Fifty staff were employed in the study to follow good clinical practices and maintain cold-chain. Staff members who were in direct contact with study participants successfully completed GCP training provided by the sponsor. All field staffs were trained about the study procedure, identification of the participants, interviewing techniques and cold chain maintenance. They were also trained on procedures of home visits and collection of data to fill up data transfer forms. Initially these training were given by the sponsors, monitors, study investigators and supervisors. selleck screening library The doctors and nurses were further trained on AGE and SAE guidelines, clinical assessment of patients, specimen collection and storage
of samples. Training was given to laboratory persons on dangerous goods handling procedures. The sponsor arranged from the PharmaLink and Family Helath International (FHI) to train the data persons on online data entry. Refresher training was given to all study personnel quarterly. Besides, every fortnightly study investigators and supervisors met with all staffs to discuss any problems and to resolve the issues. All SAE within 14 days following each dose, and death, intussusceptions and vaccine related SAEs at any time reported to local IRB, sponsors within 24 h of reporting. Data were entered from the source
documents to a central database and this was linked to web. Good Clinical Practices. The study Sodium butyrate was conducted according to Good Clinical Practices (GCP), the Declaration of Helsinki,
and local rules and regulations of Bangladesh www.selleckchem.com/products/wnt-c59-c59.html and the ICDDR,B. The protocol was reviewed for scientific quality by the Research Review Committee (RRC) of the ICDDR,B. The RRC (with 15 members), composed of clinicians, epidemiologists, social scientists, laboratory scientists, and demographers/population scientists from both within and outside the centre, reviews all scientific research proposals of the centre, evaluates their scientific merit, competence of Principal Investigators, and relevance to the Centre’s objectives and priorities. The protocol was also reviewed and approved by the Ethical Review Committee (ERC) of the ICDDR,B prior to starting the study. The ERC is a recognized committee for review of research protocols involving humans and a Federal Wide Assurance (FWA) with the US Government (FWA # 00001468). The study was also approved by the Western Institutional Review Board (Olympia, WA, USA). Written informed consent was obtained from parents or guardians of all participants. Approval was obtained from the Drug Administration, Government of Bangladesh to import and use of vaccines. Both local and international Data Safety and Monitoring Board (DSMB) were constituted to oversee activities of the vaccine study. The study was monitored by the local and international monitors from Family Health International (FHI, Dhaka and North Carolina, USA).