The Alex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA), Ebonyi State, joined other key stakeholders in the groundbreaking capacity-building program for the Lassa Fever Vaccine Clinical Trials, a phase 2b pilot efficacy study of the rVSVΔG-LASVGPC vaccine candidate.

Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), this study aims to advance the fight against Lassa fever, a critical public health threat in West Africa.

Day 3 of the training, conducted by MMARCRO, focused on equipping participants with essential knowledge and skills in clinical trial processes, ethical compliance, and team management, ensuring successful trial implementation.

Highlights from Day 3 Sessions

1. Good Documentation Practice:
Michael Ntiri opened the day with a session on Good Documentation Practice, emphasizing the role of clear and accurate documentation in regulatory compliance and trial success. Participants learned best practices for maintaining audit-ready records.

2. Team Building Exercise:
Collaboration was at the core of the team-building exercise facilitated by the MMARCRO trainers. This session featured practical activities to enhance communication, trust, and synergy among team members—a critical component for managing multidisciplinary clinical trial teams.

3. Study Documents: Source Docs and SOPs
Phillip Ayivor provided an in-depth review of source documents and standard operating procedures (SOPs). The session highlighted their role in ensuring data integrity, with practical tips for maintaining high-quality records throughout the trial.

4. CRF Completion and Data Handling:
In the afternoon, Phillip Ayivor delved into the proper completion of Case Report Forms (CRFs) and best practices for managing sensitive trial data. Participants were trained on ensuring accuracy and secure handling of participant information, key to ensuring compliance and confidentiality.

5. Study Documents Archiving
The trainer led a session on study document archiving, providing guidance on regulatory-compliant long-term data storage. He emphasized the need for organized and easily retrievable records to meet local and international standards.

6. Electronic Signatures:
Michael Ntiri discussed the implementation of electronic signatures in clinical trials. Participants gained insights into their legal validity, efficiency, and importance in maintaining data authenticity and protection.

7. Personal Data Protection:
The day concluded with a critical session on personal data protection. Trainers emphasized ethical responsibilities and compliance with data protection regulations, ensuring that participant privacy is respected at all stages of the trial.

Special Remarks from the Chief Medical Director:
The Chief Medical Director of AEFUTHA, Prof. Robinson Chukwudi Onoh, graced the training with his presence. He expressed his gratitude to all the partners, coordinators, trainers, and collaborators of the study for their commitment and contributions to advancing this critical initiative.

In his remarks, he emphasized the importance of the training, highlighting the devastating impact of Lassa fever on healthcare workers. “We have paid a dire and heavy price with the loss of active and dedicated health workers to Lassa fever. This training is crucial for our center as it equips us to take a bold step forward in combating this menace,” he said.

Prof. Onoh also informed the participants that the Federal Ministry of Health and Social Welfare, led by The Coordinating Minister of Health and Social Welfare, Prof. Muhammad Ali Pate, is aware of the training and acknowledged its significance. He noted that the program is being conducted simultaneously at four other centers within and outside Nigeria, underscoring its global importance.

He further encouraged the participants to maximize the opportunity, urging them to use the skills and knowledge gained to impact the world positively. “This is not just training; it is a call to action. You are being equipped with tools that will save lives and create a healthier future. Let this knowledge empower you to make a difference in the fight against Lassa fever and other public health challenges,” Prof. Onoh admonished.

Impact and Participant Feedback:

Day 3 provided an opportunity for participants to sharpen their skills in clinical trial management. The interactive sessions fostered active engagement and practical learning, equipping attendees with the tools to uphold global research standards.

The capacity-building activities underscore AEFUTHA's commitment to advancing health research and contributing to innovative solutions for pressing public health challenges, such as Lassa fever.

As this vital initiative progresses, AEFUTHA remains dedicated to ensuring the success of the clinical trials, aligning with our mission of delivering cutting-edge healthcare services and groundbreaking research for the benefit of humanity.

Stay tuned for updates on the progress of the Lassa Fever Vaccine Clinical Trials and more hospital activities!

Written by:
Udeze, Ezinwa Kelvinerice
Corporate Communication & Media

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