Principles & Practice
The Role of the Clinical Research Coordinator in Multicenter Clinical Trials

https://doi.org/10.1111/j.1552-6909.1997.tb02143.xGet rights and content

The clinical research coordinator plays a crucial role in organizing a site's participation in the expanding arena of multicenter medical and pharmacologic clinical trials. This summary clarifies the role of the clinical research coordinator for inexperienced staff members assuming these responsibilities and outlines planning procedures leading to successful implementation. Emphasis is placed on establishing an interdependent relationship with the principal investigator, careful protocol assessment, team building, and staff feedback. Useful tools such as study manuals and physicians' study orders are described.

Section snippets

CRC Qualifications

Before the late 1970s, CRC positions were rare (Kirchhoff, 1993) but steadily have increased in number. Organizations offer national conferences addressing the specific activities and needs of the CRC annually, and the Associates of Clinical Pharmacology (ACP) serves as a resource clearinghouse (The Associates of Clinical Pharmacology, 1012 14th St. N.W., Washington, DC 20005; 202–737–8100). The ACP offered its first certification examination in 1992 and estimates that approximately 850 CRCs

Salary Support

Salary support is available from a variety of federal, state, and private sources. New CRC positions often are funded on a grant-to-grant basis while the viability of the role is being evaluated. After an institution has made a commitment to research, it should convert the CRC role to a permanent, hospital-funded position as soon as possible; credibility, recruitment, and retention are enhanced by permanent status. When the hospital funds the CRC position, any grant funds received may be used

Protocol Assessment

The CRC’s responsibilities in this early stage of the process may vary from conceptualizing study design to implementing final protocol requirements. Ideally, the potential site will be involved in the study design phase. During this period, while the principal investigator reviews the protocol for scientific merit, the CRC can provide a perspective regarding the logistics of proposed study procedures. Protocol implementation should disrupt the hospital unit’s routines as little as possible.

Regulatory Affairs

Although the PI retains ultimate responsibility for the study, the CRC may assume accountability for many regulatory aspects. Major issues involve (a) compliance with quality assurance standards of the U.S. Food and Drug Administration and (b) initial review and approval of the protocol and consent by the hospital’s institutional review boafd (IRB). Sponsors of multicenter trials frequently distribute consent forms containing essential elements that each site may tailor to fit the requirements

Team Building

Because research studies can cause tension and lack of cooperation by certain staff members (Gunderson and Holditch-Davis, 1992, Lasoff, 1986), it is important to the success of the study to involve all hospital departments affected in any way as soon as possible. Introductory study meetings usually are more beneficial if they include working supervisors, instead of only department heads. The CRC or PI must convince the leadership staff of each department of the importance and relevance of the

Study Manuals

We prepare a study reference manual for involved staff and distribute copies to appropriate people and places, such as the nursing station in the neonatal intensive-care unit, the neonatology office, and the respiratory care department. This “cookbook” defines roles and outlines responsibilities for each category of staff participating in the study. It graphically illustrates, usually with flow charts, how study components fit together and protocol requirements are met (see Figure 1, Figure 2,

Preprinted Physicians’ Orders

To assure protocol compliance, typed physicians’ orders should be prepared for use with all study patients. This system saves time for interns and residents and promotes clarity and consistency in patient care. Because these orders become a permanent part of the patient’s medical record, they are approved by our Medical Records Forms Committee before implementation of each study.

Staff Orientation

The CRC and, when possible, the PI attend the orientation sessions for each involved department to explain briefly the overall study and focus on that department’s specific responsibilities. The presence of the PI at these sessions confirms his or her involvement, interest, and support. We believe it is crucial to attend meetings at times convenient for staff on all shifts to emphasize the study’s importance and to ensure that as many staff members as possible have the opportunity to ask

Patient Recruitment

The CRC, with assistance from the PI and other departments, must plan a comprehensive, workable, patient recruitment program. Specific details of the plan will vary depending on protocol eligibility criteria, but daily chart screening of newly admitted patients often is required. To avoid bias, every eligible patient must have the opportunity to participate in the study and the reasons for nonenrollment must be tracked. In some protocols, extra effort must be exerted to recruit patients from

Feedback

Even if cooperation and enthusiasm are generated from participating departments before the study starts, constant positive reinforcement and feedback are essential in maintaining this spirit and keeping the staff actively involved. Ongoing dialogue allows the staff to voice concerns and clarify issues (Cronenwett, 1986b, Gunderson and Holditch-Davis, 1992, Lasoff, 1986). In the update section of the study manual, we include not only protocol changes but also information about enrollment across

Study Results

Final results of the study should be shared with the staff as soon as they are released by the study sponsor or presented at scientific meetings. Findings can be announced at staff meetings or special sessions and included in hospital newsletters. Hospital staff always are interested in seeing printed abstracts and articles about the completed study; they are particularly gratified when their contributions are acknowledged in print. If study results are positive, it is crucial to clarify how

Conclusion

In our experience, the key to success has been a truly interdependent relationship between the PI and CRC. Each must understand, respect, and support the other. The CRC cannot successfully “make the study happen” without the full support of the PI; likewise, the PI cannot maintain adequate control of the study without diligent attention from the CRC.

As with all research, planning yields better performance and results. Although every eventuality cannot be anticipated, foresight combined with a

Acknowledgment

Supported by a Research Centers in Minority Institutions award, P20 RR/AI11091, from the National Center for Research Resources, National Institutes of Health.

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