Sample Test Questions Flashcards
The FDA requires specific elements to be included in an informed consent form? True or false
True
For an industry sponsored trial, a site should allow only the sponsors monitor access to the regulatory files? True or false
False
What FDA document must all investigators signed prior to participating in a drug clinical trial?
FDA 1572
The purpose of an institutional review board is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of human subjects. True or false
True
Only the principal investigator is allowed to transcribe data from the source document to the CRF. True or false
False
According to the FDA guidelines, the financial disclosure form should be completed by all study personnel that have second navigate role in the study. True or false
True
The contents of a protocol should generally contain:
- Trial objectives and purpose
- assessment of efficacy
- Data handling and recordkeeping
- all of the above
All of the above
What date should an investigator write when he failed to sign the consent form on the date of consent?
Actual date of investigator signature
Where would you look to find official government information regarding good clinical practice?
- The investigators brochure
- The US code of federal regulations
- The protocol
- All of the above
The US code of federal regulations
According to ICH guidelines, an IRB should have at least how many members?
5 members
According to you ICH guidelines, how long must an IRB retain its records for each research project?
3 years
When several hundred to several thousand subjects are in a study, what phase is the clinical investigation typically end?
Phase 3
A statement regarding the confidentiality of the subject study records must be included in all informed consent documents? True or false
True
At a site initiation meeting the IRB should be invited to attend?
False
The investigator should submit a summary of the trial status to the IRB at least:
- Once a year
- Every two years
- Every three years
Once a year
45CFR part 46 applies
To studies conducted or sponsored by the DHHS
The IRB is responsible for conducting its initial and continuing review and reporting its findings to
The investigator and the institution
An essential element of informed consent affirmed the most ethical framework is
That participation be voluntary, without penalty or loss of benefits
And essential element of consent that is affirmed in most ethical framework is that
Subject may discontinue participation at any time without penalty
The essential basic elements of consent include
A statement that the study involves research and its purpose, and description and identification of experimental procedures, the duration of the study, statements of the risk benefits and alternate procedures, any compensation for injury, and confidentiality of records and contact information regarding subject rights
An investigator is planning to submit a grant to a federal agency. Such applications
Need not be reviewed by the IRB
An investigator for a study approved by a US IRB wishes to carry out the procedures related to a study in a foreign country. The situation requires
A translated consent form, disclosure to the US IRB, and an approval from the IRB in a foreign country
Which of the following is true regarding audit of the IRB?
- OHRP does not carry out routine audits of the IRB
- The FTA audits the IRB once every 3 to 5 years
- The audit standards of the OHRP different from those of the FDA
- All of the above
All of the above
FDA suspension of the IRB can entail
Withholding approval of new FDA studies, prevention of new subjects being added to existing clinical trials, termination of ongoing studies, and notification to other state and federal agencies of IRB noncompliance.
An electronic IRB
Must be part 11 compliant
When an IRB takes on an external consultant for advice on a research study, the consultant
May not vote
The Irb may charge sponsors for the study review
For a study review regardless of approval or disapproval
A quality assurance program for clinical trials is
Is described by ICH- GCP but not by DHHS
The IRB registration is an application to the
DHHS
Exam studies cannot be carried out with which study population
Prisoners
Exempt research is exempt from
DHHS regulations described in title 45 part 46
The IRB registration must be renewed every
3 years
When the IRB makes a risk to benefit determination it should exclude
Procedures being performed for clinical treatment which are standard of care
Which of the following constitutes serious noncompliance in the IRB’s estimation?
Enrolling subjects without an authorized consent form, enrolling subjects during a lapse in IRB approval, making handwritten changes on the consent form for enrollment.
In assessing vulnerability of research subjects the IRB should
Whether the subjects may be subject to undue influence or coercion
The primary responsibility of the IRB staff members is to
Prepare and maintain adequate documentation of IRB activities
According to NIH guidelines education on GCP and IRB issues is essential for
Key personnel conducting the research
Gene therapy related studies must be reviewed by
IRB and IBC
The FDA has deferred the initial decision regarding the non-significant risk for devices to
IRB
The FDA has the authority to audit
The IRB, sponsors and clinical investigators
IRB minutes should record
Number of members voting for, against and abstaining from the motion
If a regular voting member and his ultimate net both attend the meeting then
Only the voting member can count toward the quorum
According to DHHS regulations IRB records must include
Scientific valuations that accompany each proposal, reports for injuries to subjects, copies of all correspondence between the IRB and investigators
The minutes of the IRB meeting should include sufficient detail to show attendance and practice this involves showing
The names of the attending’s and their representative roles, the earned degrees of the members attending, and the alternate members and who they are alternates for
During a meeting a voting member has a conflict of interest for a study being reviewed. The minutes must indicate
The name of the conflict a member, the name of the alternate who substitute it for the conflict a member if applicable, and the study for which the conflict was recorded.
The IRB records must be maintained for how long after the completion of the
3 years
An IRB member with a conflict of interest should
Not participate in the initial discussion or vote for the study
IRB records must include
Research proposals reviewed, approved consent documents, continuing review activities and significant new findings provided to subjects
When reviewing studies involving a vulnerable population in the IRB should
Ensure a protective measures relevant to the population
The DHHS regulations mention the following is a vulnerable category of subjects
Children, prisoners, pregnant women, and handicapped or mentally disabled persons
The IRB should
Be sufficiently qualified through the experience and expertise of its members
When reviewing studies in specialized areas the IRB should
Invite competent consultants but not have them vote
The IRB has a non-scientific member whose attendance at meetings is erratic and leads to loss of quorum the IRB may address the situation by
Appoint OHRP approved matching alternates for this number
With regard to a quorum add an IRB meeting the DHHS
Indicate only the majority of members including one scientific member must be present
A quorum for an IRB meeting must contain
A non-scientific member
IRB reviewing an IND study of mass according to FDA guidelines have at least
One physician present
An IRB has 15 members and 8 members are present, one of the members has a conflict of interest the IRB has to
vote at a future meeting where the appropriate number of members are present
And IRB meeting has six members and three members vote for the study in three vote to disapprove. The IRB
Must disapprove the study because majority is needed to approve
Exempt research
Is exempt from the regulations described in DHHS regulations and title 45 part 46
Which population does not qualify for exempt research
Prisoners
Which of the following qualifies for exemption in children
Observation of public behavior in which the investigator does not participate
Taste in food quality studies
Would qualify for an exemption only if no harmful additives were involved, would qualify for an exemption if no supplements such as proteins or creatine are added, and is the only category comments above DHHSNFDA exemptions
Review of studies under the exempt category of collection of study of existing data is most frequently applicable to
Retrospective analysis of patient charts and medical records
Survey and interview of public officials under the specific exempt category for these individuals
Is permissible using identifiers
Expedited review as applicable to
Research defined under the nine expedited categories in DHHS regulations, research that presents no more than minimal risk, minor changes to previously approved research.
Expedited review may be performed by
The IRB chair or his designee who is a member of the IRB
Investigator wishes to study the comparison of slow release hypertension drug to a rapid release hypertension drug with both drugs being used on label and not being under an IND. The study would
Qualify for expedited review
An investigator is collecting hair samples for a full genomics analysis to establish the ancestry of an isolated minority group. The study would
Need a review of convened IRB
A survey of the views of subjects on climate change will be administered and identifiers will be collected. The study would qualify for
Expedited review
A phase 2 study has completed enrollment and all research activities are completed except follow up and data analysis which are ongoing. The study
Qualifies for an expedited continuing review
A waiver of informed consent is indicated if
The research involves no more than minimal risk
Waiver of informed consent is indicated most frequently for which of the following situations
Research involving retrospective chart reviews
Waiver of documentation of informed consent may be used for
Phone surveys of illegal behaviors, anonymous Internet-based surveys of sexual practices, and in person interviews of rape victims
A waiver of informed consent can be granted and a minimal rest study if the study cannot be practically carried out without the waiver. Impact ability may arise because
Large numbers of subjects are involved, records belong to a significant number of subjects who are lost to follow up, and direct contact with the subjects would be extremely difficult to establish.
Waiver of informed consent may be granted if
The research is no more than minimal risk, the rights and welfare of the subjects will not be affected, the research cannot be practically carried out without the waiver, and pertinent information will be provided after participation.
The regulations relating to research and prisoners and title 45 part 46 is described in
Part C
With regard to payment of prisoners for research
The payment should be of such a magnitude that it does not distort the perception of risk in the limited environment of the prison
Research and prisoners must ensure that
It is comparable and risk to that and non-prisoners, it must be immune from arbitrary intervention by prison authorities, pro boards will not take the prisoner participation into account and parole decisions, arrangements must be made for follow up care if applicable if the prisoner is released, control groups must be selected from among the available prisoners
Research and prisoners
Does not qualify for exempt review, should not be expedited according to the HOHRP guidance, and has specific categories which must be reviewed by 0HRP or the secretary of DHHS
Any research involving more than minimal risk with prospect to benefit, the level of tolerable risk and research with children is defined as
The risk to benefit ratio should be at least as favorable as the alternative
In a situation where assent of the child is required by the IRB but the investigator determines with medical advice from the child’s physician that the child is cognitively unable to ascend
The investigator may waive ascent
Waiver of parental permission and research with children may be approved by the IRB if
Parental permission is not a reasonable requirement to protect the child, if neglect or abuse of child is involved, and if appropriate mechanisms to protect the child consistent with state law have a meet
The most important consideration in reporting an adverse event in a clinical trial is
Whether the event occurred in the timeframe of drug administration
A research subject enrolled in a clinical trial is involved in a car accident and suffered significant physical injuries. The event occurs while the drug administration phase of the protocol is still ongoing. The investigator should
Report the event to the sponsor and the IRB
A research subject enrolled in a clinical trial experiences significant chest pain and is admitted to the emergency department for the possible evaluation of a cardiac event. The event occurs where are the drug administration is still ongoing in the clinical trial. The casualty of the event should be determined by
The principal investigator
The sponsor must report a serious adverse event in an IND safety report to the FDA if the event is
Serious, unanticipated and possibly related to the drug
In a clinical trial under an IND subject a experiences difficulty breathing and self admits to the emergency room. Subject b experiences nausea and vomiting which is resolved by home rest for a day. Which event should be reported as serious to the FDA?
Subject a
For an adverse event to be characterized as unexpected OHRP guidance advises that the event should be in nature, severity or frequency be
Not listed in the research protocol, not listed in the informed consent, and not a characteristic of the study population.
Adverse events encompss
Physical and physiological harms
An adverse event is defined as serious as it is
Any of the following, death or life-threatening event, results in hospitalization or prolongation of hospitalization, results in a persistent or significant disability, or results in a congenital anomaly or birth defect
In a clinical trial under an IND a death or life-threatening event should be reported to the FDA within
Seven days
In a clinical trial under an IND an event that is serious but not a death or life-threatening event should be reported to the FDA within
15 days
In a clinical trial serious adverse event should be reported by the investigator to the sponsor within
One day
An investigator conducting a study of illicit drug behavior has the date on a laptop and an unencrypted fashion. The laptop is stolen. The event is
Unanticipated problem that does not involve an adverse event needs to be reported under DHHS regulations
A pharmacist made a dosing error in a clinical trial that results in no harm to any subject. The event is
Unanticipate a problem that does not involve an adverse event needs to be reported under DHHS regulations
A subject with a psychology study requires sequestration in a small space and develops claustrophobia which is described as one of the risks in the IRB approved protocol. The event is
Adverse event that does not represent an unanticipated problem and does not need to be reported
A protocol deviation is
Any departure from the procedures and practices described in an IRB approved protocol, any action associated with regulatory noncompliance, or failure to follow the appropriate procedure or protocol for the informed consent process.
A pharmacist providing an investigational drug for a phase 1 protocol makes an error in the dosing which is not associated with any adverse event in the subject. The event is
A protocol deviation, and an unanticipated event of risk to self or others
One of the most common protocol deviations is
Missed or late study visit because of patient noncompliance
During the study monitoring visit it was noted that a sample for laboratory analysis were being shipped long after the required shipment date. Many of the samples were deemed non-valuable. The event is
Protocol deviation
Laboratory related protocol deviations can include
Improper lab sample collection, and proper shipment of lab sample which results in a non-valuable sample, improper storage of the sample prior to shipment, and or shipment of the sample by non-certified personnel
During a study under an IND the investigator places the data on a laptop and the laptop is stolen. The date it was not encrypted. The event is
A protocol deviation and unanticipated event of risk to self or others
A protocol deviation should be
Reported to the IRB on forms designated for such reports
The protocol deviation should be reported to the IRB
Promptly and within the prescribed institutional guidelines
Protocol deviations are reportable to the FDA
If the event is associated with a serious adverse event
An independent DSMB for a clinical trial reaches a decision communicated in its report that the clinical trial be stopped for safety. The DSMB report should be sent to
The sponsor
DSMB’s primary responsibility is to review
Safety and efficacy as defined intervals
a decision to stop a phase 2 or phase 3 trial at all sites is the responsibility of
DSMB
The sponsor in a phase 2 clinical trial may
Choose to delegate a valuations of safety at the site to the principal investigator
The frequency of meetings of the DSMB may be
Based on a specified frequency in time, based on the number of serious adverse events observed, or based on the number of patients in rolled
A major problem in the DSMB for a sponsor-investigator clinical trial is
Conflict of interest with the principal investigator
If the DSMB suspends a clinical trial the IRB
My suspend the clinical trial added the site
The Nuremberg code was formulated by
The Nazi war crimes tribunal
Which of the following items is part of the Nuremberg code
Voluntary consent of the human subject is absolutely essential, the experiment should yield fruitful results for the good of society, the experiment should be based on animal experimentation and a knowledge of the natural history of disease, and no experiment should be conducted if there is a reason to believe that death or disability injury will occur
With regard to stopping rules for clinical trials in the Nuremberg code which of the following applies
The human subject should be at liberty to bring an experiment to an end if he has reached a physical or mental state were continuation seem to be impossible, the scientist in charge must be prepared to terminate the experiment if he has cost to believe that continuation as likely to result in injury disability or death, and the number code foreshadows the subsequent use of data and safely monitoring boards and the subsequent mandatory use of stopping rules and clinical trials.
The principle of justice in the Belmont report relates to
Distribution of burdens and benefits
Respect for persons in the Belmont report refers to
Decision on the part of subjects to voluntarily participate or not in the research
Which of the following is cited as an influence in the Belmont report
Nuremberg war crimes trial involving Nazi medical experiments
The three principles in the Belmont report relate to
Respect for persons, beneficence , and justice
The IRB should refer to the principle of beneficence in the Belmont report when it is evaluating
Risk to benefit ratio
The Belmont report addresses
Differences between practice and research
The Belmont report was formulated by
The national commission for the protection of human subjects in biomedical and behavioral research
The commission that formulated the Belmont report was created as part of
The national research act of 1974
The declaration of Helsinki was formulated by the
World medical Association
Which of the following ethical framework has been revised on several occasions
The declaration of Helsinki
Regarding the use of placebos in clinical trials the declaration of Helsinki states that
The benefit rests and burdens of a new intervention must be tested against the best proven intervention, placebo maybe used when for sans methodical reasons is important to determine safety and efficacy of the intervention, and the use of placebo will not result in additional risk or serious or irreversible harm to the subject relative to not receiving the best possible intervention
Researched is defined as
Systematic investigation to develop or contribute to generalizable knowledge
Intervention for research purposes involves
Physical procedures by which data is gathered such as vein puncture or any manipulation of the subject or the subjects environment
In order to assess protected health information of a child, HIPAA requires
Parental authorization from one parent
The best method for protection of confidentiality of electronic data is
Password protection and encryption of the data
An IRB requires a witness for the consent form. It also requires a HIPAA authorization. The witness should
There is no witness provision for the HIPAA form
And investigator wishes to review medical records for the purpose of determining the number of eligible subjects. He will probably qualify for
A partial waiver of HIPAA preparatory to research
The HIPPA authorization requires
The signature and date of the individual
Limited data sets can only use the following identifiers
A date and ZIP Code
In a study that involves children, the investigator must obtain for access to protected health information
A HIPPA Authorization from the parent only
A study monitor requests access to the entire medical record of the subject as a means of assessing source documents for the data collected. The most likely course of action is
Under the minimum necessary rule this access may be denied as the medical record contains private information unrelated to the clinical trial
Payments to research subjects should be based on
Time and inconvenience
According to FDA guidance the payments to research subject should be
Should be prorated in accordance with the research related visits
In assessing the payments to subjects in light of the Belmont report the IRB should be concerned about
The principle of justice
According to the FDA guidance on recruitment for studies under an IND, the following information needs to be reviewed by the IRB
Protocol, consent forms, recruiting scripts, investigators brochure
A physician wishes to inform his patients about a clinical trial for which he is the principal investigator, he should
Leave the clinical trial brochures in his waiting room and provide his research staff member as the contact for further information
The certificate of confidentiality is meant to protect
Research subjects
The certificate of confidentiality is designed
To prevent compelled disclosure of research subject information in the event of a court order to release such information
Withdrawal of subjects from research study implies that
Activities involving interaction or intervention will stop, assessing identifiable private information about the subject be discontinued, and observation or recording of private behavior must be stopped
If an investigator terminate the subjects participation in a clinical trial, according to OHRP guidance the investigator should
Assess subject of participation in secondary interventional component should continue
According to the FDA, if the subject withdraws from a clinical trial
All data collected up to the time of withdrawal must remain in the trial database in order for the study to be scientifically valid
According to HIPAA if the research subject revokes a HIPAA authorization
The revocation has to be in writing, we revocation does not affect use or disclose of data prior to the revocation
An IRB is converting its paper records to an electronic system. An important consideration would be
Part 11 compliance of the new system
And electronic informed consent
May take place on site or remotely, must have a method to ensure the identity of the subject participating in the study, and must have processes in place in order to answer the subjects questions
An electronic signature is one which is
Symbols which are legally binding equivalent of a hand written signature, unique nonassignable certifiable, may not be copied or excised.
Ensuring the identity of the subject and electronic informed consent may employ
Verification of a state issued identification, use of personal questions, and or biometric or visual methods.
A 1572 is a contract between
Investigator and FDA
All the following are required on a form 1572
The principal investigator CV, information on other investigators, laboratory facilities utilized, IRB information.
The investigators brochure is a central part of the submission of an IND
Form 1571
Form 1571 includes
The protocol, the investigators brochure, the chemistry manufacturing and control section, and pharmacology and toxicology data.
The sponsor may charge a subject for an investigational drug if
With written permission from the FDA
A sponsor who makes a cardiac pacemaker has secured a IND for the device. The sponsor decides to make a mirror modification to the pacemaker. The sponsor must
File an IDE because it is significant risk device
An IND is required before a new device
Can be evaluated in a clinical trial and shipped across the state lines.
A HUD is a device
Applicable to less than 4000 individuals, a device for which a clinical trial to prove effectiveness is not required, for which no comparable device exists on the market
A significant risk device is
Implantable, poses a serious risk to health, mitigate serious risk to subject, essential for diagnosis, treatment or cure
Before a HUD is used in a hospital the application must
Have a review and approval from the IRB
An investigator participating in a device study must complete
And investigator agreement
Financial disclosure and clinical trial under an IND is done on
Form 1571
With respect to financial disclosure by the principal investigator in a clinical trial be FDA requires
Disclosure of any financial arrangement, financial arrangements that could influence the outcome of the study, and financial arrangements that meet the threshold requirements set forth in form 3455.
FDA requires the disclosure by the principal investigator and financial payments of an amount greater than
$25,000
FDA requires disclosure by the principal investigator of equity interest greater than
$50,000
FDA requires disclosure by the principal investigator of proprietary interest including
Patons, copyright or trademark, intellectual property
FDA requires reporting of any financial interest of the principal investigator in the sponsor
Immediately before the trial begins, during the clinical trial, for a period of one year after the study closure at the site
The principal investigator in an IND study owns shares in a mutual fund that invest in the stock of the sponsor as one of its holdings. The investigator
Need not disclose this to the FDA on form 3455
The principal investigators wife owns equity interest greater than $50,000 directly in the sponsors stock. The principal investigator must
Disclose this to the FDA on form 3455
The principal investigator received a cash payment for consultation from the sponsor in the amount of $10,000. This amount is
Below the threshold amount for disclosure to the FDA, may have to be disclosed to the conflict of interest committee, and may have to be to disclose to the IRB if required by the institutional guidelines.
The conflict of interest committee reviewing the disclosure of a PI on an FDA clinical trial in the amount of $10,000
May require the PR to transfer consenting responsibilities to others on the research team, may require the PR to transfer the principal investigator duties to the coinvestigator who does not have a conflict of interest, may develop a customized conflict of interest management plan specific to the situation
The threshold payment amounts to be disclosed to the institutional conflict of interest committees in most institutions
Are less than the FDA guidelines
The study is designed to first introduce a drug in human beings are
Phase 1
The studies with the highest risk to benefit ratio are
Phase 1
The studies with lowest number of subjects as likely to be
Phase 1
The study is most likely to use healthy volunteers are likely to be
Phase 1
The study is most likely to employ the use of drug registry are likely to be
Phase 4
The study is most likely to influence the labeling of the drug and its approval by the FDA are
Phase 3
The studies which do not require an IND are
Phase 4
The studies which are likely to have the longest duration are
Phase 4
The studies which are likely to provide the earliest reliable information about efficacy are
Phase 2
A study enrolls 100 subjects is most likely to be
Phase 2
A phase 1 study is likely to evaluate
Dose limiting toxicity, maximum tolerated dose, and half life.
A drug that has a half life on one day and has an initial plasma concentration of 100 mg. The concentration after four days is
6.25
A drug has a half-life of one day and a minimum affect concentration of 12.5 mg. It has an initial concentration of 100 mg. The drug will stop being affective after
Four days
The minimum number of subjects that can be enrolled in a clinical trial is
One
Phase 1 studies are likely to provide the least reliable data on efficacy because
Effects are unlikely at the lowest dose is tested.
In a phase 1 oncology study and adults the subjects are likely to be
Patients with cancer who have failed standard therapy.
In a phase 3 trial subjects are randomize to treatment group and a control group the assignments remain unchanged for the duration of the trial this is an example of what study design
Parallel design
The declaration of Helsinki advises this design for clinical trials whenever possible
Treatment drug with a comparator
control
Bias in clinical trial can result from
Aspects of trial design, operational aspects of the trial, statistical analysis and evaluation of the results.
The most common techniques utilized to prevent bias in a clinical trial R
Randomization in blinding
In a two group parallel design trial neither the investigator nor the subject is aware of whether the group is the treatment drug or a placebo. This is an example of
Double blinding
In a double blind placebo controlled design the reasons for the blinding of the investigator include
Prevent the investigator from reviewing the treatment group more strenuously, prevent the investigator from not recording or reporting serious adverse events in the treatment group, prevent the investigator from making protocol changes which favor of the treatment group.
The goals of a phase 4 trial include
Detection of rare side effects, detection of side effects associated with chronic use of the drug, and desensitization and loss of the fact of the drug upon continued treatment.
And important rare side effect is observed for a drug phase for trial. The likely outcome would be
The sponsor reports it to the FDA which then imposes a black box warning on the product label.
Drug trial, which phase would most influence FDA approval and the final product label for a drug is
Phase 3
