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Published byVernon McCormick Modified over 9 years ago
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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.
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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)
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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….
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Successful Clinical Trial Principal Investigator Collaborators Data Management Pharmacy Sponsor Regulatory Nursing
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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.
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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.
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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
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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
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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
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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
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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
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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
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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
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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
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Clinical Research Associate May or may not be a nurse Responsibilities vary – Regulatory compliance – Data management – “research nurse”
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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
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A Multidisciplinary Approach To increase awareness of clinical trials as treatment options Increase participation Increase patient’s trust in the system
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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.)
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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”
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GRACIAS GRACIAS
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