ICH GCP Guidelines

Overview

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Agenda• What is ICH & GCP

• Principles of ICH & GCP

• IRB & IEC

• Investigator

• Sponsor

• Clinical trial Protocol

• Investigator brochures & Essential documents

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.

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

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

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

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.

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

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

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.

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

Records & reportsAccuracy, 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

Sponsor

MonitoringThe 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.

Monitor’s ResponsibilitiesEnsure 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

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.

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

Clinical trial Protocol

Protocol

General & Background

info

Objective

Trial design

Selection & Withdrawal of subject

Treatment

Safety assessment

Quality control

Record keeping

Investigator

brochures

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

Before trial During the trial After trial completion

IB, Signed protocol &

amendments

IB updates, Any

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

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

Referenceswww.ich.org

ICH Topic E6(R1)- Guideline for good clinical practice

www.ppdi.com

www.clininvent.com

www.emaeuropa.eu

Apps.who.int

Q & A

Thank you!