ACRP CCRA ACTUAL FINALS ANSWERS AND
QUESTIONS SET A+
✔✔Important immediate inspection preparation strategies include: - ✔✔- Inform
personnel
- Secure facility resources
- Organize study related documents
- Ensure access to original data
✔✔Directed/for-cause inspections may focus on? - ✔✔The particular reason that
prompted the inspection
✔✔What is the major focus area for routine inspections for a clinical investigator? - ✔✔-
Data reviews
- ICF process and documentation
✔✔What is the major focus area for a sponsor/CRO GCP inspection related to trial? -
✔✔- Vendor selection and management
- Data management (e.g. review of data management plan)
✔✔Common inspection management strategies include? - ✔✔- Scope of inspection
- Understand inspection timeframes
-Copy of personnel records
✔✔What does NAI stand for? - ✔✔No action indicated
✔✔What does VAI stands for? - ✔✔Voluntary action indicated
✔✔What does OAI stand for? - ✔✔Official action indicated
✔✔According the MHRA, an inspection finding is considered critical where evidence
exists that signifiant and unjustified departure from applicable legislative requirements
has occurred with evidence that: - ✔✔- Safety/well-being of subject jeopardized
- Clinical trial data are unreliable
- Systematic quality assurance failure
, ✔✔EMA uses how many categories to rate inspection findings for inspectors? - ✔✔3
✔✔Responses to a regulatory authority must? - ✔✔Come from the person most
responsible and in the timeframe specified.
✔✔For each electronic system to be acceptable for use in research the system must? -
✔✔- Be available and accessible
- Be valid
- Have back-up and internal parameters
✔✔The purpose of password protection is the limit access to the information entered
electronically, and also allow for ____________. Which can be reviewed at any time to
see who entered, altered or reviewed information at any time. - ✔✔Audit trail
✔✔What is the definition of a case report forms? - ✔✔A printed, optical, or electronic
document designed to record information to be reported to the sponsor on each trail
subject.
✔✔What's the definition of source data? - ✔✔All information in original records and
certified copies of original records of clinical findings, observations, or other activities in
a clinical trial necessary for the reconstruction and evaluation of the trial.
✔✔Examples of electronic systems utilized in clinal trials? - ✔✔- electronic medical
records
- electronic case report forms (eCRFs)
- electronic diaries
✔✔A number of attributes are considered of universal importance to source data and
the records that hold those data. These include that data records are? - ✔✔- Accurate
and legible
-Contemporaneous and original
- Attributable and consistent
✔✔Password protection allows monitors and auditors to confirm that subjects
confidentiality was maintained as well as providing a methodology to confirm that only
individuals with appropriate education, experience and training completed study related
procedures as tasked on a what? - ✔✔Delegation log
✔✔General regulatory expections for electronic systems include: - ✔✔- Password
control
- Audit trail
- Appropriate access by qualified personnel (read vs write access)
QUESTIONS SET A+
✔✔Important immediate inspection preparation strategies include: - ✔✔- Inform
personnel
- Secure facility resources
- Organize study related documents
- Ensure access to original data
✔✔Directed/for-cause inspections may focus on? - ✔✔The particular reason that
prompted the inspection
✔✔What is the major focus area for routine inspections for a clinical investigator? - ✔✔-
Data reviews
- ICF process and documentation
✔✔What is the major focus area for a sponsor/CRO GCP inspection related to trial? -
✔✔- Vendor selection and management
- Data management (e.g. review of data management plan)
✔✔Common inspection management strategies include? - ✔✔- Scope of inspection
- Understand inspection timeframes
-Copy of personnel records
✔✔What does NAI stand for? - ✔✔No action indicated
✔✔What does VAI stands for? - ✔✔Voluntary action indicated
✔✔What does OAI stand for? - ✔✔Official action indicated
✔✔According the MHRA, an inspection finding is considered critical where evidence
exists that signifiant and unjustified departure from applicable legislative requirements
has occurred with evidence that: - ✔✔- Safety/well-being of subject jeopardized
- Clinical trial data are unreliable
- Systematic quality assurance failure
, ✔✔EMA uses how many categories to rate inspection findings for inspectors? - ✔✔3
✔✔Responses to a regulatory authority must? - ✔✔Come from the person most
responsible and in the timeframe specified.
✔✔For each electronic system to be acceptable for use in research the system must? -
✔✔- Be available and accessible
- Be valid
- Have back-up and internal parameters
✔✔The purpose of password protection is the limit access to the information entered
electronically, and also allow for ____________. Which can be reviewed at any time to
see who entered, altered or reviewed information at any time. - ✔✔Audit trail
✔✔What is the definition of a case report forms? - ✔✔A printed, optical, or electronic
document designed to record information to be reported to the sponsor on each trail
subject.
✔✔What's the definition of source data? - ✔✔All information in original records and
certified copies of original records of clinical findings, observations, or other activities in
a clinical trial necessary for the reconstruction and evaluation of the trial.
✔✔Examples of electronic systems utilized in clinal trials? - ✔✔- electronic medical
records
- electronic case report forms (eCRFs)
- electronic diaries
✔✔A number of attributes are considered of universal importance to source data and
the records that hold those data. These include that data records are? - ✔✔- Accurate
and legible
-Contemporaneous and original
- Attributable and consistent
✔✔Password protection allows monitors and auditors to confirm that subjects
confidentiality was maintained as well as providing a methodology to confirm that only
individuals with appropriate education, experience and training completed study related
procedures as tasked on a what? - ✔✔Delegation log
✔✔General regulatory expections for electronic systems include: - ✔✔- Password
control
- Audit trail
- Appropriate access by qualified personnel (read vs write access)
