Integration & Reconciliation IRT Guidelines
IRT’s main function lies in Supplies Distribution throughout the study and acts as a Medication Assigning Tool during Randomization/Enrollment. IRT is designed in such a way that it captures only the minimum required data fields that are useful to carry out its functions.
It is in practice by many to capture all the unnecessary data in IRT which leads to discrepancies, data duplication and reconciliation problems. As a standard, IRT should not be used as a mini EDC but there can be chances to establish Integration between IRT and EDC. Eg: We need not capture the details of Un-scheduled non-dispensing visits in IRT as the site users may not capture the exact details which create a discrepancy in EDC during reconciliation.
The integration shall be planned in such a way that the data captured in IRT should be (sent) integrated with EDC and not vice versa as the data captured in IRT is a real-time data which would help for easy reconciliation without discrepancies. Ensure that the data captured in IRT should be non-editable during integration.
The basic integration fields such as Subject ID, Randomization ID, Visit ID, Kit ID and visit dates shall be included in the IRT and not the all the details of Inclusion Criteria, Exclusion Criteria, sub-questions related to strata and subject demographics etc.
There are few aspects in IRT, which should be integrated into EDC based on the necessity and priority. The strata factors and the dose details can be integrated from IRT to EDC based on the requirement whereas, the reasons for screen failure and code break should be integrated mandatorily in EDC.
There should always be some measures to be taken in EDC while capturing the details of replaced kits which is utmost important during the data transfers as the subject might use the medication from both the kits partially.