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SOCRA 2024 > ICH-GCP > Flashcards

ICH-GCP Flashcards

1
Q

Trial conduct

A

Processes from planning to reporting, including planning, initiating, performing, recording, oversight, evaluation, analysis and reporting activities as appropriate.

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2
Q

Good Clinical Practice (GCP)

A

Is an international, ethical, scientific and quality standard for the conduct of trials that involve human participants.

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3
Q

Following GCP ensures that the conduct of clinical investigations is consistent with

A

the principles that have their origin in the Declaration of Helsinki

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4
Q

The objective of this ICH GCP Guideline is

A

to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.

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5
Q

Clinical trials should be designed and conducted in ways that ensure ………of participants.

A

the rights, safety and well-being

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6
Q

Clinical trial participation should be …..and based on……

A

a) voluntary

b) a consent process that ensures participants (or their legally acceptable representatives, where applicable) are well-informed.

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7
Q

Clinical trials should be subject to

A

an independent review by an institutional review board/independent ethics committee (IRB/IEC).

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8
Q

Investigational products used in a clinical trial should be manufactured in accordance with ……… and be stored, shipped, handled and disposed of in accordance with the product specifications and the trial protocol.

A

Good Manufacturing Practice (GMP) standards

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9
Q

Adverse Event (AE)

A

Any unfavourable medical occurrence in a trial participant. The adverse event does not necessarily have a causal relationship with the treatment.

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10
Q

Adverse Drug Reaction (ADR) in the pre-approval clinical experience (new drug):

A

Any unfavourable and unintended response related to any dose of a medicinal product, where a causal relationship between a medicinal product and an adverse event is a reasonable possibility.

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11
Q

Adverse Drug Reaction (ADR) for marketed medicinal products:

A

A response to a drug that is noxious and unintended and that occurs at doses normally used in humans for prophylaxis, diagnosis or therapy of diseases or for modification of physiological function.

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12
Q

Serious Adverse Event (SAE)

A

Any unfavourable medical occurrence that is considered serious at any dose if it:
-results in death
-is life-threatening
-requires inpatient hospitalisation or prolongation of existing hospitalisation
-results in persistent or significant disability/incapacity
-is a congenital anomaly/birth defect

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13
Q

SUSAR

A

Suspected Unexpected Serious Adverse Reaction

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14
Q

Suspected Unexpected Serious Adverse Reaction

A

An adverse reaction that meets three criteria: suspected, unexpected and serious.

Suspected: There is a reasonable possibility that the the adverse reaction was caused by the drug

Unexpected: The nature or severity of an adverse reaction is not consistent with the applicable product information

Serious: Adverse reaction
-results in death
-is life-threatening
-requires inpatient hospitalisation or prolongation of existing hospitalisation
-results in persistent or significant disability/incapacity
-is a congenital anomaly/birth defect

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15
Q

Agreement

A

A document or set of documents describing the details of any arrangements on delegation or
transfer, distribution and/or sharing of activities and, if appropriate, on financial matters
between two or more parties (contract, protocol)

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16
Q

Applicable Regulatory Requirement(s)

A

Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.

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17
Q

Assent

A

Affirmative agreement of a minor to participate in clinical trial.

The absence of expression of agreement or disagreement should not be interpreted as assent.

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18
Q

Audit

A

A systematic and independent examination of trial-related activities and records performed by
the sponsor, service provider (including contract research organisation (CRO)) or institution to
determine:
whether the evaluated trial-related activities were conducted and the data were recorded, analysed and accurately reported according to the protocol, applicable standard operating procedures (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

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19
Q

Audit Certificate

A

A declaration of confirmation by the auditor that an audit has taken place

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20
Q

Audit Report

A

A record describing the conduct and outcome of the audit.

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21
Q

Audit Trail

A

Shows activities, initial entry, and changes to data fields or records, by whom, when and, where applicable, why.

In computerised systems, the audit trail should be secure, computer generated and time stamped.

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22
Q

Blinding/Masking

A

A procedure in which one or more parties to the trial are kept unaware of the treatment
assignment(s).

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23
Q

Single-blinding refers to

A

the participant(s) being unaware

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24
Q

Double-blinding refers to

A

the participant(s), investigator(s) or other trial staff, as appropriate, being unaware of the treatment assignment(s).

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25
Q

Case Report Form (CRF)

A

A tool designed to record protocol-required information to be reported by the investigator to
the sponsor on each trial participant

26
Q

Clinical Trial

A

Any interventional investigation in human participants intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational
product(s);

and/or

to identify any adverse reactions to an investigational product(s);

and/or

to study absorption, distribution, metabolism and excretion of an investigational product(s) with
the object of ascertaining its safety and/or efficacy.

27
Q

Clinical Trial/Study Report (CSR)

A

A documented description of a trial of any investigational product conducted in human
participants, in which the clinical and statistical description, presentations and analyses are
fully integrated into a single report

28
Q

Comparator

A

An investigational or authorised medicinal product (i.e., active control), placebo or standard of
care used as a reference in a clinical trial.

29
Q

Compliance

A

Adherence to
trial-related requirements,
GCP requirements,
applicable regulatory requirements.

30
Q

Confidentiality

A

Prevention of disclosure to other than unauthorised individuals of a sponsor’s proprietary information or of a participant’s identity or their confidential information.

31
Q

Coordinating Investigator

A

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

32
Q

Computerised Systems Validation

A

A process of establishing and documenting that the specified requirements of a computerised
system can be consistently fulfilled from design until decommissioning of the system or transition to a new system.

33
Q

Data Acquisition Tool (DAT)

A

A paper or electronic tool designed to collect data and associated metadata from a data originator in a clinical trial according to the protocol and to report the data to the sponsor.

34
Q

The data originator may be

A

-a human (e.g., the participant or trial staff),
-a machine (e.g., wearables and sensors)
-an electronic transfer of data from one system to another (e.g., extraction of data from an electronic health record or laboratory system).

35
Q

Examples of DATs include

A

CRFs
interactive response technologies (IRTs)
patient-reported outcomes (PROs)
clinical outcome assessments (COAs)
wearable devices

36
Q

Direct Access

A

Permission to examine, analyse and verify records that are important to the evaluation of a clinical trial and may be performed in person or remotely

37
Q

Essential Records

A

Essential records are the documents and data (and relevant metadata), in any format, associated with a clinical trial that facilitate the ongoing management and collectively allow the evaluation of the methods used, the factors affecting a trial and the actions taken during the trial to determine the reliability of the trial results produced and the verification that
the trial was conducted in accordance with GCP and applicable regulatory requirements

38
Q

Good Clinical Practice (GCP)

A

A standard for the planning, initiating, performing, recording, oversight, evaluation, analysis
and reporting of clinical trials that provides assurance that the data and reported results are
reliable and that the rights, safety and well-being of trial participants are protected.

39
Q

Impartial Witness

A

A person who is independent of the trial who cannot be unfairly influenced by people involved
with the trial, who attends the informed consent process if the participant or the participant’s
legally acceptable representative cannot read, and who reads the informed consent form and
any other documented information supplied or read to the participant and/or their legally
acceptable representative.

40
Q

Independent Data Monitoring Committee (IDMC)

A

An independent data monitoring committee (e.g., data safety monitoring board) that may be
established by the sponsor to assess at intervals the progress of a clinical trial, the safety data
and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify or stop a trial.

41
Q

Informed Consent

A

A process by which a participant or their legally accepted representative voluntarily confirms
their willingness to participate in a trial after having been informed and been provided with the
opportunity to discuss all aspects of the trial that are relevant to the participant’s decision to participate.

42
Q

Quality Assurance (QA)

A

Planned and systematic actions that are established to ensure that the trial is performed
and the data are generated, documented (recorded) and reported in compliance with GCP and the applicable regulatory requirement(s).

43
Q

Quality Control (QC)

A

The operational techniques and activities undertaken to verify that the requirements for quality of the trial-related activities have been fulfilled.

44
Q

Randomisation

A

The process of deliberately including an element of chance when assigning participants to groups that receive different treatments in order to reduce bias.

45
Q

Reference Safety Information (RSI)

A

Contains a cumulative list of ADRs that are expected for the investigational product being
administered to participants in a clinical trial. The RSI is included in the Investigator’s Brochure.

46
Q

Investigator’s Brochure (IB)

A

A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human participants

47
Q

Service Provider

A

A person or organisation (commercial, academic or other) providing a service used during the
conduct of a clinical trial to either the sponsor or the investigator to fulfil one or more of their
trial-related activities.

48
Q

Standard Operating Procedures (SOPs)

A

Detailed, documented instructions to achieve uniformity of the performance of a specific activity.

49
Q

Vulnerable Participants

A

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits associated with participation or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.

50
Q

Metadata

A

The contextual information required to understand a given data element.

Metadata is structured information that describes, explains or otherwise makes it easier to retrieve, use or manage data.

For the purpose of this guideline, relevant metadata are those needed to reconstruct the trial conduct.

51
Q

What sections should make up the IB?

A

Table of Contents
Summary
Introduction
Physical, chemical and pharmaceutical properties / formulation
Nonclinical studies
Clinical data
Summary of data and Investigator guidance

52
Q

According to ICH GCP, how often should the IB be reviewed?

A

At least annually and revised as necessary with compliance to sponsor’s written procedures.

53
Q

Statistical analysis plan (trial protocol)

A

A description of the statistical methods to be employed, including timing and purpose of any planned interim analysis(ses) and the criteria for the stopping of the trial.

The level of significance to be used or the threshold for success on the posterior probability in a Bayesian design.

The criteria for the termination of the trial and the criteria for the stopping of the trial.

The selection of participants to be included in the planned analyses (e.g., all randomised participants, all dosed participants, all eligible participants, all evaluable participants).

Procedures for accounting for missing, unused and spurious data.

Statement that any deviation(s) from the statistical analysis plan will be described and justified in the clinical study report.

54
Q

What information should be included in Protocol regarding “Withdrawal of Consent or Discontinuation of Participation”

A

The protocol should specify:
(a) when and how to discontinue participants from the trial/investigational product treatment;

(b) the type and timing of the data to be collected for withdrawn/discontinued participants, including the process by which the data are handled, in accordance with applicable regulatory requirements;

(c) whether and how participants are to be replaced;

(d) the follow-up for participants who have discontinued the use of the investigational product.

55
Q

What year did the ICH develop GCP guidelines?

A

1996

56
Q

What information should be included in the trial protocol?

A

-General Information (Protocol title, protocol identifying number, date, name & addresses of the sponsora and person(s) authorised to sign the protocol)
-Background Information (Name and description of the investigational product(s))
-Trial Objectives and Purpose
-Trial Design
-Selection of Participants
-Consent Withdrawal/Discontinuation of participation
-Treatment and Interventions for Participants
-Assessment of Efficacy
-Assessment of Safety
-Statistical Considerations
-Direct Access to Source Records
-Quality Control and Quality Assurance
-Financing and Insurance
-Publication Policy

57
Q

According to ICH GCP, what type of background information should be included in the clinical trial protocol?

A

-Name and description of investigational product
-Data from nonclinical studies
-Known risks and benefits
-Justification and description for route of administration, dosage, dosage regimen and treatment periods
-Statement that the trial will be conducted in compliance with the protocol, GCP, and regs
-Population to be studies
-Relevant references to literature and data

58
Q

According to ICH GCP, what info should be included in the trial design section of the trial protocol?

A

-Statement of primary and secondary endpoints
-A description of the type of design to be conducted (placebo-controlled, parallel, etc.) with a diagram
-Measures used to minimize bias (Randomization or blinding)
-Description of treatments, dosage, etc. and what the investigational product looks like
-Description of stopping or discontinuation criteria
-The expected duration of the participant’s involvement in the trial and a description of the sequence and duration of all trial periods, including follow-up, if any.
-Accountability procedures for the investigational product(s), including the placebo(s) and other comparator(s), if any.
-Randomization codes and procedures
-Data to be included in CRFs

59
Q

Measures taken to minimise/avoid bias in a clinical trial

A

(a) Randomisation
(b) Blinding

60
Q

Accountability procedures for the investigational product(s), include

A

the placebo(s) and other comparator(s)

SOCRA 2024 (9 decks)

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