What is an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
A closed system
100
According to ICH GCP where would you file the Final Trial Close Out Monitoring Report?
A) Sponsor Trial Master
B) Invtigator Trial Master
C) A & B
D) A or B
A) Sponsor Trial Master.
PharmaSchool online: ICH GCP Filing Essential Documents
100
Phase 3 studies typically include approximately how many subjects?
A) <100
B) > 100
C) It doesn't matter
D) Neither
B) more than 100.
RAN Institute; 3-minute GCP Quiz; Clinical Research Design and Phases
100
Does the FDA Form 1572 need to be submitted to the FDA?
A) Yes
B) No
B) No
The sponsor is required to collect the 1572 from the investigator, FDA does not require the form to be submitted to the agency. However, many sponsors submit the 1572 because it collects in one place all required documents. (21 CFR 312.23(a)(6)(iii)(b)
100
The investigator should maintain a list of appropriately XXXXX persons to whom the investigator has XXXXX significant trial-related duties.
qualified; delegated
ICH GCP Q&A, May 2009, page 726; 4.1.5
200
What is a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature?
According to ICH GCP where would you file the Routine Monitoring Visit Reports?
A) Sponsor Trial Master File
B) Investigator Trial Master File
C) Both
D) Neither
A) Sponsor Trial Master File.
Pharma School ICH GCP: Filing Essential Documents
200
True or False: Clinical studies with parallel groups design are restricted to two treatments.
A) True
B) False
B) False.
Ran Institute 3-minute GCP quiz; clinical research desing and phases
200
Does FDA expect a double-sided 1572, or is a two-page document printed from the FDA website acceptable?
A) Single-sided
B) Double-sided
C) A & B
D) A or B
D) A or B; Either is acceptable; however, FDA recommend that a two-page document be stapled so that there is no question about what form the investigator signed.
Info Sheet: Frequently asked questions-statement of Investigator (form FDA 1572) May 2010
200
XXXXXX XXXXXX should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.
Quality control.
ICH GCP Q&A May 2009; page 734, 5.1.3
300
Name one closed system procedure or control
Limiting system access to authorized individuals.
GCP Q&A 2009; page 624, 11.10, (d)
300
According to ICH GCP where would you file the Original Signed, Dated, and Completed Case Report Forms?
A) Sponsor Trial Master
B) Investigator Trial Master
C) Both
D) Neither
A) Sponsor Trial Master.
PharmaSchool online: Filing Essential Documents
300
A study that defines the blood levels of a new drug in normal subjects would be considered which phase of clinical investigation?
Phase 1.
Ran Institute 3-minute GCP quiz; clinical research design and phases
300
Describe one of the three instances when a FDA Form 1572 must be updated or a new 1572 completed and signed by an investigator to reflect new or changed information?
1) when an investigator completes and signs a new 1572
2) when an investigator is participating in a new protocol that has been added to the IND
3) when a new investigator is added to the study
(21 CFR 312.53 (c))
300
The sponsor should verify that each subject has XXXXX, in writing to direct access to his/her original medical records for trial-related monitoring, and IRB/IEC review, and regulatory inspection.
consented.
ICH GCP Q&A May 2009; page 739, 5.15.2
400
Each electronic signature shall be ________to one individual and shall not be _________ by, or reassigned to, anyone else.
According to ICH GCP where would you file the Signature Sheet that documents signatures and initials of all persons authorized to make entries and/or corrections on CRFs?
A) Sponsor Trial Master File
B) Investigator Trial Master File
C) A & B D) Neither
C) A & B; the Sponsor and Investigator Trial Master Files.
PharmaSchool: ICH GCP Filing Essential Documents.
400
ICH GCP defines double blind studies as those studies with more than one active treatment group being compared to placebo?
A) True
B) False
B) False.
Ran Institute 3-minute GCP quiz; clinical research design and phases
400
Does the CV or other statement of qualifications need to be updated during a clinical study?
A) Yes
B) No
C) Only when the CV has been updated
B) No. FDA regulations do not require a CV or other statement of qualifications to be updated during a clinical study.
Information Sheet: Frequently asked questions-statement of investigator (form FDA 1572), May 2010
400
The IRB/IEC should conduct XXXXX XXXXXof each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least XXXXX per year.
continuing review; once
ICH GCP Q&A May 2009; page 724, 3.1.4
500
Is a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.
Biometrics.
ICH GCP Q&A May 2009; page 624, 11.3 (3)
500
Which one of the essential documents should be located only in the Investigator's Trial Master File:
A) Sample of labels attached to investigational product containers
B) Relevant communications other than site visits
C)Subject identification code list
D) None of the above
A) Sponsor only
B) Sponsor and Investigative site
C) Investigator's site only
ICH GCP Q&A May 2009; pages 754-761
500
Which phase of clinical investigation is typically intended to establish the safety and efficacy of a drug in patients?
Phase 3.
Ran Institute 3-minute GCP quiz; clinical research design and phases
500
Are CVs required to be signed and dated?
A) Yes
B) No
C) Depends on the circumstances
B) No. FDA regulations do not require a CV to be signed and dated. The investigator's dated signature on the 1572 is sufficient to attest to the accuracy of the CV or other statement of qualifications submitted with the 1572. Information Sheet: Frequently asked questions- statement of investigators (form FDA 1572); May 2010
500
XXXXXX XXXXXX XXXXXX is a document identifying subjects who entered pre-trial screening and is located/filed with the investigator's site as well as with the sponsor.
Subject screening log.
ICH GCP Q&A, May 2009; page 759, 8.3.20