Data management of clinical trials during an outbreak of Ebola virus disease.

Hossmann, Stefanie; Haynes, Alan G; Spoerri, Adrian; Diatta, Ibrahima Dina; Aboubacar, Barry; Egger, Matthias; Rintelen, Felix; Trelle, Sven (2017). Data management of clinical trials during an outbreak of Ebola virus disease. (In Press). Vaccine Elsevier 10.1016/j.vaccine.2017.09.094

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INTRODUCTION Clinical trial data management (DM) conducted during outbreaks like that of Ebola virus disease (EVD) in West Africa, 2014-2016, has to adapt to specific, unique circumstances. CTU Bern was asked to set up a safe data capture/management system that could be launched within a few weeks and cover two different vaccine trials. This article describes some of the challenges we faced and our solutions during the two different trials. METHODS Setting up a DM system was split into four phases/tasks: (1) quick set-up of the (electronic) data capture system (EDC) and mobile infrastructure in Bern, (2) moving the EDC and infrastructure to Conakry, Guinea and implementation of a local data management centre (DMC), (3) running the DMC, and (4) data cleaning. The DMC had to meet the following criteria: (1) quick implementation, (2) efficient maintenance and handling of data, and (3) procedures to guarantee data quality. The EDC (REDCap) was setup as a local area network. In order to ensure high data quality, double data entry, and then review of inconsistencies and offline plausibility checks were implemented. RESULTS From the start of CTU Bern's involvement to the productive EDC took 11 weeks. It was necessary to adapt processes for dealing with data continuously throughout the trial conduct phase. The data management team processed 171,794 case report form pages from a total of 14,203 participants in the period between March and December 2015. CONCLUSION Data management is a key task supporting trial conduct. For trials in emergency situations, many of our approaches are suitable, but we also provide a list of aspects that might be done differently.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern

UniBE Contributor:

Hossmann, Stefanie; Haynes, Alan; Spörri, Adrian; Diatta, Ibrahima Dina; Egger, Matthias; Rintelen, Felix and Trelle, Sven

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0264-410X

Publisher:

Elsevier

Language:

English

Submitter:

Tanya Karrer

Date Deposited:

04 Jan 2018 13:39

Last Modified:

04 Jan 2018 13:39

Publisher DOI:

10.1016/j.vaccine.2017.09.094

PubMed ID:

29074200

Uncontrolled Keywords:

Clinical trial Data management Data management centre Electronic data capturing system REDCap

BORIS DOI:

10.7892/boris.106753

URI:

https://boris.unibe.ch/id/eprint/106753

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