Abstract:
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.
journal_name
BMC Med Res Methodoljournal_title
BMC medical research methodologyauthors
Rico-Villademoros F,Hernando T,Sanz JL,López-Alonso A,Salamanca O,Camps C,Rosell Rdoi
10.1186/1471-2288-4-6keywords:
subject
Has Abstractpub_date
2004-03-25 00:00:00pages
6issn
1471-2288pii
1471-2288-4-6journal_volume
4pub_type
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