Recruitment and Advertising Flashcards
According to the FDA guidance on recruitment for studies under an IND, the following information needs to be reviewed by the IRB:
a) Protocol, consent forms, recruiting scripts, investigator’s brochure
b) Protocol, debriefing forms, conflict of interest information, recruitment scripts
c) Protocol, research monitoring plans, recruitment scripts, consent forms
d) Protocol, enrollment bonuses, consent forms and investigator’s brochure
a) Protocol, consent forms, recruiting scripts, investigator’s brochure
According to the FDA guidance on recruitment the following do not need IRB review:
a) Communications intended to be seen or heard by health professionals
b) New stories
c) Publicity such as financial page advertisements intended for investors
d) All of the above.
d) All of the above.
a) Communications intended to be seen or heard by health professionals
b) New stories
c) Publicity such as financial page advertisements intended for investors
According to the FDA guidance on recruitment a web listing of a clinical trial does not need IRB review if:
a) It lists title, protocol summary, basic eligibility criteria, location and contact information
b) It discusses benefits in detail
c) It provides payment incentive information
d) It provides a list of free medical services beyond that in the consent document
a) It lists title, protocol summary, basic eligibility criteria, location and contact information
According to the FDA guidance on recruitment which of the following does not need IRB review:
a) Brochures to be confined to the clinic waiting room
b) Flyers posted only in the institution
c) E-mails sent to potential community participants
d) Dear doctor letters even when soliciting for study subjects
d) Dear doctor letters even when soliciting for study subjects
A listing of a clinical trial on clincaltrials.gov:
a) Is regarded by the IRB as a recruitment tool
b) Must be approved by the institution
c) Can be approved by the expedited process
d) Must be declared in the consent form.
d) Must be declared in the consent form.
Investigator in institution A is carrying out an IRB approved study and wishes to post flyers for his study in Institution B. According to OHRP guidance:
a) Institution B must carry out an IRB review of the study.
b) Only the institution B’s institutional official needs to be notified
c) Institution B is not engaged in the research
d) Institution B needs to have an FWA.
c) Institution B is not engaged in the research
IRB concerns about recruitment activities may include:
a) Completeness of information provided.
b) Subtle coercion of the subjects in advertisements
c) Compromised confidentiality in the initial recruitment process.
d) All of the above.
d) All of the above.
a) Completeness of information provided.
b) Subtle coercion of the subjects in advertisements
c) Compromised confidentiality in the initial recruitment process.
According to federal regulations, recruitment related activities for a clinical trial:
a) Should be free of bias
b) Should provide payment related incentives
c) Be free of coercion and undue influence
d) Imply the possibility of a cure.
c) Be free of coercion and undue influence
In a sponsored clinical trial the IRB should review:
a) The sponsor’s recruitment efforts b)
Differences between the principal investigator’s recruitment efforts and the sponsors.
c) Only a summary of the media advertisements being used by the Pl
d) All of the investigator’s recruitment materials.
d) All of the investigator’s recruitment materials.
A physician wishes to inform his patients about a clinical trial for which he is the principa investigator.
He should:
a) Present the information in person to the patient
b) Ask his nursing staff to present information to the patients
c) Leave the clinical trial brochures in his waiting room and provide his research staff member as the contact for further information
d) E-mail the information to his patients with a recommendation for enrollment thus avoiding direct patient contact.
c) Leave the clinical trial brochures in his waiting room and provide his research staff member as the contact for further information
Enrollment bonuses paid to investigators in a clinical trial represent:
a) Undue influence in the recruitment process
b) Are not addressed in DHHS regulations
c) Reflect the sponsor’s pressure to increase enrollment
d) All of the above
d) All of the above
a) Undue influence in the recruitment process
b) Are not addressed in DHHS regulations
c) Reflect the sponsor’s pressure to increase enrollment
Enrollment bonuses paid to investigators by sponsors:
a) Are regulated by the FDA
b) Are described in DHHS regulations
c) Should be declared to the IRB by the sponsors of the clinical trial
d) Should be reported to the IRB and the Conflict of Interest Committee in the initial IRB application
d) Should be reported to the IRB and the Conflict of Interest Committee in the initial IRB application
Non-monetary reward for recruitment offered to investigators by sponsors may include:
a) Token gifts
b) Promise of authorship of the clinical trial findings
c) Post study rewards including speakership bureau assignments
d) All of the above.
d) All of the above.
a) Token gifts
b) Promise of authorship of the clinical trial findings
c) Post study rewards including speakership bureau assignments
