Clinical research regulations and good clinical practices

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