Role of the Oncology Research Team

1. Role of the Oncology Research Team Carmen B. Jacobs, RN, OCN, CCRP

2. Oncology Research Team • Clinical Research Associate/ Research Nurse • Nurse/ Resident • Pharmacist • Support Staff (administrative) • Data Manager / Data Entry Clerk • Trial Participant, according to GCP

3. Clinical Research Associate / Research Nurse • The role can be the same depending on the structure of the program. • Clinical Manager • Research Nurses • Research Manager • Clinical Research Associates • Regulatory Staff

4. Duties of the CRA or RN • Screens for potential candidates • Determines eligibility • Aids in consent process • Schedules patient contacts, appointments, develop personalized study calendar • Reviews treatment orders • Documents adverse events – monitors patients symptoms • Instructs patient on QOL questionnaires

5. Duties of the CRA or RN • Follows study parameters and assess for any treatment modifications needed • Avoids any deviations or violations to the protocol • Liaison between the patient and the physician investigator • Assures compliance with IRB, FDA, GCP, NIH and cooperative groups / sponsor requirements

6. CRA / Research Nurse • Wright and colleagues • Patients first approached by a physician vs. a CRA, and then those patients whose decision was solicited by a CRA vs. a physician were more likely to enter a clinical trial. • Wright, et al. JCO 22(21) 2004: 4312-4318

7. CRA / RN Role • Plays a role on patient’s perception of the clinical trial • assesses any communication or education barriers • explains the clinical trial in a language the patient can understand • establishes trust between the patient and the research team

8. CRA / RN • protocol compliance • Clinical trials related communication • Informed consent process • Management of clinical trial patients • Documentation • Patient recruitment • Ethical issues • Financial implications • Professional development

9. Resident • A medical resident can also act as a CRA, while taking care of patients that are participating in a clinical trial. • He/ she could be instrumental in assessing together with the physician investigator the side effects and toxicities caused by the investigational drug.

10. Pharmacist • Reviews and standardizes treatment protocol • Adjusts dosing for changes according to the protocol • Logs and monitors use of IND agents • Maintains study drug for patients • Drug accountability and inventory • Assures accurate blinding procedures • Participates in IRB and hospital pharmacy committees

11. Data Manager / Data Entry clerk • submits data collected by the research nurse or CRA (paper or electronic) • checks for accuracy of data to be submitted • assists with the accurate and timely submission of adverse events and serious adverse events as mandated by the FDA • ships all pathology specimens to sponsor as required

12. Data Manager / Data Entry clerk • Meets with monitors for pharmaceutical trial • Prepares for cooperative group audits • Schedules monitor visits

13. Support Staff (administrative) • manages daily operations • coordinates financial paper work • completes budgets and contracts • manages all grant activities • marketing • staff education • Standard operating procedures updates and overview • Accrual reports

14. CRA Coordinator / Manager • Supervises program / CRAs • Budgets, cost accounting, financial planning • Negotiates contracts with sponsors • Physician investigator liaison • Maintains list of open protocols, consents and eligibility • Schedules and monitors initiation and auditing visits by study sponsors

15. CRA Coordinator / Manager • Assures compliance with IRB, FDA, GCP, NIH and other government or sponsor requirements • Monitors regulatory documents ( C.V.s, lab normals and certifications (CLIA), financial disclosures, 1572).

16. Trial Participant • The most important person in the clinical trial is the patient. • There should be concern to not directly bias patients or families. • Informed consent process documentation should show there was no coercion and that the patient was provided all information necessary for an informed consent. • Emphasis on safe patient care.

17. “Kind words can be short and easy to speak, but their echoes are truly endless.” Mother Theresa