Exam Review

Question 1

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.

Answer 1

1)Monitor’s

2) investigator

Question 2

Who determines requirements and schedule of frequency of monitoring visits?

Answer 2

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

Question 3

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

Answer 3

PI

Question 4

The monitor follows what for specifics in monitoring a trial?

Answer 4

sponsor’s written SOPs

Question 5

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

Answer 5

The sponsor
-example: version controlled documents

Question 6

Who actually reports AEs to sponsor and IRB

Answer 6

investigator

Question 7

AE Reporting

1) Investigators reports to the sponsor: 

2) Sponsors report to investigators and FDA: 

3) Investigators and sponsors report to the IRB: 

Answer 7

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

Question 8

Source document v CRF

Answer 8

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

Question 9

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

Answer 9

Source document

Question 10

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

Answer 10

closeout report

Question 11

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.

Answer 11

is dependent upon the sponsor

Question 12

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

Answer 12

-assess the initial safety and tolerability
-pharmacokinetics, pharmacodynamics

Question 13

The primary objective of a Phase II study

Answer 13

explore therapeutic efficacy.

Question 14

The primary objective of a Phase III study is

Answer 14

to demonstrate, or confirm therapeutic benefit.

Question 15

The primary objective of a Phase IV study is

Answer 15

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

Question 16

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

Answer 16

unexpected

Question 17

Site/investigator selection is a _________________responsibility

What form is used in site selection?

Answer 17

Sponsor

site evaluation form, sponsor specific

Question 18

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

Answer 18

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.

Question 19

pharmacokinetics

Answer 19

(what body does to drug)

Question 20

pharmacodynamics

Answer 20

(what drug does to body)

Question 21

Essential Documents

Answer 21

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

Question 22

What kind of documents are CRFs?

Answer 22

Source Documents

Question 23

Expedited review

Answer 23

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

Question 24

Stratification of study subjects

Answer 24

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

Question 25

_________________ is responsible for the medical care of the subject

Answer 25

PI

Question 26

All data collected during a trial should be recorded in

Answer 26

CRFs (are also source documents)

Question 27

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

Answer 27

After

Question 28

Budgets should be in place _________________ to the site initiation visit

Answer 28

prior

Question 29

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

Answer 29

1) investigator site prior

Question 30

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

Answer 30

Sponsor

Question 31

IRB/IEC updates should be submitted ___________by the investigative site. The timing of these yearly updates are based upon the ___________

Answer 31

annually initial IRB approval date

Question 32

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

Answer 32

pre-screening activity and does not require IRB review

Question 33

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

Answer 33

PI

Question 34

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

Answer 34

Source

Question 35

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

Answer 35

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.

Question 36

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

Answer 36

AEs

Question 37

Data reported on the CRF should be consistent with the___________ Discrepancies in CRF should be explained by ______________ (who?)

Answer 37

source documents whoever originally filled it out

Question 38

Trough level should be drawn ____________ to dosing

Answer 38

prior The lowest level of the drug in the patient's body

Question 39

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

Answer 39

taking appropriate actions

Question 40

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

Answer 40

immediately, IRB

Question 41

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

Answer 41

confidentiality agreement

Question 42

Name a document that the IRB does NOT review

Answer 42

Contract Budget

Question 43

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

Answer 43

Quality Control

Question 44

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

Answer 44

Sponsor, IRB, and regulatory authorities

Question 45

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.

Question 46

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.

Answer 46

monitor, auditor, the IRB, and regulatory authorities also the investigator

Question 47

IP should, by default, be ____________ after use

Answer 47

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