Short PeRiod IncideNce sTudy of Severe Acute Respiratory Infection

SPRINT-SARI is an international, multi-centre, prospective, short period incidence observational study of patients in participating hospitals and intensive care units (ICUs) with SARI.

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The SPRINT-SARI study has commenced recruitment at multiple sites in Europe and North America.
This is an important step forward in achieving preparedness to conduct observational studies of Severe Acute Respiratory Illness during future pandemics or regional epidemics. The broad objective of SPRINT SARI is to achieve, on a world-wide basis, the capacity to activate a large number of hospitals to collect observational data on patients with SARI using the same protocol and case report form. This capacity is demonstrated by sites obtaining and maintaining all necessary ethical approvals and by ‘exercising’ this capacity by screening, recruiting, and collecting data on patients with SARI for a one week period every year. That recruitment of patients has actually commenced is a a major milestone.
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About SPRINT-SARI

Aim: The primary aim of this study is to establish a research response capability for a future epidemic / pandemic through a global SARI observational study. The secondary aim of this study is to investigate the descriptive epidemiology and microbiology profiles of patients with SARI. The tertiary aim of this study is to assess the Ethics, Administrative, Regulatory and Logistic (EARL) barriers to conducting pandemic research on a global level.

Rational: Severe acute respiratory infection (SARI) continues to be of major relevance to public health worldwide. In the last 10 years there have been multiple SARI outbreaks around the world.  The 2009 H1N1 pandemic was estimated to result in more than 200,000 respiratory deaths globally. The World Health Organization (WHO) defines SARI as an acute respiratory infection of recent onset (within 10 days) requiring hospitalisation, manifested by fever (≥380C) or a history of fever and cough. There is international consensus that it is important to undertake observational studies of patients with SARI as an essential component of pandemic and epidemic research preparedness.

Study Progress: SPRINT-SARI is commencing during the northern hemispheric winter (2015/2016) and following on during the subsequent southern hemispheric winter (2016). Tropical regions are expected to participate in-between these times.


SPRINT-SARI Ethical Administrative Regulatory and Logistic barriers (EARL) 
 

This sub-study (SPRINT-SARI-EARL) aims to follow and describe the application of SPRINT–SARI for all applicable EARL approvals in each participating region / nation. We will describe the experience of the researcher submitting the applications and the differing responses received and timelines of the committees (i.e. ethics committees) to a single protocol used in SPRINT-SARI that may create barriers to the rapid deployment of future observational studies and clinical trials in the event of a pandemic.


Contact
: For further information about this study, please contact:
Central Project Manager, by email
CliRes Data Management System, by email.

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This study is supported by ISARIC, InFACT and PREPARE

Resources
Study Protocol
Study Protocol (Español)
Expression of Interest letter for networks
Case Report Form
Case Report Form (Español)
Case Report Form (Français)
Completion Guidelines (all tiers)
Centralised Data Entry Webpage
Frequently Asked Questions
Free educational training opportunities (PDF)
Free educational training opportunities (Word) 

Ethical Administrative Regulatory and Logistics (EARL) Protocol 
EARL Expression of Interest letter
IRB/Ethics Master Guide (e.g. a draft of an IRB/Ethics application for sites/networks to adapt to meet local requirements)