SOCRA 2
Yes! Because of the new indication
For an investigation looking at a new indication for a marketed drug, would an IND have to be submitted?
Statement of investigator
Form FDA 1572
All three!
ICH E6 describes standards that apply to (investigators/sponsors/IRBs)?
sponsor('s)
The _______must notify FDA of any unexpected fatal or life-threatening suspected adverse reactions no later than 7 calendar days after the ________initial receipt of the information
The study is minimal risk
Under what circumstance does the FDA allow verbal consent prior to participation in a research study?
30
Upon notification by FDA that an IND is going to be placed on inactive status, the sponsor shall have_____days to respond as to why the IND should continue to remain active
Either signed or unsigned is acceptable
What do the FDA regulations say regarding whether the subject should receive a signed or unsigned copy of the consent form?
Form FDA 1572
What form is the Statement of Investigator?
IND safety report form
What is FDA Form 3500A?
Investigational New Drug Application [IND]
What is Form FDA 1571?
Taste and food quality evaluations and consumer acceptance studies (if wholesome foods without additives or if a food is consumed that contains a food ingredient at or below the level and for use found to be safe)
___________studies are exempt from IRB requirements/review
the president
________can deem informed consent not necessary in national security interest
Phase 1
______also include studies of drug metabolism, structure-activity relationships, and mechanisms of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes
Financial disclosures
______are required for "covered clinical studies," which are 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
clinical investigation
______means any experiment that involves a test article and one or more human subjects
Phase 3
______studies are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
Phase 2
______studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients.
Phase 2
______studies include the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication(s) in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug.
unexpected adverse event or unexpected suspected adverse reaction
_____occurs when an adverse event or suspected adverse reaction is not listed in the investigator brochure or not listed at the specificity or severity that has been observed
Phase 1
_____studies are designed to determine the metabolism and pharmacologic actions of the drugs in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.
Phase 3
_____studies are expanded controlled and uncontrolled trials.
phase 3
_____studies usually include from several hundred to several thousand subjects
Phase 2
_____studies usually involve no more than several hundred subjects
Phase 1
_____study protocols should be directed primarily at providing an outline of the investigation, and should specify in detail only those elements of the study that are critical to safety.
adverse event
____means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
suspected adverse reaction
___occurs when there is a reasonable possibility that there is a causal relationship between the drug and an adverse event
ICH guidelines...FDA regulations
(ICH or FDA?) allows broader regulatory agency access to research records and to otherwise confidential medical records than is required by (ICH or FDA?)
ICH...FDA
(ICH or FDA?) does not include provisions for waiving or altering consent for no more than minimal risk research, whereas (ICH or FDA?) does
Minimize the need for redundant research
A primary purpose of the ICH is to______
60 days
A sponsor shall, within _____days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation
5
An IND is terminated if is has been inactive for ____years or more
3
An IRB must renew its registration every____years
30
An IRB's decision to disband must be reported within____days
30
An IRB's decision to review new types of FDA-regulated products, or to discontinue reviewing clinical investigations regulated by the FDA is a change that must be reported within ____days of the change
50K
An investigator must report any equity interest in a publicly held company that exceeds____ in value
25K
An investigator must report significant payments or provision of items valued at _____or more (not including payments for covering costs of conducting the study)
3...4
Approximately 25-30% of phase___ trials move on to phase____
2...3
Approximately 33% of phase___ trials move on to phase____
1...2
Approximately 70% of phase___ trials move on to phase____
70
Approximately ____% of phase 1 trials move on to phase 2
33
Approximately ____% of phase 2 trials move on to phase 3
25-30
Approximately ____% of phase 3 trials move on to phase 4
No, the FDA regulations are law. They are law in many other countries, so it can help to follow these guidelines, so that the research can be translated to many countries standards
Are ICH GCP guidelines adapted as law in the United States?
Form FDA 1572/Statement of Investigator
By signing this form, the investigator enters into a legally binding contract with the FDA. The sponsor is the conduit for transmitting this information to the FDA. By signing this form, the investigator assumes full responsibility for the study, attests that he/she has read the IB, and agrees to conduct the study according to the protocol and FDA regulations.
Yes, but they have to submit a list of all of the responsibilities transferred in the IND for the study
Can a sponsor transfer their responsibilities to a contract research organization?
30 days
Clinical investigations involving an exception from informed consent is not permitted to proceed without the prior written authorization from the FDA. FDA shall provide a written determination ____days after FDA receives the IND or earlier.
30
Clinical investigations under an IND on inactive status may only resume_____days after FDA receives the protocol amendment, unless the FDA notifies the sponsor that the investigations described in the amendment are subject to a clinical or just if the FDA lets them know it's cool at an earlier date
3
Determinations of exceptions from informed consent must be retained by the IRB for at least _____ years after the completion of the clinical investigation.
No, as long as it is not intended a significant change in labeling, advertising, indications, and does not require exemption from informed consent.
Do investigations using a marketed drug require submission of an IND?
to disapprove research
During expedited review, the reviewer(s) may exercise all authorities of the IRB except____
witness
During short form consent, ___________shall be present
Phase 1.....Phase 2
During_____studies, sufficient information about the drugs pharmacokinetics and pharmacological effects should be obtained to permit the design of the well-controlled, scientifically valid, ______studies
5
Each IRB shall have at least ____members
Affiliated with the institution or the immediate family member of someone who is
Each IRB shall include at least one member who is not ______.
in scientific area and non-scientific
Each IRB shall include at least one member whose primary concerns are ______and one who primary concerns are _____
2.......1
FDA may place an IND on inactive status if no subjects are entered into clinical studies for a period of ___year(s) or more under the IND, or if all investigations under an IND remain on clinical hold for ____year(s) or more.
Phase 2 and Phase 3
FDA's review of ______study submissions will include not only assessing safety, but also an assessment of the scientific quality of the clinical investigations and the likelihood that the investigations will yield data capable of meeting statutory standards for marketing approval.
3
IRB records shall be retained for at least _____years after completion of the research. The records shall be accessible for inspection and copying by authorized representatives of the FDA
30
If FDA proposes to terminate an IND, FDA will notify the sponsor in writing, and invite correction or explanation within a period of ____days
sponsor
If an IND is terminated the_____shall end all clinical investigation conducted under the IND and recall or otherwise provide for the disposition of all unused supplies of the drug.
90
If an IRB's contact or chair person information changes, the IRB must revise its registration information by submitting any changes in that information within_____days of the change
5 working days
If immediate use of the test article is not sufficient to obtain the independent determination typically required in order to preserve the life of the subject, documentation shall be submitted to the IRB within________after use of the test article.
15 calendar days
If the results of a sponsor's investigation show that an adverse event not initially determined to be reportable is so reportable, the sponsor must report such suspected adverse reaction in an IND safety report no later than_____after the determination is made
annual reports
Investigators must submit ___________ (also referred to as IND reports) to the sponsor-investigator and the sponsor-investigator must submit annual reports to the FDA within sixty (60) days of the anniversary date that the IND went into effect.
60
Investigators must submit annual reports (also referred to as IND reports) to the sponsor-investigator and the sponsor-investigator must submit annual reports to the FDA within_____ days of the anniversary date that the IND went into effect.
The subject or the subject's representative
Only the short form itself is to be signed by___________.
patients or normal volunteers
Phase 1 trials can have________subjects
several hundred
Phase 2 studies usually involve no more than ______subjects
from several hundred to several thousand
Phase 3 studies usually include_________subjects
one year
Progress reports are required to be submitted annually starting ______ after the approval of the IDE.
phase 1 more flexible than phase 2 and 3
Protocol for phase__studies may be less detailed and more flexible than protocols for phase __ studies
Phase 1
The total number of subjects and patients included in_______studies varies with the drug, but is generally in the range of 20-80
15...7
Serious adverse events should be reported within ___calendar days. Life threatening or fatal adverse events should be reported within___calendar days.
FDA-1571
The IND cover sheet is Form_____
FDA regulations. This role is not mentioned in the ICH guidelines.
The dual role of sponsor-investigator is only recognized by (ICH or FDA?)
The witness
The only person to sign both the short form and a copy of the summary during short-form consent is___________.
a copy of the written summary
The person actually obtaining consent during a short-formed consent shall sign__________
investigator's brochure
The purpose of the_____is to document that relevant and current scientific information about the investigational product has been provided to the investigator.
Signed protocol and amendments, if any, and sample case report form (CRF)
The purpose of the____is to document investigator and sponsor agreement to the protocol/amendment(s) and CRF
7 calendar days
The sponsor must notify FDA of any unexpected fatal or life-threatening suspected adverse reactions no later than_____days after the sponsor's initial receipt of the information
life-threatening suspected adverse reactions
The sponsor must notify FDA of any unexpected fatal or_______no later than 7 calendar days after the sponsor's initial receipt of the information
15 calendar days
The sponsor must notify the FDA and all participating investigators in an IND safety report of potential serious risks (found from animal or human studies, or serious/unexpected adverse reactions) no later than _____days after the sponsor determines the information qualifies for reporting
15 calendar
The sponsor must submit to the FDA any additional data or information regarding an IND safety report no later than _____days after receiving the request.
10
Unanticipated adverse *DEVICE* effects are submitted to the FDA within______working days after the sponsor first receives notice of the effect.
20 to 80
The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of ________
sponsor, 15 calendar days, sponsor
The________must notify the FDA and all participating investigators in an IND safety report of potential serious risks (found from animal or human studies, or serious/unexpected adverse reactions) no later than _____days after the ______ determines the information qualifies for reporting
parent institution
The_____is presumed to be responsible for the operation of an IRB
investigator
The_____reports to the IRB proposed research changes
FDA Form 3500A
What is the IND safety report form?
For sponsors, the advantage of complying with the ICH E6 guidelines is that the FDA and equivalent government agencies in other countries will consider studies conducted in accordance with the ICH guidelines to meet the regulatory requirements of the drug approval processes for all of these countries.
What is the advantage of complying with ICH E6 guidelines?
Form FDA 1571
What is the form for Investigational New Drug Application [IND]?
30 days
When a new investigator is added to and IND, the sponsor shall notify the FDA within____days of the investigator being added
clinical hold
When an ongoing study is placed on______, no new subjects may be recruited to the study and placed on the investigational drug; patient already enrolled should be taken off therapy unless FDA approves otherwise
When an investigator is participating in a new protocol that has been added to the IND AND when a new investigator is added to the study
When does an investigator need to sign a new 1572?
30 days after the FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold
When does and IND go into effect? (an IND that doesn't ask for consent exemption)
The sponsor-investigator, although if the FDA reviews and disagrees, it will change
Who is responsible for making the initial risk determination for a device being used in a study?
investigator
Who is ultimately responsible for the overall conduct of a clinical trial?
The sponsor or sponsor-investigator
Whose responsibility is it to submit an IND?
covered clinical studies
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
investigator and sub-investigator
it is required in the protocol submitted in and IND that the qualifications of each _____are submitted
