question

What must you file before conducting human clinical trials with an experimental drug?

answer

IND application (Form FDA 1571)

question

During the clinical development phase of the IND process, what must sponsors do?

answer

Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports

question

this document notifies FDA of relevant changes in investigators conducting clinical trials under the IND.

answer

Form FDA 1572

question

What is the timeline of drug development?

answer

Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV)

question

When does a sponsor submit the IND?

answer

Prior to clinical development phases (human trials). *30 day process.

question

What is the NDA?

answer

New Drug Application, submitted prior to Phase IV marketing phase.

question

How long does the NDA submission take?

answer

6 months - 2 years.

question

What is determined for a drug in the preclinical phase

answer

Pharmacokinetics and bioavailability Outcome shows promise of safety and efficacy warranting additional studying.

question

How long does FDA have to review IND submission?

answer

30 days

question

How long is the clinical development phase (Phase 1-III) in process for IND?

answer

6-7 years.

question

Determine the trial phase: - Assess toxicity - Determine drug's PK and PD profiles - Determine doses resulting in sufficient biological level of drug

answer

Phase I

question

Determine the trial phase: - Determine drug's effectiveness (primary goal) - Determine long-term drug safety - Confirm findings

answer

Phase III

question

Determine the trial phase: - Determine drug's short-term risk (safety) (primary goal) - Examine preliminary effectiveness of drug

answer

Phase II

question

Determine the trial phase from the subject population: Controlled studies enrolling limited numbers of patients

answer

Phase II

question

Determine the trial phase from the subject population: Controlled and uncontrolled studies (but typically placebo-controlled and double-blinded) enrolling larger patient numbers.

answer

Phase III

question

Determine the trial phase from the subject population: Normal healthy volunteers unless toxicity prevents exposure (e.g, cancer drugs). In this, case patients with end-stage disease might be enrolled.

answer

Phase I

question

If an IND application is submitted and the FDA has not contacted the physician within 30 days after acknowledging receipt, can the trial start?

answer

Yes, one of two conditions must be met. 1. 30 days elapsed since FDA received IND application and no hold as been placed. 2. Correspondence has ben received from FDA allowing the trial to start.

question

What must be provided to investigators before they beginning conducting trials at their site?

answer

Protocol and Investigator's Brochure

question

What regulation must a PI comply with in order to use an edc system for a clinical trial?

answer

21 CFR Part 11

question

What happened because of the concern and confusion regarding interpretation of Part 11in 2003.

answer

FDA withdrew all the guidance documents related to Part 11, while re-examining. They then issued: Guidance for Industry: Part 11, Electronic Records; Electronic Signatures-Scope and Application (2003) and Guidance for Industry: Computerized Systems Used in Clinical Investigations (2007). ** The 2007 guidance "supplements the 2003 guidance"

question

Development of most new drugs from discovery to marketing approval usually takes:

answer

9 years or more

question

The first randomized, controlled study of an experimental drug versus aspirin for postoperative pain control will enroll 55 patients in each arm. Which of the following best describes the clinical phase of this study?

answer

Phase 2

question

Adults with more than a 12-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical phase of this study?

answer

Phase 3

question

Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?

answer

Preclinical

question

Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?

answer

Phase 1

question

For a Phase 1 new drug study in humans, what is the primary source of the data included in the initial Investigator's Brochure?

answer

Preclinical data

question

What is ICH's more specific name?

answer

International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use.

question

what is the goal of the ICH?

answer

to minimize redundant research. and standardize technical guidelines and requirements.

question

Define the term: an individual, or judicial or other body, authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedures involved in the research

answer

Legally Authorized Representative (LAR)

question

an unplanned excursion from the requirements of the protocol that is not implemented or intended as a systematic change.

answer

Protocol Deviation (or Violation)

question

What are the 6 regulatory and pharmaceutical industry groups that have representatives working for ICH?

answer

-European Commission (EC) -European Federation of -Pharmaceutical Industries' Association (EFPIA) -Ministry of Health, Labor, and Welfare, Japan (MHLW) - Japan Pharmaceutical Manufacturers Association (JPMA) - US Food and Drug Administration (FDA) - Pharmaceutical Research and Manufacturing of America (PhRMA)

question

How do the World Health Organization (WHO) and the European Free Trade Association (EFTA) [represented by Swissmedic, and Health Canada participate with ICH?

answer

As observers.

question

How is the ICH governed?

answer

a Steering Committee

question

Who supports the ICH?

answer

the ICH Secretariat

question

Who provides the ICH secretariat?

answer

The International Federation of Pharmaceutical Manufacturers Association (IFPMA)

question

How many seats on the Committee does each of the 6 working groups of ICH have?

answer

2

question

who nominates other nonvoting participants to attend ICH steering Committee meetings?

answer

The observer groups (WHO, Health Canada, and EFTA)

question

Is the ICH GCP regulation or guideline?

answer

Depends, several countries adopted it as law, but the U.S FDA adopted it only as guidance. (Federal Register, Vol. 62, MAY 9, 1997)

question

What are the four main categories covered by ICH guidelines?

answer

Q: Quality topics (chemical and pharmaceutical assurance) S: Safety topics: in vitro and in vivo preclinical research E: Efficacy topics: relating to research in human subjects M: Multidisciplinary topics: those that do not fit uniquely into one of the above categories. (QSEM)

question

What are the expert working groups responsible for?

answer

developing specific guidelines. * The ICH then provides an efficient process and format to standardize the new requirements across agencies and countries.

question

ICH E6 guideline pertains specifically to what

answer

the conduct of clinical research to support marketing applications for drugs.

question

Provides a unified standard for designing, conducting, recording, and reporting research involving human subjects.

answer

ICH E6 guideline for good clinical practice.

question

What are the two important goals of the ICH E6 standard?

answer

To assure that 1: The rights, well-being, and confidentiality of trial subjects are protected. 2: Trial data are credible.

question

Where do the ethical principles followed by ICH GCP guidelines originate from?

answer

the Declaration of Helsinki

question

What ethical principles stem from the Declaration of Helsinki?

answer

in notes....

question

If planning to market drugs outside the US, what guidance must a PI follow while conducting the clinical trial?

answer

ICH E-6 Good Clinical Practice.

question

Can an employee at the research site be witness to a patient's consent?

answer

No, they are involved in the trial. Witness must be "a person who is independent of the trial, who cannot be unfairly influenced by people involved in the trial"

question

What must a witness do before the consent process starts?

answer

Read the consent form and other written information provided to the participant. They must also determine whether the participant has any other questions and should sign the impartial witness signature block on the consent document.

question

If following ICH guidelines who all should sign the consent form between the subject, witness, and person obtaining consent.

answer

All of them.

question

Define: Oversee research involving human subjects to assure the protection of their rights, safety, and welfare.

answer

IRBs/IECs

question

FDA or ICH: requires the consent form to include a statement that "monitors, auditors, the IRB/IEC, and the regulatory authorities will be granted access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject is authorizing such access

answer

ICH GCP

question

FDA or ICH: Treatment alternatives only need to be listed in the consent form

answer

FDA

question

FDA or ICH: requires that the potential benefits and risks of the alternatives should also be included in the consent form.

answer

ICH

question

What does the ICH E6 guidelines require in a consent form for treatment arms.

answer

Description of each arm, the likelihood of being assigned to each of the study arms, and an explanation of " the subject's responsibilities"

question

Does FDA require description in consent if research provides no expected benefit?

answer

No, only an explanation of expected benefits of the research?

question

What does ICH require in terms of benefits in the ICF?

answer

If there is no intended clinical benefit to the subject, Section 4.8.10(h) requires that the subject be made aware. Consent form should describe the anticipated prorated payments to subjects (recommended for FDA as well)

question

Is assent required for both FDA and ICH?

answer

Yes, and the consent of the parents.

question

Define Assent

answer

The agreement of someone who cannot consent for his or herself.

question

FDA vs. ICH when enrolling an adult who is unable to consent for him or herself.

answer

ICH E6 requires assent along with permission from their LARs. Not required by FDA.

question

ICH or FDA: Only subjects who are able to consent for themselves are allowed to enroll in non-therapeutic research studies (a trial in which there is no anticipated direct clinical benefit to the subject.

answer

ICH

question

When can ICH allow subjects to be enrolled that cannot consent for themselves? (Exceptions)

answer

studies where: - the objectives cannot be met without including these subjects. the foreseeable risks to the subject are low as is the negative impact. - the study is not illegal AND The IRB/IEC has specifically agreed to include these subjects.

question

T/F: FDA requires Investigator to inform the subject's primary physician about the subject's participation in the trial if subject has a PCP and if the subject agrees to the primary physician being informed.

answer

False, this is a requirement of ICH E6 guidelines.

question

FDA or ICH requirement: IRB/IEC is required to review -written ICF and updates - trial protocols/amendments - subject recruitment procedures (advertisements) - written information to be provided to subjects - IBs Safety information Info about payments and compensation to subjects - CVs and qualifications - any other docs IRB/IEC may require to fulfill its responsibilities

answer

ICH E6 Guideline. FDA not clear in requirements for IRB/IEC review of documents.

question

Per FDA requirements, what is required of the IRB/IEC?

answer

to review the consent form (21 CFR 56.109) and to keep "copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents.

question

A primary purpose of the ICH is to: - require publication of negative trial results. - develop mandatory worldwide regulations for drug development. - require FDA registration of worldwide clinical trials. - minimize the need for redundant research

answer

Minimize the need for redundant research.

question

The ICH GCP guidelines: - set standards for the design, conduct, monitoring and reporting of clinical research. - guarantee that a submission in any ICH region will be approved for marketing. - require certification of clinical research sites and investigators - replace FDA regulations for internationally conducted studies of drugs that will be marketed in the U.S.

answer

Set standards for the design, conduct, monitoring and reporting of clinical research.

question

The ICH E6 GCP describes standards that apply to: -Investigators, sponsors, and IRBs. - Research sponsors only - Investigators only - IRBs only

answer

Investigators, sponsors, and IRBs.

question

In the United States, following the ICH E6 GCP is: - Voluntary for FDA-regulated drug studies. - Mandatory for studies conducted outside the United States. - Mandatory for investigational device studies. - Mandatory for drug studies.

answer

Voluntary for FDA-regulated drug studies

question

The FDA will apply: - The ICH E6 GCP standards - The Code of Federal Regulations - Local IRB requirements - State law where the sponsor's headquarters are located.

answer

The code of federal regulations

question

What is the legal status of ICH in the U.S.?

answer

It is a guideline

question

Regarding subject signature on consent forms, which is true about dates?

answer

Both the FDA and ICH require

question

ICH requires a witness when enrolling illiterate subjects, true or false?

answer

True

question

Regarding probability of assignment to trial arms in consent forms, which is true?

answer

Only ICH recommends.

question

When is there "Sponsor-investigators"

answer

Investigator-initiated trials of investigational drugs.

question

Who addresses the role of "Sponsor-investigators?"

answer

FDA

question

means in addition to producing the drug, the company also supplies the investigator with the drug for use in the study

answer

Drug Supplier/Manufacturer

question

means the entity who takes responsibility for and initiates a clinical investigation. The sponsor can be any legal entity, including a company, an academic organization, or an individual. The intent of the sponsor's IND is to allow testing for marketing approval of the drug. These are generally considered commercial or corporate INDs. Note: the sponsor is often but not always the entity that funds the clinical research.

answer

Sponsor

question

means an individual who both initiates and conducts the clinical investigation and under whose immediate direction the investigational drug is being administered, used, or dispensed. The sponsor-investigator assumes all of the responsibilities of the sponsor as well as all the responsibilities of an investigator as outlined in the Form FDA 1572 (see the module, Investigator Obligations in FDA-Regulated Research). Usually, the intent of the sponsor-investigator trial is to gain scientific knowledge without seeking market approval for the drug. These are considered investigator-initiated or sponsor-investigator trials.

answer

Sponsor-investigator

question

Usually, the intent of the sponsor-investigator/investigator-initiated trial is to

answer

gain scientific knowledge without seeking market approval for the drug.

question

the regulation stating: exception from informed consent for emergency research

answer

21CFR 50

question

What can Investigators reference when unsure if an IND is required for a study of an approved drug?

answer

IND exemptions for studies of lawfully marketed drug or biological products for the treatment of cancer OR seek opinion from FDA.

question

Form FDA ______: Statement of the Invesitgator

answer

1572

question

Form FDA ____: Investigational New Drug Application, NDA

answer

1571

question

detailed requirements for the content and format of an IND can be found in

answer

21 CFR 312

question

what can be cross-referenced when the manufacturer of an IND already has an active IND for the drug being studied?

answer

Chemistry, manufacturing, and controls (CMC) information Pharmacology and toxicology information Previous human experience with the drug

question

Form: contractual agreement between the sponsor and FDA.

answer

FDA 1571

question

21 CFR 56

answer

IRBs

question

The content for an IND for studies of marketed products is the same as the content for studies of new drugs, with the following exception:

answer

a copy of the approved labeling (including the package insert) can be provided in lieu of the Investigator's Brochure.

question

what are the three types of protocol amendments?

answer

-new sponsor protocol -a change in an existing protocol when the entire sponsor protocol is not revised - identifying and adding new investigator to a study

question

submitted when new toxicology, chemistry, or other technical information is available. Study discontinuation is also submitted as this.

answer

Information amendments

question

When do Annual Reports need to be submitted to the FDA?

answer

within sixty (60) days of the anniversary date that the IND went into effect.

question

The following are purposes of what: -The rights and well-being of human subjects are protected. -The reported trial data are accurate, complete and verifiable from source documents. -The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements.

answer

Trial monitoring

question

When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA? A. IND renewal application B. Adverse Event Summary Report, but only from unblinded portions of studies ("open-label IND safety report") C. IND report D. Marketing plan (i.e. annual updated projection of sales and profits)

answer

C. IND report

question

Which of the following is a criterion for determining if a study of an approved drug is exempt from the require of an IND? A. The study intends to invoke an exception from informed consent. B. The study involves a route of administration that significantly increases the risks to the patient. C. The study is not intended to be reported to FDA to support a new indication or support a labeling change. D. The study intends to involve more than 100 patients in a study.

answer

C. The study is not intended to be reported to FDA to support a new indication or support a labeling change.

question

Which of the following reports must be filed using an FDA Form 1572? A. Annual Reports B. Addition of a new investigator C. Protocol amendments

answer

B. Addition of a new investigator.

question

the tool used to record data collected during a clinical trial

answer

CRF, case report form

question

document that includes information needed for potential subjects to have sufficient info to provide informed consent to participate in a clinical trial. The FDA regulations and ICH E6 describe the information that must be included in the consent form.

answer

Informed Consent Document

question

any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. " Assure the protection of the rights and welfare of the human subjects.

answer

IRB

question

All info in original records and certified copies of original records of clinical findings ETc

answer

source data.

question

Initial documentation of data in a clinical study and includes recorded observations, laboratory reports, medical records, etc.

answer

Source Document.

question

This agreement is a contract that defines both the terms of study conduct and the financial agreements

answer

CTA (Clinical Trial Agreement)

question

When is it necessary for an investigator to complete and sign a new 1572?

answer

- when participating in a new protocol that has been added to the IND - When a new investigator is added to the study.

question

What needs to be done when there are other changes to information contacted on a signed and dated 1572? (IRB/IEC address change, addition of a clinical research lab)

answer

investigator should document the changes in the clinical study records and inform the sponsor of the changes, so that the sponsor can appropriately updated the IND.

question

ICH or FDA, requires submission of up to date curriculum with changes?

answer

ICH

question

clinical trials of drugs or devices from which the data will be submitted to the FDA to support a marketing application or relied upon by the FDA to establish effectiveness.

answer

"covered clinical studies"

question

For purposes of financial disclosures, the term (blank) includes anyone who is directly involved in the treatment or evaluation of research subjects. The term also includes the spouse and each dependent child of the (blank).

answer

Investigator

question

21 CFR 54

answer

Financial Disclosure by Clinical Investigators

question

The investigator's financial interests with the pharmaceutical company (sponsor) or to the outcome of the clinical investigation is reported directly to the FDA by: A) The investigator's institution B) The investigator C) The IRB D) The sponsor

answer

D. The sponsor

question

In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to: A) Maintain a contract with the sponsor B) Maintain records indefinitely C) Report to the FDA any adverse events that occur. D) Conduct or supervise the investigation personally

answer

D. Conduct or supervise the investigation personally.

question

Form FDA 1572, Statement of Investigator, is legally binding between the Investigator and the: A) Subjects B) Sponsor C) FDA D) IRB

answer

C) FDA

question

The investigator must report adverse events to the: A) Subject B) Sponsor C) FDA D) IRB only

answer

B) Sponsor

question

When must the investigator update the IRB about the progress of a trial? A) During the conduct of the study and at termination B) During the conduct of the study only C) Never D) At study termination only

answer

A) During the conduct of the study and at termination

question

Which of the following is an investigator's commitment to the sponsor? A) Submit documents to sponsor for yearly approval to continue the study B) Retain study documents for 3 years after study completion at the site C) Provide the financial disclosure document directly to FDA D) Submit a new FDA form 1572 to sponsor as needed

answer

D) Submit a new FDA form 1572 to sponsor as needed

question

"...any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries"

answer

Biological Product (Biologic)

question

"...a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use" (ICH GCP E6 Section 1.33).

answer

Investigational Drug

question

"...a new drug, antibiotic drug, or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes" (21 CFR 312.3).

answer

Investigational New Drug (IND)

question

Which of the following is an important component of drug accountability? A) Environmental controls B) Drug shipping and disposition records C) Patent expiration date D) Manufacturer's compounding procedures

answer

Drug shipping and disposition records

question

Who has ultimate responsibility for an investigational product?

answer

Investigator

question

Investigational product dispensing or administration info for the sponsor is recorded on the:

answer

Case Report Form

question

The packaging of investigational drugs should ideally A) look like a marketed product B) allow subjects to identify placebo pills C) be designed to help with subject compliance D) be attractive so the study coordinators will use it

answer

be designed to help with subject compliance

question

Where is info on storage requirements for the investigational product usually found? A) on the product code-breaker label B) In the CRF directions C) In the drug accountability log D) In the study protocol

answer

in the study protocol

question

A 46-year-old man is currently enrolled in a Phase 3 study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?

answer

Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug

question

Which of the following statements in a consent form is an example of language that appears to waive a subject's rights?

answer

I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

question

An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual's legal representative. Under the FDA regulations, which of the following describes the best course of action for the investigator:

answer

The investigator and another physician who is not part of the study team agree that the situation necessitates the use of the test article and the IRB will be notified later.

question

Under which circumstance does the FDA allow verbal consent prior to participation in a research study?

answer

The study is minimal risk.

question

Which of the following should take place during periodic site visits?

answer

Identification of protocol violations

question

Which of the following best describes when the majority of CRF data are verified against source record information?

answer

Periodic site visits.

question

When should the sponsor-monitor conduct the most detailed review of the study protocol with the site's study staff?

answer

Site initiation visit.

question

The FDA requires retention of investigational drug study records for:

answer

At least 2 years after the investigational drug's approval by the FDA.

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