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GOOD CLINICAL PRACTICE IN EAST AFRICA: A REVIEW
Abstract
Objective: To call for harmonisation of good clinical practice guidelines in East Africa as one
of the necessary precedents to enhancing their quality and quantity in the region.
Data sources: There were two main sources of background information for this review. The
first was a series of articles discussing and documenting the harmonisation process in East
Asia and in Latin America. The other was a short survey conducted in Kenya in July 2000.
Study area selection: Most of the survey participants were drawn from the Kenya Medical
Research Institute (KEMRI) in Nairobi, Kisurnu and Kilifi with a few coming from the
vicinity of these areas.
Data processing and aitalysis: The survey tool was a fourteen page questionnaire seeking
information in various areas. These were: personal information, general clinical research
information, medical practitioners, clinical research experience, human subject participation,
sponsors, clinical trial supplies, investigator sites and general comments. Data entry was
performed in Microsoft Access@. Forty four researchers participated in a period of three
weeks. Data summaries and reports were performed in SASB.
Conclusion: The advancing capacity for clinical research in East Africa will be accelerated
by harmonising clinical research requirements and guidelines.
of the necessary precedents to enhancing their quality and quantity in the region.
Data sources: There were two main sources of background information for this review. The
first was a series of articles discussing and documenting the harmonisation process in East
Asia and in Latin America. The other was a short survey conducted in Kenya in July 2000.
Study area selection: Most of the survey participants were drawn from the Kenya Medical
Research Institute (KEMRI) in Nairobi, Kisurnu and Kilifi with a few coming from the
vicinity of these areas.
Data processing and aitalysis: The survey tool was a fourteen page questionnaire seeking
information in various areas. These were: personal information, general clinical research
information, medical practitioners, clinical research experience, human subject participation,
sponsors, clinical trial supplies, investigator sites and general comments. Data entry was
performed in Microsoft Access@. Forty four researchers participated in a period of three
weeks. Data summaries and reports were performed in SASB.
Conclusion: The advancing capacity for clinical research in East Africa will be accelerated
by harmonising clinical research requirements and guidelines.
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