SOCRA CCRP COMPLETELY GUARANTEED
EXAM DETAILED QUESTION & ANSWERS 100%
PASS EXAM.
True or false: the federal food, drug, and cosmetic act is United States, federal law enacted by
Congress? - ANSWER>>True
True or false: the FD&C act can be found in the US code, which contains all general in
permanent US laws beginning at 21 U.S.C.301? - ANSWER>>True
Food, Drug, and Cosmetic Act of 1938 - ANSWER>>Requires new drugs must be proven safe
before marketing
21 CFR 10.115 what are Guidance documents - ANSWER>>Documents prepared for FTA, staff,
applicants, sponsors, and the public that describe the agencies interpretation or policy and
regulatory issues.
Phase 1 clinical trials
Safety phase
Small in #'s
Healthy subjects used
-Is it safe? - ANSWER>>Phase 1 clinical trial
Phase 2 clinical trials
Efficacy
"Proof of concept"
Larger #'s
Those with the disease (issue) needing treatment - ANSWER>>Phase 2 clinical trial
Phase 3 clinical trials
"Pivotal Study"
Larger #'s
,Those with the disease
-seeks statistical evidence - ANSWER>>Phase 3 clinical trials
Phase 4 clinical trials
"Post market surveillance"
General public
Longer years of data collection
Post regulatory approval
-what are the long term effects - ANSWER>>Phase 4 clinical trial
What is 21 CFR 10.115 - ANSWER>>The good guidance practice regulations
Medical device classifications
Pilot (smaller #'s) &
Pivotal trials (larger #'s)
-No phases only Classes 1-3 - ANSWER>>Medical device classifications
Medical device class 1
General controls
Nothing required form wise
Bandaids, gloves, depressors example
*minimal potential harm to patient - ANSWER>>Medical device class 1
Medical device class 2
General controls & special controls
Pumps, X-ray machines, monitors, POC devices
May need 501K clearance
*These devices have a moderate to high risk to the patient and/or user. - ANSWER>>Medical
device class 2
Medical device class 3
General controls & premarket approval & drug eluting
, Pacemakers, implants, drug eluding stents
*These devices usually sustain or support life, are implanted, or present potential
unreasonable risk of illness or injury - ANSWER>>Medical device class 3
Essential documents - ANSWER>>Instigators brochure
Insurance statement
Pretrial monitoring report,
Trial initiation monitoring report
Clinical study report
Essential document-investigators brochure
Document showing relevant and current scientific info about the investigational product
provided by the investigator - ANSWER>>Essential document-investigators brochure
Essential document-insurance statement
Document that compensation to subject for trial related injury, will be available -
ANSWER>>Essential document-insurance statement
Essential document-pretrial monitoring report
Document that the site is suitable for the trial. - ANSWER>>Essential document-pretrial
monitoring report
Essential document-trial initiation monitoring report
Document that the trial procedures were reviewed with the investigator and the staff -
ANSWER>>Essential document-trial initiation monitoring report
Essential document-clinical study report
Documents the results and interpretation of the trial. - ANSWER>>Essential document-clinical
study report
Alcoa
Attributable
EXAM DETAILED QUESTION & ANSWERS 100%
PASS EXAM.
True or false: the federal food, drug, and cosmetic act is United States, federal law enacted by
Congress? - ANSWER>>True
True or false: the FD&C act can be found in the US code, which contains all general in
permanent US laws beginning at 21 U.S.C.301? - ANSWER>>True
Food, Drug, and Cosmetic Act of 1938 - ANSWER>>Requires new drugs must be proven safe
before marketing
21 CFR 10.115 what are Guidance documents - ANSWER>>Documents prepared for FTA, staff,
applicants, sponsors, and the public that describe the agencies interpretation or policy and
regulatory issues.
Phase 1 clinical trials
Safety phase
Small in #'s
Healthy subjects used
-Is it safe? - ANSWER>>Phase 1 clinical trial
Phase 2 clinical trials
Efficacy
"Proof of concept"
Larger #'s
Those with the disease (issue) needing treatment - ANSWER>>Phase 2 clinical trial
Phase 3 clinical trials
"Pivotal Study"
Larger #'s
,Those with the disease
-seeks statistical evidence - ANSWER>>Phase 3 clinical trials
Phase 4 clinical trials
"Post market surveillance"
General public
Longer years of data collection
Post regulatory approval
-what are the long term effects - ANSWER>>Phase 4 clinical trial
What is 21 CFR 10.115 - ANSWER>>The good guidance practice regulations
Medical device classifications
Pilot (smaller #'s) &
Pivotal trials (larger #'s)
-No phases only Classes 1-3 - ANSWER>>Medical device classifications
Medical device class 1
General controls
Nothing required form wise
Bandaids, gloves, depressors example
*minimal potential harm to patient - ANSWER>>Medical device class 1
Medical device class 2
General controls & special controls
Pumps, X-ray machines, monitors, POC devices
May need 501K clearance
*These devices have a moderate to high risk to the patient and/or user. - ANSWER>>Medical
device class 2
Medical device class 3
General controls & premarket approval & drug eluting
, Pacemakers, implants, drug eluding stents
*These devices usually sustain or support life, are implanted, or present potential
unreasonable risk of illness or injury - ANSWER>>Medical device class 3
Essential documents - ANSWER>>Instigators brochure
Insurance statement
Pretrial monitoring report,
Trial initiation monitoring report
Clinical study report
Essential document-investigators brochure
Document showing relevant and current scientific info about the investigational product
provided by the investigator - ANSWER>>Essential document-investigators brochure
Essential document-insurance statement
Document that compensation to subject for trial related injury, will be available -
ANSWER>>Essential document-insurance statement
Essential document-pretrial monitoring report
Document that the site is suitable for the trial. - ANSWER>>Essential document-pretrial
monitoring report
Essential document-trial initiation monitoring report
Document that the trial procedures were reviewed with the investigator and the staff -
ANSWER>>Essential document-trial initiation monitoring report
Essential document-clinical study report
Documents the results and interpretation of the trial. - ANSWER>>Essential document-clinical
study report
Alcoa
Attributable
