The document provides an overview of ICH (International Conference on Harmonization) and GCP (Good Clinical Practices) guidelines, emphasizing their role in ensuring the ethical and scientific quality of clinical trials. It outlines the responsibilities of various parties involved, including investigators, sponsors, and review boards (IRB/IEC), and highlights the importance of informed consent and quality assurance. Key documents required for compliance and monitoring throughout the clinical trial process are also discussed.

1. ICH GCP Guidelines
Overview
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2. Agenda
• What is ICH & GCP
• Principles of ICH & GCP
• IRB & IEC
• Investigator
• Sponsor
• Clinical trial Protocol
• Investigator brochures & Essential documents

3. What is ICH & GCP
“The International Conference on Harmonization -
Technical Requirements for Registration of
Pharmaceuticals for human use.”
 Unifying regulatory authorities & pharmaceutical
industry
 Geographies - Europe, Japan and the US
 Discuss scientific and technical aspects of drug
registration.

4. GCP – Good Clinical Practices
“International quality standard that is provided by ICH”
 Ethical and Scientific quality standard
 For designing , conducting, recording and
reporting trials
 Provides public assurance that the rights, safety,
confidentiality and wellbeing of trial subjects are protected
 Consistent with the principles of the Declaration of
Helsinki (developed by World medical Association)
 It’s a statement of ethical principles for medical research
involving human subjects, including research on
identifiable human material and data

5. Principles of ICH-GCP
Ethical Principles-Applicable regulatory
requirements
Foreseeable risks Vs. Anticipated benefits
Adequate clinical & non clinical information of
an investigational product
Trial should be in compliance with the protocol
that received prior approval from IRB & IEC

6. Principles of ICH-GCP contd.
Medical decisions – Qualified physician
Personnel Conducting trials – Qualified by education, training &
experience
Freely given ICF from every subject prior to trial participation
Investigational product –GMP practice – quality assurance
All information- recorded, handled, and stored that allows
accurate reporting, interpretation & verification

7. IRB & IEC
 IRB- Institutional Review Board is an independent
body constituted of medical, scientific & non scientific
members
 IEC-Independent Ethics Committee (A review
board/committee/regional/national) an independent
body constituted medical/non medical members
 Responsible to ensure protection of rights, safety &
wellbeing of human subjects involved in a trial
 IRB/IEC should obtain following documents-trial
protocol(s) amendments, Written ICF, Advertisements,
Investigator brochure, payment info & CV of
investigator.

8. IRB & IEC
 Composition & Functions
 At least 5 members(1 member-non scientific area & 1 member
independent of the institution/trial site)
 Perform its function according to written operating procedures.
 Review a proposed trial in a reasonable time and document its
view.
 Approval/Modification/disapproval/termination
 Should comply with GCP & applicable regulatory requirements
 Notification in writing trial related decisions, reasons, procedures,
for appeal
 Retain trial records for 3 years

9. Investigator
 Responsible for the conduct of the clinical trial qualified by
education, training, & experience.
 Thoroughly familiar with correct use of investigational products
described in protocol
 Aware of & comply with GCP & applicable regulatory requirements
 Adequate resources
 Medical care of the trial subjects
 Communication with IRB/IEC
 Compliance with protocol
 Investigational product(s)
 Randomization procedures/ unblinding

10. Informed consent -process
In obtaining & documenting informed consent, investigator
should comply with applicable regulatory requirement(s),
adhere to GCP
Prior approval from IRB/IEC
Neither investigator nor trial staff coerce or unduly
influence the subject to participate in the trial.
Language used in written ICF should be non technical,
practical & understandable in their own language.
If both the subject and their legally accepted
representative are unable to read, an impartial witness
should be present during discussion.

11. Informed consent discussion
Purpose of trial
Trial treatments & procedures
Subject’s responsibilities, Foreseeable risks/in
conveniences
Alternative procedure/treatment, Compensation/treatment
in event of trial related injury
Voluntary participation
Prior to participation in trial, subject should receive a copy
of signed and dated written IC form

12. Records & reports
Accuracy, completeness, legibility & timeliness of data
Data reported on CRF that are derived from source documents
should be consistent
Any correction to a CRF should be dated, initiated and explained
Essential documents should be retained until at least 2 years
Submission of trial status, All SAE,s should be reported immediately
to IRB/IEC
Premature termination promptly informed to sponsor, IRB/IEC
Final reports- A summary of trial outcome

13. Sponsor

14. Monitoring
The act of overseeing the progress of a clinical trial, and of ensuring that it is:
 Conducted
 Recorded
 And reported
In accordance with
 The protocol
 Standard operating procedures (SOP’S)
 Good clinical practice (GCP) and
 Applicable regulatory requirements
Trial monitoring is an integral component of trial quality assurance process, and critical for
GCP fulfillment.

15. Monitor’s Responsibilities
Ensure that the trial is conducted and documented properly
Acting as the main line of communication between sponsor and
investigator
Verifying
 The investigator’s qualification
 Investigational products
 Following the approved protocol
 ICF, Investigator’s brochure,
 Source documents, trial records are accurate, complete, timely,
legible, dated, accuracy & completeness of the CRF

16. Audit
“A Systematic and independent examination of trial
related activities and document to determine”
 Whether the evaluated trial related activities were
conducted
 The data were recorded, analyzed, & accurately
reported according to the protocol, sponsor SOP’S,
GCP, applicable regulatory requirements
 Purpose of a sponsor’s audit is to evaluate the trial
conduct & compliance with quality systems & SOPs
,protocol, and GCP.

17. What to Audit?
 Organization and personnel
 Qualification, training, & adequacy of staff
 List of monitors
 Quality management systems
 Investigational drug
 IRB/IEC
 Investigators & sub investigators
 Essential documents

18. Clinical trial Protocol
General &
Background
info
Objective
Protocol
Trial design
Selection &
Withdrawal
of subject
Treatment
Record
keeping
Safety
Quality
control
assessment

19. Investigator
brochures

20. Essential documents
 Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of
the data produced.
 Documents are grouped in to three sections
1. Before the clinical phase of the trial commences
2. During the clinical conduct of the trial
3. After the completion or termination of the trial

21. Before trial During the trial After trial completion
IB, Signed protocol &
IB updates, Any
amendments
revision(protocol)
Investigational products
accountability
ICF
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IRB/IEC Approval Documentation of IP
destruction
Financial aspects Regulatory authority
notifications
Subject identification
code list
Insurance aspects updates of CV Audit certificate
Signed agreement Updates of lab values Final trial closeout
monitoring report
IRB IEC approval Monitoring visit reports Treatment allocation &
decoding documentation
CV /Qualifications Signed ICF, Source
documents
Final report by
investigator to IRB/IEC,
regulatory authorities

22. Before trial During the trial After trial completion
Bio medical values Signed dated completed
CRF
Clinical study report
Medical/lab tests Notification of AE,SAE
Handling Investigational
products, shipment
Subject screening log,
identification code list
Investigational products
accountability
Pre trial monitoring, trial
initiation report
Interim/annual reports to
IRB/IEC

23. References
www.ich.org
ICH Topic E6(R1)- Guideline for good clinical practice
www.ppdi.com
www.clininvent.com
www.emaeuropa.eu
Apps.who.int

24. Q & A

25. Thank you!