SOCRA CCRP LATEST EXAM 2024/2025 QUESTIONS AND
VERIFIED CORRECT ANSWERS/ ALREADY GRADED A++
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
3455 disclosure, financial interest and arrangement of clinical investigators
3500 for voluntary reporting of adverse event and product problems
3500A for use by user/facilities, mandatory reporting
FD&C Act
Federal Food, Drug, and Cosmetic Act of 1938
The FDA operates within these guidelines.
21 USC 301 -ANSWER FD&C Act
US code of federal regulations part 45 and 46
45. Protects the general public welfare.
46 protection of human subjects -ANSWER US code of federal regulations
part 45 and 46
45 CFR 46.116. -ANSWER The process of obtaining informed consent
must comply with the requirements of. __________________
ADR
adverse drug reaction -ANSWER ADR
CRO
Contract Research Organization -ANSWER CRO
,IDMC
Independent Data Monitoring Committee
An independent data monitoring committee established by the sponsor to
assist at intervals, the progress of a clinical trial, the safety data, and the
critical efficacy endpoints. Also used to recommend to the sponsor,
whether to continue modify or stop a trial -ANSWER IDMC
IEC
Independent Ethics Committee
An independent body constituted of medical professionals and non-medical
members whose responsibility it is to ensure the protections of the rights,
safety and well-being of human subjects involved in a trial.
Can be forms as a review board or a committee - institutional, regional,
national or supranational -ANSWER IEC
LAR
Legally Acceptable Representative
Individual or judicial or other body authorized to consent, on behalf of a
prospective subject concerning their participation in a clinical trial -
ANSWER LAR
QA
Quality Assurance
All those planned and systematic actions established to ensure the trial is
performed and data is generated documented and reported in compliance
with GCP and applicable regulatory requirements -ANSWER QA
QC
Quality Control
Operational techniques and activities undertaken within quality assurance
systems to verify that the requirements for quality of the trial related
activities have been fulfilled. -ANSWER QC
SAE
, Serious adverse event
Any untold medical occurrence that may result in...
death
Or is life-threatening
Or requires hospitalization or prolonging of existing admission
Or results in persistent or significant disability/incapacity
Or is a congenital anomaly/birth defect -ANSWER SAE
SADR
Serious Adverse Drug Reaction
Any untold medical occurrence that may result in...
death
Or is life-threatening
Or requires hospitalization or prolonging of existing admission
Or results in persistent or significant disability/incapacity
Or is a congenital anomaly/birth defect -ANSWER SADR
UADR
Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with
the applicable product information
(investigator's brochure) -ANSWER UADR
Sponsor-Investigator
An individual who both initiates and actually conducts, alone or with others,
a clinical investigation, i.e., under whose immediate direction the test article
is administered or dispensed to, or used involving, a subject. The term
does not include any other person other than an individual, e.g. corporation
or agency. (21 CFR, sec. 50.3) -ANSWER Sponsor-Investigator
Sub investigator
Any individual member of the clinical trial team designated and supervised
by the investigator at a trial site to perform critical trial-related procedures
and/or to make important trial-related decisions. -ANSWER Sub
investigator
Investigator's Brochure
VERIFIED CORRECT ANSWERS/ ALREADY GRADED A++
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
3455 disclosure, financial interest and arrangement of clinical investigators
3500 for voluntary reporting of adverse event and product problems
3500A for use by user/facilities, mandatory reporting
FD&C Act
Federal Food, Drug, and Cosmetic Act of 1938
The FDA operates within these guidelines.
21 USC 301 -ANSWER FD&C Act
US code of federal regulations part 45 and 46
45. Protects the general public welfare.
46 protection of human subjects -ANSWER US code of federal regulations
part 45 and 46
45 CFR 46.116. -ANSWER The process of obtaining informed consent
must comply with the requirements of. __________________
ADR
adverse drug reaction -ANSWER ADR
CRO
Contract Research Organization -ANSWER CRO
,IDMC
Independent Data Monitoring Committee
An independent data monitoring committee established by the sponsor to
assist at intervals, the progress of a clinical trial, the safety data, and the
critical efficacy endpoints. Also used to recommend to the sponsor,
whether to continue modify or stop a trial -ANSWER IDMC
IEC
Independent Ethics Committee
An independent body constituted of medical professionals and non-medical
members whose responsibility it is to ensure the protections of the rights,
safety and well-being of human subjects involved in a trial.
Can be forms as a review board or a committee - institutional, regional,
national or supranational -ANSWER IEC
LAR
Legally Acceptable Representative
Individual or judicial or other body authorized to consent, on behalf of a
prospective subject concerning their participation in a clinical trial -
ANSWER LAR
QA
Quality Assurance
All those planned and systematic actions established to ensure the trial is
performed and data is generated documented and reported in compliance
with GCP and applicable regulatory requirements -ANSWER QA
QC
Quality Control
Operational techniques and activities undertaken within quality assurance
systems to verify that the requirements for quality of the trial related
activities have been fulfilled. -ANSWER QC
SAE
, Serious adverse event
Any untold medical occurrence that may result in...
death
Or is life-threatening
Or requires hospitalization or prolonging of existing admission
Or results in persistent or significant disability/incapacity
Or is a congenital anomaly/birth defect -ANSWER SAE
SADR
Serious Adverse Drug Reaction
Any untold medical occurrence that may result in...
death
Or is life-threatening
Or requires hospitalization or prolonging of existing admission
Or results in persistent or significant disability/incapacity
Or is a congenital anomaly/birth defect -ANSWER SADR
UADR
Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with
the applicable product information
(investigator's brochure) -ANSWER UADR
Sponsor-Investigator
An individual who both initiates and actually conducts, alone or with others,
a clinical investigation, i.e., under whose immediate direction the test article
is administered or dispensed to, or used involving, a subject. The term
does not include any other person other than an individual, e.g. corporation
or agency. (21 CFR, sec. 50.3) -ANSWER Sponsor-Investigator
Sub investigator
Any individual member of the clinical trial team designated and supervised
by the investigator at a trial site to perform critical trial-related procedures
and/or to make important trial-related decisions. -ANSWER Sub
investigator
Investigator's Brochure
