ACRP CCRC STANDARD EXAMS ANSWERS AND
QUESTIONS SET A+
✔✔Responsibilities of monitor - ✔✔*Main line of communication b/w investigator &
sponsor
*Verify investigator qualifications
*Verify product
*Verify product storage
*Verify dosing & who is receiving it
*Subjects receive direction on product use
*Products are accounted for appropriately
*Verify protocol is being followed
*verify written consent on each subject
*ensure investigator has investigator brochure
*ensure all staff are informed about the trial
*verify only eligible subjects are being enrolled
*report recruitment rate
*verify source documents (CRFs match)
*patient withdrawal or missed visits are reported on CRFs
*notify PI of any missing data or signed edits to data
*monitor reporting of AEs
*report on deviations
✔✔Auditors vs Monitors vs inspectors - ✔✔*Monitors - address data, storage of drug, &
report to sponsor/investigator. They can be internal
*Auditors - focused on compliance which is separate from routine monitoring - they
should not be part of trial; independent committee reviewing data
*Inspectors - IRB or regulatory body reviewing data
✔✔Audit Plans - ✔✔differ based upon study design, complexity, number of subjects on
trial, etc
✔✔Required essential documents provided before study opens - ✔✔*IB
*signed protocol & amendments
*CRFS
,*ICF
*ads to promote study
*financial aspects of study
*agreements (signed)
*Approved by IRB study materials
*Composition of IRB
*Signed CVs of PIs
*Storing & Handling of device/drug
*shipping information
*Emergency decoding procedures for blinded study
*Master randomization list
* Pre-trial monitoring report
✔✔Required essential documents provided during study - ✔✔*updates to IB
*updates to protocol / CRF, etc
*approvals from IRB of updated materials
*updates to any procedures / tests / shipping
*records of any monitoring visits
*signed ICF
*completed CRFs, signed & dated
*documentation of edited CRFs
*source docs for completing CRFs
*documentation of AEs/SAEs
*subjects screening log
*Subject enrollment log
*subject ID code list
* investigational product accountability
*signature sheet (KSP)
*record of samples
✔✔Required essential documents at completion of trial - ✔✔*Investigational product
accountability at site (ensures products were used appropriate ensures which products
were used/returned
*device construction list
*ID code list
*audit certificate
*final monitoring report
*decoding document returned
*final report of trial by PI
*clinical study report (interpret trial)
✔✔Serious vs Severe events - ✔✔Severe = degree of event (mild/moderate, etc)
Serious = overall event outcome; dictates regulatory documentation & reporting
, ✔✔Events that should be reported expeditiously - ✔✔Events that are BOTH serious
and unexpected (does not include events that are not study related, non-serious events
and serious, but expected events)
✔✔Reporting time frame for events - ✔✔Fatal/Life threatening unexpected = ASAP; no
more than 7 days after event
Non fatal/Life threatening = 15 days
*ok if not all info is available --> submit what you have
✔✔Reporting for blinded studies - ✔✔*when SAE occurs, it is generally suggested to
break the blind for the patient unless
*PI doesn't do this, the sponsor should
*Blind should be maintained for research personnel, even if subject is told
✔✔Phase I Trials - ✔✔Human Pharmacology; assess safety & tolerability
*usually non-therapeutic in nature
*may use healthy volunteers unless its cancer
*PKs & PDs
15-30 patients
Goals: figure out if its safe and best administration
Population: normal, healthy adults; if cancer --> end stage
✔✔Phase II Trials - ✔✔Therapeutic exploratory; explore medications - establish dose
for phase III
*begin to test drug therapeutically
*Typically enrolls a very specific criteria on patients
*may help lay groundwork for endpoints in phase III
Fewer than 100 patients
Goals: determines short term risks, examine preliminary effectiveness
Population: controlled study with limited population
✔✔Phase III - ✔✔Therapeutic Confirmatory; confirm early findings; *establish efficacy
*establish drug as beneficial to treat condition
*set stage for marketing approval
100-1000's of patients
Goals: confirm drug works, control & investigational group, double-blinded controlled
studies
✔✔Phase IV - ✔✔Therapeutic use; outcomes of use, multiple endpoints, large trials
*comes after drug approval (Think LINX PAS but for meds)
*Basically confirms dosing, safety & effectiveness
✔✔Note about Phase IV trials - ✔✔Therapeutic use is never in phase I, II or II, but
others can fall into continuum.
QUESTIONS SET A+
✔✔Responsibilities of monitor - ✔✔*Main line of communication b/w investigator &
sponsor
*Verify investigator qualifications
*Verify product
*Verify product storage
*Verify dosing & who is receiving it
*Subjects receive direction on product use
*Products are accounted for appropriately
*Verify protocol is being followed
*verify written consent on each subject
*ensure investigator has investigator brochure
*ensure all staff are informed about the trial
*verify only eligible subjects are being enrolled
*report recruitment rate
*verify source documents (CRFs match)
*patient withdrawal or missed visits are reported on CRFs
*notify PI of any missing data or signed edits to data
*monitor reporting of AEs
*report on deviations
✔✔Auditors vs Monitors vs inspectors - ✔✔*Monitors - address data, storage of drug, &
report to sponsor/investigator. They can be internal
*Auditors - focused on compliance which is separate from routine monitoring - they
should not be part of trial; independent committee reviewing data
*Inspectors - IRB or regulatory body reviewing data
✔✔Audit Plans - ✔✔differ based upon study design, complexity, number of subjects on
trial, etc
✔✔Required essential documents provided before study opens - ✔✔*IB
*signed protocol & amendments
*CRFS
,*ICF
*ads to promote study
*financial aspects of study
*agreements (signed)
*Approved by IRB study materials
*Composition of IRB
*Signed CVs of PIs
*Storing & Handling of device/drug
*shipping information
*Emergency decoding procedures for blinded study
*Master randomization list
* Pre-trial monitoring report
✔✔Required essential documents provided during study - ✔✔*updates to IB
*updates to protocol / CRF, etc
*approvals from IRB of updated materials
*updates to any procedures / tests / shipping
*records of any monitoring visits
*signed ICF
*completed CRFs, signed & dated
*documentation of edited CRFs
*source docs for completing CRFs
*documentation of AEs/SAEs
*subjects screening log
*Subject enrollment log
*subject ID code list
* investigational product accountability
*signature sheet (KSP)
*record of samples
✔✔Required essential documents at completion of trial - ✔✔*Investigational product
accountability at site (ensures products were used appropriate ensures which products
were used/returned
*device construction list
*ID code list
*audit certificate
*final monitoring report
*decoding document returned
*final report of trial by PI
*clinical study report (interpret trial)
✔✔Serious vs Severe events - ✔✔Severe = degree of event (mild/moderate, etc)
Serious = overall event outcome; dictates regulatory documentation & reporting
, ✔✔Events that should be reported expeditiously - ✔✔Events that are BOTH serious
and unexpected (does not include events that are not study related, non-serious events
and serious, but expected events)
✔✔Reporting time frame for events - ✔✔Fatal/Life threatening unexpected = ASAP; no
more than 7 days after event
Non fatal/Life threatening = 15 days
*ok if not all info is available --> submit what you have
✔✔Reporting for blinded studies - ✔✔*when SAE occurs, it is generally suggested to
break the blind for the patient unless
*PI doesn't do this, the sponsor should
*Blind should be maintained for research personnel, even if subject is told
✔✔Phase I Trials - ✔✔Human Pharmacology; assess safety & tolerability
*usually non-therapeutic in nature
*may use healthy volunteers unless its cancer
*PKs & PDs
15-30 patients
Goals: figure out if its safe and best administration
Population: normal, healthy adults; if cancer --> end stage
✔✔Phase II Trials - ✔✔Therapeutic exploratory; explore medications - establish dose
for phase III
*begin to test drug therapeutically
*Typically enrolls a very specific criteria on patients
*may help lay groundwork for endpoints in phase III
Fewer than 100 patients
Goals: determines short term risks, examine preliminary effectiveness
Population: controlled study with limited population
✔✔Phase III - ✔✔Therapeutic Confirmatory; confirm early findings; *establish efficacy
*establish drug as beneficial to treat condition
*set stage for marketing approval
100-1000's of patients
Goals: confirm drug works, control & investigational group, double-blinded controlled
studies
✔✔Phase IV - ✔✔Therapeutic use; outcomes of use, multiple endpoints, large trials
*comes after drug approval (Think LINX PAS but for meds)
*Basically confirms dosing, safety & effectiveness
✔✔Note about Phase IV trials - ✔✔Therapeutic use is never in phase I, II or II, but
others can fall into continuum.
