IVR/IWR Systems in Clinical Trials
Introduction
Interactive Voice Recognition (IVR) and Interactive Web Recognition (IWR) systems are used in clinical trial study management.
These systems have been used for optimising the supply of Investigational Medicinal Product (IMP) and other clinical trial materials to study sites. Clinical trial study design does not only lead to an increase in subjects as the study moves through the phases, but they can be incredibly complex with multiple sites, multiple study arms.
IVRS/IWRS can be used to coordinate replenishment strategies, but sponsors have begun to request enhanced uses; among them the management of expiry dates.
Those familiar with Annex 13 of Eudralex will know that expiry date extensions result in labelling that can be carried out by appropriately trained clinical staff at the sites. These systems could replace the need for this physical step leading to the interface between Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) becoming even more important.
Some points of interest:
- If you are involved in QA with clinical trials, how do you assess your IVRS/IWRS systems and providers? How could you adapt your existing assessment to account for additional GMP requirements?
- IVRS/IWRS system providers to have appropriate QMS accounting for GMP/GCP
- Robust communication and effective timelines for sponsor to system provider to implement revised expiry date.
- Secondary ‘release’ in the system for the sponsor.
To open the Reflection Paper on the use of Interactive Response Technologies (Interactive Voice/web recognition systems) in Clinical Trials click HERE
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Simply add comments in the comment field of this page or email me on advocacy@pqg.org
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When should you comment by?
I will collate all comments and respond on behalf of the PQG members by the deadline for the consultation (which is the 15th February 2012).
With this in mind, can you provide all comments by Monday 13th February 2012.
Thanks!
4 Responses to “IVR/IWR Systems in Clinical Trials”
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This recognition by EMA of the importance of IVRS/IWRS technology to the conduct of clinical trials is welcome. In particular, it is appreciated that there is acceptance of the fact that such systems might, in certain circumstances, be used to justify the removal of expiry dates from Investigational Medicinal Product (IMP) labels and thus overcome challenges with expiry date extensions in the field. However, it is disappointing that the paper’s perspective is that “There is currently no justification… for omission of labelling of use-by date … if the IMP is handed out to trial subjects for use at home” (lines 119-121). This is much more restrictive than in other countries, such as the US, and significantly limits the potential benefits that may be derived from such systems. The only reason given for this position is “Patients not returning kits and then utilising them past their expiry date” (line 125). Whilst accepting that it could be a problem if this was to happen, this should not fundamentally be a reason to prevent use of technology in this way. There are already strict GCP requirements for IMP accountability and if a company can demonstrate a robust system for ensuring materials did not remain with trial subjects past their expiry date, then this should be acceptable.
The Annex I QP declaration appears to be added bureaucracy with unclear value. It is agreed that the certifying QP should ensure that if an IVRS/IWRS is used to control expiry dates then it is fit for purpose and there is traceability back to appropriate audits. However, the audit/validation traceability could be addressed through internal control processes and the needs of those downstream covered by the QP’s certification of the batch. To create and maintain a form in every Product Specification File and Trial Master File (ref. line 135) is unnecessary bureaucracy. Furthermore, what is the objective of listing assembly and distribution sites and including them within this?
Should the declaration be retained, then
(a) the focus should be on the IRS itself, not specific locations within the supply chain.
(b) guidance notes on its completion will be required. For example, what is meant by the ‘date of last audit (completion)’? Is this the last day of fieldwork; date of report issue; date of Corrective Action Plan acceptance; date of closure of all actions arising from the audit?
IR technology is likely to become more integrated into clinical supply chain and data management systems in future and I am concerned that this document is written in a manner that may constrain technological advances. This document should be written with a focus on the fundamentals, e.g. the need for relevant persons to have ready access to confirmation of the expiration date, without stipulating how this must be achieved, e.g. the delivery of documents or printouts. That way there is flexibility to allow for direct reference to and recording within the system itself without the need for additional paper records.
My initial reaction to the argument given in Section 2.2.3. line 125 is that patients who are not motivated to return unused medication, as they are always instructed to do, are just as likely to ignore an expiry date if present and take the medication anyway. Possibly not a sound opinion in terms of a philosophical patient safety, but one that accounts for the realities of patient (non-)compliance!