1. Who owns the data and samples?

2. Who monitors the Network studies?

3. Any new studies planned?

4. How are decisions made within the Network?

1. Who owns the data and samples?

Responsibility for data, clinical samples, and virus isolates generated by individual partners as part of Network activities rests with those individual partners. Each partner is committed to sharing data and samples to advance the shared scientific agenda of the Network and the scientific community at large. Specifically, the Network appreciates the importance of making all strains and sequence data publicly available in a timely fashion and is committed to doing so with the full approval of the relevant national ministries of health and other relevant national authorities.

2. Monitoring of the studies will take place at several levels.

First, each site will have ongoing Quality Assurance and Quality Control.

Safety reporting will be through a Network Safety Office

An independent Data Safety and Monitoring Board will also provide oversight of data quality and subject safety and provide ongoing assessments of progress and conduct of each of the Network studies.

Finally, in accordance with ICH, independent site monitoring will be conducted by contract organization.

3. Any new studies planned?

The Network currently has two protocols in development: SEA022 (Oseltamivir treatment in severe, virologically confirmed influenza A or B in hospitalized children less than one year of age in Hanoi, Ho Chi Minh City and Bangkok) and SEA023 (The viral etiology of hospitalized children less than one year of age in Hanoi and Bangkok).  More information on Network studies can be found in Research Activities . 

4. How are decisions made within the Network? 

A Network Steering Committee (NSC), composed of one representative from each of the participating country (currently Indonesia, Thailand, Vietnam) and international institutional partners (above) is responsible for providing leadership on Network mission, decisions on membership, decision on prioritization and timing of specific clinical trials, oversight of the Trial Operations Committee (TOC), and Data Safety Monitoring Board (DSMB), publication and presentation policies and expansion of training capacities.

The TOC includes at least one representative from each participating country, selected sub committees (eg, laboratory, regulatory, pharmacy, data management) and interested partners and is responsible for implementation and oversight of specific clinical studies.