OVERVIEW OF ICH-GCP GUIDELINES

Introduction
 Historical background
 Sections
 Principles
 Ethics committee
 Responsibilities of sponsor, investigator and monitor
 Investigator brochure
 Informed consent process
The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines provide internationally recognized standards for the design, conduct, monitoring, recording, analysis, and reporting of clinical trials involving human subjects. These guidelines aim to ensure that the rights, safety, and well-being of trial participants are protected and that the clinical trial data generated is credible and reliable.
Key components of the ICH-GCP guidelines include:

Investigator Responsibilities: The guidelines define the responsibilities of the investigator, who is typically a qualified physician overseeing the conduct of the trial at a study site. This includes ensuring that the trial is conducted in compliance with the protocol, maintaining the confidentiality of participant data, and reporting adverse events and other relevant information promptly.

Ethics Committee/Institutional Review Board (IRB) Oversight: The guidelines stress the importance of independent ethics committees or IRBs in reviewing and approving the trial protocol, providing ongoing oversight, and protecting the rights and well-being of trial participants.

Informed Consent: The guidelines emphasize the importance of obtaining informed consent from each trial participant. Informed consent is a process that involves providing participants with relevant information about the trial, its purpose, potential risks and benefits, and any alternative treatments, enabling them to make an informed decision about participation.

Safety Reporting: The guidelines outline procedures for monitoring and reporting adverse events and any other safety concerns that arise during the course of the trial. Safety reporting ensures that potential risks to participants are identified and communicated appropriately.

Data Integrity: The guidelines emphasize the need for accurate and reliable data collection, recording, and reporting. This includes maintaining source documents and case report forms, as well as implementing data quality control measures.

Quality Assurance and Quality Control: The guidelines highlight the importance of quality assurance and quality control measures to ensure that the trial is conducted in compliance with the protocol, applicable regulations, and Good Clinical Practice.

Monitoring of Clinical Trials: The guidelines stress the need for systematic monitoring of the trial's progress to ensure that it is conducted in compliance with the protocol, applicable regulations, and Good Clinical Practice. Monitoring activities may include on-site visits, source data verification, and assessment of trial conduct.
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Overall, the ICH-GCP guidelines provide a framework for the ethical and scientific conduct o

1. Overview Of ICH –GCP Guidelines
Presented by:
Aditya Malan
M.Pharmacy (pharmacology)
Roll no -22
Presented To :
DR MANJUSHA CHAUDHARY
(Clinical Research and pharmacovigilance)
INSTITUTE OF PHARMACEUTICAL SCIENCES
KURUKSHETRA UNIVERSITY

2. CONTENT
Introduction
Historical background
Sections
Principles
Ethics committee
Responsibilities of sponsor, investigator and monitor
Investigator brochure
Informed consent process

3. Good Clinical Practices (GCP)
It is an international scientific and ethical quality standard for designing
conducting , recording, reporting trails that involve the participation of
human beings and ensure the rights, safety and well –being of the trail
subjects is protected.
Results in producing the data of higher quality and up to global
standards .

4. The International Conference On
Harmonization (ICH-GCP)
the objective of ICH GCP guidelines is to provide a unified standard for
the European union (EU), japan and the united states to facilitate the
mutual acceptance of clinical data by the regulatory authorities in these
jurisdictions.
The guidelines were developed with consideration of the current good
clinical practices of the European union, japan, and the united states as
well as those of Australia , Canada , the Nordic countries and the world
health organization (WHO).

5. HISTORY GCP GUIDELINES

6. 8-SECTIONS OF ICH-GCP GUIDELINES

7. Glossary of various terms
Adverse drug reaction and adverse event.
Case report form and clinical study report
Coordinating committee and contract research
Independent ethics committee and institutional review board
Investigator and investigator brochure
Monitoring and monitoring report
Protocol and protocol amendment
Serious adverse event
Source data and source documents
Standard operating procedure
Vulnerable subjects

8. Principles of ICH-GCP
1.Clinicaltrailsshouldbeconductedinaccordancewiththeethicalprinciplesthathave
theirorigininthedeclarationofHelsinki,andthatconsistentwithGCPandthe
applicableregulatoryrequirements.
2.Beforeatrailisinitiated,foreseeablerisksandinconveniencesshouldbeweighedagainst
theanticipatedbenefitfortheindividualtrailsubjectandsociety.Atrailshouldbe
imitatedandcontinuedonlyiftheanticipatedbenefitsjustifytherisks.
3.Theright,safetyandwell-beingofthetrailsubjectsarethemostimportant
considerationsandshouldprevailoverinterestsofscienceandsociety.
4.Theavailablenonclinicalandclinicalinformationonaninvestigationalproductandshould
beadequatetosupporttheproposedclinicaltrail.
5.Clinicaltrailsshouldbescientificallysound,anddescribedinaclear,detailedprotocol.
6.Atrailshouldbeconductedincompliancewiththeprotocolthathasreceivedprior
intuitionalreviewboard(IRB)/independentethicscommittee(IEC)approval/favorable
opinion.

9. 7.Themedicalcaregiveto,andmedicaldecisionsmadeonbehalfof,subjectsshouldalwaysbetheresponsibilityofa
qualifiedphysicianor,whenappropriate,ofaqualifieddentist.
8.Eachindividualinvolvedinconductingatrailshouldbequalifiedbyeducation,trainingandexperiencetoperform
hisorherrespectivetasks.
9.Freelygiveninformedconsentshouldbeobtainedfromeverysubjectpriortoclinicaltrailparticipation.
10.Allclinicalinformationshouldberecorded,handledandstoredinawaythatallowsitsaccuratereporting,
interpretationandverification.
11.Theconfidentialityofrecordthatcouldidentifysubjectsshouldbeprotected,respectingtheprivacyand
confidentialityrulesinaccordancewithapplicableregulatoryrequirements.
12.Investigationalproductsshouldbemanufactured,handledandstoredinaccordancewithapplicablegood
manufacturingpractice(GMP).Theyshouldbeusedinaccordancewiththeapprovedprotocol.
13.Systemswithprocedurethatassurethequalityofeveryaspectofthetrailshouldbeimplemented.

10. ETHICS COMMITTEE RESPONSIBLITIES
1.To protect the dignity , rights and well beings of research participants.
2.To ensure that universal ethical values and international scientific
standards are followed.
3.To assist in the development and the education of a research community
responsive to local health care requirements.
COMPOSTION
1.Chairperson
2.1-2 basic medical scientists(preferably one pharmacologists).
3.1-2 clinicians from various institutes
4.One legal experts or retired judge
5.One social scientist/ respresentive of non-government voluntary agency
6.One philosopher/ ethicist
7.One lay person from the community
8.Member secretary

11. SENSOR RESOPNSIBLITIES
REVIEW
CONFIRMATION
by IRBs
INVESTIGATIONAL
PRODUCTS
FINANCINGINVESTIGATION
CRO Medical expertise
TRAIL DESIGN
AND
MANAGEMENT
QUALITY
ASSURANCE

12. INVESTIGATOR RESPONSIBILITIES
Familiar with
investigational
products
Comply with
GCP and
regulatory
requirements
Investigational
products
Adequate
resources
Randomization
procedure/
unblinding
Medical care
of the trail
subjects
Communication
with IRB/IEC
Compliance
with protocol
Serious adverse
events

13. CLINICAL TRAIL PROTOCOL
GENERAL AND
BACKGROUND
INFO
TREATMENT
SAFETY
ASSESSMENT
OBJECTIVE
QUALITY
CONTROL
TRAIL DESIGN
RECORD
KEEPING
SELECTION AND
WITHDRWAL
OF SUBJECT

14. INVESTIGATORS BROCHURE
The investigators brochure is compilation of the clinical and
non-clinical data on the investigational products that are
relevant to the study of the products in human subjects.
Its purpose is to provide the investigators and other involved
in the trail with information to facilitate their understanding
of the rationale for, and their compliance with , many key
feature of the protocol, such as the dose, dose frequency/
interval, methods of administration and safety monitoring
procedures.

15. INFORMED CONSENT PROCESS
The PI discusses the trails risks, benefits and other aspect with potential
participants and if required, the participants legal representative, before
the trail begins.
The PI gives the potential ample time and opportunity to ask questions
about the trial and discuss it with relatives and family members.
If potential participant decides to get involved in the trail, he or she
provides voluntary consent by signing and dating the written informed
consent document of which he or she also receives a copy. The
participant has the right to withdraw consent at any time without
penalty repercussions or reason.

16. Significance In Clinical Trail Workings
Harmonization of standards for protecting the rights safety and well-
being of human subjects.
Minimization of the human exposure to harmful medical products.
Clinical trail data quality improvement.
Prevention of duplication of the clinical trails, resulting in reduced cost of
treatment.

17. Thank you….