Data and Safety Monitoring Board (DSMB)

The Southeast Asia Infectious Disease Clinical Research Network (SEAICRN) has established an Independent Data and Safety Monitoring Board (DSMB) to address the research participant safety and protection and to make recommendations regarding the continuation, termination or modification of SEAICRN-sponsored studies. 

The DSMB will monitor all SEAICRN interventional phase I, II, III, and IV trials and other selected trials or studes as determined by Network Steering Committee (NSC) and the Network.

The DSMB members are required to be free from conflict of interest with respect to the studies they will be expected to review and its composition reflects the disciplines and medical specialties necessary to interpret data from the studies being monitored and in particular to fully evaluate the safety of participants in those studies.

The following are several Network DSMB related documents to help Principal Investigators and Network members to learn more about the DSMB and to help prepare necessary submissions and reports: 

Latest Versions

Guidance for Investigators Presenting a Study for Preview to SEAICRN DSMB (v2.0)

Operational Plan for the SEAICRN DSMB (V2.0)

DSMB Report Templates:

DSMB Report Cover Sheet

Report-Level 1 (Open Session)

Report-Level 2 (Closed Safety)

Report-Level 3 (Closed Efficacy)

For prompt responses on SEAICRN DSMB related matters, please contact:

Sara Tenorio,
Administrative Assistant to the DSMB
E-mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
Family Health International

U.S. Mail:
PO Box 13950                                                        
Research Triangle Park, NC 27709                  
Phone: 919-544-7040 Ext 11424
Fax: 919-544-7261

Express Mail and Courier Delivery:
2224 E NC 54
Durham, NC 27713

Mark Van Raden,
Executive Secretary to the DSMB   
Biostatistics Research Branch, DCR, NIAID, NIH
E-mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

U.S. and NIH Mail:
6700-B Rockledge Dr., MSC 7609                    
Bethesda, MD 20892-7609                                
Phone: 301-451-5126
Fax: 301-480-0912

Express Mail and Courier Delivery:
6700-A Rockledge Dr., Room 5135      
Bethesda, MD 20817          
 
Mario Chen,
DSMB Specialist
E-mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
Family Health International

U.S. Mail:
PO Box 13950                                                        
Research Triangle Park, NC 27709                  
Phone: 919-544-7040 Ext 11399
Fax: 919-544-7261

Express Mail and Courier Delivery:
2224 E NC 54
Durham, NC 27713