GCP

Question 1

What is ICH

Answer 1

International Council for Harmonisation. The mission of the ICH is to promote public health by achieving greater harmonisation through the development of technical Guidelines and requirements for pharmaceutical product registration by creating standardized guidelines for clinical research of investigational drugs.

Question 2

what is the purpose of GCP

Answer 2

to standardize training to avoid repeating trials due to variations between countries and make sure trials are well designed and conducted so that human subjects are treated ethically.

Question 3

who formed the ICH

Answer 3

US, Japan, and EU

Question 4

What is the ICH E6(R2)

Answer 4

consistent with the Declaration of Helsinki (DOH). Additionally, it provides a unified standard for designing, conducting, recording, and reporting research involving human subjects.

Question 5

categories of ICH members

Answer 5

regulators, industry members, and observers (reps from Brazil, China, South Korea, and WHO)

Question 6

4 main categories of ICH guidelines

Answer 6

Quality, Safety, Efficacy, and Multidisciplinary

Question 7

Quality Guidelines

Answer 7

Stability Testing, Impurity Testing, Good Manufacturing Practice, Pharmaceutical Development

Question 8

Safety Guidelines

Answer 8

Carcinogenicity Testing, Genotoxicity Testing, Pharmacology Studies

Question 9

Efficacy Guidelines

Answer 9

Dose Response Studies, Clinical Trials in Geriatric Population, Multi-Regional Clinical Trials, Good Clinical Practice

Question 10

Multidisciplinary Guidelines

Answer 10

Medical Terminology, Electronic Standards, The Common Technical Document (CTD), Data Elements and Standards for Drug Dictionaries, Gene Therapy, Genotoxic Impurities, Electronic Common Technical Document

Question 11

Declaration of Helsinki

Answer 11

a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA).

Question 12

Differences between ICH GCP and the Declaration of Helsinki (DOH)

Answer 12

The ICH GCP guidelines do not address certain ethical requirements that are found in the DOH, such as:

The use of placebo versus standard therapy
Post-study access to treatment and other benefits for subjects
Public disclosure of study design
Publication of study results
Disclosure of conflicts of interests

Question 13

What responsibilities and expectations are described in ICH E6

Answer 13

ICH E6 describes the responsibilities and expectations of all research personnel in the conduct of clinical trials including investigators, monitors, sponsors, and Institutional Review Boards (IRBs)/Independent Ethics Committee (IEC)/Research Ethics Boards (REBs). GCP covers aspects of monitoring, reporting, and archiving of clinical trials and the use and management of key documents including protocols, investigational brochures, and essential documents.

Question 14

2 important goad of the ICH E6 standard

Answer 14

To assure that the rights, well-being, and confidentiality of trial subjects are protected; and
To assure that trial data are credible.

Question 15

In the US compliance with E6(R1) and E6(R2)

Answer 15

is voluntary but compliance is considered part of GCP

Question 16

Clinical trials should be conducted

Answer 16

in accordance with the ethical principles in Declaration of Helsinki and consistent with GCP and applicable regulatory requirements

Question 17

initiation and continuation of a trial should only occur if

Answer 17

the anticipated benefits justify the risks

Question 18

The rights, safety, and well-being of the trial subjects are

Answer 18

he most important considerations and should prevail over interests of science and society

Question 19

The available nonclinical and clinical information on an investigational product

Answer 19

should be adequate to support the proposed clinical trial.

Question 20

Clinical trials should be

Answer 20

scientifically sound, and described in a clear, detailed protocol.

Question 21

A trial should be conducted in compliance with

Answer 21

the protocol that has received prior IRB/IEC/REB approval/favourable opinion.

Question 22

The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of

Answer 22

a qualified physician or, when appropriate, of a qualified dentist.

Question 23

Each individual involved in conducting a trial should be qualified by

Answer 23

education, training, and experience to perform his or her respective task(s).

Question 24

Every subject should freely give informed consent

Answer 24

before clinical trial participation

Question 25

All clinical trial information should be recorded, handled, and stored in a way that allows

Answer 25

its accurate reporting, interpretation, and verification. This principle applies to all records (paper or electronic) referenced in this guideline.

Question 26

The confidentiality of records that could identify subjects should be

Answer 26

protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

Question 27

Investigational products should be manufactured, handled, and stored in accordance with

Answer 27

applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

Question 28

Systems with procedures that assure the quality of every aspect of the trial

Answer 28

should be implemented.

Question 29

For studies conducted under a U.S. Investigational New Drug (IND) application or Investigational Device Exemption (IDE)

Answer 29

the research must comply with the Code of Federal Regulations (21 CFR 312 for products and 21 CFR 812 for devices), which represents U.S. law.

Question 30

ISO

Answer 30

International Organization for Standardization

Question 31

overall goal of Canada regulations, FDA regulations, and ICH E6

Answer 31

to assure the ethical, efficient conduct of human research, and the credibility of the resulting data

Question 32

A Primary purpose of the ICH E6 guideline

Answer 32

minimize the need for redundant research

Question 33

The two important goals of the ICH E6 standard are:

Answer 33

To assure that the rights, well-being, and confidentiality of trial subjects are protected; to assure that trial data are credible.

Question 34

Investigator’s responsibilities

Answer 34

the overall conduct of the study at the site: includes protecting the rights and welfare of human research subjects and ensuring the validity and integrity of the data collected

Question 35

Sponsor (individual, company, institution, or organization)

Answer 35

takes responsibility for the initiation, management, and/or financing of a clinical trial

Question 36

investigator

Answer 36

A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Question 37

sub-Investigator

Answer 37

any individual member of the clinical study team designated and supervised by the lead or principal investigator at a study site to perform critical study-related procedures and/or to make important study-related decisions (associate, residents, research fellows, nurses).

Question 38

3 qualifications of an investigator

Answer 38

1) have education, training, and experience necessary
2) demonstrate awareness of GCP and regulatory requirements
3) familiar with the protocol, Investigator’s Brochure, and use of the investigational product

Question 39

investigator must ensure that all staff are

Answer 39

1) adequately informed and are familiar with purpose of study, protocol, and investigational product
2) aware of regulatory requirements, GCP, and standards
3) informed of pertinent changes during the study

Question 40

Delegation Log

Answer 40

investigator is required to supervise all tasks that are delegated and maintain a DoA

Question 41

Adequate resources for a study

Answer 41

1) suitable research subjects
2) time to conduct, supervise, and complete study
3) adequate facilities and qualified study team members

Question 42

information required during informed consent

Answer 42

purpose, duration, risks, benefits, costs and additional expenses, description of procedure, alternate care options, and subject rights

Question 43

US Common Rule

Answer 43

further US requirement for consent: including that consent begin with a clear and concise presentation of the key information for decision making to help with subject comprehension

Question 44

Besides signing the consents, what else is part of the consent process

Answer 44

documentation of consent

Question 45

What is included in documentation of consent

Answer 45

who performed the consent discussion, who was in attendance along with the questions asked and answers given

Question 46

source document

Answer 46

any document in which information, an observation or data generated relevant to a study is recorded (paper-based or electronic) for the first time (that is the original source).

Question 47

examples of source documents

Answer 47

original documents, data and records and could be hospital records, laboratory notes, subject diaries, x-rays, and pharmacy dispensing records.

Question 48

essential documents

Answer 48

documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced (for example, the Investigator’s Brochure, informed consent form, curriculum vitae for investigator, documentation of investigational product and trial related materials shipment).

Question 49

6 things source data should be

Answer 49

attributable, legible, contemporaneous, original, accurate, and complete.