ICH GCP Principles, Recent DCGI Recommendations and ICF Process - Video Recording

Dr. Shiva Murthy N.MBBS, MD, MBA, CEIM.
Head, Clinical Pharmacology Unit A CRO in New Delhi Area shivuindia@yahoo.com
This presentation is only for education purpose only. Not for commercial sale.
FUNDAMENTALS OF ICH GCP
compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com
Good Clinical Practice (GCP) is an

International Ethical and scientific Quality standard for Designing, conducting, recording and reporting trials that Involve the participation of human subjects.
Compliance with this standard provides

Public assurance that the Rights, safety and well-being of trial subjects are protected, Consistent with the principles that have their origin in the Declaration of Helsinki, and that the Clinical trial data are credible. compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com
The objective of this ICH GCP Guideline 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 guideline was 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).
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 anticipated benefits 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/Favourable opinion.
The medical care given to, and Medical decisions Made on behalf of, subjects Should always be the responsibility of a qualified physician or, When appropriate, of a qualified dentist.
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.
Not documented Means not done

The confidentiality of records That could identify subjects should be

Protected, Respecting the privacy and Confidentiality rules In accordance with The applicable regulatory requirement(s).
Investigational products should be

Manufactured, Handled, and Stored In accordance with Applicable good manufacturing practice (GMP).
They should be used

In accordance with the approved protocol.
Systems With procedures That Assure The Quality of Every Aspect of the Trial Should be Implemented.
RECENT ETHICAL CONCERNS
Clinical trials and many errors Nida Khan and HT Correspondent, Hindustan Times Indore/New Delhi, October 23, 2013 First Published: 02:07 IST(23/10/2013) | Last Updated: 13:21 IST(23/10/2013)
Amendments to Drugs and Cosmetic act 1940 Rule no 122 DAB GSR 63(E) 30th Jan 2013 Compensation in case of Injury or death during clinical trials Rule no 122 DAC GSR 63(E) 01st Feb 2013 Permission to conduct clinical trial Rule no 122 DD GSR 72(E) 8th Feb 2013 Regulation of IECs and their registrations
Harmonization in reporting of SAEs done F.No. 12-01/13-DC (Pt-13A ) Effective date 18.02.2013 - System of Pre-screening for submission of reports of
ANNEXURE-A - CHECKLIST FOR SUBMISSION OF SERIOUS ADVERSE EVENT REPORT (SAE) OCCURRING IN CLINICAL TRIAL SAEs to CDSCO
FORMULA TO DETERMINE THE QUANTUM OF COMPENSATION IN THE CASES OF SERIOUS ADVERSE EVENTS (SAEs) OF DEATHS OCCURRING DURING CLINICAL TRIALS
under the Chairmanship of DR. A K Agarwal the compensation amount will vary from
a minimum of Rs.4 lacs to a maximum of Rs.73.60 lacs depending on the age of the deceased and the risk factor.
However, in case of patients

whose expected mortality is 90 % or more within 30 days, a fixed amount of Rs. 2 lac should be given
Report of the prof. Ranjit Roy Chaudhury Expert Committee

To formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs July 2013
F.No.GCT/20/SC/Clin./2013 DCGI Dated 19/Nov/2013 Mandatory to Audio Video Recording of ICF process
Any Handy Cam can help to record the ICF process Minimum of two cameras should be available to capture simultaneous activities Operation method Two parts Study information sheet Group presentation and question and answer session Informed consent One to one discussion and final affirmation
Study information sheet

- 10-15 page document. Provides details of the study Group presentation - more than one patient/volunteer/subject can attend this presentation)
Informed consent Final affirmation of the subject and certify that he is in complete knowledge of the study and all queries are clarified. One to one presentation - this should be done one to one in presence of witness / guardian of the volunteer/subject/patient Witness also can be present in this meeting and sign the consent form for illiterate / minor/ vulnerable subjects
Both Group presentation One to one presentation Should be AV captured and stored indefinitely
Advantages
Saves investigators from future litigations Can act as evidence if the subject sues in court Provides transparency Protects vulnerable subjects from risk Protects industry from media and socialist false claims Sponsor should be paying for it
Disadvantage
Additional step and responsibility to do this work Maintain the confidentiality and long term storage Practical aspects of administration
Thank you

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Dr. Shiva Murthy N.MBBS, MD, MBA, CEIM.

Head, Clinical Pharmacology Unit A CRO in New Delhi Area shivuindia@yahoo.com

FUNDAMENTALS OF ICH GCP

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Good Clinical Practice (GCP) is an

Compliance with this standard provides

The objective of this ICH GCP Guideline is to provide a

THE PRINCIPLES OF ICH GCP

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Clinical trials should be conducted in accordance with the

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Before a trial is initiated,

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Each individual involved in conducting a trial should be Qualified by

To perform his or her respective task(s).

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

All clinical trial information should be

Allows its accurate

Not documented Means not done

The confidentiality of records That could identify subjects should be

Investigational products should be

They should be used

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

RECENT ETHICAL CONCERNS

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

However, in case of patients

Report of the prof. Ranjit Roy Chaudhury Expert Committee

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

Study information sheet

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

compiled by Dr. Shiva Murthy N, shivuindia@yahoo.com

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