What makes a successful Principal Investigator of a Clinical Trial Craig Pfister, BS, CCRP Temple Un - PowerPoint PPT Presentation

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What makes a successful Principal Investigator of a Clinical Trial Craig Pfister, BS, CCRP Temple Un


Academic Health Center. IRB. Sponsored Projects. Additional Committees. Research Subjects ... Review the commitments of the principal investigator that must be ... – PowerPoint PPT presentation

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Title: What makes a successful Principal Investigator of a Clinical Trial Craig Pfister, BS, CCRP Temple Un

What makes a successful Principal Investigator of
a Clinical Trial?Craig Pfister, BS, CCRP
Temple UniversityNovember 16, 2004
  • What measures success?

The Clinical Trial A Collaborative Relationship
  • Good Clinical Science
  • Good Statistical Design
  • Sound Ethical Conduct
  • Integrity Quality
  • Understanding the roles and responsibilities of
    the Sponsor, Investigator, and Regulatory

  • Study Sponsor
  • In house Study Team
  • Medical monitor
  • Study Management
  • Clinical Research Associate
  • Investigative Site
  • Principal Investigator
  • Research Coordinator

Research Subjects
  • Academic Health Center
  • IRB
  • Sponsored Projects
  • Additional Committees

  • Review the commitments of the principal
    investigator that must be adhered to when
    implementing a clinical trial consistent with the
    ICH/GCP guidelines.
  • Identify the roles and responsibilities of the
    principal investigator during the conduct of a
    clinical trial.
  • Describe 3 ways the principal investigator can
    influence the research process to better protect
    human research participants.

Principal Investigator Responsibilities
  • Responsibilities are assigned by federal
    regulations and ethical conduct
  • 21 CFR 50 Protection of Human Subjects
    Informed Consent
  • 21 CFR 56 Institutional Review Board
  • 21 CFR 312, Subpart D Responsibilities of the
    Sponsor and Investigator

Investigator Responsibilities
  • CFR 312.60 General Responsibilities of
  • An investigator is responsible for ensuring that
    an investigation is conducted according to the
    signed investigator statement, the
    investigational plan, and applicable regulations
    for protecting the rights safety and welfare of
    subjects under the investigators care and for the
    control of drugs under investigation.

Investigator Responsibilities
  • A Serious Commitment
  • Statement of Investigator
  • Form FDA 1572
  • This is a legally binding document!

Investigator Responsibilities
  • 1572 is a legally binding agreement
  • Principal Investigator
  • Sponsor
  • Food and Drug Administration (FDA)
  • Ensure Protections for study participant

Ensure Accountability
Ensure Protections
Study participant
Statement of Investigator-1572
  • I agree to conduct the study(ies) in accordance
    with the relevant, current protocol(s) and will
    only make changes in a protocol after notifying
    the sponsor, except when necessary to protect the
    safety, rights, or welfare of subjects.
  • I agree to personally conduct or supervise the
    described investigation(s).
  • I agree to inform any patients, or any persons
    used as controls, that the drugs are being used
    for investigational purposes and I will ensure
    that the requirements relating to obtaining
    informed consent in 21 CFR Part 50 and
    institutional review board (IRB) review and
    approval in 21 CFR Part 56 are met.
  • I agree to report to the sponsor adverse
    experiences that occur in the course of the
    investigation(s) in accordance with 21 CFR

Statement of Investigator-1572
  • I have read and understand the information in the
    investigator's brochure, including the potential
    risks and side effects of the drug.
  • I agree to ensure that all associates,
    colleagues, and employees assisting in the
    conduct of the study(ies) are informed about
    their obligations in meeting the above
  • I agree to maintain adequate and accurate records
    in accordance with 21 CFR 312.62 and to make
    those records available for inspection in
    accordance with 21 CFR 312.68.
  • I will ensure that an IRB that complies with the
    requirements of 21 CFR Part 56 will be
    responsible for the initial and continuing review
    and approval of the clinical investigation....
  • I agree to comply with all other requirements
    regarding the obligations of clinical
    investigators and all other pertinent
    requirements in 21 CFR Part 312.

Investigator Responsibilities The Crux of
the Issue
  • Good
  • Clinical
  • Practices

Good Clinical Research Practices
  • What are GCPs?
  • Define the industry standards for researching and
    developing a new product regulated by the FDC
    Act and governed by FDA.
  • An international ethical and scientific quality
    standard adopted by industry for designing,
    conducting, monitoring, recording, and reporting
    trials involving human research participants
  • GCP standards have their origin in several
    milestone ethical principles

Good Clinical Research Practices
  • Why is compliance so important?
  • Yes, regulations are absolutely binding!
  • No, regulations are not difficult to follow!
  • Compliance with the GC(R)P standard provides
    public assurance that rights, well-being, and
    confidentiality of clinical participants are
    observed and consistently protected
  • Tarnished reputations are hard to reverse

Good Clinical Research Practices
  • Ethical/Scientifically Relevant Research
  • Participate in research trials designed with
    reputable scientific quality
  • Know the pre-clinical and clinical information of
    the investigational product
  • Regulatory Compliance
  • Prepare and obtain IRB approval prior to study
  • Submit regulatory documents to the sponsor (i.e.
    Investigator C.V./medical license, financial
    disclosure, 1572)
  • Maintain communication with the IRB and the
    sponsor for the duration of the study (i.e. IND
    Safety Letters, Annual Reports)

Good Clinical Research Practices
  • Qualified Staffing and Adequate Facilities
  • Allocate sufficient time to properly conduct the
  • Delegate study related tasks to qualified staff
    members and document
  • Confirm study staff understands and is competent
    to complete study related tasks
  • Medical decisions are always the responsibilities
    of a qualified individual
  • Subject Recruitment/Protection
  • Demonstrate, recruit, and enroll the appropriate
    subject population
  • Obtain valid informed consent from each study
    subject prior to study procedures
  • Respect study participants rights to not
    participate or to withdraw from a clinical trial
  • Ensure confidentiality of records that could
    identify the research subject

Good Clinical Research Practices
  • Study Conduct/Protocol Adherence
  • Conduct the study in compliance with the IRB
    approved study protocol
  • Complete comprehensive and accurate source
    documentation - that is legible!!!
  • Clinical trial information should always be
    recorded handled, and stored in a way that will
    afford and ensure accurate reporting monitoring,
    interpretation, and verification
  • Report and follow-up all adverse and serious
    adverse events experienced during the course of
    the study and at least 30 days after completion

Good Clinical Research Practices
  • Clinical Trial Documentation/Necessity
  • Report and follow-up all adverse and serious
    adverse events experienced during the course of
    the study and at least 30 days after completion
  • Ensure accuracy completeness and legibility of
    Case Report Forms (CRFs)
  • Retain essential documents until notified by the
    sponsor to destroy
  • Be compliant and cooperative with sponsor QA
    groups and regulatory authorities

Crossroads to Success
Do the
  • Awareness
  • Sensitivity
  • Application

right thing
Quality research
Investigator Responsibilities
  • Awareness
  • Responsibilities to the study participants
  • Responsibilities to the Institutional Review
  • Responsibilities to the sponsor
  • Responsibilities to the regulatory authorities
  • Responsibility to complete the trial following
    Good Clinical (Research) Practices (ICH/GCP)

Investigator Responsibilities
  • Sensitivity
  • Rights, safety, and well being of the research
  • Integrity to the conduct of the clinical trial
  • Importance for reporting AEs and SAEs
  • Quality of data produced is credible
  • Requirements of the IRB
  • Respectful to the confidential sensitivity in
    conducting clinical research (patient and
  • Initiatives of the regulatory authorities

Investigator Responsibilities
  • Application
  • Investigators must personally supervise all
    research activities
  • Implement study procedures that are safe and
    accommodating for study participants
  • Communicate progress of research activities with
    research participant, IRB, study staff, and
  • Accept absolute responsibilities for all study
    conduct at the investigative site

In Summary
  • The two primary goals of GCPs
  • To ensure the quality and integrity of the data
    obtained from clinical research.
  • To protect the rights and welfare of human
    research subjects participating in clinical

How can I impact the research process?
  • Awareness of the FDA regulations and
    GC(R)P guidelines
  • Sensitivity to the ethical conduct of
    clinical research
  • Application able to implement a clinical
    trial with an awareness and sensitivity to the
    clinical research process.

Clinical Trials-Outcome
  • Characterize the new drug by answering the
    following questions posed by the sponsor
  • Safety - are the side effects acceptable?
  • Tolerability - will the drug be taken?
  • Efficacy - Can the drug work?
  • Effectiveness - does the drug work under specific
  • Efficiency - does it provide sufficient value?

  • Craig J. Pfister, BS, CCRP
  • Temple University
  • Office Of Clinical Trials
  • cpfister_at_temple.edu
  • Phone 215 707-3106
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