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Quality System Documentation for Research Ethics Clinical Effectiveness Unit Division, PS & MD 2005. BACKGROUND HK has no Statute specifically on clinical research Ethical oversight relies on Professional self-discipline Administrative control of academia & healthcare providers.

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slide1

Quality System Documentation forResearch EthicsClinical Effectiveness UnitDivision, PS & MD 2005

slide2

BACKGROUND

  • HK has no Statute specifically on clinical research
  • Ethical oversight relies on
    • Professional self-discipline
    • Administrative control of academia & healthcare providers
ha policy consideration

Goal: To develop a sound ethical framework for clinical research

HA Policy Consideration
  • Protect research subjects (HA patients)
  • Uphold standard of research conduct among employees (& affiliated investigators)
  • Manage research-related liabilities
  • Ensure service priority
a survey at 2001

Insufficient enforcement mechanism

Performance did not meet ICH-GCP standard, a prerequisite for international drug trials

A Survey at 2001

29 Hospital Ethics Committees

< half had operating guideline

only 2 regularly met to vet application

< 1/3 vet indemnity document

No standard requirement on application dossier

Rely on EC secretaries to extract information from study protocols

No independent oversight of REC performance

slide7

Quality System Documentation

as the backbone of Research Ethics practice (& development) in HA

importance of documentation system
Importance of Documentation System

Enforceability

  • Internalize ethical principles & global best practices into explicit “HA standards”
  • Provide clear expectations on performance
  • Align system & process to policy
  • Assure consistent, impartial & transparent processes
  • Delineate ethical responsibilities
  • Facilitate communication, feedback, training & compliance oversight
importance of documentation system1
Importance of Documentation System
  • Internalize ethical principles & global best practices into explicit “HA standards”
  • Provide clear expectations on performance
  • Align system & process to policy
  • Assure consistent, impartial & transparent processes
  • Delineate ethical responsibilities
  • Facilitate communication, feedback, training & compliance oversight

Procedural justice

documentation promotes procedural justice

Practice point: Corrections made in document must be crossed out (still see through), initialled & dated

Documentation promotes Procedural Justice
  • Consistent, impartial & transparent procedures are the best guarantee for fair outcomes & to gain trust
  • Justice must be seen to be done
  • Standard of documentation must allow evaluation of the conduct of review & the quality of the decision reached
    • In audit, not documented ≡ not done
    • In dispute, intention is judged (inferred) objectively

必須有目共睹

importance of documentation system2
Importance of Documentation System
  • Internalize ethical principles & global best practices into explicit “HA standards”
  • Provide clear expectations on performance
  • Align system & process to policy
  • Assure consistent, impartial & transparent processes
  • Delineate ethical responsibilities
  • Facilitate communication, feedback, training & compliance oversight

Sharing ethical responsibilities

sharing ethical responsibilities
Sharing Ethical Responsibilities

Sponsors

Global references

Dept of Health

Medical Council

  • IDMC
  • Site audit

Research Organizations

HA’s

jurisdiction

Hospital Authority

CUHK, HKU

  • Policy & Standards
  • Compliance oversight
  • Training
  • Appeal (REC decision)

Medical Faculty

HA REC

Policy & requirements on research

Study Site Administration

Study Site Administration

  • Investigator privilege
  • Study site facilities
  • Clinical trial agreement
  • Indemnity agreement
  • Risk Mx, insurance
  • Handle complaints & malpractice

Non-teaching

hospitals

Teaching hospitals

University facilities

CU / HKU REC

Cluster REC

  • Gate keeping
  • Ethical review
  • Study oversight
  • AE oversight
  • Progress reports

Investigators

Investigators

Research subjects

Research subjects

HA

patients

Non-HA

patients

importance of documentation system3
Importance of Documentation System
  • Internalize ethical principles & global best practices into explicit “HA standards”
  • Provide clear expectations on performance
  • Align system & process to policy
  • Assure consistent, impartial & transparent processes
  • Delineate ethical responsibilities
  • Facilitate communication, feedback, training & compliance oversight

Compliance oversight & CQI

documentation enables compliance oversight
Documentation enables Compliance Oversight
  • REC’s performance is subject to monitoring
  • Annual inspection
    • Review REC operating procedures against HA standards & requirements
    • Random checking of records for compliance to HA standards & REC operating procedures
    • Interview staff on practices
  • Continuous improvement: corrective actions, revising standards, refresher training
slide16

HA REC

Cluster RECs

Research Subject

Protection

Investigators

Hospital

(Study Sites)

Administration

HA delivers research ethics through

by adopting a Quality System approach

slide18

Documents accommodate Different Obligations & Audience Perspectives

REC / IRB

  • Study oversight requires prompt SAE reporting to REC
  • Review all SAE reports
  • Alert HA REC if SAE demands study termination

Investigators

1. Study has measure for early detection

& Mx of possible adverse outcome

2. Inform participants affected (& their clinicians if indicated) & report to sponsors, REC, HA Legal Services & Regulatory Agency (if required by law)

e.g. on handling SAE

3. Update participants (& consent form) if the SAE is relevant to subjects’ willingness to participate

Study Sites

  • Ensure investigator competence
  • Administrative oversight & legal support
1 rec guide internalizing best practices
1. REC Guide (internalizing best practices)

Local standards & practices

  • Established by Cluster REC:
  • Guides operation
  • Enables audit

Cluster REC Standard Operating

Procedure & Forms

  • Established by HA REC:
  • HA-wide Standards
  • Guiding document for Cluster REC
  • Enables audit
  • Basis for harmonizing with CU & HKU

ICH GCP (E6)

Other references,

e.g. FDA IRB Guide

HA Guide for

Cluster REC

International

requirements

& practices

Applicable regulations

Professional Code & Conduct

HA policy

Declaration of Helsinki

Local requirements

2 study site guide
2. Study Site Guide
  • Institutes engaging in clinical research are obliged to:
    • Support REC
    • Control research privilege: investigator qualification, policy in granting access right to non-employees
    • Verify adequate facility & resource support for study & no undue influence on service
    • Undertake formal dealings with sponsor: indemnity agreement, clinical trial agreement
    • Manage risk: insurance, policy on collaboration with non-affiliated study sites
    • Handlecomplaint & misconduct
3 investigator s code of practice
3. Investigator’s Code of Practice
  • Has prime responsibility in protecting research subjects & be answerable to the institution. Investigator should:
    • qualify scientifically, i.e. proficient in the area of study
    • understand & willing to comply with regulatory, professional & institutional requirements on research
    • declare conflict of interest
    • abide by REC decisions
  • PI has overall responsibilityin technical, administrative & fiscal management of study
slide23

QS documentation is especially important for:

  • Large organization
  • Activities characterized by
    • high stake (narrow safety margin, serious consequences)
    • multi-parties involvement
    • labor intensive processes