1. September Edition │Issue 2
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Dear Colleagues,
I extend to you all, my best wishes for the festive season. Congratulations to Harrison’s
Tech Consultants for the second issue of this newsletter. I feel this is an excellent medium
to share Industry updates and to communicate with it.
The government has released new regulations which has eliminated all but the serious
players. Over the last two years the trial numbers are increasing with NCEs and biosimilars
dominating the trial field. All the best and we hope you enjoy reading this and all editions
of HTC Scope.
Dr. Ravindra B. Ghooi
Scientific Technical Advisor,
Harrison's Tech Consultants
(A consensus DRAFT TEXT has been released for
internal and external consultation, and is open for
comments)
EU: Deadline for comments by 31 January 2016
MHLW: Deadline for comments by 30 September 2015
FDA: Deadline for comments by 31 January 2016
Read the whole addendum here:
http://www.ich.org/fileadmin/Public_Web_Site/ICH_Pr
oducts/ Guidelines/Efficacy/E6/E6_R2__Addendum_St
ep2.pdf
Section: Introduction
Following lines have been added regarding the purpose
of guideline.
"Since the development of the ICH GCP Guideline, …. In
these jurisdictions"
Section 1: Glossary
Section 1.11.1 Certified Copy Definition is added. "A
paper or electronic copy …. as the original.”
Section 1.38.1 Monitoring Plan definition is added
Section 1.39 Monitoring report definition has been
modified.
Section 1.60.1 Validation of computerized
systems definition is added.
Section 2: Principles of ICH GCP
2.1 All clinical trial information should be recorded,
handled, and stored in a way that allows its accurate
reporting, interpretation and verification.
Section 4: Investigator
In Section 4.2 Adequate
resources, 4.2.5 and 4.2.6 have been added.
4.2.5 The investigator is responsible for supervising
any individual or party to whom the investigator
delegates study tasks conducted at the trial site.
4.2.6 If the investigator/institution retains the services
of any party to perform study tasks they should ensure
this party is qualified to perform those study tasks and
should implement procedures to ensure the integrity
of the study tasks performed and any data generated.
In Section 4.9, Records and Reports, 4.9.0 has been
added which describes Sponsor's responsibility of
Source documents.
Section 5: Sponsor
A new section 5.0: Quality Management has been
added, which contains definitions of:
5.0.1 Critical Process and Data Identification
5.0.2 Risk Identification
5.0.2 Risk Identification
RegUpdate
Amendments in ICH E6 (R1) : E6 (R2) Guideline for GCP

2. September Edition │Issue 2
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5.0.3 Risk Evaluation
5.0.4 Risk Control
5.0.5 Risk Communication
5.0.6 Risk Review
5.0.7 Risk Reporting
5.2 : Contract Research Organization (CRO)
Given Statements have been inserted in the following
sections:
5.2.1 The sponsor should ensure oversight of any trial-
related duties and functions carried out on its behalf.
5.2.2 The sponsor should document approval of any
subcontracting of trial-related duties and functions by
a CRO.
5.5: Trial Management, Data Handling, and Record
Keeping
5.5.3 (b) This point has been modified describing SOPs
"The SOPs should cover system setup….. use of the
Round the Corner
Workshop on preparation for Accreditation in Nasik,
on August 22, 2015
The Final Accreditation Guideline is soon expected from the NABH (National Accreditation Board for
Hospitals and Healthcare Providers). It is welcoming to see that Hospitals (Sites), Ethics Committees that
conduct Clinical trials or wish to enter Clinical trials have started preparing for the Accreditation.
Kudos to Shatabdi Hospital Ethics Committee, Nasik for organizing this workshop on preparation for
Accreditation on August 22, 2015. Over 80+ participants attended the Workshop. Audience included
Principal Investgators, Ethics Committee members, CRAs, CRCs and other interested people from the
Clinical research field.
systems"
5.5.3 Point (h) has been introduced.
5.18: Monitoring
5.18.3 Extent and Nature of Monitoring has been
modified further specifying the responsibility of
sponsor in monitoring.
5.18.6 Monitoring Report, point (e) has been added.
5.18.7 Monitoring Plan is added.
5.20: Noncompliance.
In this section, 5.20.1 has been modified
Section 8: Essential Documents for the conduct of
a Clinical Trial
8.1 : "The sponsor and investigator/institution ….
Before, during & after the trial" has been added in the
Introduction section, which explains the precautions to
be taken when it comes to documentation.

3. September Edition │Issue 2
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Buzz Around Us...
Rising Rates of FDA Approvals
In 2008, companies asked for 134approvals and got 75 of them, a56% approval rate. That rate hovered
steady in 2009 and 2010, and then rose to about 70% in 2011, 2012, and 2013. Last year it jumped to 77%,
with 97 out of 126requests for approval coming back positive. This year’s approval rate was 88%.
Those numbers come from a new analysis commissioned by Forbes from BioMedTracker. The 2015
rejection count includes rejections of Avycaz, a new antibiotic from Allergan, for hospital-acquired
pneumonia, and selling Jardiance, a diabetes drug from Eli Lilly and Boehringer Ingelheim , in combination
of metformin. But Avycaz was approved for two other uses and Jardiance is on the market by itself. So in
reality, the FDA approval rate is more like96%. Eliminating BioMedTrackers counting of multiple uses for
the same drug means FDA approved 23 drugs and rejected 1, Merck ’s anesthesia antidote, Bridion. Again,
that means19 of 20 new drug applications were approved.The FDA points out that one reason that drug
approval rates are going up is because it is doing its job. The agency has deadlines for when it is supposed
to approve new drugs, and it is meeting them. More than that, it has instituted new procedures to make
sure it communicates well with drug companies before they file new drug applications. A new bill called
the 21st Century Cures Act attempts to further speed up approvals and remove red tape. But the risks of
speeding up approvals should be pretty clear, too. The approval boom is good only so long as it doesn’t
trigger another drug safety conference.
(Source: http://www.forbes.com/sites/matthewherper/2015/08/20/the-fda-is-basically-approving-
everything-heres-the-data-to-prove-it/)

4. September Edition │Issue 2
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Quiz
1] According to Schedule Y, In case of death, within how many days should the analysis report be submitted
by the Invesigator to the Expert Committee?
A) 10 days C) 15 days
B) 14 days D) 21 days
2] According to ICH GCP which one of the following is not one of the purposes of monitoring?
A) ensure investigator’s patients are not over researched
B) ensure informed consents are signed
C) ensure investigational site is adequate
D) ensure rights and well being of human subjects are protected
3] Who is responsible for the risk assessment of a trial?
A) The sponsor C) The monitor
B) The Regulatory Authority D) The investigator or sub-investigator
4] According to ICH GCP. non-compliance with the protocol, SOPs, GCP and/or regulatory requirements by
an investigator/institution or member(s) of the sponsor staff should lead to what?
A) an audit being performed by the sponsor
B) a suspension of all trial related work at the site
C) prompt action by the sponsor to secure compliance
D) an additional monitoring visit by the sponsor
Send your Answers on harrisonstechconsultants@gmail.com OR Call on 9910906014. First 3 people to answer will
be honored with a surprise gift.
Harrison's Tech Consultants
1902, Seahomes, Sector 36, Karave, Nerul.
Navi Mumbai 400706.
Website: www.harrisonstechconsultants.com
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