medigraphic.com
SPANISH

Salud Pública de México

Instituto Nacional de Salud Pública
  • Contents
  • View Archive
  • Information
    • General Information        
    • Directory
  • Publish
    • Instructions for authors        
  • medigraphic.com
    • Home
    • Journals index            
    • Register / Login
  • Mi perfil

2003, Number 1

<< Back Next >>

salud publica mex 2003; 45 (1)

Coordination of international multicenter studies: Governance and administrative structure

Bangdiwala SI, De Paula CS, Ramiro LS, Muñoz SR
Full text How to cite this article

Language: English
References: 5
Page: 58-66
PDF size: 981.31 Kb.


Key words:

multicenter studies, organization and administration, epidemiologic studies, clinical trials.

ABSTRACT

A well-conducted multicenter study needs to assure standardization, uniformity of procedures, high data quality, and collaboration across sites. This manuscript describes the organization and dynamics of multicenter studies, focusing on governance and administrative structures among countries of diverse cultures. The organizational structure of a multicenter study is described, and a system for oversight and coordination, along with roles and responsibilities of participants in the multicenter study, are presented.The elements of a governance document are also reviewed, along with guidelines and policies for effective collaboration.The experience of an ongoing multi-country collaboration, the World Studies of Abuse in the Family Environment (World-SAFE), illustrates the implementation of these guidelines. It is essential that multicenter studies have an objective coordinating center and that the investigators jointly develop a written governance document to enable collaboration and preserve collegiality among participating investigators.


REFERENCES

  1. International Clinical Epidoiniology Network 2000; WorldSAFE and India SAFE. Studying the prevalence of family violence, Philadelphia (PA): INCLEN Monograph Ser ies on Critical International Health Issues No. 9.

  2. Mowery Williams OD. Aspects of clinic monitoring in large-scale multiclinic trials. Clin Pharmacol Ther 1979;25:717-719.

  3. Bangdiwala SI, Paton CC, jackson MR. Clinic monitoring in collaborative clinical studies. En:Okuno T, ed. Biometry. Clinical trials and related topics. Amsterdam: Excerpta Medica. 1988:37-46.

  4. Blumenstein BA, James Ke, Lind BK, Mitchell HE. Functions and organization of coordinating centers for multicenter studies. Controlled Clin Trials 1995;16:4s-29s.

  5. Parkins LL, Cutter GR, Wagenknecht LE, Savage PJ, Dyer AR, Birch R. Distributed data analysis in a multicenter study: The CARDIA Study. Controlled Clin Trials 1992; 13:80-90.




2020     |     www.medigraphic.com

Mi perfil

C?MO CITAR (Vancouver)

salud publica mex. 2003;45