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Criado por A M
aproximadamente 9 anos atrás
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Who is the sponsor?
The sponsor can be
The intent of the sponsor's CTA/IND or ITA/IDE is
Who funds the clinical research?
A sponsor-investigator is
Investigator-initiated or sponsor-investigator CTAs/INDs or ITAs/IDEs
For drug trials in Canada, the responsibilities of a sponsor-investigator are outlined on
For drug trials in the US, thre responsibilities of an investigator are outlined in
In both the US and Canada, the sponsor-investigator also assumes the responsibilities of
Drug supplier/manufacturer role
What kind of acitivity falls under the scope of "practice of medicine"?
In Canada, when a physician wants to study a new intended use for an approved drug, what needs to be done?
Review period after the CTA submission or a CTA Amendment is screened and acknowledged
During the review of the CTA or CTA Amendment, if questions are received from Health Canada a response is required within
What happens in case a drug or device is developed by the investigator him/herself?
Unlike the new drugs/devices developed by the investigator, not every study using an approved drug requires
CTA stands for
Health Canada and the US Food and Drug Administration regulate
Health Canada and FDA conduct a thorough review of drugs, biologics and medical devices, before granting approval for marketing in their respective countries, for
Before a product is marketed, the sponsor submits an application for
The application submitted by the sponsor to the regulator contains
The package insert or labeling submitted by the sponsor to the regulator summarizes
The regulatory approval decision is based upon
ITA
IND
IDE
For a drug/device/biologic that has not yet reached the marketplace or that studies a new use of the marketed product, research protocols are evaluated by
The regulator will allow human studies to proceed if it determines that
Determination of whether the risk of exposure to the drug is reasonable is based upon
Clinical investigation of a marketed drug does not require a CTA/IND if the following conditions are met:
Sponsors must file applications to conduct clinical trials in the following phases
In the US, exemption from IND submission requirements does not mean exemption from
CTSI
CTSI form must be submitted for
For all the clinical trial site information that becomes available after the time of application
Form 1572 outlines
Form 1572 must list
Who MUST sign Form 1572
The sponsor's responsibilities include
Investigator responsibilities include (1)
Investigator responsibilities include (2)
Investigator responsibilities include (3)
Investigator responsibilities include (4)
Good clinical practice
Compliance with GCP standards assures
ICH and full name
Goal of ICH
Why ICH?
The working groups of ICH have representatives from 6 regulatory and pharmaceutical industry groups
Observers for ICH
ICH is governed by and supported by
Steering committee composition
The observer groups
ICH topics and guidelines
M topics
Development of ICH standards involves
The expert working groups are responsible
E6 topic of the ICH guidelines
E6 defines GCP in a manner
E6 also provides
The 2 important goals of the E6 ICH standard are
Health Canada adopted the E6 guideline in
How many sections are there as part of the ICH GCP E6 Guideline
ICH GCP E6 Guideline Introduction
ICH GCP E6 Guideline Section 1
ICH GCP E6 Guideline Section 2
ICH GCP E6 Guideline Section 3
ICH GCP E6 Guideline Section 4
ICH GCP E6 Guideline Section 5
ICH GCP E6 Guideline Section 6
ICH GCP E6 Guideline Section 7
ICH GCP E6 Guideline Section 8
Pertinent ICH Documents (other than E6 guidlelines)
When does the ICH guideline apply?
For compliance for research sites outside of Canada
For drug studies conducted under a Canadian Trial Application (CTA), adherence to GCP is expected, but in case of discrepancy
For studies conducted under a US IND or IDE the research must comply with the
How do Health Canada Regulations, US FDA regulations and ICH guidelines differ?
Boundaries for best practice
To supplement the published FDA and Health Canada regulations
Pharmacokinetics
Pharmacodynamics
Bioavailability
Controlled means
In Canada, the Food and Drug Regulations, Part C, Division 5
In the US, the Code of Federal Regulations (CFR) indicates that
To provide Health Canada and/or the US FDA with the requested evidence, a sponsor seeks to show safety and efficacy of a new drug by
Unlike the US IND process, in Canada each study
Initiation of a clinical trial at the Canadian site requires approval from
Conduct of Phase 4 clinical trials must be in accordance with
It is illegal to give an experimental article to a human being according to
The IND application includes
The Sponsor must maintain a current IND application throughout each clinical trial by
Preclinical studies refers to
Time taken by Health Canada to review the CTA and evalutate the data to determine whether the study can be conducted in human subjects
Upon approval of the study (CTA)
An Information Request will be issued by Health Canada if
How does health Canada send the Information Request
In response to an Information Request, Health Canada needs to respond
If Health Canada deems the study to be unsafe
Will Health Canada always send out a notification to the Sponsor withing 30 days of submission?
If the 30 day default review period passes without notification from Health Canada
After the study has received approval, should changes be made to any of the information within the original CTA submission then
The only exception to the requirement for pre-approval of CTA amendments is due to
Analog of CTA in the US is
Phase 1 goals and subject population
Phase 2 goals and subject population
Phase 3 goals and subject poplulation
Which submission (data obtained to provide evidence of safety and efficacy) requests permission to market the product?
NDS or NDA review typically takes
What is the Investigator's Brochure (IB)?
What is the purpose of the IB?
The IB is generated initially from the
QIU
CRF
SAE
Investigators should report to the Ethics committee: New information that may affect adversely the safety of the subjects or the
According to ICH GCP what should the investigator, or person designated by the investigator, do for deviations from the protocol?
MAH
If compliance is poor, that means
CAPA
Is every ICH GCP deviation a protocol deviation?
Is every protocol deviation an ICH GCP deviation?
Minor protocol deviation
Major protocol deviation
Protocol violation
What is a clinical study report?
The integrated full
report of a study (clinical study report) should not be derived by simply joining
The investigator should ensure that the investigational product(s) are used only in accordance with
Who submits written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC ?
The investigator provides evidence of his/her qualifications to perform the research through
The investigator is familiar with the appropriate use of the investigational product(s), as described in
The investigator conducts the research in accordance with
The investigator shall permit investigational product(s) to be used with subjects only under
The investigator shall maintain accurate, complete, and current records, including aspects as
relevant to the research:
The investigator shall obtain consent from each subject as follows, except for research
involving a waiver of consent that has been approved by the IRB:
Is the subject obliged to give his or her reasons for withdrawing prematurely
from the clinical trial ?
The investigator reports serious adverse events to the sponsor except for those events
If the IRB terminates or suspends its approval of the research then
The investigator maintains a list of appropriately qualified persons
Is the investigator expected to understand law? If yes, by whom?
LAR
Which are the 3 IND types?
Investigator IND
Emergency use IND
Treatment IND
Which are the 2 IND categories?
Who is responsible for implementing and maintaining quality
assurance and quality control systems with written SOPs to ensure that trials are
conducted and data are generated, documented (recorded), and reported in
compliance with the protocol, GCP, and the applicable regulatory requirement(s)?
Who is responsible for securing agreement from all involved parties
to ensure direct access to all trial- related sites, source
data/documents, and reports for the purpose of monitoring and auditing by the
sponsor, and inspection by domestic and foreign regulatory authorities?
What should be applied to each stage of data handling to ensure
that all data are reliable and have been processed correctly?
Who is responsible for the quality and integrity of
the trial data?
Who should designate appropriately qualified medical personnel who will be
readily available to advise on trial-related medical questions or problems?
IDMC
What is an IDMC and who may set one up?
Unexpected
Disability
Life-threatening adverse drug experience
ICH GCP states: " An investigator shall promptly report to the sponsor
The industry standard is to report all SAEs within
The reporting requirements for reporting any adverse effect are spelled out
SAEs are recorded on
Form FDA 3500 A is the
Information to include in SAE Reports