This reflection paper was initially published on 10 December 2013 under reference EMA/INS/GCP/600788/2011. It was updated in view of the entry into application of the Clinical Trials Regulation (CTR) No. 536/2014, only to clarify that the removal of expiry dates from the labels is not allowed for clinical trials conducted under the CTR (see section 2.3 of the reflection paper). The rest of the reflection paper was not reviewed and reflects the state of thinking at the time of initial publication. Additional information on the expected requirements for interactive response technologies may be found in the Guideline on computerized systems and electronic data in clinical trials, once finalized.
This paper seeks to provide guidance on what national competent authorities (NCAs) expect from such systems and in particular their use for handling of the expiry date of the Investigational Medicinal Product (IMP). These positions will form suggestions for sponsors and IRT providers on the validation requirements for systems. Specific computer system validation is not discussed in detail since this is the subject to a large number of other publications. This paper is aimed at sponsors and providers of such systems.
Currently, the information surrounding the use of IRT in the clinical trial authorization (CTA) applications is only included with reference to IRT use in randomization where this function is outsourced. As a consequence, the NCA might have little knowledge of the extent of use of these systems, particularly where the system is an in-house one. For this reason, it would be helpful if Appendix I be completed by the sponsor and submitted to the NCA along with the CTA.
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