accreditation of investigator, site and IRB

1. BY: MANISHA VERMA
16CRM 2488

2. Accreditation – the formal recognition by an independent body,
generally known as an accreditation body, that the certification body
operates according to standards.
Accreditation- process to improve the quality of ethical research.
a) Institute ethics committees
b) Principal investigators
c) Centers desirous of carrying out clinical trials.
INTRODUCTION

3. Benefits for Subjects
Benefits for Sites
Benefits for Regulatory bodies
Benefits for Site Staff

4. highest possible standards and protections
assurance of quality
improves efficiency, effectiveness
Government recognition

5.  sole non-governmental organization in USA, which was established to promote accreditation as a way
to improve the quality of research and protect research participants.

7. OBJECTIVE: EC is adequately qualified, experienced, and
knowledgeable in ethical issues and applicable rules and regulations for
conduct of clinical trials ensuring scientific integrity and protection of
subject rights, safety and wellbeing.
OUTCOME:
1. EC competently assesses risk and scientific validity of trials.
2. EC has appropriate measures to ensure protection of subject rights,
safety and wellbeing.
3. There shall be transparency in EC functioning and procedures are
followed for all essential activities.

8. 1.1 Authority for formation of Ethics Committee
1.2 Standard Operating Procedures (SOPs)
1.3 Ethics Committee Composition
1.4 Protection of subject rights, safety and wellbeing
1.5 Administrative support
1.6 Review Process
1.7 Decision making and post meeting activities
1.8 Monitoring
1.9 Self-Assessment
1.10 Record keeping and archival

9.  OBJECTIVE: Investigators are adequately qualified, experienced and knowledgeable
in trial processes, ethical issues and applicable rules and regulations for conduct of
clinical trials ensuring data integrity and protection of subject rights, safety and
wellbeing.
 OUTCOME:
1. Clinical trial conduct is ethical and in compliance with the applicable rules and
regulations.
2. There are appropriate measures to ensure protection of subject rights, safety and
wellbeing.
3. There is transparency in the conduct of clinical trials and documented procedures
are followed by the investigators/relevant site staff for all essential activities.

10. 2.1 Qualification, Experience and Training
2.2 Compliance to standard operations procedures (SOPs)
2.3 Protection of subject rights, safety and wellbeing
2.4 Informed consent process
2.5 Safety Reporting and Management
2.6 Clinical Trial documents and materials
2.7 Clinical Trial Conduct

11.  OBJECTIVE: Clinical Trial Sites shall have adequate infrastructure, facilities,
documented procedures and oversight mechanism to support clinical trial conduct as
per applicable rules and regulations ensuring trial integrity and protection of subject
rights, safety and wellbeing.
 OUTCOME:
1. Clinical Trial conduct must be ethical and in compliance with the applicable rules
and regulations.
2. There are appropriate measures to ensure protection of subject rights, safety and
wellbeing.
3. There is transparency in the conduct of Clinical Trials and documented procedures
are available and followed by accredited investigators associated with the clinical
trial site.
4. There is an oversight mechanism by the Clinical Trial Site to maintain the ethical
and quality standards.

12. 3.1 Responsibility of management for the Clinical Trial Site(s)
3.2 Qualification, Experience and Training
3.3 Site SOPs and documented procedures
3.4 Protection of subject rights, safety and wellbeing
3.5 Clinical Trial materials, documentation and IT systems
3.6 Clinical Trial Oversight

13. Full Accreditation
Qualified Accreditation
Accreditation-Pending
Accreditation Withheld

14. Full Accreditation
Reaccreditation-Pending
Probation
Accreditation Revoked