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1

Formed in the early 90s' by representatives of the European Union, Japan and the United States.

The International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use, commonly referred to as the International Conference on Harmonisation

2

In what year did the International Conference on Harmonisation become the International Council for Harmonisation

2015

3

What is the goal of the ICH?

to standardize technical guidelines and requirements for drug marketing registrations, so that applications for marketing to various regulatory agencies around the world can occur without redundant testing.

4

ICH E6 has become...

the international standard for the design, conduct, monitoring, and reporting of clinical research of investigational drugs.

5

In what year was the ICH revised the E6 guideline to reflect the current research landscape, reflecting increases in globalization, study complexity, and technological capabilities? What were they entitled?

2016.
Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice E6(R2)

6

Legally Authorized Representative (LAR)

is an individual, or judicial or other body, authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

7

Protocol Deviation (or Violation)

is generally an unplanned excursion from the requirements of the protocol that is not implemented or intended as a systematic change.

8

Current ICH membership includes the following five (5) regulators.

1) Health Canada (Canada)
2) European Commission (European Union)
3) Ministry of Health Labor and Welfare/Pharmaceuticals and Medical Devices (PDMA from Japan)
4) Swissmedic (Switzerland)
5) Food and Drug Administration (USA)

9

Current ICH membership also includes the following three (3) industry members:

1) European Federation of Pharmaceutical Industries and Associations (EFPIA from EU)
2) Pharmaceutical Research and Manufacturers of America (PhRMA from U.S.)
3) Japan Pharmaceutical Manufacturers Association (JPMA from Japan).

10

The current ICH E6 expert working group includes:

1) Fourteen representatives from the six ICH founding members (four from U.S., four from EMA/EU, and six from Japan)
2) Two experts -- one each from the two new ICH members Canada and Switzerland (Health Canada and Swissmedic joined the ICH Steering Committee in June 2014)
3) Four observers -- one each from ANVISA (Brazil Sanitary Vigilance National Agency from Brazil), Department of Health (DoH of Chinese Taipei), Ministry of Drug and Food Safety (MFDS from South Korea), and World Self Medication-Industry (WSMI is a non-governmental organization [NGO] representing the self-medication industry)

11

True or False: In the U.S. compliance with ICH E6 is voluntary, but as with any published FDA guidance, compliance is considered part of GCP.

True

12

For sponsors, what is the advantage of complying with the ICH guideline?

the FDA and equivalent government agencies in other countries will consider studies conducted in accordance with ICH E6 to meet the regulatory requirements of the drug approval processes for all of these countries.

13

ICH guidelines cover four (4) main categories and a letter of reference codes each category.

Q-Quality
S-Safety
E-Efficacy
M-Multidisciplinary

14

Quality (Q) Topics

Those relating to chemical and pharmaceutical quality assurance

15

Safety (S) Topics

Those relating to in vitro and in vivo preclinical research

16

Efficacy (E) Topics

Those relating to research in human subjects

17

Multidisciplinary (M) Topics

Topics that do not fit uniquely into one of the categories above

18

The ICH E6 topic falls under the "Efficacy" category in the ICH guidelines and pertains specifically to...

the conduct of clinical research to support marketing applications for drugs. It provides a unified standard for designing, conducting, recording, and reporting research involving human subjects.

19

The two important goals of ICH E6 are to assure that:

1) The rights, well-being, and confidentiality of trial subjects are protected
2) Trial data are credible

20

The principles of ICH GCP as presented in ICH (2016) E6 are: (13)

1) 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).
2) 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.
3) The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
4) The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.
5) Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
6) 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.
7) 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.
8) Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
9) Freely given informed consent should be obtained from every subject prior to clinical trial participation.
10) All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification. This principle applies to all records (paper or electronic) referenced in this guideline.
11) 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).
12) 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.
13) Systems with procedures that assure the quality of every aspect of the trial should be implemented.

21

Investigators participating in clinical research take on specific obligations: (9)

1) qualifications
2) resources
3) medical care of research subjects
4) interactions with IRBs/IECs
5) compliance with protocols
6) management of investigational products
7) informed consent of subjects
8) record keeping
9) reporting

22

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.

23

The investigator is responsible for supervising...

any individual or party to whom the investigator delegates study tasks conducted at the trial site.

24

Who must implement a quality management system throughout the design, conduct, recording, evaluation, reporting, and archiving of clinical trials

The Sponsor

25

The ICH E6 guideline recommends the quality management system use?

A risk-based approach

26

Although a sponsor may transfer any or all of their responsibilities and functions to a Contract Research Organization (CRO), the sponsor should...

ensure oversight of the CRO and specify in writing what responsibilities are transferred.

27

Sponsor responsibilities include: (11)

1) quality management
2) quality assurance and control
3) trial design
4) trial management
5) investigator selection
6) compensation to subjects and investigators
7) confirmation of review by IRB/IEC
8) supplying and handling the investigational product
9) adverse drug reaction reporting
10) monitoring
11) auditing

28

Content standards for clinical trial protocols: (11)

1) selection and withdrawal of subjects
2) treatment of subjects
3) safety and efficacy assessment
4) statistics
5) direct access to source data/documents
6) quality control and assurance
7) ethics
8) data handling and recordkeeping
9) financing and insurance
10) publication policy
11) supplements.

29

True or False: ICH E6 is codified in U.S. federal regulation and carries the same legally binding weight of the code of federal regulations.

False.

30

what is the 21 CFR 50?

Protection of Human Subjects FDA regulation