ACRP CCRC, CCRC Study Set Already Graded A+
ADR
Adverse Drug Reaction
Audit
Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance)
Brainpower
Audit Certificate
Confirmation audit took place
Audit Report
Written Evaluation - not regula...
ACRP CCRC, CCRC Study Set Already Graded A+
ADR
Adverse Drug Reaction
Audit
Reviews how the research was conducted; takes into account SOPs, IRB requirements
& GCP (ensures compliance)
Brainpower
Audit Certificate
Confirmation audit took place
Audit Report
Written Evaluation - not regularly made available to 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
Comparator
Item used as an active control references in a clinical trail
Coordinating Committee
Group a sponsor comprises to coordinate multi-center trials
Coordinating Investigator
An investigator who oversees multiple sites of a clinical trial (multicenter)
IDMC
Independent Data Monitoring Committee, Data & Safety Monitoring Board (DSMB),
Data Monitoring Committee: Oversee safety & progress; make recommendations to
continue, modify or stop
IEC
Independent Ethics Committee; group who oversees protection, rights, safety & well-
being of human subjects
Investigator's Brochure
Compilation of data on an investigational product used in human subjects
Legally acceptable representative
person whom is lawfully able to consent on behalf of another
SAE
Serious Adverse Event - Results in death, is life-threatening, requires long-term
hospitalization, results in long term disability/hospitalization incapacitation or is a
congenital birth defect
Source data
original clinical information from source documents (medical record information)
Vulnerable subjects
*Hierarchical structure employees
*armed forces
*detainees
,*incurable disease pts
*homeless
*poor
*those in nursing home
*minors
*those unable to give consent
ICH
International Conference on Harmonization
Principles of ICH & GCP
*Protect research subjects
*conduct research as it has been approved
*research should be clear, organized & approved by an IRB/IEC
IRB / IEC Responsibilities
*Oversee principles of ICH/GCP
*Make sure the PI / Co-Is are qualified
* Review studies at least once a year
Requirements of an IRB
* at least 5 members
* one non-scientific member
* one non-institute member
What needs reported to the IRB?
*Changes / deviations from protocol due to unforeseen hazard
* changes to subject risk
* adverse events
* new info that may impact subject safety
Payment to subjects must be....
prorated & not contingent on subject completing study
Investigator Responsibilities
*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
* Adhere to approved protocol
*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)
Protocol amendments should be submitted to
1. IRB
2. Sponsor
3. Regulatory Authority
Changes in risk to subjects...
should be included & approved on an updated ICF - patients enrolled should be re-
consented
Consenting illiterate subjects
is okay, but must have impartial witness present
,Necessary aspects of ICF
*Trial involves research
*Trial purposes
*Treatments - randomization aspect if applicable
* Procedures
*Subject responsibilities
*Experimental Aspects of trial
*Risks
*Benefits
*Alternatives to participating
*Compensation
* Compensation for trial related outcomes
*Voluntary nature of trial
*Who has access to direct records
*Confidentiality of research records
*New information will be made available to subject
*Who to Contact
*Involuntary termination
*Trial Duration
*Subjects to be enrolled
Non-therapeutic trials can be conducted with consent from legal rep IF
*trial objectives cannot be met by personal subject consent
*low risk
*trial is not prohibited by law
*IRB has approved such inclusion
How long must documents be retained per GCP?
At least 2 years after last approved marketing application (organizations/sponsors, etc
usually set a longer required period of 5-7 years)
When to submit SAE to sponsor?
Immediately (usually within 24 hours)
Sponsors role
*Complete & ensure SOPs are followed
*seeks agreements from all parties
*may use CRO to oversee; however, the sponsor is ultimately responsible
CRO
Contract Research Organization
Sponsor/Investigator agreement should contain
1. Agreement to comply w/ GCP (adhere to protocol & IRB)
2. Agree to comply with data recording
3. Agree to permit monitoring
4. Agree to retain documents for specified length of time
*Agreement should be signed by both parties
Purpose of Trial monitoring
*Ensure rights & safety of subjects are protected
*Report on accuracy of trial data
*Ensure trial is compliant (protocol, GCP, etc)
, How is a monitor selected?
*Appointed by sponsor
*Adequately trained & qualified
*familiar with protocol, ICF, etc
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
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