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ACRP CCRC 2022 > ACRP CCRC Study Prep > Flashcards

ACRP CCRC Study Prep Flashcards

1
Q

What is parrallel study?

A

Two groups of treatments: A & B

One group receives only A, other group receives only B

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2
Q

-Trial where the treatment assignment is not known by the study participant - The investigator and staff are aware of the treatment but the subject is not, or vice-versa

A

Single Blind study

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3
Q

Therapeutic Confirmatory Study

A

Phase III

-demonstrate/confirm efficacy (the ability to produce a desired or intended result).
-establish safety profile
-provide an adequate basis for assessing the benefit/risk
relationship to support licensing
-establish dose-response relationship

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4
Q

What are the 3 principles of the Belmont Report?

A
  1. Respect for Persons-“voluntary consent”
  2. Beneficence- “protected from harm”
  3. Justice- “participants be selected fairly”
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5
Q

What are the 3 essential documents included in the Trial Master File?

A
  1. Product accountability Log
  2. Subject Screening Log
  3. Signed Informed Consent Logs
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6
Q

Statistical methods to be employed must be included in _______?

A

The Protocol

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7
Q

Medical/Pharm/Nursing/Dental Students, Prisoners, and military personnel are considered ________?

A

Vulnerable Subjects

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8
Q

How many members does the IRB have?

A

Atleast 5

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9
Q

Define Bioavailability

A

The amount of active drug which enters the body system and is therefore available at the target site

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10
Q

What is the investigator responsible for providing to the ethics commmitee?

A

The Investigator’s Brochure

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11
Q

An IRB/IEC is required to retain records for atleast ____ years after completion of the trial.

A

3 years

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12
Q

Where will you find the schedule of study events?

A

The protocol and/or the appendix to the protocol

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13
Q

How often should the IRB/IEC conduct continuing review?

A

Atleast once a year

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14
Q

After an audit is complete, what does the auditor submit?

A

Audit Certificate

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15
Q

Study Endpoints

A

Response Variables

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16
Q

Formula for calculating weight from pounds to kg

A

____lbs x 0.453=_____kg

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17
Q

What is root cause analysis?

A

This is initiated by the study manager to implement to the site for investigator non-compliance.

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18
Q

What study design examines the interaction of A and B

A

Factorial Design

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19
Q

What design is randomized to 1 of 2 or more arms, each arm being a different treatment?

A

Parallel Design

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20
Q

Absorption, Distribution, Metabolism, Excretion are examples of what?

A

Pharmacokinetics

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21
Q

What is used to determine sample size?

A

Primary Endpoint

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22
Q

What is the most important document when preparing for an audit?

A

Trial Master File

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23
Q

Define Benefincence

A

All human subjects must be treated ethically at all times during an experiment

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24
Q

Just selection

A

Researcher personally selects subjects, doesnt make an effort to give all potential participants a fiar chance of being included.

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25
Q

What does IND stand for?

A

Investigational new drug application

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26
Q

What is the formula for drug accountability?

A

(TOTAL # OF PILLS - # OF PILLS RETURNED) / (DAYS BETWEEN VISITS x DAILY DOSE)

DAILY DOSE= # OF PILLS TAKEN PER DAY

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27
Q

STUDY INITIATION MEETING ARE HELD AFTER WHAT?

A

THEY ARE HELD AFTER THE SITE HAS RECEIVED ALL THE STUDY MATERIALS AND IS READY TO START ENROLLMENT

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28
Q

WHAT MUST BE FILED BY AN INVESTIGATOR RUNNING A CLINICAL TRIAL TO STUDY A NEW DRUG OR AGENT?

A

FDA 1572

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29
Q

WHO REPORTS SAE’S TO WHO?

A
  • THE SITE REPORTS SAE’S TO THE CRA WITHIN 24 HOURS
  • THE CRO REPORTS THEM TO THE SPONSOR
  • THE SPONSOR PREPARES AN IND SAFETY REPORT ON MEDWATCH 3500A FORM AND SUBMITES THESE TO THE FDA
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30
Q

WHO IS RESPONSIBLE FOR THE PROTOCOL PREPARATION, PROTOCOL UPDATES, AND CLINICAL TRIAL DESIGN?

A

THE SPONSOR

The CRO is authorized tp distribute any updates to the sites but is not authorized to make any changes.

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31
Q

Who is responsible for the preparations of the IB and updates to it?

A

The Sponsor

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32
Q

If a subject is upset and wants to know whom she should contact regarding her rights as a research subject, who should the CRC tell her to contact?

A

Individual listed in the ICF

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33
Q

What is Trough Blood Level?

A

The lowest concentration in the patients bloodstream. Therefore, the specimen should be collected just prior to administration of the drug.

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34
Q

What is Peak blood level?

A

The highest concentration of a drug in the patient’s bloodstream

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35
Q

Timeline for reporting Adverse Drug Reactions that are fatal or life threatening?

A

ASAP, but no later than 7 calendar days

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36
Q

Reporting non life-threatening Adverse Drug Reactions

A

No later than 15 calendar days

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37
Q

How many times has the declaration of Helinski been revised?

A

9 times

38
Q

When was the Declaration of Helinski most recently revised?

A

October 2013

39
Q

Phase II Trial

A

“Therapeutic Exploratory”

40
Q

Phase I Trial

A

Pharmcokinetics & Pharmadynamics

41
Q

WHAT THE DRUG DOES TO THE BODY IS CALLED WHAT?

A

PHARMACODYNAMICS

42
Q

WHAT PHASE IS “THERAPEUTIC USE”

A

PHASE 4

43
Q

IN WHAT WAY DID THE BEECHER ARTICLE IMPACT RESEARCH IN THE U.S.?

A

IT HEIGHTENED AWARENESS OF PROBLEMS WITH UNETHICAL RESEARCH

44
Q

OHRP IS AN OVERSIGHT BODY PRIMARILY CONCERNED WITH ____?

A

THE PROTECTION OF HUMAN SUBJECTS.

45
Q

AST

A

AN ENZYME FOUND IN THE LIVER AND HEART.

THIS BLOOD TEST IS USED TO DETECT LIVER FAILURE

46
Q

HDL

A

LIPO-PROTEIN MADE BY THE LIVER.

THIS PROTEIN REMOVES FAT MOLECULES FROM CELLS

47
Q

LDL

A

LIPO-PROTEIN MADE IN THE LIVER.

48
Q

BUN

A

BLOOD UREA NITROGEN

(KIDNEY TEST)

49
Q

WHAT FDA CLASSIFICATION THAT MEANS THAT DEVIATIONS FROM REGULATIONS WERE FOUND BUT ARE NOT SERIOUS?

A

VAI

50
Q

HOW MANY YEARS AFTER THE COMPLETION OF A TRIAL IS THE IRB/IEC REQUIRED TO RETAIN RELEVANT RECORDS?

A

3 YEARS

51
Q

ALT

A

ENZYME FOUND MOSTLY IN THE LIVER

NORMAL RANGE= 8-37

LOW #= NOT TYPICALLY A CONCERN

HIGH #= CAN INDICATE CERTAIN TOXINS. SUCH AS, ACETAMINOPHEN, ALCOHOL, OR HEPATITIS

52
Q

BY REGULATION, INVESTIGATORS ARE REQUIRED TO MAKE A FINAL REPRT TO

  1. _____
  2. _______
A
  1. SPONSOR
  2. IRB
53
Q

ALP

A

FOUND IN THE LIVER AND SOMETIMES BONE

54
Q

WHAT ARE THE 2 MAIN ASPECTS LOOKED AT BY THE FDA DURING AN AUDIT?

A
  1. STUDY CONDUCT
  2. STUDY DATA
55
Q

HOW OFTEN IS THE DECLARATION OF HELINSKI REVIEWED AND UPDATED?

A

EVERY 4 YEARS

56
Q

DEVELOPMENT FOR MOST NEW DRUGS, FROM DISCOVERY TO MARKETING APPROVAL USUALLY TAKE HOW LONG?

A

9 YEARS OR MORE

57
Q

WHAT DOES THE BELMONT REPORT PROVIDE?

A

IT PROVIDES THE ETHICAL FOUNDATION FOR HUMAN SUBJECT RESEARCH IN THE US

58
Q

WHAT ARE THE 3 MAIN PRINICIPLES DISCUSSED IN THE BELMONT REPORT?

A
  1. RESPECT FOR PERSONS
  2. BENEFICENCE
  3. JUSTICE
59
Q

WHAT MUST BE FILED BY AN INVESTIGATOR RUNNING A CLINICAL TRIAL TO STUDY A NEW DRUG OR AGENT?

A

FDA 1572

60
Q

______ METHODS TO BE EMPLOYED MYUST BE DESCRIBED IN A PROTOCOL

A

STATISTICAL METHODS

61
Q

WHAT 2 THINGS DOES PHARMACOKINETIC STUDY ASSESS?

A
  1. ASSESS THE CLEARANCE OF THE DRUG
  2. ASSESS THE POSSIBLE DRUG TO DRUG INTERACTIONS
62
Q

DEFINE PHARMACOKINETICS

A

THE STUDY OF THE TIME COURSE OF A DRUG’S ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION.

  • (PHARMACOKINETICS= WHAT THE BODY DOES TO THE DRUG)*
  • (PHARMACODYNAMICS= THAT THE DRUG DOES TO THE BODY)*
63
Q

ACCORDING TO THE ICH GUIDELINES, THE SOURCE DOCUMENT SHOULD CONTAIN WHICH OF THE FOLLOWING INFORMATION REGARDING INFORMED CONSENT?

A. TIME THE CONSENT FORM WAS SIGNED BY THE SUBJECT

B. DATE THE PI AND SUBJECT SIGNED THE CONSENT FORM

C. DATE AND TIME CONSENT FORM WAS SIGNED BY THE WITNESS

D. EVIDENC THAT THE CONSENT FORM WAS SIGNED PRIOR TO TRIAL RELATED PROCEDURES

A

D. EVIDENCE THAT THE CONSENT FORM WAS SIGNED PRIOR TO TRIAL RELATED PROCEDURES

64
Q

ALL OF THE FOLLOWING ARE REGULATORY DOCUMENTS EXCEPT

  1. INFORMED CONSENT
  2. PROTOCOL SIGNATURE
  3. LABORATORY CERTIFICATION
  4. CONFIDENTIALITY AGREEMENT
A

4. CONFIDENTIALITY AGREEMENT

65
Q
A
66
Q

A SPONSOR/INVESTIGATOR (INVESTIGATOR-INITIATED RESEARCH) EXPANS A TRIAL FROM A SINGLE SITE TO FOUR TRIAL SITES IN DIFFERENT AREAS OF THE COUNTRY. THE SPONSOR/INVESTIGATOR SHOULD DO WHICH OF THE FOLLOWING?

  1. MONITOR COMPLIANCE WITH GCP
  2. REPORT AE’S TO THE SITES
  3. KEEP INVESTIGATORS INFORMED OF NEW FINDINGS
  4. UPDATE INVESTIGATORS REGARDING SUBJECT RECRUITMENT
A

1 AND #3 ONLY

67
Q

NAME THE TYPE OF MASKING IN WHICH TWO OR MORE PARTIES INVOLVED WITH THE CIINICAL TRIAL DO NOT KNOW WHICH PARTICIPANTS HAVE BEEN ASSIGNED TO WHICH INTERVENTIONS.

(TYPICALLY THE INVESTIGATOR AND THE SUBJECT)

A

DOUBLE BLIND STUDY

68
Q

WHICH OF THE FOLLOWING ARE REPSONSIBILITES OF AN IDMC/DSMB?

  1. ASSESS THE FINANCIAL ASPECTS OF A TRIAL
  2. ASSESS THE PROGRESS OF A TRIAL
  3. RECOMMEND INITIATING A TRIAL
  4. RECOMMEND STOPPING A TRIAL
A
  1. ASSESS THE PROGRESS OF A TRIAL
  2. RECOMMEND STOPPING A TRIAL
69
Q

FACTORIAL DESIGN

A

SUBJECT GROUPS RECEIVE ONE OF SEVERAL COMBINATIONS OF INTERVENTIONS AND ARE EVALUATED SIMULTANEOUSLY

70
Q

MULTI CENTER TRIAL

A

A CLINICAL TRIAL CONDUCTED AT MORE THAN 1 SITE AND CARRIED OUT BY MORE THAN 1 INVESTIGATOR

71
Q

WHAT IS THE NUREMBERG CODE?

A

A SET OF 10 PRINICIPLES THAT COVERN ETHICAL RESEARCH ON HUMAN SUBJECTS

72
Q

LARGE MULTI CENTER STUDIES ARE USUALLY DONE IN WHAT PHASE?

A

PHASE 3

73
Q

WHAT TYPE OF TRIAL IS AN ADEQUATELY CONTROLLED TRIAL IN WHICH THE HYPOTHESIS IS STATED IN ADVANCE AND EVALUATED?

A

CONFIRMATORY TRIAL

74
Q

OPEN LABEL

A

A TRIAL IN WHICH TREATMENT IDENTITIES ARE KNOWN TO EVERYONE INVOLVED

75
Q

GLOBAL VARIABLES

A

ASSESS THE OVERALL OUTCOMES IN OBJECTIVE TERMS

76
Q

WHAT IS THE MOST TYPICAL PHASE 2 STUDY?

A

THERAPEUTIC EXPLORATORY

77
Q

THE ICH GUIDELINES SET A STANDARD FOR WHAT?

A

DESIGN

CONDUCT

MONITORING

AND REPORTING FOR CLINICAL RESEARCH

78
Q

BENEFICENCE REFERS TO WHAT?

A

PROTECTION OF PERSONS FROM HARM BY MAXIMIZING ANTICIPATED BENEFITS AND MINIMIZING POSSIBLE RISKS OF HARM

79
Q

RESPECT FOR PERSONS REFERS TO WHAT?

A

VOLUNTARY CONSENT

80
Q

COORDINATING COMMITEE

A

A COMMITTEE THAT A SPONSOR MAY ORGANIZE TO COORDINATE THE CONDUCT OF A MULTICENTRE TRIAL

81
Q

WHAT IS THE DECLARATION OF HELINSKI

A

A FORMAL DOCUMENT DETAILING ETHICAL PRINCIPLES THAT PROTECT HMAN SUBJECTS FROM MISTREATMENT IN MEDICAL RESEARCH.

82
Q

WHAT ARE THE DOCTORS TRIALS?

A

23 INDIVIDUALS WERE CHARGED WITH CRIMES AGAINST HUMANITY. THIS FOLLOWED THE NUREMBERG TRIALS, WHICH SERVED TO PROSECUTE NAZI WAR CRIMINALS.

THESE TRIALS RESULTED IN THE NUREMBERG CODE.

83
Q

WHAT DOCUMENT WAS ONE OF THE FIRST TO PRIMARILY GUIDE PHYSICIANS ON ETHICAL PRINCIPLES?

A

THE DECLARATION OF HELINSKI

84
Q

SPECIAL POPULATIONS

A

PREGNANT WOMEN, NURSING WOMEN, AND CHILDREN

85
Q

WHAT WERE THE NUREMBERG TRIALS AND WHEN WERE THEY HELD?

A

1945-1949

SERVED TO PROSECUTE NAZI WAR CRIMINALS

86
Q

WHEN WAS THE DECLARATION OF HELINSKI CREATED?

A

1964

87
Q

WHO CREATED THE DECLARATION OF HELINSKI

A

THE WORLD MEDICAL ASSOCATION

88
Q

WHERE WAS THE DECLARATION OF HELINSKI FIRST ADOPTED?

A

HELINSKI, FINLAND

89
Q

WHAT IS NEEDED FOR UNCONSCIOUS PATIENTS BEFORE THEY CAN BE ENROLLED?

A

DOCUMENTED APPROVAL/FAVORABLE OPINION FROM THE IRB/IEC

90
Q

WHAT TYPE OF SYMPTOM WOULD BE CONSIDERED AN OBJECTIVE PARAMETER?

A

AN OBJECTIVE SYMPTOM CAN BE MEASURED OR OBSERVED AND IS NOT DEPENDENT ON, OR INFLUENCED BY, THE SUBJECTS FEELINGS OR OPINIONS

91
Q

WHAT TYPE OF STUDY DESIGN DOES A SUBJECT SERVE AS HIS OR HER OWN CONTROL?

A

CROSS-OVER STUDY DESIGN

ACRP CCRC 2022 (1 decks)

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