SOCRA CCRP EXAM QUESTIONS AND
ANSWERS
/. Phase 0 clinical trial
(PK) Pharmokinetics and (PD) Pharmodynamics.
Very small in #'s
1st in Humans
-is it consumable for humans? - Answer-✅Phase 0 clinical trial
/.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
Legible
Contemporaneous
Original
Accurate.
CFR 312.62 - Answer-✅ALCOA
/.The investigator or those the investigator assigns and delegates to the task.
CFR 812.140 - Answer-✅Who must maintain case histories during the study?
/.FDA Forms - Answer-✅482 notice of inspection
483 inspectional observations
1572 statement of the investigator
3454 certification of financial interest and arrangements of the clinical investigator
ANSWERS
/. Phase 0 clinical trial
(PK) Pharmokinetics and (PD) Pharmodynamics.
Very small in #'s
1st in Humans
-is it consumable for humans? - Answer-✅Phase 0 clinical trial
/.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
Legible
Contemporaneous
Original
Accurate.
CFR 312.62 - Answer-✅ALCOA
/.The investigator or those the investigator assigns and delegates to the task.
CFR 812.140 - Answer-✅Who must maintain case histories during the study?
/.FDA Forms - Answer-✅482 notice of inspection
483 inspectional observations
1572 statement of the investigator
3454 certification of financial interest and arrangements of the clinical investigator
