Where parental permission is to be obtained, the IRB may find that the permission of ________ is sufficient, if consistent with state law, for clinical investigations to be conducted under 50.51 and 50.52.

a legally authorized representative

Clinical investigation involving greater than minimal risk but presenting the prospect of direct benefit may involve children as subjects only if the IRB finds and documents that ______.

the risk is justified by the anticipated benefit

adequate provisions are made for soliciting the assent of the children and permission of their parents and guardians

the relation of the anticipate benefits to the risk is at least as favorable to the subjects as presented by the alternatives

Even when the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement if ________.

the clinical investigation involves no more than minimal risk

the waiver will adversely affect the rights and welfare of the subjects

the clinical investigation could not practically be carried out without the waiver

When determining whether children are capable of providing assent, the IRB must take into account ______.

psychological state of the children involved

Phases Of An Investigation Quiz Questions

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Questions: 141 | Attempts: 1,812 | Updated: Mar 22, 2023

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Phases Of An Investigation Quiz Questions

The ______ has overall responsibility for the technical conduct of the study.

Corrective action should be taken and documented when unforeseen circumstances may affect the quality and integrity of the nonclinical study.

The quality assurance unit shall assure management that ____ are in conformance with the regulations.

A copy of the master schedule sheet for all nonclinical laboratory studies should not be maintained at the testing facility.

A representative of the _____ shall have access to the written procedures established for the inspection.

Each testing facility shall maintain _______ for each individual engaged in or supervising a nonclinical laboratory study.

Testing facility management may replace the study director during the conduct of the study.

The ______ will maintain copies of all protocols pertaining to the nonclinical laboratory studies.

Personnel engaged in a nonclinical study can wear any type of clothing they see fit to wear.

The quality assurance unit will prepare and sign a statement that will be submitted with the final study report.

A/An ______ must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the clinical investigation.

Subpart D deals with clinical investigations for _________ .

Children that are wards of the state or any other agency, institution, or entity can be included in clinical investigations.

Where parental permission is to be obtained, the IRB may find that the permission of ________ is sufficient, if consistent with state law, for clinical investigations to be conducted under 50.51 and 50.52.

Clinical investigation involving greater than minimal risk but presenting the prospect of direct benefit may involve children as subjects only if the IRB finds and documents that ______.

If the clinical investigation involves more than minimal risk and no prospect of direct benefit, children may only be involved if the ______ provides approval.

Even when the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement if ________.

When determining whether children are capable of providing assent, the IRB must take into account ______.

When the IRB determines that assent is required, it also must determine whether and how assent must be documented.

If a clinical investigation is approved, the IRB must require appointment of a/an ______ for each child who is a ward.

A clinical investigation involving the use of a placebo is exempt from the requirements of this part if the investigation does not otherwise submission of an IND.

FDA stands for the ________.

________ means an individual who actually conducts a clinical investigation.

Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.

After the sponsor has found that the results of an investigation appear to establish sufficient data to support a marketing application, it is acceptable for the sponsor to prolong the investigation.

A waiver request is required to contain at least _______.

IND means ______.

Investigational new drug means a _______ that is used in a clinical investigation.

An IEC ensured the protection of the ______ of human subjects in a clinical investigation.

The contract research organization assumes all of the following for a sponsor except for ______.

An IND may be submitted for one or more phases of an investigation.

The FDA shall provide a written determination ______ after FDA received the IND or earlier.

______ studies usually include from several hundred to several thousand subjects.

In general, protocols for ______ studies may be less detailed and more flexible.

A protocol is required to contain ________.

For a Phase 2 study, which of the following statements is not correct:

_______ are expanded controlled and uncontrolled trials.

Phase 1 studies may be conducted in ______.

The sponsor shall submit a/an ______ to the FDA, if the sponsor intends to conduct a clinical investigation.

The sponsor shall submit a/an _____ of all submissions to the IND file, including the original submission and all of the amendments and reports.

The obtaining of informed consent shall be deemed feasible unless, before use of test article, both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing that _______.

The information that is given to a subject or the representative does not need to be in a language understandable to the subject or the representative.

DOD stands for _______.

The ________ may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member's participation in a particular military operation.

The sponsor will provide training to the appropriate medical personnel and potential recipients on the specific investigation new drug to be administered prior to its use.

The _______ is responsible for ensuring the adequacy of the information required in Section 50.25 (except for the information described in 50.25(a)(8).

The documentation required after using a test article shall be submitted to the IRB within _____ working days.

Each member involved in military operation will be given, prior to administration of the investigational new drug, a specific ______.

The ______ provide adequate follow-up to assess whether there are beneficial or adverse health consequences that result from the use of the investigational product.

The duly constituted IRB, must include at least ______ non-affiliated members who shall not be employees or officers of the Federal Government and shall be required to obtain any necessary security clearances.