1. ISARIC/WHO BIOLOGICAL SAMPLING PROTOCOL www.prognosis.org/isaric Ken Baillie MD PhD, Chair, Genetics, Pathogenesis and Pharmacology Working Group, International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC)

2. The problem Emerging pathogens (MERS CoV, H7N9 influenza, H5N1 influenza) are a major potential threat to global health Cases may be spread across national borders We have to be ready in advance to conduct high-quality observational research www.prognosis.org/isaric

3. Objectives -Facilitate local research -Make it as easy as possible for local investigators to set up and run independent observational studies -Support research in low- and middle-income countries -Coordinated observational research -Local investigator-led studies from different parts of the world can ultimately be combined to gain more powerful insights into emerging infection -Be ready before the outbreak www.prognosis.org/isaric

4. Case report forms Minimal case report form Supplementary data forms Intensive data collection forms for first 50 cases worldwide Serial data collection where possible Foundation for biological sampling studies www.prognosis.org/isaric

5. Biological sampling study criteria Urgency – How urgent is the clinical question? Local cost – How difficult is it to recruit a patient? Requirement for global collaboration – Could a regional/national network do this? Peacetime role – Is this a valid question for a common infection now? www.prognosis.org/isaric

6. Structure TIER 0: Case report forms only – (ethical approval not required in most jurisdictions) TIER 1: One set of biological samples per patient TIER 2: Serial biological samples TIER 3: Labour-intensive studies STRATIFICATION ACCORDING TO LOCAL RESOURCE REQUIREMENT www.prognosis.org/isaric

7. Modular protocol

8. Adaptable to needs/resources

9. Low sampling intensity low resource OR large number of cases sought

10. Moderate sampling intensity

11. High sampling intensity eg. Early in new outbreak, in high-resource setting

12. Automatically generated protocol www.prognosis.org/isaric Text is added/removed from protocol, information sheets, consent forms according to local needs prognosis.org/isaric

13. The International Severe Acute Respiratory and Emerging Infection Consortium