Regulatory and Research Trainings
Summary of Training Requirements for UNC Vietnam Staff
To conduct a clinical trial safely and properly, we must comply with applicable regulatory authorities, local laws/regulations, and institutional policies governing the conduct of sponsored research. Our staff are adequately trained before being delegated any study-specific duties/tasks. This training includes:
- International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines (ICH E6)
- Human Subjects Protection (HSP)
- Protocol-specific trainings
- DAIDS required trainings
- Trainings specific to their delegated roles and duties
Human Subjects Protection (HSP) and Good Clinical Practice (GCP) Trainings
Our staff complete HSP and GCP trainings prior to their conducting any study-related activities and every three years thereafter. The HSP training covers the basic U.S Department of Health and Human Services Policy for Protection of Human Research Subjects (“Common Rule”) and additional protections for vulnerable participants as well as trainings on the Belmont Report, Declaration of Helsinki, and the Nuremberg Code. The GCP training covers investigator roles and responsibilities, relevant topics in sponsor responsibilities, Essential Documents, Sources Documents, and other topics required by the sponsor and protocol team. In addition, according to the Vietnam Ministry of Health (MOH) Circular on clinical trials of drugs, our clinical trial staff must also complete MOH GCP training and have GCP certificates granted by the MOH.
U.S. Division of Aids (DAIDS) Required Trainings
In addition to GCP and HSP training, staff involved in DAIDS-sponsored studies complete additional role-specific training to facilitate their understanding of DAIDS policies, systems, and general research and clinical trial requirements. A few examples include courses on Clinical Quality
Management Plan (CQMP) for all staff working with data, Good Clinical Laboratory Practice (GCLP) for laboratory staff, DAIDS Clinical Trials Networks Pharmacy Guidelines training for pharmacy staff, and Clinical Site Monitoring training for relevant staff.
Additional Trainings
Qualitative Research Training: Our UNC qualitative research experts train and mentor a team of UNC Vietnam staff in qualitative research methods, including how to conduct in-depth interviews, focus group discussions, and cognitive interviewing, as well as conducting qualitative analyses and using qualitative research software.