Network Steering Committee

Trial Operations Committee

Data Management Committee

Pharmacy Committee

Regulatory Committee

Site Management Committee

Laboratory Committee

CIRAS

Committee Mission

The Network Steering Committee will ensure the Network mission and objectives are followed by offering support to all Network committees and to provide leadership. The committee is responsible for final approval of all Network protocols.

Committee Goals

• Approve Network membership and regulate decisions on prioritization and timing of specific clinical trials.
• Oversee the Trials Operation Committee (TOC) and Data Safety and Monitoring Board (DSMB).
• Manage Network-wide administrative issues, external relations and interactions with national or international media, expansion of Network-related training capacities, and Network publication and presentation policies.
• Ensure membership of the NSC is composed of one voting representative from each of the participating country (currently Indonesia, Thailand, Vietnam) and international institutional partners (NIAID, Oxford University, Wellcome Trust, WHO).
• The NSC will convene at least quarterly, including at least one face-to-face meeting annually.

Committee Members*

* Members serve for periods of 2 - 4 years renewable once. All members of the NSC are non-voting members of the TOC.    Members (or their designated alternates) have voting rights at NSC meetings.
** The chair of the NSC is selected by vote from its members and serves for a period of 2 years renewable once.

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Committee Mission

The TOC is responsible for the development, implementation, and oversight of specific clinical studies, including selection of the overall study principal investigator (PI). The TOC will be responsible for trial design and development of study protocols.

Committee Goals

• Provide overall supervision of the trial, in particular, progress of the trial, adherence to the protocol, patient safety, and consideration of new information that may have impact on the trial conduct.
• Establish subcommittees to implement and oversee specific aspects of the trial (i.e. site management, clinical, laboratory, data management, pharmacy, regulatory, pharmacokinetics).
• Ensure one representative from each participating country, selected subcommittees, CIRAS, and interested partners are active committee members.
• The TOC will convene at least monthly including at least one face to face meeting annually .

Committee Members

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Committee Mission

To provide data management expertise and support to SEA ICRN committees (clinical, trial steering, site startup, lab) and research sites to successfully implement and complete data management activities sponsored by the network.

Committee Goals

• Create case report forms with input from Clinical and Trial Steering Committee
• Create Data Management plans with input from all RDMCs and DCSs
• Create job descriptions and standard operating procedures for staff at RDMCs and DCSs
• Monitor the progress of startup activities at the RDMCs and DCSs
• Monitor the progress of RDMCs and DCSs during trial in order to make recommendations for additional support if needed

Committee Members

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Committee Mission

The mission of the SEA Pharmacy Committee is to provide guidance on pharmacy services for clinical trials to research pharmacy staff in the Southeast Asia community with NIAID sponsored/co-funded programs in order to achieve Good Pharmacy Practice (GPP), and maintain study participant safety and study data integrity according to Good Clinical Practice (GCP). As well as to assure that each clinical pharmacy develops a study product management record keeping system to comply with FDA and local regulations governing the receipt, use and disposition of study products being investigated in clinical trials.

Committee Goals

• Provide GCP, GPP, and study specific training
• Ensure each clinical pharmacy has the capacity to initiate, conduct, participate in, and support the pharmacy services for clinical trials
• Support the development of the site specific Pharmacy Plans and SOPs
• Ensure adequate communication among pharmacy staff across sites to enhance GPP through shared experiences

Committee Members

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Committee Mission

The mission of the SEA Regulatory Committee is to provide guidance and services that facilitate investigators and other research staff in the Southeast Asia community with NIAID sponsored/co-funded programs to conduct clinical research of the highest quality in accordance with applicable regulations, standards and appropriate guidelines.

Committee Goals

• Assist participating investigators and related research staff in SEA in resolving issues of a regulatory nature in compliance with regulations, procedures and guidances .
• Act as a proactive group in formulating resolutions to regulatory issues brought to the committee by SEA clinicians and associated research staff.
• Providing guidance to SEA leadership on regulatory issues.

Committee Members

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Committee Mission

To ensure successful activation, implementation, and completion of the "High vs. Standard Dose Oseltamivir in Influenza Study" at the site level (individual and collective) by foreseeing and overseeing operational processes, providing central coordination, leadership, expertise, and responsibility for completion of tasks, and ensuring compliance with international standards of conduct.

Committee Goals

• Oversee finalization & execution of clinical site prep plans (including non-lab
  infrastructure needs & training plans)
• Review and approve final version of study MOOP, oversee and ensure site training on MOOP
• Ensure key staff meet NIH Human Subjects Training requirements, ensure site staff training on GCP (including articulation of timelines)
• Assist to develop and oversee delivery of role specific training for study site staff (regional and site level)
• Give final approval /authority for sites to begin the study (contingent upon site activation approval letter from sponsor/PPD)
• Oversee quality assurance and quality management of site level activities, maximize participant follow up
• Review monitoring reports (from PPD) and assist sites to develop action plans in response, troubleshoot challenges at sites
• Oversee completion of all other tasks related to start up of sites and site operations (including opening of sites and enrollment of participants)

Committee Members

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Network laboratory related activities are supported by two laboratory committees: (1) Reference Laboratory Committee and (2) Clinical Laboratory Committee. The main focus of the Reference Laboratory Committee are research related endpoint measurements. The focus of the Clinical Laboratory Committee are enhancing routine clinical laboratory procedures.

Reference Laboratory Committee

The Reference Laboratory Committee provides support and expertise to all laboratories involved in the network in order to successfully implement laboratory procedures required for Network studies, and will actively participate in designing new studies and writing the protocols.

Committee members are representatives from the reference laboratories in Indonesia, Singapore, Thailand and Viet Nam (Hanoi and HCMC), Oxford Clinical Research Units (Vietnam and Bangkok) and laboratory experts from Family Health International.

Committee Goals

• Active participation in writing laboratory sections for Network protocols
• Exchange ideas regarding laboratory aspects of network studies
• Support the procurement of appropriate equipment, consumables and reagents
• Ensure adequate specimen chain of custody procedures are in place
• Provide or review standard operating procedures for endpoint testing as required by Network study protocols.
• Provide or ensure laboratory training to site staff
• Provide laboratory advice and expertise whenever requested
• Ensure proficiency testing
• Encourage labs to participate in QA/QC program
• Support the development of laboratory best practices for Network protocols
• Lead the development and validation of research laboratory methods required for Network protocols
• Support the Clinical Laboratory Committee to meet their objectives
  

Reference Laboratory Committee Members

Clinical Laboratory Committee

The Clinical Laboratory Committee provides support and expertise to all routine clinical laboratories involved in the network. The mission of this committee is to enhance the clinical laboratories across the network. This is essential for Network studies and building the capacity of Network laboratories to provide reliable quality clinical laboratory services for the entire patient population served.

Committee members are representatives from the clinical laboratories in Indonesia, Singapore, Thailand and Viet Nam (Hanoi and HCMC), Network coordinating center and laboratory experts from Family Health International.

Committee Goals

• Encourage labs to participate in QA/QC program
• Support the Network-supported laboratory enhancement program and in particular to lead the program in their institution
• Share manuals and standard operating procedure and collaborate in developing best practices.
• Define reference ranges for routine laboratory tests
• Exchange ideas regarding laboratory aspects of network studies
• Provide clinical laboratory advice and expertise whenever requested
• Ensure proficiency testing
• Develop and implement programs to enhance knowledge on routine laboratory testing and quality
• Support the Reference Laboratory Committee to meet their objectives

Clinical Laboratory Committee Members

Standard Operating Procedures, Manuals, and Useful Tools

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About CIRAS

The Center for International Research Assistance and Support (CIRAS) is located at Family Health International (FHI). CIRAS is an NIAID Center supporting the Southeast Asian Influenza Clinical Research Network and providing site support during study preparation and implementation phases.

FHI is a multidisciplinary public health research organization working with many partners around the world. An interdisciplinary team of experts in various areas of clinical research support the center and partners.

Services Provided

CIRAS Staff

North Carolina , USA :

Bangkok , Thailand :

Hanoi , Vietnam :

Ho Chi Minh City , Vietnam :

Jakarta , Indonesia :

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