ICF Harmonised Guideline for GCP

Question 1

what is the ICH?

Answer 1

International Council for Harmonisation

Question 2

ICH harmonised guideline for GCP

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 trials; incorporates Essential Documents and IB addenda agreed on earlier via ICH process

Question 4

What is GCP?

Answer 4

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 the 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

untoward medical occurrence in a subject who received study drug that 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 SOPs, GCP, and the applicable regulatory requirements

Question 9

comparator

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, good clinical practice requirements, and the applicable 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 commitee

Answer 12

a committee that a sponsor may organized 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 (clinical?) research organization (CRO)

Answer 14

a person or an organization 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

13 principles of ICH GCP

Answer 17

1) ethics
2) trial risk vs trial benefit
3) trial participants
4) info on medicinal product
5) good quality trials
6) compliance with study protocol
7) medical decisions
8) trial staff
9) informed consent
10) clinical trial data
11) confidentiality
12) good manufacturing practice
13) quality assurance

Question 18

when were ICH GCP guidelines developed?

Answer 18

1996