U18BTT7002 PRECLINICAL AND
CLINICAL REGULATORY AFFAIRS
W3: MODULE 1: S4
GCP, CRF & INFORMED CONSENT
Mrs. Veerabhuvaneshwari Veerichetty
Department of Biotechnology
ASYNCHRONOUS SESSION LINKS
Scope of Clinical Research & I) NPTEL-GCP I) https://www.youtube.com
History of clinical research II) Courseera- GCP /watch?v=BntTcZT5Z5M&f
Good Clinical Practices (GCP) III) CONDUCTING CLINICAL eature=emb_logo
TRIALS II) https://
www.youtube.com/watch?
v=PP7IoOaOc2U&feature=
emb_logo
Good Clinical Practice (GCP)
A standard for the Design, Conduct, Performance, Monitoring,
Auditing, Recording, Analyses, and Reporting of clinical trials
that provides assurance that the data and reported results are
credible and accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected.
THE PRINCIPLES OF ICH GCP
Clinical trials should be conducted in accordance with the
ethical principles that have their origin in the Declaration of
Helsinki, and that are consistent with GCP and the applicable
regulatory requirement(s).
Before a trial is initiated, foreseeable risks and inconveniences
should be weighed against the anticipated benefit for the
individual trial subject and society. A trial should be initiated and
continued only if the anticipatedbenefits justify the risks.
THE PRINCIPLES OF ICH GCP
The rights, safety, and well-being of the trial subjects are the
most important considerations and should prevail over interests
of science and society.
The available nonclinical and clinical information on an
investigational product should be adequate to support the
proposed clinical trial.
Clinical trials should be scientifically sound, and described in a
clear, detailed protocol
THE PRINCIPLES OF ICH GCP
A trial should be conducted in compliance with the protocol
that has received prior institutional review board
(IRB)/independent ethics committee (IEC) approval/ favorable
opinion.
The medical care given to, and medical decisions made on
behalf of, subjects should always be the responsibility of a
qualified physician
THE PRINCIPLES OF ICH GCP
Each individual involved in conducting a trial
should be qualified by education, training, and
experience to perform his or her respective
task(s).
Freely given informed consent should be
obtained from every subject prior to clinical trial
participation.
All clinical trial information should be recorded,
handled, and stored in a way that allows its
accurate reporting, interpretation and verification.
INSTITUTIONALREVIEW BOARD/INDEPENDENT ETHICS
COMMITTEE (IRB/IEC).
INVESTIGATOR.
SPONSOR
CLINICAL TRIAL PROTOCOL AND PROTOCOL
AMENDMENT(S)
INVESTIGATOR’S BROCHURE
ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A
CLINICAL TRIAL
INSTITUTIONAL REVIEW BOARD /INDEPENDENT
ETHICS COMMITTEE (IRB/IEC)
Purpose & Responsibilities
Documents obtain to review.
Composition, Functions and Operations
Procedures
Records
INVESTIGATOR
Investigator's Qualifications and Agreements
Adequate Resources
Medical Care of Trial Subjects
Communication with IRB/IEC
Compliance with Protocol
Investigational Product(s)
Randomization Procedures and Unblinding
Informed Consent of Trial Subjects
Records and Reports
Progress Reports
Safety Reporting
Premature Termination or Suspension of a
Trial
Final Report(s) by Investigator
SPONSOR
• An individual, company, institution, or organization
which takes responsibility for the initiation,
management, and/or financing of a clinical trial.
INVESTIGATOR’S BROCHURE
The Investigator's Brochure (IB) is a compilation of the
clinical and nonclinical data on the investigational
product(s) that are relevant to the study of the
product(s) in human subjects
CLINICAL TRIAL PROTOCOL AND PROTOCOL
AMENDMENT(S)
General Information
Back ground information
Trial objective & Purpose
Trial Purpose
Trial Design
Selection & withdrawal of subjects
Treatment of subjects
Assessment of efficacy
Assessment of safety
Statistics
Direct access to source data & Documents
Quality control & quality assurance
Ethics
Data handling and record keeping
Financing & Insurance
Publication Policy
Supplements
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CLINICAL TRIAL PROTOCOL
INFORMED CONSENT
