ICH 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

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.

Australia, Canada, Nordic countries (Iceland, Norway, Sweden, Denmark and Finland) and WHO’s GCP were also taken into consideration

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, adn 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 requiremetns, good clinical practice requirements, adn 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

The act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authorities to be realted 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 13 principles of ICH GCP

Answer 17

1. Should be done in line with declaration of Helsinki and consistent with GCP
2. Risks and inconveniences should be weighed against the benefit to the individual or society. Should only be continued if justified.
3. Rights, safety and well-being of subjects is the most important consideration.
4. The nonclinical and clinical information on the investigational product (IP) should support the proposed trial.
5. Should scientifically sound and described clearly
6. Trial must be conducted in line with the IRB approved protocol
7. Medical care takes priority
8. Those conducting the trial must be qualified by education, training, and experience
9. Freely given informed consent should be obtained prior to participation
10. All trial information should be recorded and stored to allow for accurate reporting
    Addendum
11. Identifiable information must remain confidential
12. IP must be manufactured in accordance with GMP. And should be used in accordance with the protocol
    Quality control should be implemented for the study

Question 18

What year did the ICH develop GCP guidelines?

Answer 18

1996