Consent Validation during Distribution

This page is applicable only for versions on or after 7.0 and having the EDC plugin deployed. For the versions prior to v7.0, refer ‘Consent Validation before Distribution’ from Distribution wiki.

Consent validation rules can be defined for distributing specimens, in the same way as they are defined for collecting visits and specimens.

This will allow/disallow the distribution based on whether participants have provided all the required consents.

The rules can be added at the distribution protocol, via DP overview > Consents tab

The system will allow the distribution of specimens only if they are from patients whose consents satisfy the above rule.

Prerequisites:

User should have the admin privileges (super admin/ institute admin)
Coded consent statements should already be added

Follow the below steps to define the validation rules in DP:

From the distribution protocol overview page, click on the ‘Consents’ tab.
Click on ‘Add Rules’.
A popup appears with three fields- Statement, Match, Response.

Statement- Provides a dropdown of all the consents added in the system. These consents are present in Home > Consents
Match- Provides the operators (is, is not, is one of, is not one of)
Response- Provides consent responses for the statements. These responses are present in Dropdown Manager > Consent Responses.
Click on the ‘Statement’ field and select the consent statement from the dropdown.
Select the matching operator.
Select the ‘Response’ for the consent statement.
Click on ‘Add’ once the rule is defined. The below rule translates as- Response for Consent to participate in biobank activities (C0001) should be “Yes”.
The rule appears in the consents tab screen.
Follow steps 4 to 7 to add multiple consent validation rules.
Now, select the “Match” for these set of rules from - ANY, ALL, ADVANCED.

ANY- Equivalent to OR. Ensures that distribution is possible if at least one of the specified rules is satisfied
ALL- Equivalent to AND. Ensures that distribution possible only when all the specified rules are satisfied
ADVANCED- A combination of AND and OR can be implemented to define a complex rule.
Click on ADVANCED for defining a combination of rules.

A text area appears. Write the appropriate expression in this area and click on ‘Save’ to save the rule.
The numbers 1, 2, 3 specify the individual consent rules added.
Click on ‘Edit’ to change the rule.

So when specimens are distributed using this DP, this validation rule is checked, and if the rule is not satisfied, an error is thrown.

If no rule is specified, the specimens can be distributed using the DP. No error will be thrown.