question

T/F: When a sponsor transfers some or all of it's obligations to a CRO, the CRO is required to comply with all regulations designated as sponsor requirements for the transfered obligations.

answer

True

question

Controlled trials evaluating the effectiveness of multiple doses of a drug in patients would be considered as what phase of the investigation?

answer

Phase II

question

What phase of a study typically evaluates the pharmacokinetics of a drug in normals?

answer

Phase I

question

When a sponsor receives information from an IRB regarding public disclosure of research, what action must the sponsor take?

answer

Submit copies of the information disclosed to both the IND file and the Dockets Management Branch of the FDA.

question

Studies which provide an overall evaluation of a drug and an adequate basis for physician labeling would be considered as what phase of the investigation?

answer

Phase III

question

To whom may a sponsor provide investigational drugs?

answer

Investigators participating in the clinical investigations under the IND.

question

What statement must the label of all investigational drugs bear?

answer

"Caution: New Drug - Limited by Federal law to investigational use"

question

Who must specifically be named on the FDA Form 1572?

answer

1. Investigator 2. Institution where the investigation will be conducted 3. Clinical lab to be used in the study 4. IRB responsible for review and approval 5. Sub-investigators who will assist the investigator

question

What information must an investigator provide study subjects regarding the drug they may receive?

answer

That the drug is being used for investigational purposes.

question

Who has the responsibility for ensuring that an IRB that complies with the requirements of 21 CFR 56 will provide review and approval of an investigation?

answer

The Investigator

question

What actions must an investigator take to make changes in a study protocol?

answer

1. Inform the sponsor, request the change, and obtain a protocol amendment, if required 2. Inform the IRB, and request review and approval of the amendment 3. Modify the consent form, if required, and obtain the IRB approval 4. Inform study patients of the pertinent changes, and obtain new informed consent, if applicable

question

Give an example of the type of information required to be filed as an information amendment to an original IND application.

answer

New technical information such as a toxicolocy or chemistry; reports regarding discontinuation of a clinical investigation.

question

What is the FDA's preferred filing frequency for information amendments by sponsors?

answer

At intervals of 30 days.

question

What is the FDA's definition of the term "associated with the use of the drug" with respect to evaluation of AE's?

answer

There is a reasonable possiblity that the experience may have been caused by the drug.

question

What types of experiences does the FDA classify as serious adverse drug experiences in clinical trials? Any event that results in...

answer

1. Death 2. A life-threatening drug experience 3. Inpatient hospitalization or prolongation thereof 4. Significient or persistent disability 5. Congenital anomoly or birth defect * Important medical events may also be serious events

question

What additional information is availabe from thr FDA that applies to and supports interpretation of the FDA regulations?

answer

FDA guidance documents which support interpretation of the regulations are available from both the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.

question

What is the FDA's definition of disability, as it relates to SAE's?

answer

A substantial disruption of a person's ability to conduct normal life functions.

question

What is the FDA criterion which classifies an adverse drug experience as unexpected?

answer

Any adverse experience, the specificity or severity of which is not consistent with the current Investigator Brochure, or other designated document when an Investigator Brochure is not required.

question

Unless the FDA notifies a sponsor that investigations in an IND are subject to a clinical hold, how soon may a soposnr being a clinical investigation after filing the IND?

answer

30 days after the FDA receives the IND submission.

question

Generally, sponsors may request FDA comment and advice on which components of an IND submission?

answer

1. Adequacy of technical data to support an investigational plan. 2. Design of a clinical trial. 3. A determination of whether proposed investigations are likely to produce the data and information needed for an NDA.

question

Reasons for the FDA to impose a clinical hold for a Phase I, II, or III investigation:

answer

1. Subjects would be exposed to unreasonable and significant risk of ilness or injury 2. Unqualified investigators 3. Inadequate Investigator Brochure 4. IND lacks safety data 5. Gender bias on subject elegibility

question

If enrollment in a sponsored, adequate and well-controled investigation is being impeded by a treatment-IND investigation, what action may the FDA take?

answer

The FDA may place the treatment-IND on clinical hold

question

T/F: Resumption of clinical investigators which were subject to a clinical hold must always be issued in writing by the FDA to a sponsor.

answer

False - If permitted in the clinical hold order, investigators may be resumed as soon as the deficiencies are corrected. Resumption notification for clinical hold cases requiring sponsor response, may be made by telephone or other rapid communication means.

question

For what length of time must all clinical investigations under an IND remain on hold prior to the FDA converting the IND to inactive status?

answer

One year or more

question

If a sponsor fails to inform the FDA of all SAE's, what is the most significant action the FDA may take relative to the IND?

answer

Termination of the IND

question

On what grounds may the FDA terminate an IND immediately, without opportunity for sponsor response?

answer

If the FDA concludes that continuation of the investigation presents a substantial danger to the health of individuals.

question

If an IND is placed on inactive status by the FDA, what action must the sponsor take with drug supplies?

answer

Arrange with all investigators for the return or other proprt method of disposal of the investigational drug.

question

At what point in the clinical development process of a drug does the FDA encourage meetings with an IND sponsor?

answer

At the end of Phase II and prior to NDA submission

question

End of Phase II meeting between FDA and a sponsor are generally reserved for what type of IND?

answer

IND's involving new molecular entities or major new uses of marketed drugs.

question

Purposes of Pre-NDA or Pre-BLA meetings between a sponsor and the FDA:

answer

1. To uncover any major unresolved problems. 2. To identify studies on which the sponsor will rely to establish effectiveness. 3. To identify the status of ongoing or needed studies, to assess pediatric safety and effectiveness. 4. To acquaint FDA reviewers with the technical content. 5. To discuss statistical analysis methods. 6. To determine the optimal approach for presenting and formatting of NDA date.

question

Who at the FDA is responsible for issuing a clinical hold?

answer

The Division Director with responsibility of review of the IND

question

When the FDA approves a shipment of a drug for emergency use from a telephone request, what additional requirement typically is made of the sponsor?

answer

The sponsor must make an appropriate IND submission as soon as practicable after receiving the approval.

question

T/F: Filingh a seperate IND with the FDA is required if a sponsor elects to conduct investigations involving waiver of informed consent in emergency research.

answer

True

question

What are the labeling requirements for investigational drugs with respect to sagety or effectiveness of the product?

answer

The lable can bear no misleading statement and shall not represent that the drug is safe or effective for the purposes for which it is being investigated.

question

T/F: A promotional claim is acceptable on investigational drug supply labeling, provided the claim was previously approved by the FDA.

answer

False - Promotional claims may not appear on investigational drug supply labels.

question

Describe the FDA requirement for charging for investigational drugs under an IND.

answer

Charging under an investigational drug IND is not permitted without prior written approval from the FDA. Written explanation of why charges are necessart and not a normal cost of doing business is required.

question

T/F: Charging a reasonable amount for investigational drugs under a treatment IND is permissable provided certain criteria are met and there is no commercialization or promotion involved.

answer

True

question

T/F: All of the safeguards incorporated in the FDA regulations regarding informed consent, IND, NDA, and Biologics also apply to drugs intended to treat life-threatening or severely debilitating illness.

answer

True

question

Criteria necessary for importing investigational new drugs into the US: The Consignee is:

answer

1. The US sponsor of the IND. 2. A qualified investigator named in the IND. 3. The domestic agent of a foreign sponsor, who is responsible for the control and distribution of the drug and is so indentified in the IND.

question

Name two individuals who may submit a request for authotization to the FDA to export investigational drug outside the US.

answer

1. The person in the US who seeks to export the drug, or 2. An authorized official of the Government of the country to which the drug is proposed to be shipped

question

Name the international doctrine of ethical principles that is the standard requirement for acceptance of foreign studies in support of an IND or NDA.

answer

The Declaration of Helsinki

question

In general, the FDA accepts foreign studies not conducted under an IND, provided what conditions are present? Provided the studies are:

answer

1. Well designed 2. Well conducted 3. Performed by qualified investigators 4. Conducted in accordance with ethical principles acceptable to the world community.

question

T/F: The FDA may disclose the existance of an IND, even if it has not previously been made public.

answer

False

question

T/F: Some clinical investigations involving an in vitro diagnostic biologic product may be exempt from the IND regulations if it is used only to confirm a diagnosis made by another medically established diagnostic product or procedure.

answer

True

question

T/F: Clincial research on blood grouping serum, reagent RBC's and anti-human globulin are generally exepmt from the FDA's IND Regulations.

answer

True

question

T/F: Use of a marketed drug or biologic product for an unlabeled indication in the practice of medicine is not subject to IND regulations.

answer

True

question

What is the definition of a CRO, according to the FDA's IND regulations.

answer

A person working with the sponsor as an independent contractor who assumes one or more of the obligations of the sponsor.

question

What types of products are generally subject to the IND regulations?

answer

Investigational new drugs, biological drugs, and biological products used in vitro for diagnostic purposes that are to be used in a clinical investigation.

question

How much time does the FDA have to provide a sponsor with a written approval to proceed with an IND that involves waiver from informed consent due to emergency conditions?

answer

30 Days

question

What phase of clinical investigation includes a study that evaluates security-activity relationships or mechanism of action in humans?

answer

Phase I

question

Two conditions under which the FDA can place an IND on inactive status:

answer

1. If no subjects are entered into clinical trials for a period of 2 yrs or more under the IND 2. If all investigations under the IND remain on clinical hold for a period of more than one year.

question

What is the FDA's primary objectives when reviewing an IND regarding Phase I?

answer

Safety Assessment

question

What is the FDA's primary objectives when reviewing an IND regarding Phase II & III?

answer

Safety/Efficacy - and to help assure scientific evaluation

question

What is the FDA's primary objectives when reviewing an IND regarding all phases?

answer

Assure the rights and safety of subjects.

question

List the general responsibilities of sponsors:

answer

1. Select qualified investigators, providing them with information to properly conduct the trial. 2. Ensure proper monitoring. 3. Ensure the study is conducted in compliance with the protocol. 4. Maintain an effective IND. 5. Ensure FDA and investigators are provided full safety information.

question

How soon does a sponsor have to submit a new investigator amendment to an IND?

answer

30 days following the addition of the investigator.

question

Sponsors are required to maintain an ongoing review of safety information from which sources?

answer

Any foreign or domestic source including clinical epidemiology, and animal investigations, commercial marketing experience, scientific literature reports, and unpublished scientific papers, and reports from foreign regulatory authorities not previously reported to the FDA.

question

What is the time requirement for fliing IND safety reports with the FDA?

answer

ASAP and never later than 15 calendar days after the sponsor's initial receipt of the information.

question

How soon must the FDA be notified of a fatal or life-threatening adverse experience which is associated with use of a drug?

answer

By telephone or facsimile, no later than 7 calendar days after sponsor receipt of the information, followed by a written report no later than 15 calendar days after initial receipt of the information by the sponsor.

question

For the purposes of filing IND safety reports with the FDA, what is the definition of a :life-threatening event"?

answer

The patient was at immediate risk of death from the reaction as it occurred.

question

Who must approve modifications on the reporting format or frequenct of IND safety reports to a sponsor deviating from the regulations?

answer

The Division Director at the FDA.

question

When are sponsors required to file follow-up information for IND safety reports?

answer

As soon as the relevant information is available.

question

If a sponsor evaluates an adverse event and determines that it is reportable as an IND safety report, but it was not originally reported as such, how long does the sponsor have to report the event as an IND safety report?

answer

ASAP, but in no event later than 15 calendar days after the determination is made.

question

T/F: If a sponsor submits an IND safety report, it is assumed by the FDA that the drug caused or contributed to the event, unless it is specifically denied by the sponsor.

answer

False - Mere submission of a report under the IND safety report requirements does not reflect conclusion, by the sponsor or FDA, that the drug caused or contributed to the reported event.

question

What is the time frame in which a sponsor must file an IND annual report?

answer

Within 60 days of the anniversary date that the IND went into effect.

question

What are the required elements to be reported for each individual study reported in an IND annual report?

answer

1. Study title, identifier an dpurpose, description of patient population and completion status. 2. Total number of subjects (Initially planned for inclusion, Entered to date, Who completed as planned, Dropped for any reason.) 3. Brief description of any interim or final analysis results, if available.

question

Name specific clinical adverse experience summary items required in an IND annual report:

answer

1. Most frequent and most serious adverse experiences by body system. 2. IND safety reports submitted w/I thepast year 3. list of subjects who died with cause of death 4. list of subjects who dropped due to an adverse experience.

question

T/F: Summary information for clinical trials activity within the past year is required in the IND annual report, while results or pre-clinical studies are not.

answer

False - Pre-clinical summary information for studies completed of conducted within the past year must be included in the IND annual report.

question

For what type of studies do FDA officials intend to monitor study progress and evaluation to facilitate appropriate progress of the trials?

answer

Drugs intended to treat life-threatening or severely debilitating illnesses.

question

What should be the main focus of an initial IND submission?

answer

The general investigational plan and the protocols for specific human studies.

question

Name the factors that determine the amount of information that must be submitted in an IND.

answer

1. Novelty of the drug 2. Extent to which the drug has been previously studied 3. Known or suspected risks 4. Particular developmental phase

question

Fda form 1571 requires the names and titles of two persons with specific functions. Who are they?

answer

1. The person responsible for monitoring the conduct and progress of the evaluation 2. The person responsible for review and evaluation of safety information for the drug.

question

T/F: FDA Form 1571 contains a statement that an IRB that complies with the requirements of 21 CFR 56 will be responsible for review of all studies conducted under the IND.

answer

True

question

Name the elements required in the general investigational plan of an original IND application.

answer

1. Rationale for the drug or study. 2. Indication(s). 3. General evaluation approach. 4. Types of trials to be conducted in the first year. 5. Estimated number of patients to be studied in the first year. 6. Any anticipated risks of particular severity or seriousness.

question

Describe the level of detail required for Phase I protocols vs Phase II & Phase III protocols.

answer

Phase I may be less detailed and more flexible than Phases 2 and 3. Phase I should outline the plan, specify the number of patients, describe safety measures and include a dosing plan. Phases 2-3 should be very detailed, and will generally not permit unanticipated protocol changes.

question

Required sections in a clinical research protocol for a study conducted under an IND:

answer

1. objectives and purpose 2. name, address, and qualifications of investigators and of the reviewing IRB 3. inclusion/exclusion criteria 4. study design 5. dosing information 6. planned observations and measurements 7. clinical procedures to evaluate safety

question

Required content elements in the Chemistry, Manufacturing, and Controls section of an original IND Application. Information on:

answer

1. Drug Substance 2. Drug Product 3. Placebo composition if applicable 4. Labeling 5. Environmental analysis requirements

question

The pharmacology and toxicology section of an original IND application requires the names and qualifications of the individuals who performed what tasks?

answer

Those who evaluated the results of pre-clinical studies and concluded it was reasonably safe to begin the proposed clinical investigations.

question

Results of pre-clinical studies on abuse potential and drug dependence are required in the original IND application for which classes of drugs?

answer

Psychotrophic substances or any other drug with abuse potential.

question

What are the FDA's requirements for translation and inclusion of documents in an IND application which are not English?

answer

A complete English translation must be included as well as a copy of the original publication in the foreign language.

question

Name the three categories of protocol amendments which require a sponsor to undate the original IND application:

answer

1. New Protocols 2. Changes in a protocol 3. New investigators

question

T/F: During the investigator selection process, sponsors are required to obtain a commitment from an investigator to provide financial disclosure statements before, during, and for one year after the completion of a study.

answer

True

question

When a sponsor is conducting investigations under 21 CFR 50.24, in emergency research conditions, what information must the sponsor promptly file with the FDA, under the IND?

answer

Information received from the IRB concerning the public disclosure required by the regulation.

question

What information document must a sponsor provide to an investigator prior to beginning an investigation?

answer

Investigator Brochure

question

What is a sponsor's obligation relative to review of a patient data in an ongoing investigation?

answer

The sponsor must review and evaluate safety and efficacy data as it is obtained from the investigator.

question

What records must a sponsor maintain regarding investigational drug supplies?

answer

Records of receipt, shipment or other disposition of the drug, which should include the name of the investigator, as well as the date, quantity, and batch or code mark of each shipment.

question

What records are sponsors required to retain regarding financial interests of it's investigators?

answer

1. Complete and accurate records showing any financial interest paid to investigators by the sponsor of the study 2. Complete and accurate records concerning all other financial interests of the investigator in compliance with 21 CFR 312.87

question

How long must a sponsor retain records of clinical investigators?

answer

Two years after a marketing application is approved, or if an application is not approved for the drug, two years after the shipment and delivery of the drug for investigational use is discontinued and the FDA has been notified.

question

T/F: Sponsors are required to reserve samples of any test article and reference standards used in bioequivalence or bioavailability studies, yet are not required to release these samples to the FDA.

answer

False - Sponsor is requested to release these samples to the FDA upon their request.

question

What authority does the FDA have regarding inspection of sponsor records?

answer

The FDA may have access to, inspect, copy, and verify any records and reports relating to a clinical investigation at reasonable times.

question

Who may inspect records of investigational drugs that are also controlled substances?

answer

The FDA and the DEA of the US Dept of Justice

question

What precautions must a sponsor take regarding storage of investigational drugs that are also controlled substances?

answer

Ensure the drug is stored in securely locked, or substantially constructed cabinet or other securely locked, substantially constructed enclosure, access to which is limited to prevent theft or diversion of the substance into illegal channels of distribution.

question

Under what conditions may an investigator dispose of investigational drug?

answer

Only under written authorization by the sponsor; the sponsor must also ensure that the disposition method will not expose humans to risks from the drug.

question

What records must be maintained by investigators for investigational drug supplies?

answer

Records of drug disposition including dates, quantities, and use by study subjects.

question

For how many years must an investigator retain records of investigational drug supplies and study subject case records?

answer

Two years after NDA approval, or if an NDA is not approved, two years after the investigation has been discontinued and the FDA has been informed.

question

What types of reports is an invsestigator obligated to provide to the sponsor of a study?

answer

1. Progress Reports 2. Safety Reports 3. Final Reports 4. Financial Disclosure Reports

question

What information must an investigator provide to a sponsor regarding financial interests?

answer

Sufficient, accurate information to allow the sponsor to file required reports with the FDA, and any changes to their financial interests during or for one year after the close of the study.

question

Information which an investigator must promptly report to the reviewing IRB:

answer

1. All changes in the research 2. All unantacipated problems involving risk to human subjects or others

question

If an investigator is disqualified by the FDA, what impact might this event have for the sponsor?

answer

Data from disqualified investigators may be eliminated from NDA consideration, and ultimately result in the FDA's failure to approve the NSA. Further, for approved drugs, data from disqualified investigators could result in withdrawl of marketing approval by the FDA.

question

T/F: Once the FDA disqualifies an investigator, he or she may never again receive investigational drug.

answer

False

question

What is the basic premise, relative to risk, of the IND regulations regarding drugs intended to treat life-threatening and severely debilitating disease?

answer

Physicians and patients are generally willing to accept greater risk or side effects from drugs intended to treat these types of illnesses.

question

What are the criteria for life threatening diseases or conditions to which special IND regulations apply for clinical trials? Diseases or conditions:

answer

1. Where the likelihood of death is high unless the disease is interrupted 2. With outcomes where the end point of the clinical trial analysis is survival.

question

What is the FDA's definition of a "severely debilitating" disease?

answer

A disease or condition that my cause irrerersible morbidity.

question

What types of early consultation meetings are usually available for IND's to evaluate life-threatening or severely debilitating illnesses?

answer

1. A pre-IND meeting to review animal data or study design, to discuss Phase I trial designs or data presentations in the IND. 2. An end-of-Phase I meeting to discuss the design of Phase 2 trials.

question

For what purpose might the FDA undertake docused regulatory research?

answer

To evaluate critical rate-limiting aspects of the drug development process in facilitating the development of therapies to treat life-threatening or severely debilitating illnesses.

question

What form specifies the content and order of an IND submission?

answer

1571

question

If a clinical hold order is issued by telephone, how soon thereafter must the FDA provide the sponsor with a written explanation of the basis for the clinical hold?

answer

30 Days

question

T/F: The FDA may place a treatment IND on clinical hold if a sponsor is not pursuing marketing approval with dur diligence.

answer

True

question

When a clinical hold order is issued by the FDA for an ongoing study, what actions must the sponsor take?

answer

Notify all investigators to stop recruitment, remove subjects from the drug, unless specifically permitted to continue the ongoing patients, in the interest of safety.

question

T/F: When a licensed medical practitioned files a TX IND with the FDA, the investigator becomes a sponsor-investigator, even though the sponsor may be supplying the drug.

answer

True

question

Only a sponsor may interrupt a treatment IND investigation if inadequate supplies are available to support it as well as concurrent controlled trials.

answer

False - The FDA may also place the treatment-IND on clinical hold under these circumstances.

question

T/F: For treatment IND's, the investigator is responsible for reporting safety information directly to the FDA.

answer

True

question

Who may bring consultants to an end of phase II meeting?

answer

Both the FDA and the sponsor.

question

What clinical items must a sponsor provide the FDA at least one month in advance of an end of phase II meeting?

answer

A summary of Phase I and II investigations, specific protocols for phase III, plans for any pediatric studies or requests for waiver or deferral of pediatric studies, and tentative labeling for the drug.

question

T/F: The FDA may place a treatment IND or treatment protocol on clinical hold if a comparable or satisfactory alternative therapy or drug becomes available for patients with condirions intended to be treated in the investigation.

answer

True

question

What is the proper sequence of actions a sponsor should take when attempting to resolve an administrative or procedural dispute with the FDA?

answer

1. Attempt to resolve the dispute with the reviewing division of CDER or CBER, beginning with the assigned Consumer Safety Officer. (CSO). 2. If the dispute is not resolved via the CSO, seek resolution via an ombudsman.

question

What is the proper sequence of actions a sponsor should take when attempting to resolve a scientific or medical dispute with the FDA?

answer

1. Discuss the matter directly with the responsible reviewing officials. 2. If unresolved, request a meeting with the reviewing officials, and management representatives.

question

A revised copy of an Investigator Brochure in an IND annual report must be accompanied by what additional information?

answer

A description of the revisions.

question

What does the phrase emergency use of an investigational drug imply, in the FDA's IND regulations?

answer

Use of a drug in an emergency situation for which an IND application has not yet been filed.

question

T/F: The terms "treatment protocol" and "treatment IND" are interchangeable and mean the same thing.

answer

False - A treatment protocol is sponsored by a sponsor, while a treatment IND is sponsored by a liscensed medical practitioned who becomes a sponsor-investigator.

question

T/F: Serious or life-threatening diseases in patients for whom no alternative drug or comparable therapies are available may be evaluated outside of sponsor-planned clinical trials in a treatment protocol.

answer

True

question

T/F: "Treatment use" protocols are generally used once a drug's initial safety in Phase II trials has been demonstrated.

answer

True

21 CFR 312 – Investigational new Drug Applications – Flashcards

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