GCP & Informed Consent

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 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
 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
 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
13
CLINICAL TRIAL PROTOCOL
INFORMED CONSENT

GCP & Informed Consent

Uploaded by

Copyright:

Available Formats

GCP & Informed Consent

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

GCP & Informed Consent

Uploaded by

Copyright:

Available Formats

U18BTT7002 PRECLINICAL AND

CLINICAL REGULATORY AFFAIRS

Scope of Clinical Research & I) NPTEL-GCP I) https://www.youtube.com

A standard for the Design, Conduct, Performance, Monitoring,

 Clinical trials should be conducted in accordance with the

 Before a trial is initiated, foreseeable risks and inconveniences

 The available nonclinical and clinical information on an

Clinical trials should be scientifically sound, and described in a

 A trial should be conducted in compliance with the protocol

 The medical care given to, and medical decisions made on

 Freely given informed consent should be

 All clinical trial information should be recorded,

Purpose & Responsibilities

• An individual, company, institution, or organization

You might also like