Operationalizing the Role of the Protocol Coordinator in a Clinical Research Setting

In an adult oncology day hospital in the Washington metropolitan area that has over 10,000 patient visits annually system for introducing new protocols to ensure safety, integrity, and efficiency of data collection was established. The adult oncology day hospital nurses are clinical research nurses (CRN) specialized in the administration of chemotherapy/biotherapy agents to patients. Nurses in the day hospital balance patient care needs and the requirements of the research process.

The role of the protocol coordinator is defined as an experienced CRN who assumes the responsibilities as the nursing specialty team leader for a group of patients, based on a set of related protocols within a patient care unit. The volume and variety of protocols seen in the day hospital necessitated the expansion of this role to include a “lead protocol coordinator” to manage this complexity and volume of research protocols.

The lead protocol coordinator grouped each protocol seen in the DH by disease entity and assigned a nurse to each disease grouping. The lead protocol coordinator developed the expectations and responsibilities for each population-specific protocol coordinator and trained each nurse on the expectations of the role. Each population specific protocol coordinator after training serves as the liaison between the research team and the day hospital nurses. The population-specific protocol coordinator serves as a protocol expert regarding protocol requirements and amendments, including drug administration, protocol time points, side effects, and adverse events.

A protocol impact query system was developed to promote protocol accountability and continuity of care. The protocol impact query system assesses resource needs, educational needs, and skills required prior to launching any new protocol in the day hospital setting. This query ensures that day hospital nurses are kept up to date on study requirements to promote patient safety and clinical quality and strict adherence to maintaining protocol integrity. Actualization of the role provides a systematic, coordinated method for administering clinical trials in a demanding outpatient setting. The impact query form is now used exclusively throughout the oncology service as a means of communicating new protocol prior to implementation.

The success of this process will be determined by its replication in other clinics or day hospitals. This process can be applied to an ambulatory area with multiple protocols and it is vital to the success of protocol implementation and integrity.