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

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.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.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.Randomized, controlled trials represent the most definitive method to determine the effectiveness or ineffectiveness of a cancer intervention [1,2]. In addition, when meeting very rigid medical, scientific and ethical standards, they also represent "Good Medicine" (i.e. a standard of care) [2].Nowadays it is widely accepted that the design, implementation, coordination and analysis of modern clinical trials require a multidisciplinary specialist approach [3]. The basic research team includes the principal investigator, sub-investigators, clinical monitors (also called clinical research associates or "CRAs"), the data management team, statisticians, and a relatively recent position: the clinical research