Good Practice Guide: Interactive Response Technology

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.