Meredith Mealer, RN, CCRN
Research Supervisor
Senior Research Coordinator
Emory University School of Medicine, Division of Pulmonary, Allergy, and Critical Care

Introduction:

If clinical research is an area of interest that you are trying to explore in the critical care environment, a lot of thought must go into the planning phase for a successful outcome. Whether your research is NIH funded or industry-sponsored, the bottom line for meeting research goals is patient enrollment. To do this, you need a competent and reliable research coordinator. A research coordinator must possess a variety of personality and interpersonal characteristics such as organization, efficiency, initiative, attention to detail, and commitment to having a productive working relationship with your team of investigators, ancillary staff, and patients/families.

Before hiring a research coordinator, decide on the type of clinical research you plan to conduct. A critical care nurse is probably the best choice but if your research does not involve highly technical skills in the intensive care unit (ICU) environment, other candidates can be considered such as non-ICU nurses, critical care pharmacists, respiratory therapists or physicians in training. A critical care nurse has valuable experience and knowledge regarding pathophysiology and disease processes common to the ICU patient population. In addition, the critical care nurse is often quite accomplished in procedural skills that may be needed to execute study protocols in the ICU. These skills include procedures such as drawing blood from venous or arterial lines, administering intravenous (IV) medications, placing peripheral IV lines, and Swan-Ganz catheter interpretation. In addition, proficiency with standard ICU equipment including bedside monitors, IV pumps, and mechanical ventilators is extremely important. Two additional qualifications to consider in a critical care nurse being considered for a coordinator are critical care registered nurse (CCRN) certification and prior experience conducting clinical research. CCRN certification is sponsored by the American Association of Critical Care Nurses (AACN) and involves passing an examination in neonatal, pediatric and/or adult critical care nursing. Certification is renewed every two years and requires 100 hours of continuing education in the critical care field. This commitment denotes dedication and expertise in critical care nursing. To find out more information about CCRN certification, visit the AACN website at www.aacn.org. Prior experience with clinical research is also very helpful because it provides a knowledge base to draw on when dealing with regulatory demands required by the local institutional review board (IRB) and in industry-sponsored studies. This experience is also helpful when dealing with the process of obtaining informed consent and ensuring that grant billing procedures are performed accurately.

Getting a Study Started:

There has been a steady increase in the regulatory documentation required for clinical research. Most local IRB's require both research coordinators and investigators to complete some form of human subjects education prior to official involvement in a study. This education program consists of mandatory coursework including the history and ethical principles involved in clinical research, basic IRB regulations and review processes, the informed consent process, research involving protected populations, FDA regulated research, HIPAA and Human Subjects Research, and conflicts of interest in research involving human subjects. After human subjects education has been completed, the research coordinator can begin the process of IRB approval for each study being conducted. IRB approval involves completing an initial submission form (ISF) provided by the local IRB office. At some institutions, the ISF is signed by the department head and division chief and must be accompanied by a protocol, an informed consent, lay summary, investigational brochures, and any advertisements to the IRB for committee approval (refer to Table 1).

The research coordinator may be responsible for drafting the informed consent document (ICD). If a study is industry-sponsored, a template for the ICD is usually provided that in turn must be modified with the specific language required by your local IRB. If a study is NIH-funded, or otherwise not sponsored by industry, the research coordinator must draft the ICD using the IRB guidelines and language. Once IRB approval is granted (a process that usually takes weeks) the screening process, recruitment, and enrollment can begin. If you work for a university system with more than one hospital affiliation, a separate approval process may take place at each hospital. This process usually requires the submission of additional documentation with the principal investigator's signature as well as the department head's signature from each hospital. The study protocol is again reviewed by a specialized research committee in each hospital and granted approval. Renewals are generally required annually; however, if the research is considered "high risk", the IRB office may require renewal more frequently.

Enrolling Patients:

Screening is the first step to enrolling patients in a study and involves reviewing patient charts, lab results, and radiology results to determine if the patient meets the criteria for enrollment. The screening process is often time consuming but is an important component to insure appropriate patient enrollment and integrity of the study results. After enrollment begins, the research coordinator must keep the IRB informed of serious adverse events (SAE's) that occur with the study and the study patients. If a study is industry-sponsored with multicenter enrollment, the IRB also wants to know about SAE's occurring outside of your institution as well as recommendations made by the Data Safety Monitoring Board (DSMB) assigned to review the study. The SAE process involves standardized form(s) generated by your IRB office and by the industry sponsoring the study (where applicable). Information is collected about the likelihood of the SAE being caused by a study-related procedure, medication, or treatment. If the study is industry-sponsored and involves a drug or device, the SAE report is required within 24 hours of the study team being notified of the event. If the study is not industry-sponsored, the IRB office usually sets guidelines for notification requirements. In each case, supporting documentation including lab results, radiology results, medications received, and a narrative including a time line from hospital admission until the event occurred must accompany the SAE form when submitted. The study coordinator is also required to report modifications to the IRB in a timely fashion, including adding or deleting study personnel, protocol amendments, consent changes, increases in enrollment requests, adding new procedures, adding or deleting a site, changes in funding, and advertisement approvals. If your site is participating in multiple studies, both NIH- and industry-sponsored, additional staff may be needed to keep up with all of the regulatory documentation. Refer to table 2 for a list of important regulatory agencies and their web links.

Table 2

After Enrollment:

Industry-sponsored studies have an extra layer of documentation and regulation that must be considered when hiring a research coordinator and budgeting time. Since industry-sponsored studies usually involve a drug or a device, a detailed case report form (CRF) is required for each patient enrolled. The CRF captures information that is updated on a daily basis such as patient history, inclusion/exclusion criteria, hemodynamic monitoring, study procedure start and stop times, adverse events (AE's), SAE's, and patient outcomes. This is a very detail-oriented process that requires extensive review of the patients' medical records and diagnostic reports. A clinical research associate (CRA) employed by the sponsor of the study will visit your site to monitor the case report forms. Monitoring the CRFs includes comparing the patient's medical record with the information recorded in the CRF. At the same time, the regulatory binder for the particular study will be examined for completeness. The regulatory binder includes documents such as the study protocol, protocol amendments, CV's and licenses of investigators, site training, lab licenses and certificates, and correspondence with the sponsor. After the CRA has monitored the CRF and examined the regulatory binder, the research coordinator will make the necessary changes in the CRF where discrepancies were found. The CRA will be at your site for up to a week depending on the number of patients that have been enrolled. Although this can be very time consuming, it prepares your site for potential FDA audits. An audit is a systematic and independent examination of study related activities and documents to determine whether the evaluated study related activities were conducted, and the data were recorded, analyzed, and accurately reported according to protocol, the sponsor's standard operating procedures (SOP's), good clinical practice (GCP), and all the applicable regulatory requirements were followed.

In addition to working with CRAs from Industry sponsored studies, the Research Coordinator will also potentially interact with pharmacy, lab, and radiology to successfully implement a study. The Research Coordinator and Investigator will work together to ensure that the appropriate patients are being enrolled into a study and that the protocol is being followed correctly. The investigator will also supervise the overall conduct of the study. The Research Coordinator will communicate with the investigational pharmacist, if applicable, prior to IRB and contract approval. The pharmacist will calculate a budget for storing, preparing, and dispensing the study drug to help the investigator decide if the study budget needs are appropriate to account for pharmacy fees. He/she will also need time to in-service staff on the protocol and the proper dispensing of the study drug. The lab and radiology will also need to be aware of the protocol if their departments will be used for diagnostic tests required in the study. This is usually done prior to enrolling the first patient and involves negotiating the budget, as described above, and setting up a billing system so that a grant or specified budget can be billed instead of the patient.

Informed consent needs to be obtained from the patient or the patient's surrogate prior to initiating any study procedures. Oftentimes in the ICU setting, the research coordinator and/or investigator are the first person(s) the patient and family members have had the opportunity to talk to in depth about the reason for the patient's illness. Because of this, the coordinator spends a lot of time answering general questions about the ICU and why the patient is in the ICU before the consent issue is even raised. Once the consent form has been signed and the patient is enrolled, it is still worthwhile to update the patient/family members daily on the study and answer any questions they might have. The nursing staff in the units where patients are recruited and enrolled will play an important role in the execution of the study protocol. They must be familiar with the medications and devices that will be used, how they function, and how they are administered. This will require frequent in-services for the nursing staff and supervision by the Research Coordinator when patients are enrolled. Depending on the protocol and the timing of events, the investigator may choose to have the Research Coordinator administer the study medication, perform device measurements, and draw appropriate lab work to ensure that the strict timing guidelines specified in a study protocol are followed without burdening the patient's ICU nurse.

Finally, after completion of a study, all study related documents must be kept in a secure location to protect confidentiality. To comply with HIPPA regulations, only de-identified information should be used when creating and analyzing a database or writing an abstract or manuscript. A separate list should be maintained and secured that contains information such as patient name and contact information, in the event that new information regarding the study has become available about which the patient needs to be informed.

Benefits of the Position:

After considering the type of research that you will be conducting and the qualifications that you would like the research coordinator to have, it is important to understand the benefits that this position will provide to a research coordinator. These salient points will help "sell" the position to nurses who may have reservations because of salary issues. RN's working in the ICU can often negotiate higher salaries because of their experience and because of the shortage of critical care nurses. Also, RN's in large metropolitan areas can take advantage of working for an agency, traveling contract, and/or an institution's registry, all of which yield attractive salaries. The downside of this, however, is that the RN is subjected to long hours, forfeiture of benefits, and the uncomfortable unfamiliarity of working in several institutions. The position of research coordinator provides a stable, overall less stressful environment that allows for professional growth in the critical care field. The position offers a flexible schedule which is a benefit to nurses who have small children or are interested in pursuing an advanced degree through continuing education. The coordinator also enjoys the benefits of attending specialty critical care conferences, receiving support to pursue independent investigations of interest, and attaining skills that are unique and highly marketable. ICU nurses that are accustomed to shift work will have to adapt to viewing their position as a profession. The Research Coordinator, on occasion, will have to come back to the hospital after hours, make frequent calls to the ICU when a patient is enrolled, stay at the hospital later than normal to complete enrollment, and potentially come in on a weekend to carry out study procedures on patients already enrolled.

In conclusion, the role of a critical care research coordinator can be very complex, requiring the coordinator to draw on prior experiences and specialized knowledge of the ICU. In addition to his/her clinical experience and expertise, the coordinator must also possess an organized and detail-oriented personality to navigate the evolving regulatory requirements. Finding the appropriate person for this position will help ensure that quality clinical research is being performed in your institution as well as providing a productive and rewarding career for the research coordinator.