INCTR

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Building a Strong Research Team

• Melissa Adde, INCTR

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What Do We Mean by a Strong Research Team?

• Research Team A group of people working together
  in a systematic and scientific manner to
  establish facts
• Strong Research Team Committed to applying the
  principles of Good Clinical Practice (GCP) in
  clinical research that may have an impact on the
  safety and well-being of human subjects

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Good Clinical Practice (GCP)

• GCP is an international and scientific
  quality standard for designing, conducting,
  recording and reporting trials that involve the
  participation of human subjects
• Compliance with GCP provides public assurance
  that the rights, safety and well-being of trial
  subjects are protected, consistent with the
  Declaration of Helsinki, and that the clinical
  trial data and reported results are accurate and
  credible

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Why Do We Need GCP?
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Evolution Towards Standards of GCP

• International concern for the protection of
  human subjects has increased
• Historical influences
• Need for research to advance medical knowledge
• Unified to facilitate mutual acceptance of
  clinical data by regulatory authorities (1996)

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How Can the Research Team Apply GCP?

• By being familiar with GCP
• By knowing their roles and responsibilities in
  the conduct of clinical research

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Members of the Research Team at the Site

• Principal Investigator
• Co-Investigators or Associate Investigators
• Clinical Research Coordinator -?
• Data Manager
• Clinical Pharmacist - ?
• Statistician - ?
• Patient
• IRB
• Regulatory Bodies

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Principal Investigator

• Also known as the PI
• An individual who actually conducts the clinical
  trial
• Is the leader of the research team at the site
• Is responsible for the conduct of the study

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Qualifications of the PI

• An appropriately qualified person (MD, PhD, Pharm
  D, nurse)
• Trained and experienced in clinical research
• Familiar with the background of the study and the
  requirements of the study
• Has high ethical standards and professional
  integrity

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Responsibilities of the PI

• Obtain IRB approval of the protocol and informed
  consent prior to initiation of study
• Enroll eligible patients
• Obtain informed consent from patients or
  parents/guardians of children
• Observe, measure and document all effects of
  study (response, AEs, etc)
• Record all data pertinent to study

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Responsibilities of the PI

• Evaluate, manage (treat) all toxicities
• Report toxicities as specified in protocol
• Submit protocol changes or amendments to the
  IRB for approval
• Notify IRB of any issues that pose a threat to
  the welfare of the patients on the study
• Maintain study documentation and make this
  available for data verification (per study set
  up)
• Comply with all procedures specified in protocol
  in accordance with GCP.

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Co-Investigators

• Investigators who share responsibility or who
  have designated responsibilities that are
  determined by the PI

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Data Manager

• Ensuring that the CRFs are completed accurately
  and that supporting source documentation is
  available
• Performs data entry into the study database (if
  performed at the site level) and ensures that the
  data entered mirrors data recorded on CRFs.
• Responsible for the quality (data is accurate,
  verifiable) and integrity of data
• Works closely with the PI

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Patients or Research Subjects

• A human who participates in a clinical trial
• May be a healthy individual (as in prevention
  studies) or a patient with a disease
• May be referred to research subject, patient
  or study participant

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Institutional Review Board or Ethical Committee

• Reviews, approves the initiation of, and conducts
  periodic review of biomedical research involving
  human subjects
• Purpose to assure protection of the rights and
  welfare of human research subjects

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Other Members of the Research Team

• Clinical Research Coordinator
• May be a dual role for research nurse or data
  manager
• Key liaison between PI, patients, IRB and data
  center
• Study implementation expert manages all aspects
  of the study
• Manages critical study documentation (record
  keeping) and data collection
• Clinical Pharmacists
• Drug accountability
• Statisticians
• Design, analysis and reporting of results
• Governmental Regulatory Bodies

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Quality Assurance

• Planned and systematic actions that are
  established to ensure
• Trial is performed in compliance with Good
  Clinical Practice (GCP)
• Data are generated, documented and reported in
  compliance with GCP
• All members of the Research Team have QA
  responsibilities (Sponsor, PI, Data Managers)

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Conclusions

• Strong Research Teams
• Know their responsibilities in the context of
  clinical research
• Strive to meet the high standards of GCP in order
  to provide public assurance that the
• Rights, safety and well-being of patients are
  PROTECTED
• Data is ACCURATE
• Reported results are CREDIBLE

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Thank You