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8uiIding o Sfrong Peseorch

Teom
Melissa Adde, INCTR
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hof Do e Meon by o Sfrong

Peseorch Teom7
Research Team A group oI people working
together in a systematic and scientiIic
manner to establish Iacts
$9rong Research Team Committed to
applying the principles oI Good Clinical
Practice (GCP) in clinical research that may
have an impact on the saIety and well-being
oI human subjects
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ood CIinicoI Procfice (CP)

GCP is an international and scientiIic 6:ali9
s9andard Ior designing, conducting, recording and
reporting trials that involve the participation oI
human subjects
Compliance with GCP provides p:-lic ass:rance
that the rights, saIety and well-being oI trial
subjects are protected, consistent with the
Declaration oI Helsinki, and that the clinical trial
da9a and repor9ed res:l9s are acc:ra9e and
credi-le
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hy Do e Meed CP7
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;oIufion Towords Sfondords

of CP
International concern Ior the protection oI
human subjects has increased
Historical inIluences
Need Ior research to advance medical
knowledge
UniIied to Iacilitate mutual acceptance oI
clinical data by regulatory authorities
(1996)
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ow Con fhe Peseorch Teom

AppIy CP7
y being Iamiliar with GCP
y knowing their roles and responsibilities
in the conduct oI clinical research
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Members of fhe Peseorch

Teom of fhe Sife
Principal Investigator
Co-Investigators or Associate Investigators
Clinical Research Coordinator -?
Data Manager
Clinical Pharmacist - ?
Statistician - ?
Patient
IR
Regulatory odies
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PrincipoI In;esfigofor
Also known as the PI
An individual who actually conducts the
clinical trial
Is the leader oI the research team at the site
Is responsible Ior the conduct oI the study
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"uoIificofions of fhe PI
An appropriately qualiIied person (MD,
PhD, Pharm D, nurse)
Trained and experienced in clinical research
Familiar with the background oI the study
and the requirements oI the study
Has high ethical standards and proIessional
integrity
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PesponsibiIifies of fhe PI
btain IR approval oI the
protocol and inIormed consent
prior to initiation oI study
Enroll eligible patients
btain inIormed consent Irom
patients or parents/guardians oI
children
bserve, measure and
document all eIIects oI study
(response, AEs, etc)
Record all data pertinent to
study
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PesponsibiIifies of fhe PI
Evaluate, manage (treat) all toxicities
Report toxicities as speciIied in protocol
Submit protocol changes or amendments to the
IR Ior approval
NotiIy IR oI any issues that pose a threat to the
welIare oI the patients on the study
Maintain study documentation and make this
available Ior data veriIication (per study set up)
Comply with all procedures speciIied in protocol
in accordance with GCP.
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Co-In;esfigofors
Investigators who share responsibility or
who have designated responsibilities that
are determined by the PI
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Dofo Monoger
Ensuring that the CRFs are completed accurately
and that supporting source documentation is
available
PerIorms data entry into the study database (iI
perIormed at the site level) and ensures that the
data entered mirrors data recorded on CRFs.
Responsible Ior the quality (data is accurate,
veriIiable) and integrity oI data
Works closely with the PI
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Pofienfs or Peseorch
Subjecfs
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 reIerred to research subject,
patient or study participant
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InsfifufionoI Pe;iew 8oord

or fhicoI Commiffee
Reviews, approves the initiation oI, and
conducts periodic review oI biomedical
research involving human subjects
Purpose to assure protection oI the rights and
welIare oI human research subjects
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fher Members of fhe

Peseorch Teom
Clinical Research Coordinator
May be a dual role Ior research nurse or data manager
Key liaison between PI, patients, IR and data center
Study implementation expert manages all aspects oI the study
Manages critical study documentation (record keeping) and data
collection
Clinical Pharmacists
Drug accountability
Statisticians
Design, analysis and reporting oI results
Governmental Regulatory odies
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"uoIify Assuronce
Planned and systematic actions that are
established to ensure
Trial is perIormed in compliance with Good
Clinical Practice (GCP)
Data are generated, documented and reported in
compliance with GCP
All members oI the Research Team have
QA responsibilities (Sponsor, PI, Data
Managers)
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ConcIusions
Strong Research Teams
Know their responsibilities in the context oI
clinical research
Strive to meet the high standards oI GCP in
order to provide public assurance that the
W Rights, saIety and well-being oI patients are
PRTECTED
W Data is ACCURATE
W Reported results are CREDIE
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Thonk You