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U.S. Department of Health and Human Services

About FDA

Train-the-trainer Good Clinical Practices (GCP)

Description: Forge a partnership with the Secretariat of the Southern African Development Community (SADC) and the Drug Regulatory Authority of Botswana to provide a regional regulatory Good Clinical Practices (GCP) program to enhance their regulatory oversight of clinical trials in the region.

Accomplishment: The Africa Office (AO) completed a 4-day GCP-1 Workshop co-hosted with the SADC and Botswana Ministry of Health in Gaborone, Botswana in October 2010. Thirty-one government officials from Botswana, Lesotho, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Tanzania, Zambia and Zimbabwe attended. FDA expert staff provided attendees a basic, common core of knowledge and skills in GCP and inspection processes and procedures through lectures and skill-building exercises designed for use specifically in the Southern African region. This information sharing was valuable to workshop participants and to the FDA faculty to more fully understand the strengths and challenges of the various national drug regulatory authorities. Workshops of this nature support the ongoing efforts of the International Conference on Harmonization, World Health Organization (WHO), and other stakeholders working to strengthen regulatory authority and capacity among national counterparts.

In September 2011, FDA co-hosted the 5-day GCP-2 Workshop with the SADC in Pretoria, South Africa in August 2011. Twenty seven government officials from Botswana, Lesotho, Malawi, Mozambique, Namibia, Seychelles, South Africa, Tanzania, Zambia, Zimbabwe attended. The agreed-upon goals of this GCP-2 training were: 1) to review the basic core knowledge and skills in GCP/inspection acquired during the GCP-1 workshop; 2) to apply these core skills in a small-group, hands-on full mock inspection exercise, including both oral and written reporting of the mock inspection; and 3) to develop teaching skills through use of a mentored team and team leader approach. By design, the GCP-2 Workshop began the process of training a first cadre of team leaders, who would guide their teams through a mock GCP inspection exercise, serve as intermediaries between faculty and team members, and acquire skills as trained trainers. The GCP-2 Workshop provided participants the opportunity to utilize the knowledge learned during GCP-I by conducting mock audits of clinical trial sites. The participants were broken into four teams led by participants from Botswana, South Africa, and Tanzania. FDA faculty assisted the team leaders in guiding their teams through the WHO’s 15 key activities in a clinical trial, as set forth in the WHO’s “Handbook for Good Clinical Research Practice: Guidance for Implementation.” Each team conducted a mock audit, presented their findings to the larger class, and is responsible for submitting a written mock inspection report a month after the workshop.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Discuss course content and logistics with SADC, Drug Regulatory Authority in Botswana and other key partners

3/1/2010

Completed 2/18/2010

B. Finalize a mutually acceptable date and the training site

3/31/2010

Completed 3/3/2010

C. Develop a cooperative agreement or other appropriate mechanism to define responsibilities associated with the training (e.g. fund cite cable, training materials, site location, contract, etc.)

5/7/2010

Completed 5/7/2010

D. Finalize a tool to assess the effectiveness of the training program

7/9/2010

Completed 7/9/2010

E. Conduct GCP training

8/16/2010 - 8/20/2010 or 9/20/2010 - 9/23/2010

Completed 10/15/2010

F. Evaluate success of training via assessment tool and participant feedback

11/22/2010

(4/30/2011)

Completed 5/27/2011

G. Agree on timing and content for second phase of GCP training for SADC

3/1/2011

Completed 2/6/2011

H. Agree on clinical trial protocols and training sites for GCP training

4/1/2011

Completed 5/30/2011

I. Conduct second phase of GCP training

8/26/2011 - 9/2/2011

Completed 8/26/2011 – 9/2/2011

Footnotes

  • As projects progress, approaches and strategies can change including the milestones listed under each project. In instances where approaches and strategies change and milestones and dates are affected, the revised milestone date will be provided in italics under the original milestone date.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.