Abstract T P266: Training and Certification of Research Teams Across Countries: The INDO-US Project Experience

Abstract

Background: The Indo-US Stroke Registry and Infrastructure Development Project, jointly funded by NINDS and the Indian Dept. of Biotechnology, currently includes 5 academic tertiary hospitals in India and 1 in USA. The aim is to develop high-quality stroke centers in India, modeled after the US center. Methods: From Jun’12-Jun’13, 5 Indian PIs (one per center) hired 19 research coordinators or fellows and one project manager across all sites. The US collaborators developed a web-based registry with data variables/definitions consistent with the NINDS Stroke Common Data Elements and the AHA GWTG-Stroke Projects. Before launch of prospective data collection, the US PI and project manager trained the Indian collaborators as follows: (a) coordinator training via 2 video-conferences/web discussions and 1 interactive telephone training session for data entry, NIHSS and mRS certification, stroke classification, and imaging data (b) 2 teleconferences for MD training on data definitions, stroke subtypes using an automated web-based system, and image analysis (c) Data entry, logic check and query resolution for all co-investigators via 6 sessions using teleconference and remote computer access (d) Recently, we developed video training modules. Enrollment progress reports were sent out monthly. Post-launch, we conducted 5 teleconferences (one every 2 months) to resolve queries. In April ’13, site monitoring and audit visits were conducted by the Project managers. We compared our experience before and after the in-person site monitoring visit. Results: After the in-person site monitoring visit in April ’13, enrollment improved by 150% (27 patients per month in May-June 2013, vs. an average of 17 per month from Nov-2012 to May-2013). The in-person site visit resulted in significantly better data quality, with a 60% decrease in data entry errors. Research coordinators unanimously expressed a better understanding of consent procedures, regulatory aspects, and accurate data collection. Conclusion: Cross-country research collaboration requires extensive resources for training and certification purposes. In-person site visits appear essential for improving data quality and should be conducted in addition to video, telephone and web-based training.