REQUIREMENTS FOR QUALITY CLINICAL RESEARCH AS IT PERTAINS TO CLINICAL INVESTIGATORS - PowerPoint PPT Presentation

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REQUIREMENTS FOR QUALITY CLINICAL RESEARCH AS IT PERTAINS TO CLINICAL INVESTIGATORS

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Test Article Accountability. Record Retention. Disqualification of Clinical Investigators ... Test article. Protocol. Obligations. Authority Delegated ... – PowerPoint PPT presentation

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Title: REQUIREMENTS FOR QUALITY CLINICAL RESEARCH AS IT PERTAINS TO CLINICAL INVESTIGATORS


1
REQUIREMENTS FOR QUALITY CLINICAL RESEARCH AS IT
PERTAINS TO CLINICAL INVESTIGATORS
  • ANTHONY A. CHARITY
  • CONSUMER SAFETY OFFICER (Investigator)
  • PHILADELPHIA DISTRICT OFFICE
  • FOOD and DRUG ADMINISTRATION
  • FEBRUARY 23, 2001
  • Temple University Clinical Research Conference

2
OUTLINE
  • Clinical Investigators Responsibility
  • Investigators Statement
  • Compliance
  • FDA Regulations and Guidelines
  • Authority Administration
  • Protocol
  • Subject Records
  • Consent
  • IRB
  • Sponsor
  • Test Article Accountability
  • Record Retention
  • Disqualification of Clinical Investigators
  • Clinical Investigator Deficiency

3
CLINICAL INVESTIGATORSRESPONSIBILITY
  • To ensure that studies are 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 test article under investigation.

4
INVESTIGATORS STATEMENT
  • A signed Form FDA 1572 that contains
  • Name and address of the investigator
  • Name and code number of the protocol
  • Name and address of the facility in which the
    study is being conducted
  • Name and address of any clinical laboratory
  • Facilities used in the study

5
INVESTIGATORS STATEMENT
  • STATEMENT (continued)
  • Name and address of the IRB responsible for
    reviewing and approving the study
  • A commitment by the investigator (Section 9) to
  • conduct the study in accordance with current
    protocol
  • comply with all requirements regarding their
    obligations

6
INVESTIGATORS STATEMENT
  • STATEMENT (continued)
  • personally conduct or supervise the study
  • inform any potential subjects that the test
    article being used is for investigational
    purposes
  • report to the sponsor adverse experiences that
    occur in the course of the study

7
INVESTIGATORS STATEMENT
  • STATEMENT (Continued)
  • ensure that all associates, colleagues, and
    employees assisting in the conduct of the
    study(ies) are informed about their obligations
    in meeting the above commitments.
  • List of names of the sub-investigators who will
    be assisting the investigator in the study

8
INVESTIGATORS STATEMENT
  • STATEMENT (continued)
  • Will promptly report to the IRB all changes in
    the research study and all unanticipated problems
    involving risks to human subjects or others, and
    will not make any changes in the study without
    IRB approval

9
COMPLIANCE
  • Objective to assure the integrity of data
    submitted to FDA and to determine that the
    welfare of human and animal subjects are
    adequately protected.
  • FDA Regulations and Guidelines
  • FDA Audits

10
FDA REGULATIONS
  • Authority administration
  • Protocol
  • Subject records
  • Consent
  • IRB
  • Sponsor
  • Test article accountability
  • Record Retention

11
AUTHORITY ADMINISTRATION
  • CI training provided by the Sponsors Monitor
  • Test article
  • Protocol
  • Obligations
  • Authority Delegated
  • Names addresses of facilities performing
    laboratory testing

12
PROTOCOL
  • Maintain original
  • Unchanged
  • Changed (amendments)
  • a. must be documented by the CI
  • b. must be dated
  • c. maintained with the original
  • d. reported to the sponsor
  • e. approved by the IRB

13
SUBJECT RECORDS
  • Raw data (source records)
  • Adequate documentation
  • Study subjects did exist and were alive during
    the study.
  • Case report forms should reflect same data as the
    source records.

14
SUBJECT RECORDS (continued)
  • Clinical lab testing
  • Adverse reactions and deaths
  • Concomitant therapy and/or intercurrent illnesses
  • Subject dropouts
  • Subjects loss to follow-up
  • Subjects who completed the study

15
CONSENT FORM
  • Original form
  • actual form used
  • approved by IRB
  • Consent must be obtained prior to subject entry
    into study
  • Written must conform with 21 CR 50
  • Verbal must conform with 21 CFR 50

16
INSTITUTIONAL REVIEW BOARD (IRB)
  • Name, address and chairperson
  • Standard Operating Procedures used to ensure
    compliance
  • Maintain copies of all reports submitted to the
    IRB and reports of all actions by the IRB
  • Prior approval
  • Protocol
  • Modifications to the protocol
  • Subject consent
  • Media ads for patient/subject recruitment

17
SPONSOR
  • A copy of the IRB approved consent form
  • Periodic reports
  • Deaths and adverse reactions
  • Intercurrent illness and/or concomitant therapy
  • Case Report Forms
  • Dropout and Lost to follow-up reported

18
  • TEST ARTICLE ACCOUNTABILITY
  • Authority
  • Accountability Procedures
  • Storage Area
  • Test Article Returned

19
RECORDS RETENTION
  • Custody Access
  • Retained for Specified Time

20
FDA AUDITS
  • From the field perspective, this is not an
    attempt to scientifically evaluate the data or
    protocols, but to assure the integrity of the
    data submitted to FDA

21
DISQUALIFICATION OF CLINICAL INVESTIGATORS
  • Submitted to FDA or to the sponsor false
    information in any required report.
  • a. an explanation is offered but not accepted
    by
  • the CDER or CBER
  • b. Regulatory hearing
  • c. Commissioner
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