SOCRA CCRP/SOCRA CCRP Exam 2025
| Complete Guide to Clinical Research,
FDA Regulations, Trial Phases, GCP &
Key Terms.
Phase 0 clinical trial
(PK) Pharmokinetics and (PD) Pharmodynamics.
Very small in #'s
1st in Humans
-is it consumable for humans?
Phase 0 clinical trial
True or false: the federal food, drug, and cosmetic act is United States, federal law enacted by
Congress?
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?
True
Food, Drug, and Cosmetic Act of 1938
Requires new drugs must be proven safe before marketing
21 CFR 10.115 what are Guidance documents
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?
Phase 1 clinical trial
,Phase 2 clinical trials
Efficacy
"Proof of concept"
Larger #'s
Those with the disease (issue) needing treatment
Phase 2 clinical trial
Phase 3 clinical trials
"Pivotal Study"
Larger #'s
Those with the disease
-seeks statistical evidence
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
Phase 4 clinical trial
What is 21 CFR 10.115
The good guidance practice regulations
Medical device classifications
Pilot (smaller #'s) &
Pivotal trials (larger #'s)
-No phases only Classes 1-3
Medical device classifications
Medical device class 1
,General controls
Nothing required form wise
Bandaids, gloves, depressors example
*minimal potential harm to patient
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.
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
Medical device class 3
Essential documents
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
Essential document-investigators brochure
Essential document-insurance statement
Document that compensation to subject for trial related injury, will be available
, Essential document-insurance statement
Essential document-pretrial monitoring report
Document that the site is suitable for the trial.
Essential document-pretrial monitoring report
Essential document-trial initiation monitoring report
Document that the trial procedures were reviewed with the investigator and the staff
Essential document-trial initiation monitoring report
Essential document-clinical study report
Documents the results and interpretation of the trial.
Essential document-clinical study report
Alcoa
Attributable
Legible
Contemporaneous
Original
Accurate.
CFR 312.62
ALCOA
The investigator or those the investigator assigns and delegates to the task.
CFR 812.140
Who must maintain case histories during the study?
FDA Forms
482 notice of inspection
483 inspectional observations
1572 statement of the investigator
3454 certification of financial interest and arrangements of the clinical investigator
3455 disclosure, financial interest and arrangement of clinical investigators
| Complete Guide to Clinical Research,
FDA Regulations, Trial Phases, GCP &
Key Terms.
Phase 0 clinical trial
(PK) Pharmokinetics and (PD) Pharmodynamics.
Very small in #'s
1st in Humans
-is it consumable for humans?
Phase 0 clinical trial
True or false: the federal food, drug, and cosmetic act is United States, federal law enacted by
Congress?
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?
True
Food, Drug, and Cosmetic Act of 1938
Requires new drugs must be proven safe before marketing
21 CFR 10.115 what are Guidance documents
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?
Phase 1 clinical trial
,Phase 2 clinical trials
Efficacy
"Proof of concept"
Larger #'s
Those with the disease (issue) needing treatment
Phase 2 clinical trial
Phase 3 clinical trials
"Pivotal Study"
Larger #'s
Those with the disease
-seeks statistical evidence
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
Phase 4 clinical trial
What is 21 CFR 10.115
The good guidance practice regulations
Medical device classifications
Pilot (smaller #'s) &
Pivotal trials (larger #'s)
-No phases only Classes 1-3
Medical device classifications
Medical device class 1
,General controls
Nothing required form wise
Bandaids, gloves, depressors example
*minimal potential harm to patient
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.
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
Medical device class 3
Essential documents
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
Essential document-investigators brochure
Essential document-insurance statement
Document that compensation to subject for trial related injury, will be available
, Essential document-insurance statement
Essential document-pretrial monitoring report
Document that the site is suitable for the trial.
Essential document-pretrial monitoring report
Essential document-trial initiation monitoring report
Document that the trial procedures were reviewed with the investigator and the staff
Essential document-trial initiation monitoring report
Essential document-clinical study report
Documents the results and interpretation of the trial.
Essential document-clinical study report
Alcoa
Attributable
Legible
Contemporaneous
Original
Accurate.
CFR 312.62
ALCOA
The investigator or those the investigator assigns and delegates to the task.
CFR 812.140
Who must maintain case histories during the study?
FDA Forms
482 notice of inspection
483 inspectional observations
1572 statement of the investigator
3454 certification of financial interest and arrangements of the clinical investigator
3455 disclosure, financial interest and arrangement of clinical investigators
