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 1.protocol compliance 2.Clinical trials related communication 3.Informed consent process 4.Management of clinical trial patients 5.Documentation 6.Patient recruitment 7.Ethical issues 8.Financial implications 9.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