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Building a Strong Research Team. Melissa Adde, INCTR. 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

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building a strong research team

Building a Strong Research Team

Melissa Adde, INCTR

INCTR

2005

what do we mean by a strong research team
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

INCTR

2005

good clinical practice gcp
Good Clinical Practice (GCP)

GCP is an international and scientific qualitystandard 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 areaccurate and credible

INCTR

2005

evolution towards standards of gcp
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)

INCTR

2005

how can the research team apply gcp
How Can the Research Team Apply GCP?
  • By being familiar with GCP
  • By knowing their roles and responsibilities in the conduct of clinical research

INCTR

2005

members of the research team at the site
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

INCTR

2005

principal investigator
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

INCTR

2005

qualifications of the pi
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

INCTR

2005

responsibilities of the pi
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

INCTR

2005

responsibilities of the pi11
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.

INCTR

2005

co investigators
Co-Investigators
  • Investigators who share responsibility or who have designated responsibilities that are determined by the PI

INCTR

2005

data manager
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

INCTR

2005

patients or research subjects
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”

INCTR

2005

institutional review board or ethical committee
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

INCTR

2005

other members of the research team
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

INCTR

2005

quality assurance
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)

INCTR

2005

conclusions
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

INCTR

2005

thank you
Thank You

INCTR

2005