1. Role of the Oncology Research Team Carmen B. Jacobs, BS, RN,OCN, CCRP U.T.M.D. Anderson Cancer Center Houston, Texas U.S.A.

2. 2003 ASCO Study An ASCO study completed in 2003: – Physicians account for 9% of overall time required to conduct a clinical trial – Nurses account for about 30% – Data managers for about 30% – CRA (may or may not be a nurse)

3. Principal Investigator Oversees all aspects of the clinical trial – Protocol design – Recruitment – Data collection – Analysis and interpretation of results  Some tasks can be and are delegated….

4. Successful Clinical Trial Principal Investigator Collaborators Data Management Pharmacy Sponsor Regulatory Nursing

5. The Research Team The P.I. is responsible for ensuring all research team members have appropriate education, training and qualifications to assume the delegated tasks.

6. The Research Team All study team members are responsible for ensuring that the conduct of the study is compliant with institutional, state, federal and industry guidance and regulations.

7. Collaborators (Sub or Co-Investigator) Responsibilities: o May perform all or some of the PI functions o Does not have primary responsibility for the research study o Under the supervision of the PI o Responsible for performing study-related procedures o Makes important study-related decisions in compliance with the ethical conduct of the study

8. Investigational Pharmacy Responsibilities o Proper storage and handling of study drugs o Preparation of study drugs o Dispensing study drugs o Study drug accountability o study drug destruction/return according to sponsor and/or institution’s guidelines

9. Infusion Nurse Responsibilities o Administers the medication as ordered by physician, according to protocol o Documents administration of medication, including start and stop dates and time o Assesses and documents patient’s side effects, adverse events o Patient teaching on side effects

10. Regulatory Coordinator Responsibilities: o Drafting or editing the protocol document and submitting new protocols, amendments, continuing (annual) reviews and safety reports to the IRB for review o Maintaining regulatory binders in accordance with sponsor specifications and general industry standards o Keeps delegation of authority (responsibilities) log

11. Data Coordinator Responsibilities: o Overall data management of the research study o Ensure accurate and timely data entry in electronic databases, electronic case report forms (eCRFs) or paper case report forms (CRFs) o Works closely with monitors and resolves any data queries that may be generated o Works closely with the research team in identifying key data points for collection and analysis and generating reports

12. Research Nurse Responsibilities o Coordinates the daily activities of clinical research studies o Works closely with the clinical team and investigator to ensure that all protocol required procedures and visits occur according to protocol specific guidelines o Manages participant enrollment o Ensures compliance with protocol and other applicable regulations

13. Research Nurse Ensures compliance: – Participant recruitment – Obtaining informed consent – Educating participants in the details of the research study – Assesses participant’s eligibility – Facilitates participant’s care and follow-up per protocol – Creates source documentation

14. Research Nurse Ensures compliance: – Assists in the assessment of the toxicities/adverse events and reporting serious adverse events per IRB and sponsor requirements – Teaches patient about prompt reporting of any new symptoms, side effects, adverse events

15. Clinical Research Associate May or may not be a nurse Responsibilities vary – Regulatory compliance – Data management – “research nurse”

16. CRA / RN Main source of interaction with patients on study Influence patient enrollment Establishment of trust Speak the “language” of the patient Responsibilities vary according to his/her role

17. A Multidisciplinary Approach To increase awareness of clinical trials as treatment options Increase participation Increase patient’s trust in the system

18. Participant – Responsibilities: Voluntary informed consent Keep the protocol required doctor visits, tests, etc. Report any side effects or new symptoms Communicate with research staff (nurse, study coordinator, etc.)

19. Good Clinical Practice Remember: The participant is the reason to conduct the clinical trial Per WHO Guidelines for Good Clinical Practice: “To protect the rights, safety, and well-being of humans participating in clinical research”

20. GRACIAS GRACIAS