GCP Study 2 Flashcards
GCP Study 2
What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial?
A) Enroll other patients
B) Try to obtain the subjects’ reason for withdrawal
C) Try to convince patient to stay on trial
B) Try to obtain the subjects’ reason for withdrawal
CRO recently switched from paper CRF to an EDC System. The EDC System must confirm to the established requirements for:
A) Validation, Accuracy, Reliability, Completeness (VARC)
C) Accuracy
D) Validation
E) Reliability
F) Completeness
A) Validation, Accuracy, Reliability, Completeness (VARC)
Part of Sponsor’s responsibility pertaining to electronic trial data handling is to ?
A) Maintain an audit trail, data trail, and edit trail
C) None
D) Hold investigator responsible
E) Hold ERB responsible?
A) Maintain an audit trail, data trail, and edit trail
A research subject’s responsibilities for study participation should be described in the ?
A) Protocol
B) ICF (Informed Consent Form
D) Investigator Brochure
B) ICF (Informed Consent Form
What document would an investigator reference to learn more about previous clinical and nonclinical results of studies of the IP?
A) Protocol
B) ICF
C) IB (Investigator Brochure)}
C) IB (Investigator Brochure)}
During a multi-site clinical study, whose responsibility is it to report subject recruitment rate?
A) Sponsor
B) Investigator
C) CRA
C) CRA
An unconscious adult subject was enrolled in a study after obtaining consent from an LAR, and protocol therapy was initiated. The subject showed significant improvement in his clinical condition, and regained consciousness. The investigator should inform the subject about the study and?
A) Obtain consent from the subject for the study
B) Do noting since LAR approved consent
C) Get consent from his family
A) Obtain consent from the subject for the study
A site is in the startup phase of an industry sponsored phase 3 trial and has received IRB approval. The site can begin enrolling subject after?
A) A signed clinical trial agreement is in place between the sponsor and the site
B) Immediately
C) After IRB gives the go ahead
A) A signed clinical trial agreement is in place between the sponsor and the site
A research study in which there is no intended clinical benefit to the subject is being submitted to the IRB. What benefit information should be included in the ICF?
A) Financial benefit being provided to patients
B) Nothing
C) wording indicating that there is no expected benefit
C) wording indicating that there is no expected benefit
A site is screening potential subjects for a study looking at mild cognitive impairment. One of the inclusion critera is a score of 25 or less on a psychometric test, a research specific tool which measures cognitive ability. Which of the following individuals can administer the psychometric test to the potential subjects?
A) Doctor
B) Dentis
C) Nurse
D) A research assistant who is certified to administer the psychometric test
D) A research assistant who is certified to administer the psychometric test
A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is prior to the effective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do first?
A) Nothing
B) Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates.
C) Notify the sponsor
B) Confirm dates of initial receipt of the sponsor protocol and the IRB submission dates
In a multi arm, randomized clinical trial, one arm of the protocol was terminated due to an increased risk of cancer in subjects. Who is responsible for providing a written report to the IRB?
A) Sponsor
B) CRA
C) PI (Principal Investigator)
D) CRC
C) PI (Principal Investigator)
After completion of a study, the final trial close out monitoring report prepared by the CRA should be filed in which of the following stakeholder files?
a) Sponsor’s files
b) investigator files
C) IRB files
a) Sponsor’s files
A blood sample collection is required to screen for bloodborne pathogens before subject could be enrolled in a study. Where will subjects find information of the procedures and any foreseeable risks or inconveniences?
A) ICF (Inform Consent Form)
B) IB (Investigator Brochure)
C) Protocol
A) ICF (Inform Consent Form)
When should a research study involving human subjects be registered in a publicly accessible database?
A) Before signing protocol
B) Before recruiting the first subject
C) After securing first site
B) Before recruiting the first subject
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF?
A) Wife
B) Family
C) The subjects legally acceptable representative
C) The subjects legally acceptable representative
A medical student is approached by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the study?
A) Consenting in the presence of figure of authority
B) Not consenting
C) Delaying consent
A) Consenting in the presence of figure of authority
A research study, in which there is no intended clinical benefit to the subject, is being submitted to the IRB/IEC. What benefit information should be included in the ICF?
A) The benefits section should be left out on the ICF, as it is not applicable.
B) Wording indicating that there is no expected clinical benefit should be included
C) A section on the benefits of clinical research in general should be added.
D) a description of the subject visit stipends should be included as a benefit
B) Wording indicating that there is no expected clinical benefit should be included
Prior to archiving a study, documentation of IP destruction at the site should filed in the study files of the ?
A) PI
B) SPONSOR
C) PI AND SPONSOR
C) PI AND SPONSOR
During a monitoring visit, what records would a CRA reference to verify a subject’s compliance to the study visit schedule and assessments?
A) Protocol
B) IB (Investigator Brochure)
C) Electronic Medical Records
C) Electronic Medical Records
Which of the following required elements should be included in a clinical trial protocol?
A) Subject Inclusion and Exclusion criteria
B) Nothing
C) Design Criteria
A) Subject Inclusion and Exclusion criteria
When considering participation in a study, the investigator should determine if he?
A) is ready for a study
B) he sees enough patients who would qualify for the study
C) has enough funds to lead the study
B) he sees enough patients who would qualify for the study
New safety information has become available from the Sponsor about the IP being used ina clinical trial. The investigator must:
A) Submit a revised ICF to the IRB noting the new safety information
B) Continue study
C) Update Sponsor
A) Submit a revised ICF to the IRB noting the new safety information
Per ICH, and IRB must keep correspondence for at least how long after the completion of a clinical trial?
A) 1 year
B) 5 Years
C) 3 years
C) 3 years
When would an impartial witness be needed during the consent process for an illiterate subject?
A) to observe the consent process
B) review consent process.
C) not needed
A) to observe the consent process
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be?
A) Phase 1
B) Phase 2
C) Phase 3
D) Phase 4
B) Phase 2
An investigator is notified by the sponsor that a study will terminate. The PI would like to continue to follow the subjects for another year. What should the PI do?
A) Continue following the subjects in the study
B) Request permission from the IRB/EIC to continue the study
C) Consent subjects to a new IRB/IEC approved protocol
D) Request IP from the sponsor to continue the study
C) Consent subjects to a new IRB/IEC approved protocol
