Good Practice Guide: Interactive Response Technology
Title:
Good Practice Guide: Interactive Response Technology
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Author(s): Abdelkafi, Chedia; Anderson, Jerry; Arnold, Michael, RPh; Bradley, Ted; Brand, Adam; Britland, Sue; Conway, Lynn; Davis, Ethan, PMP; Eli, Massimo; Feliz, Miguel; Flynn, Gayle; Foust, Michelle; Gasman, Charles; Geiger, Fiona; Gerritsen, Jeroen; Gram, Karen; Jacobs, Steve; Junker, Henryk; Keating, Madaline; Lamb, Rongvald; Larrabee, Patricia; Lingbeek-Brummelhuis, Kirsten; Litzinger, Lauren; Mazuk, Katie; McDermott, Donna; McEntegart, Damian; Meyer, Julia; Milligan, Christine; Pal, Vijay; Pfefferkorn, Heidi; Ramuthaga, Nathaniel; Ribic, Michael; Robinson, Alan; Schultz, Tom; Seesing, Marloes; Shaver, Angela; Smith, Robert; Soulakian, Sandy; Swinney, Justine; Tsang, Louisa; White, Lekishia; Yoder, Steve
Interactive response technology is a tool that can be used to support multiple business processes and this Guide describes how the pharmaceutical industry can apply the technology to support various clinical trial activities.
The Guide provides guidance on how to: successfully implement an interactive response technology to manage key clinical trial activities, particularly expiry date management and program pooling; ensure robustness of the technology, contributing to its effectiveness and reliability; and communicate and foster a standardized, industry wide approach to critical functionality of Interactive Response Technology when used in managing investigational medicinal product.
Table of Contents
Good Practice Guide: Interactive Response Technology
- Preface 24
- Acknowledgements 35
- Table of Contents 57
- 1 Introduction 79
- 2 Overview of Interactive Response Technology 1517
- 3 System-Design and Controls 2729
- 3.1 Validation 2729
- 3.1.1 User Requirement Specifications 2729
- 3.1.2 Standard Requirements for an IRT System 2830
- 3.1.3 Additional Requirements of an IRT System for Removal of Expiry Dates or When Pooling Medication 2931
- 3.1.4 Functional Specification 3133
- 3.1.5 Randomization Specification 3133
- 3.1.6 Risk Assessment 3234
- 3.1.7 Validation of Interactive Response Technology 3234
- 3.1.8 User Acceptance Testing (UAT) 3234
- 3.1.9 Document Control 3335
- 3.1.10 Change Control 3335
- 3.1.11 Audit Trail 3436
- 3.1.12 Archiving of Interactive Response Technology 3436
- 3.1.13 Audit of Interactive Response Technology Suppliers 3436
- 4 Pooling of Supplies 3537
- 5 Warehousing and Distribution 4143
- 6 Training Considerations 4749
- 7 Monitoring Critical Activities (Risk Considerations) 5153
- 8 Appendix 1 – GCP Considerations 5759
- 9 Appendix 2 – Example UAT Scheme 6365
- 10 Appendix 3 – Frequently Asked Questions: Pooling 6769
- 11 Appendix 4 – Frequently Asked Questions: Removal of Use-By-Dates 7173
- 12 Appendix 5 – Interactive Response Technology Minimal Functional Standards Requirements Checklist 7577
- 13 Appendix 6 – References 7981
- 14 Appendix 7 – Glossary 8183
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