CCRC NEED TO MASTER QUIZZES &
ANSWERS.
Documents collected during SIV? ANS - 1. FDA 1572 Form
2. Financial disclosures
3. protocol and signature
4. DOA log and sit training log
5. Training certificate and medical licenses of personnel
6. IRB application and approval
List of documents during Site Closeout Visit: ANS - 1. Inventory Log
2. On site destruction form
3. IRB IEC final report
4. Accountability Log
5. Duty delegation log and site training log
6. Shipping record
What are the clinical development stages for DEVICES ANS - 1) Pilot Study
2) Pivotal Study (only needs to be on 100's, not 1000's of subjects)
3) Post-market studies
What are the abbreviated requirements for device studies? ANS - -label device
-ensure investigators records and make reports
-obtain IRB approval
-Informed consent
-Monitoring of study
-refraining from promotion
,What 3 principles governing the good & ethical phase 1 study? ANS - Efficiency
Ethical Conduct
Safety
2 principles of trial design ANS - 1. has to protect subjects
2. has to have a scientific approach
what fraction of experimental drugs pass phase 1 and 2 testing? ANS - 1/3
what needs to be done before intiation of phase III if pregnant women are used? ANS - -all
reproduction toxicity studies
-standard genotoxicity tests should be completed
A study to assess spironolactone's efficacy in patients with heart failure is performed 450 patients
receive either spironolactone or placebo for two years. Neither the patients nor physicians are aware of
who takes the drug or placebo. The study setup described above is most effective in preventing. ANS -
observer bias
Vulnerable subjects in order of hierarchy ANS - employees
armed forces
detainees
incurable disease pts
homeless*poor
those in nursing home
minors
those unable to give consent
IRB / IEC Responsibilities ANS - *Oversee principles of ICH/GCP
*Make sure the PI / Co-Is are qualified
, * Review studies at least once a year
What needs reported to the IRB? ANS - *Changes / deviations from protocol due to unforeseen hazard
* changes to subject risk
* adverse events
* new info that may impact subject safety
Non-therapeutic trials can be conducted with consent from legal rep IF ANS - *trial objectives cannot
be met by personal subject consent
low risk
trial is not prohibited by law
*IRB has approved such inclusion
Purpose of Trial monitoring ANS - *Ensure rights & safety of subjects are protected
*Report on accuracy of trial data
*Ensure trial is compliant (protocol, GCP, etc)
Responsibilities of monitor and what they verify ANS - *Main line of communication b/w investigator &
sponsor
*Subjects receive direction on product use
*drug accountability log
*ensure all staff are informed about the trial
*report recruitment rate
*verify source documents (CRFs match)
*patient withdrawal or missed visits are reported on CRFs
*missing data or signed edits
*monitor reporting of AEs
*report on deviations
ANSWERS.
Documents collected during SIV? ANS - 1. FDA 1572 Form
2. Financial disclosures
3. protocol and signature
4. DOA log and sit training log
5. Training certificate and medical licenses of personnel
6. IRB application and approval
List of documents during Site Closeout Visit: ANS - 1. Inventory Log
2. On site destruction form
3. IRB IEC final report
4. Accountability Log
5. Duty delegation log and site training log
6. Shipping record
What are the clinical development stages for DEVICES ANS - 1) Pilot Study
2) Pivotal Study (only needs to be on 100's, not 1000's of subjects)
3) Post-market studies
What are the abbreviated requirements for device studies? ANS - -label device
-ensure investigators records and make reports
-obtain IRB approval
-Informed consent
-Monitoring of study
-refraining from promotion
,What 3 principles governing the good & ethical phase 1 study? ANS - Efficiency
Ethical Conduct
Safety
2 principles of trial design ANS - 1. has to protect subjects
2. has to have a scientific approach
what fraction of experimental drugs pass phase 1 and 2 testing? ANS - 1/3
what needs to be done before intiation of phase III if pregnant women are used? ANS - -all
reproduction toxicity studies
-standard genotoxicity tests should be completed
A study to assess spironolactone's efficacy in patients with heart failure is performed 450 patients
receive either spironolactone or placebo for two years. Neither the patients nor physicians are aware of
who takes the drug or placebo. The study setup described above is most effective in preventing. ANS -
observer bias
Vulnerable subjects in order of hierarchy ANS - employees
armed forces
detainees
incurable disease pts
homeless*poor
those in nursing home
minors
those unable to give consent
IRB / IEC Responsibilities ANS - *Oversee principles of ICH/GCP
*Make sure the PI / Co-Is are qualified
, * Review studies at least once a year
What needs reported to the IRB? ANS - *Changes / deviations from protocol due to unforeseen hazard
* changes to subject risk
* adverse events
* new info that may impact subject safety
Non-therapeutic trials can be conducted with consent from legal rep IF ANS - *trial objectives cannot
be met by personal subject consent
low risk
trial is not prohibited by law
*IRB has approved such inclusion
Purpose of Trial monitoring ANS - *Ensure rights & safety of subjects are protected
*Report on accuracy of trial data
*Ensure trial is compliant (protocol, GCP, etc)
Responsibilities of monitor and what they verify ANS - *Main line of communication b/w investigator &
sponsor
*Subjects receive direction on product use
*drug accountability log
*ensure all staff are informed about the trial
*report recruitment rate
*verify source documents (CRFs match)
*patient withdrawal or missed visits are reported on CRFs
*missing data or signed edits
*monitor reporting of AEs
*report on deviations
