Specimen collection date allows 'Date and time data entry. In this Edit check, similar date format is provided for both the date fields.)

Shipment page examples

Attribute Type	Description	Example JSON
Shipment Shipped Date	Shipment Shipped date should be lesser than current date/time
Received Date	Shipment received date should be lesser than current date/time
Shipment Shipped Date Vs. Specimen Collection Date	Shipment Shipped date should be greater than the specimen collection date
Shipment Received Date Vs. Specimen Collection Date	Shipment received date should be greater than the specimen collection date
Shipment shipped Date Vs. Specimen Collection Date	Shipment shipped date should be greater than the specimen collection date, where the collection is date considered as one day earlier than actual. Passing condition: Shipped date:07-02-2023 00:00 Collection date:07-02-2023 22:14 Failed condition: Shipped date:07-02-2023 00:00 Collection date:08-02-2023 02.14
Shipment shipped Date Vs. Specimen Collection Date	Shipment shipped date should be greater than the specimen collection date on specimen event page edit. The regular expression of comparing shipped Vs collection date doesn’t work on Specimen Event page. To ensure the check validate on ‘Editing' the ‘Collection Event date and time’ this expression is used.
Shipment shipped Date Vs. Specimen Collection Date	The Shipment shipped date can be lesser than specimen collection date by 24 hours, not more than that. Passing condition: Shipped date:06-02-2023 20:00 Collection date:07-02-2023 18:14 Failed condition: Shipped date:06-02-2023 20:00 Collection date:08-02-2023 22.14
Shipment shipped Date Vs. Specimen Collection Date	This expression only compares both shipped date Vs Collection Date and ignore the time attached to both fields.

Order page examples

Attribute Type	Description	Example JSON

Attribute Type	Description	Example JSON
Distribution date	Order date should be lesser than current date/time
Distribution date Vs. Collection Date	Order date should be greater than the specimen collection date

Field Dictionary

Core Fields Dictionary for Participants, Visits, and Specimens.

Level	Field Name	Field Expression

Level	Field Name	Field Expression
Participant	PPID
Participant	First Name
Participant	Middle Name
Participant	Last Name
Participant	Registration Date
Participant	External Subject ID
Participant	Registration Site
Participant	Birth Date
Participant	Social Security Number
Participant	eMPI
Participant	Gender
Participant	Vital Status
Participant	Death Date
Participant	Races
Participant	Ethnicity
Participant	MRN
Visit	Name
Visit	Name
Visit	Status
Visit	Missed By
Visit	Missed Reason
Visit	Visit Date
Visit	Visit Site
Visit	Clinical Diagnosis
Visit	Clinical Status
Visit	SPR
Visit	Visit Comments
Specimen	Label
Specimen	Barcode
Specimen	Lineage
Specimen	Collection Status
Specimen	Type
Specimen	Anatomic Site
Specimen	Laterality
Specimen	Pathology Status
Specimen	Initial Qty
Specimen	Available Qty
Specimen	Concentration
Specimen	Parent Specimen Label
Specimen	Biohazard
Specimen	Location
Specimen	Created On
Specimen	Freezer Thaw Cycle
Specimen	Increment Freeze Thaw Cycle
Specimen	Comments
Specimen	Collection Date
Specimen	Collector
Specimen	Received Date
Specimen	Receiver
Specimen	Collection Container
Specimen	Collection Procedure
Specimen	Received Quality
Specimen	Frozen Time
Specimen	Frozen Method
Specimen	Frozen Comments