ACRP CCRC Questions & Answers 100% Verified
(Grade A+)
Save
Terms in this set (138)
ADR Adverse Drug Reaction
Reviews how the research was conducted; takes into
Audit account SOPs, IRB requirements & GCP (ensures
compliance)
Audit Certificate Confirmation audit took place
Written Evaluation - not regularly made available to
Audit Report regulatory body; only when serious evidence exists
concerning non-compliance
Audit Trail Documentation of audit events
Single Blind Study Subjects Unaware
Double Blind Study Subjects & Researchers are unaware
Item used as an active control references in a clinical
Comparator
trail
Group a sponsor comprises to coordinate multi-
Coordinating Committee
center trials
An investigator who oversees multiple sites of a
Coordinating Investigator
clinical trial (multicenter)
, Independent Data Monitoring Committee, Data &
Safety Monitoring Board (DSMB), Data Monitoring
IDMC
Committee: Oversee safety & progress; make
recommendations to continue, modify or stop
Independent Ethics Committee; group who oversees
IEC protection, rights, safety & well-being of human
subjects
Compilation of data on an investigational product
Investigator's Brochure
used in human subjects
Legally acceptable person whom is lawfully able to consent on behalf of
representative another
Serious Adverse Event - Results in death, is life-
threatening, requires long-term hospitalization, results
SAE
in long term disability/hospitalization incapacitation or
is a congenital birth defect
original clinical information from source documents
Source data
(medical record information)
*Hierarchical structure employees
*armed forces
*detainees
*incurable disease pts
Vulnerable subjects *homeless
*poor
*those in nursing home
*minors
*those unable to give consent
ICH International Conference on Harmonization
*Protect research subjects
*conduct research as it has been approved
Principles of ICH & GCP
*research should be clear, organized & approved by
an IRB/IEC
, *Oversee principles of ICH/GCP
IRB / IEC Responsibilities *Make sure the PI / Co-Is are qualified
* Review studies at least once a year
* at least 5 members
Requirements of an IRB * one non-scientific member
* one non-institute member
*Changes / deviations from protocol due to
unforeseen hazard
What needs reported to
* changes to subject risk
the IRB?
* adverse events
* new info that may impact subject safety
Payment to subjects must prorated & not contingent on subject completing
be.... study
*Maintain delegation long
*Ensure staff are trained/informed about the protocol
(give delegated tasks)
* Ascertain reason study participant withdraws
consent while respecting their privacy & rights
Investigator * Adhere to approved protocol
Responsibilities *Document & explain any deviations from approved
protocol
* Process protocol amendments according to GCP
*Manage proper storage & care for trial
devices/drugs. (PI can delegate this task to trained
professional - PharmD, etc)
1. IRB
Protocol amendments
2. Sponsor
should be submitted to
3. Regulatory Authority
Changes in risk to should be included & approved on an updated ICF -
subjects... patients enrolled should be re-consented
Consenting illiterate is okay, but must have impartial witness present
subjects
(Grade A+)
Save
Terms in this set (138)
ADR Adverse Drug Reaction
Reviews how the research was conducted; takes into
Audit account SOPs, IRB requirements & GCP (ensures
compliance)
Audit Certificate Confirmation audit took place
Written Evaluation - not regularly made available to
Audit Report regulatory body; only when serious evidence exists
concerning non-compliance
Audit Trail Documentation of audit events
Single Blind Study Subjects Unaware
Double Blind Study Subjects & Researchers are unaware
Item used as an active control references in a clinical
Comparator
trail
Group a sponsor comprises to coordinate multi-
Coordinating Committee
center trials
An investigator who oversees multiple sites of a
Coordinating Investigator
clinical trial (multicenter)
, Independent Data Monitoring Committee, Data &
Safety Monitoring Board (DSMB), Data Monitoring
IDMC
Committee: Oversee safety & progress; make
recommendations to continue, modify or stop
Independent Ethics Committee; group who oversees
IEC protection, rights, safety & well-being of human
subjects
Compilation of data on an investigational product
Investigator's Brochure
used in human subjects
Legally acceptable person whom is lawfully able to consent on behalf of
representative another
Serious Adverse Event - Results in death, is life-
threatening, requires long-term hospitalization, results
SAE
in long term disability/hospitalization incapacitation or
is a congenital birth defect
original clinical information from source documents
Source data
(medical record information)
*Hierarchical structure employees
*armed forces
*detainees
*incurable disease pts
Vulnerable subjects *homeless
*poor
*those in nursing home
*minors
*those unable to give consent
ICH International Conference on Harmonization
*Protect research subjects
*conduct research as it has been approved
Principles of ICH & GCP
*research should be clear, organized & approved by
an IRB/IEC
, *Oversee principles of ICH/GCP
IRB / IEC Responsibilities *Make sure the PI / Co-Is are qualified
* Review studies at least once a year
* at least 5 members
Requirements of an IRB * one non-scientific member
* one non-institute member
*Changes / deviations from protocol due to
unforeseen hazard
What needs reported to
* changes to subject risk
the IRB?
* adverse events
* new info that may impact subject safety
Payment to subjects must prorated & not contingent on subject completing
be.... study
*Maintain delegation long
*Ensure staff are trained/informed about the protocol
(give delegated tasks)
* Ascertain reason study participant withdraws
consent while respecting their privacy & rights
Investigator * Adhere to approved protocol
Responsibilities *Document & explain any deviations from approved
protocol
* Process protocol amendments according to GCP
*Manage proper storage & care for trial
devices/drugs. (PI can delegate this task to trained
professional - PharmD, etc)
1. IRB
Protocol amendments
2. Sponsor
should be submitted to
3. Regulatory Authority
Changes in risk to should be included & approved on an updated ICF -
subjects... patients enrolled should be re-consented
Consenting illiterate is okay, but must have impartial witness present
subjects
