ePRO Resources
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ePRO Resource Center > ePRO Technology Options
ePRO Technology Options
There are a wide variety of technologies available for sponsors who choose to capture Patient Reported Outcomes (PRO) data electronically. From hand-held eDiaries to Interactive Voice Response Systems (IVRS) and other technology-enabled solutions, sponsors now have many options to select from in order to identify the ePRO method that best fits their trial needs.
Presented below are related articles and additional information about ePRO technology options.
- Read “Electronic Diaries and Questionnaires: Designing User Interfaces that are Easy for all Patients to Use”; Palmblad, M., Tiplady, B., Quality of Life Research, 2004
Summary: In this article, the authors propose a set of requirements for designing handheld computer systems for electronic collection of patient diary and questionnaire data in clinical trials. Guidelines are presented so bias may be avoided both in patient selection and in the responses made; so that electronic data collection may be as effective as possible, and study procedures are convenient and unobtrusive for the patients. - Read “Developing and Validating Electronic Diaries”; Stokes, T., Paty, J., Applied Clinical Trials, 2003
Summary: In this 3rd part of a Technology update series, the authors discuss the development and validation of an eDiary system that meets regulatory requirements based upon a clinical protocol. - Read “Assessment of post-surgical recovery after discharge using a pen computer diary”; Begg, A., Drummond, G., Tiplady, B., Anaesthesia, 2003
Summary: Patients were assessed after their return home from gynaecological surgery using a daily pen-based electronic diary. They also completed a questionnaire at the end of the study month. The article concludes that daily electronic pen-diaries are an acceptable method of obtaining better information on the extent and duration of symptoms and other difficulties after discharge following surgery. - Read “The Role of the Clinical Protocol in Developing and Implementing Electronic Diaries”; Stokes, T., Paty, J., Applied Clinical Trials, 2003
Summary: This article presents the clinical, technical, and regulatory issues involved in the development and implementation of eDiary trials that meet regulatory requirements. Although clinicians have reasonable concerns about adopting technology, the authors demonstrate that the collaboration of clinical and technology teams can result in a robust clinical trial executed in a timely fashion. - Read “What is a Subject Diary and What Regulations Apply”; Stokes, T., Paty, J., Applied Clinical Trials, 2002
Summary: In this article, the authors address the following questions about regulatory issues in subject diary research: Why are subject diaries important to clinical research? How does ICH GCP apply to subject diaries—electronic and paper? How do FDA guidance and 21 CFR 11 apply to subject diaries—electronic and paper? What are the audit and inspection criteria for subject diary data? - Read “Collecting Reliable Real-Time Patient Experience Data”; Stokes, T., Paty, J., Hufford, M., Drug Information Journal, 2001
Summary: To succeed in a clinical trial, an electronic diary system must simultaneously meet two related standards: clinical integrity and system integrity. This article reviews the challenges and promises of such an eDiary system and highlights the importance of building a robust, subject-friendly system that can enhance subjects’ protocol compliance.