Immunization standards

Good Clinical Practices (GCP) Inspection training course
25-29 June 2007 in Harare, Zimbabwe

Background

GCP inspection course was delivered for the first time. The training material was developed based on the GCP inspection checklist that was prepared by the DCVRN. The instructional material development was done in collaboration with the National Department of Health, Medicines Regulatory Affairs in South Africa, National Agency of Drug and Food Control of Indonesia, the Collaborative Centre on Cold Chain Management in South Africa, University of Cape Town and the Ministry of Health in Turkey. The training material is based fully on adult learning methodologies.

Objectives

The course objectives are as follows: After completing the course, the participants will be able to;

  • plan, coordinate, and conduct a GCP inspection
  • identify and classify observations and deviations
  • arrive at regulatory decisions with regards to compliance of the study with GCP standards
  • report the outcome to the sponsor/clinical trial site.

Participants and trainers

A total of 19 representatives from National Regulatory Authorities and Ethics Committees have participated in the first course: Botswana (1), Ethiopia (2), Gambia (1), Ghana (1), Malawi (2), Nigeria (1), Tanzania (1), Uganda (1), Zimbabwe (8), and Mozambique (1).

The trainer team was set from South Africa (Joey Gouws, Laurette Bonthuys, Nkhumiseni Sinyela), and Indonesia (Hary Wahyu). Since the course was delivered for the first time, a special coaching team worked throughout the course with the trainers: Ümit Kartoğlu (WHO, Geneva, GTN/VQ Coordinator), Nihal Babalioglu (WHO consultant, MOH Turkey) and Ushma Mehta (WHO consultant, University of Cape Town, South Africa). Coaches worked closely with the trainers in preparation of the course as well as during extended hours of trainers' meeting at the end of each day.

Outcome

The training course is developed for a total of 27 hours, which is conducted consecutively in a working week. The course is divided into seven sessions (modules) of between 80 and 280 minutes each, using a variety of teaching methods, including illustrated lectures, demonstrations, brainstorming, work in smaller groups, readings, role plays, simulations and exercises. The course programme is arranged in a way that one session builds on another. The programme of the week is accessible through this link:

Detailed actual timing of deliveries were kept in order to finalize the course material. In terms of evaluation, a session was held at the end of each day at the plenary. We received extremely positive feedback and participants were grateful especially with the methodology that increases the level of their active participation. Participants also underlined their appreciation of the audiovisual tools used (video, DVD and especially the extensive use of flip charts and VIP cards).

A pre-course questionnaire was given on the first day to understand the group performance and also to make necessary fine tuning in the training material. Mid-course questionnaire was applied on Day 4 to allow trainers to meet with participants individually to discuss the answers on Day 4 afternoon and on Day 5.

Formal evaluation of the course is expected to be finalized at the end of July with consolidation of feedback reports from all trainers and participants.

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