Transcript Oncology Research Team

Role of the Oncology Research
Team
Carmen B. Jacobs, RN, OCN, CCRP
Oncology Research Team
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Clinical Research Associate/ Research Nurse
Nurse/ Resident
Pharmacist
Support Staff (administrative)
Data Manager / Data Entry Clerk
Trial Participant, according to GCP
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
Duties of the CRA or RN
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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
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
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.
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Wright, et al. JCO 22(21) 2004: 4312-4318
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
CRA / RN
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protocol compliance
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Patient recruitment
2.
Clinical trials related
communication
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Ethical issues
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Financial implications
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Professional development
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Informed consent process
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Management of clinical trial
patients
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Documentation
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.
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
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
Data Manager / Data Entry clerk
• Meets with monitors for pharmaceutical trial
• Prepares for cooperative group audits
• Schedules monitor visits
Support Staff (administrative)
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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
CRA Coordinator / Manager
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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
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).
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.
“Kind words can be short and easy
to speak, but their echoes are truly
endless.”
Mother Theresa