The role of the clinical research coordinator – data manager – in oncology clinical trials

BMC Medical Research Methodology

Rafael Rosell¹  Carlos Camps²  Oscar Salamanca³  Antonio López-Alonso³  Juan-Luis Sanz³  Teresa Hernando³  Fernando Rico-Villademoros³ 

[1] Medical Oncology Service, Institut Català d'Oncologia, Hospital Germans Trias i Pujol, Ctra. Canyet s/n, 08916-Badalona (Barcelona), Spain;Oncology Department, Hospital General de Valencia, Avda Tres Cruces s/n, 46014-Valencia, Spain;Biometrica, Eloy Gonzalo 27, 28010-Madrid, Spain

关键词: Research Nurse;    Data Manager;    Clinical Research Coordinator;    Clinical Trial;    Cancer;    Oncology;   

Others  :  1143200
DOI  :  10.1186/1471-2288-4-6

 received in 2003-12-23, accepted in 2004-03-25,  发布年份 2004

【 摘 要 】

Background

The purpose of this study was to determine the standard tasks performed by clinical research coordinators (CRCs) in oncology clinical trials.

Methods

Forty-one CRCs were anonymously surveyed, using a four-page self-administered questionnaire focused on demographics, qualifications, and professional experience. The survey questions on responsibilities consisted of an ad-hoc 32-item questionnaire where respondents had to rate the frequency of involvement in the listed activities using a 3-point scale. We defined as "standard" a task that was rated as "in all or nearly all trials" by at least half of the respondents.

Results

A response rate of 90% (37 out of 41) was achieved after two mailings. Less than half of the respondents had received additional training in oncology, clinical research or Good Clinical Practices (GCP). Overall, all standard tasks performed by CRCs were in the category of "monitoring activities" (those usually performed by a Clinical Research Associate "CRA") and included patient registration/randomization, recruitment follow-up, case report form completion, collaboration with the CRA, serious adverse events reporting, handling of investigator files, and preparing the site for and/or attending audits.

Conclusions

CRCs play a key role in the implementation of oncology clinical trials, which goes far beyond mere data collection and/or administrative support, and directly contributes to the gathering of good quality data.

【 授权许可】

   
2004 Rico-Villademoros et al; licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original URL.

【 图 表 】

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