Building a Strong Research

Team

Melissa Adde, INCTR INCTR

2005
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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2005
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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2005
 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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2005
 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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2005
 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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2005
 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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2005
 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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2005
 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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2005
 Co-Investigators
 Investigators who share responsibility or
who have designated responsibilities that
are determined by the PI

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2005
 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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2005
 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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2005
 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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2005
 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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2005
Thank You

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2005