The Botswana Harvard AIDS Institute Partnership (BHP)’s Clinical Trials Unit (CTU) and the HIV Prevention Trials Network (HPTN) sites on the 15 of May 2020 held DAIDS Applied Research Training (DART) for 11 staff members comprising study Physicians, Research Nurses and Data Managers. DAIDS is the Division of AIDS of the National Institute of Health (NIH) , USA which sponsors HIV/AIDS research in different NIH supported networks including HPTN, ADULT Clinical Trials Group (ACTG) and International Maternal PaediatricsAdolescents Clinical Trails (IMPAACT) to which the BHP/HSPH is affiliated as a CTU. The internal DART training follows the main pilot event that was held in Johannesburg, South Africa in September 2019 attended by five BHP staff members.
The training was attended by teams from different Clinical Trials sites that include, South Africa, Zimbabwe and Mozambique. The BHP team was made up of Siamisang Balosang, Head Research Nurse – HPTN, Boitshepho Seme, Head Research Nurse – CTU, Moakanyi Ramogodiri, Head Research Nurse – CTU, Omphemetse Motswagole, Data Manager – CTU and Selebogo Mokgweetsi, Quality Assuerance Nurse – HPTN.
Balosang told BHP Quarterly that the training came after DAIDS realised that there were many citations discovered during monitoring visits, and decided to train research staff with less than five years in research on DAIDS requiremets across all the CTU sites.DART participants were equipped with instructor guides and tool kits to share what they have learned with colleagues at their respective sites.
“We were trained on different topics and each teamwas tasked with a project of training our team members. Going forward, we intend to train all new staff members to be well conversant with DAIDS requirements from the onset,” said Balosang.
The objective of the internal training was to share important information to site staff, improve the safety of study participants through compliance of DAIDS standards and to improve data integrity. Balosang stated that after the training, there shall be an evaluation by DAIDS to assess improvements in data quality and research conduct processes. The evaluation outcomes will also help inform future training events. She explained that DART focuses on applied Good Clinical Practice/ International Conference on Harmonization of Research (GCP/ICH) compliance at all clinical research sites to strengthen regulatory compliance across the HIV/AIDS Network enterprise.
The training focused on application-based training, in which attendees worked in small group settings to review specific case studies, designed to enhance clinical GCP/ICH compliance. The application-based training sessions allow learners to use problem solving and critical thinking skills to respond to relevant scenarios that occur in the clinical research setting.
The topics covered include the following:
- Good Clinical Practice
- Source Documentation
- Study Product Administration
- Investigator’s Responsibilities
- Informed Consent
- Audit and Inspection Readiness