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
(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
