Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

ACRP - CCRC Exam > Exam Review > Flashcards

Exam Review Flashcards

1
Q

It is the 1)____________ responsibility to determine if AEs were reported appropriately in the proper timeframe, it is the 2)_____________responsibility actually report these events.

A

1)Monitor’s

2) investigator

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Who determines requirements and schedule of frequency of monitoring visits?

A

-determined by the sponsor
- adjusted according to the needs of the particular trial
-not effected by ICH or regulatory guidelines

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Who is ultimately responsible for the conduct of the trial, including making time for the trial activities

A

PI

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

The monitor follows what for specifics in monitoring a trial?

A

sponsor’s written SOPs

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

Who is responsible for quality control and assurance in a trial?

A

The sponsor
-example: version controlled documents

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Who actually reports AEs to sponsor and IRB

A

investigator

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

AE Reporting

1) Investigators reports to the sponsor: 

2) Sponsors report to investigators and FDA: 

3) Investigators and sponsors report to the IRB: 

A

1) Any adverse event (AE) determined to be caused by (or probably caused by) the drug

2)  Any AEs associated with the study drug that are both serious and unexpected, as well as any finding from animal research suggesting a significant risk to human subjects

3) All unanticipated problems (UAPs) involving risks to human subjects or others

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Source document v CRF

A

Source data are contained in source documents (original or certified).

A Case Report Form (CRF) is a printed or electronic document designed to record all of the study data about a study participant

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

The first place data is recorded in a trial is known as ____________

A

Source document

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

The _____________________ documents that all closeout activities are complete and that all essential documents are held in the appropriate file.

A

closeout report

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

The clinical program typically includes a number of individual clinical trials, and the investigator will likely not have participated in all of them. Therefore, in practice, an investigator may not know the status of the sponsor’s clinical program and so would not know when their record retention obligations under ICH had been met. The investigator in this case is _________________ to notify the site when records retention is no longer required according to the status of their clinical program.

A

is dependent upon the sponsor

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

The primary objective of a Phase I study is to:.

A

-assess the initial safety and tolerability
-pharmacokinetics, pharmacodynamics

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

The primary objective of a Phase II study

A

explore therapeutic efficacy.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

The primary objective of a Phase III study is

A

to demonstrate, or confirm therapeutic benefit.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

The primary objective of a Phase IV study is

A

to delve further into the approved IP’s safety, efficacy and dose definition.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

If the events are not listed in the IB, the events are considered ________________.

A

unexpected

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

Site/investigator selection is a _________________responsibility

What form is used in site selection?

A

Sponsor

site evaluation form, sponsor specific

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

Study subject experiences SAE, in what order should people (IRB, PI, Sponsor) be notified?

A

1) PI should be notified first as he/she is responsible for the subject’s wellbeing while on the clinical trial and should ensure that adequate medical care is provided to the subject for all adverse events.
2) SAEs should be reported immediately to the study sponsor 3)the IRB/IEC per applicable regulatory requirements.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

pharmacokinetics

A

(what body does to drug)

20
Q

pharmacodynamics

A

(what drug does to body)

21
Q

Essential Documents

A

Documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced

These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good
Clinical Practice and with all applicable regulatory requirements.

DOCUMENTS IN ISF and SUBJECT BINDERS

22
Q

What kind of documents are CRFs?

A

Source Documents

23
Q

Expedited review

A

review involving minimal risk and minor changes to research previously approved by the full committee

24
Q

Stratification of study subjects

A

partitioning of subjects and results by a factor other than the treatment given

25
Q

_________________ is responsible for the medical care of the subject

A

PI

26
Q

All data collected during a trial should be recorded in

A

CRFs (are also source documents)

27
Q

Enrollment logs are established (when) _____ initiation of the site

A

After

28
Q

Budgets should be in place _________________ to the site initiation visit

A

prior

29
Q

An insurance statement is also required to be on file _______________(what site and when) to commencing a study

A

1) investigator site prior

30
Q

Pre-study monitoring reports are only required to be located in the file of the ______________

A

Sponsor

31
Q

IRB/IEC updates should be submitted ___________by the investigative site.

The timing of these yearly updates are based upon the ___________

A

annually

initial IRB approval date

32
Q

A chart review in preparing for research is a ___________ activity and ________ require an IRB review

A

pre-screening activity and does not require IRB review

33
Q

Who has ultimate responsibility for activity at site, such as documenting CRF/ICF discrepancies?

A

PI

34
Q

All trial-related visits and procedures must be documented in the __________________documents

A

Source

35
Q

Subject requires at study related blood draw, but only available tubes are expired. What should be done?

A

No useable data can be obtained by drawing blood into an expired tube.
It is unethical to subject a subject to an invasive procedure that will produce unusable data.
The best option is obtain an unexpired tube, even if this may delay sample collection.

36
Q

At minimum, __________________(what trial related collection) should be collected from the time of screening throughout the entire study duration

A

AEs

37
Q

Data reported on the CRF should be consistent with the___________

Discrepancies in CRF should be explained by ______________ (who?)

A

source documents

whoever originally filled it out

38
Q

Trough level should be drawn ____________ to dosing

A

prior

The lowest level of the drug in the patient’s body

39
Q

The monitor should insure that the investigator is (what) ______________________ designed to prevent recurrence of detected deviations from the study protocol

A

taking appropriate actions

40
Q

Investigators report SAEs (timeframe) ____________________ to sponsor. Also report to (who) __________ if required by local regulations

A

immediately, IRB

41
Q

What document needs to be signed before investigator receives protocol and IRB from the sponsor?

A

confidentiality agreement

42
Q

Name a document that the IRB does NOT review

A

Contract Budget

43
Q

What type of activities does the monitor perform? (QA v QC)

A

Quality Control

44
Q

If the investigator has deviation from protocol, who do they inform?

A

Sponsor, IRB, and regulatory authorities

45
Q

Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry. Sponsors should provide guidance to investigators on making such corrections. Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor’s designated representatives are documented, are necessary, and are endorsed by the investigator. The investigator should retain records of the changes and corrections.

A
46
Q

The __________________ (who?) will be granted direct access to the subject’s original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject or the subject’s legally acceptable representative is authorizing such access.

A

monitor, auditor, the IRB, and regulatory authorities

also the investigator

47
Q

IP should, by default, be ____________ after use

A

returned to the investigator
*unless an alternative dispossion if authoried by sponsor

ACRP - CCRC Exam (14 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions