ICH E6 - Harmonised Guideline for Good Clinical Practice

Question 1

What is the ICH?

Answer 1

International Council for Harmonisation.

Question 2

ICH Harmonised Guideline for Good Clinical Practice

Answer 2

finalized in November 2016 – the Good Clinical Practices document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs.

Question 3

What does GCP cover?

Answer 3

Aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigators Brochures which had been agreed earlier thorugh the ICH process.

Question 4

What is GCP?

Answer 4

DR. RC
An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

Question 5

What is the objective of this ICH GCP?

Answer 5

To provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

Question 6

Adverse Drug Reaction

Answer 6

All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.

Question 7

Adverse Event

Answer 7

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.

Question 8

Audit

Answer 8

Systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures, GCP, and the applicable regulatory requirements.

Question 9

Comparator (Product)

Answer 9

An investigational or marketed product, or placebo, used as a reference in a clinical trial.

Question 10

Compliance

Answer 10

Adherence to all the trial-related requirements, GCP requirements, and the applicable regulatory requirements.

Question 11

Confidentiality

Answer 11

Prevention of disclosure, to other than authorized individuals, of a sponsor’s proprietary information or of a subject’s identity.

Question 12

Coordinating Committee

Answer 12

A committee that a sponsor may organize to coordinate the conduct of a multicenter trial.

Question 13

Coordinating Investigator

Answer 13

An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial.

Question 14

Contract Research Organization (CRO)

Answer 14

A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.

Question 15

Direct Access

Answer 15

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.

Question 16

Inspection

Answer 16

An official review conducted by regulatory authority of: study documents, facilities, records, and any other resources that are deemed by the authorities to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s facilities, or at other establishments deemed appropriate by the regulatory authorities.

Question 17

Name the 10 principles of ICH GCP

Answer 17

MR. TRIN SCID
1 - Medical care of subjects should always be the responsibility of the physician/dentist
2- Foreseeable Risks and inconveniences should be weighed against benefit before a trial is initiated. A trial should only be initiated and continued if the benefits outweigh the risks
3 - Each individual involved in the trial should be qualified by education, TRAINING and experience to perform his/her respective task/s
4- The RIGHTS, safety and well-being of subjects should come first and prevail over interests of science and society
5 - INFORMED consent should be obtained prior to trial participation
6 - The available NON-clinical and clinical information of the IP should be adequate to support proposed clinical trial
7- Clinical trials need to be SCIENTIFICALLY sound, should be described clearly and in detail in the protocol
8 - A trial should be conducted in COMPLIANCE with the protocol that has received approval from IRB/IEC
9 - All clinical trial INFORMATION should be recorded, handled and stored in a way that allows its accurate, interpretation and verification
10 - Declaration of Helsinki - Clinical trials should be conducted in accordance with its ethical principles

Question 18

What year did the ICH develop GCP guidelines?

Answer 18

1996