
ACRP-CCRC | ACRP Certified Clinical Research Coordinator
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ACRP-CCRC - ACRP Certified Clinical Research Coordinator - braindump
Vendor | Nursing | |
Exam Number | ACRP-CCRC | |
Exam Name | ACRP Certified Clinical Research Coordinator | |
Questions | 920 Q & A | |
Updated On | Click to Check Update | |
Free PDF Download | ACRP-CCRC Brain Dump | |
Download Full Braindumps PDF | Killexams ACRP-CCRC Complete Document |
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Exam Number : ACRP-CCRC
Exam Name : ACRP Certified Clinical Research Coordinator
Vendor Name : Nursing
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ACRP-CCRC Exam Format | ACRP-CCRC Course Contents | ACRP-CCRC Course Outline | ACRP-CCRC Exam Syllabus | ACRP-CCRC Exam Objectives
- elements of a protocol
- Identify and/or explain study objective(s) and endpoints
- Conduct prescreening activities with potential study subjects
- Screen trial subjects
- elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual)
- Identify and/or explain study design
- Identify and/or explain study objective(s) and endpoints
- Identify the safety and expected therapeutic effects of the investigational product using various study documents including the protocol and IB
- elements of and rationale for subject eligibility requirements
- Identify and/or explain study objective(s) and endpoints
- Conduct prescreening activities with potential study subjects
- Screen trial subjects
- rationale for complying with a protocol
- Identify and/or explain study objective(s) and endpoints
- Ensure compliance with study requirements and regulations
- Follow a study plan
- management plan
- monitoring plan
- statistical principles
- Identify and/or explain study design
- Maintain randomization procedures of investigational product
- Collect, record, and report accurate and verifiable data
- study design characteristics
- double-blind
- crossover
- randomized
- Identify and/or explain study design
- Maintain unblinding procedures of investigational product
- Evaluate study for feasibility (site determining ability to successfully conduct the study)
- study objective(s) and end points/outcomes
- Identify and/or explain study design
- Identify and/or explain study objective(s) and endpoints
- Ensure and document follow-up medical care for study subjects, as applicable
- use of supplemental/rescue/comparator product in study design
- Identify and/or explain study design
- Implement plan of action for management of adverse event(s)
- stop investigational product
- retest
- treat subject
- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies
- treatment assignments
- randomization
- open label
- registries
- Identify and/or explain study design
- Maintain randomization procedures of investigational product
- Instruct subjects on proper use of investigational product
- adverse events classification, documentation and reporting
- Maintain follow-up to determine resolution of adverse event(s)
- Ensure appropriate reporting and documentation of adverse event(s)
- Differentiate the types of adverse events that occur
- blinding procedures
- Maintain unblinding procedures of investigational product
- Conduct unblinding procedures as applicable
- Dispense investigational product
- components of subject
- Identify and/or explain study design
- eligibility requirements
- Conduct prescreening activities with potential study subjects
- Screen trial subjects
- confidentiality and privacy requirements
- Comply with subject privacy regulations
- Ensure compliance with electronic data requirements (e.g., passwords and access)
- Ensure access to source data by authorized parties, and protect confidentiality by limiting unauthorized access
- elements of the IB
- Identify the safety and expected therapeutic effects of the investigational product using various study documents including the protocol and IB
- Review the Investigators Brochure
- Prepare and/or submit documents for IRB/IEC and/or sponsor review/approval
- elements of the informed consent form
- Develop and/or review informed consent form
- Ensure IRB/IEC review/written approval of study and study documents
- Identify and/or maintain Essential Documents required for study conduct
- informed consent process requirements (e.g. paper, eConsent, assent)
- Participate in and document the informed consent process(es)
- Ensure adequate consent and documentation of the informed consent process
- Comply with IRB/IEC requirements
- protection of human subjects
- Assess subject safety during study participation
- Verify that investigational staff is qualified
- Minimize potential risks to subject safety
- protocol deviation/violation identification, documentation, and reporting processes
- Ensure investigator/site protocol compliance
- Assess, manage, and/or review subject laboratory values, test results, and alerts
- Inform the sponsor and IRB/IEC of any deviations from the protocol and document as appropriate
- recruitment plan/strategies (e.g. social media, digital, print, etc)
- Document reasons for subject discontinuation
- causes
- contact efforts
- Follow a study plan
- management plan
- monitoring plan
- Re-evaluate the recruitment strategy as needed
- safety monitoring
- Implement plan of action for management of adverse event(s)
- stop investigational product
- retest
- treat subject
- Oversee the management of safety risks at the site
- clinical holds
- product recalls
- Create, document, and/or implement corrective and preventive action (CAPA) plans
- subject discontinuation criteria/procedures
- Document reasons for subject discontinuation (i.e., causes, contact efforts) Comply with IRB/IEC requirements
- Implement plan of action for management of adverse event(s)
- stop investigational product
- retest
- treat subject
- subject retention strategies
- Develop and/or implement study education plan and/or tools for subjects
- Re-evaluate the recruitment strategy as needed
- Prepare and/or submit documents for IRB/IEC and/or sponsor review/approval
- subject safety issues
- Oversee the management of safety risks at the site
- clinical holds
- product recalls
- Minimize potential risks to subject safety
- Escalate significant findings as appropriate
- vulnerable subject populations
- Identify and/or address potential ethical issues involved with study conduct
- Ensure adequate consent and documentation of the informed consent process
- Participate in and document the informed consent process(es)
- conflicts of interest in clinical research
- Identify and/or address potential ethical issues involved with study conduct
- Identify and report potential fraud and misconduct
- Identify the role and proper composition of IRB/IECs
- audit and inspection processes (preparation, participation, documentation, and follow-up)
- Submit documents to regulatory authorities
- Prepare for and/or participate in audits and inspections
- Respond to or facilitate response to audit/inspection findings
- clinical development process (e.g., preclinical, clinical trial phases, device class)
- Submit documents to regulatory authorities
- Evaluate study for feasibility (site determining ability to successfully conduct the study)
- Prepare and/or submit documents for IRB/IEC and/or sponsor review/approval
- clinical trial registries and requirements
- Comply with IRB/IEC requirements
- Inform study subjects of trial results, in accordance with regulatory requirements
- Ensure consistency between the sites standard operating procedures (SOPs) and the study requirements
- elements of fraud and misconduct
- Identify and report potential fraud and misconduct
- Identify the role and proper composition of IRB/IECs
- Identify and/or address potential ethical issues involved with study conduct
- IRB/IEC reporting requirements
- Prepare study summary and/or close-out letter for IRB/IEC
- Ensure compliance with study requirements and regulations
- Comply with IRB/IEC requirements
- IRB/IEC role, composition and purpose
- Identify the role and proper composition of IRB/IECs
- Comply with IRB/IEC requirements
- Coordinate protocol and/or protocol amendments through appropriate approval processes
- IRB/IEC
- sponsor
- regulatory authority
- protocol and protocol amendment submission and approval processes
- Coordinate protocol and/or protocol amendments through appropriate approval processes
- IRB/IEC
- sponsor
- regulatory authority
- Implement protocol amendments
- Ensure IRB/IEC review/written approval of study and study documents
- regulatory reporting requirements
- Prepare and/or submit documents for IRB/IEC and/or sponsor review/approval
- Inform the sponsor and IRB/IEC of any deviations from the protocol and document as appropriate
- Prepare and/or participate in close-out monitoring visit(s)
- safety reporting requirements
- Follow standards for handling hazardous goods
- International Air Transport Association (IATA)
- Ensure timely review of safety data
- Ensure appropriate reporting and documentation of adverse event(s)
- significant milestones in the evaluation of efficacy and safety (e.g., interim analysis result, DSMB review )
- Create, document, and/or implement corrective and preventive action (CAPA) plans
- Ensure compliance with study requirements and regulations
- Prepare, and/or participate in interim monitoring activities (including onsite, remote, and risk-based)
- Clinical Trial Operations (GCPs)
- delegation listing
- Verify that investigational staff is qualified
- Prepare and/or participate in study initiation activities
- Plan, conduct and/or participate in training of the investigational staff
- elements of an effective corrective and preventive action (CAPA) process(es) and plans
- Create, document, and/or implement corrective and preventive action (CAPA) plans
- Identify issues and recommend investigator/site
- corrective actions
- Minimize potential risks to subject safety
- elements of and rationale for monitoring plan(s)
- Follow a study plan
- management plan
- monitoring plan
- Ensure investigator/site protocol compliance
- Ensure monitoring activities are conducted according to plan
- indemnification/insurance requirements
- Minimize potential risks to subject safety
- Identify and/or maintain Essential Documents required for study conduct
- Develop and/or review informed consent form
- monitoring activities (frequency of visits, data review, and follow up)
- Ensure monitoring activities are conducted according to plan
- Prepare, and/or participate in interim monitoring activities (including onsite, remote, and risk-based)
- Document, communicate, and follow up on site visit findings
- pre-study/site selection visit activities
- Evaluate study for feasibility (site determining ability to successfully conduct the study)
- Schedule, coordinate, and/or participate in pre-study site visit
- Ensure appropriate staff, facility, and equipment availability throughout the study
- principal investigator responsibilities
- Ensure and document follow-up medical care for study subjects, as applicable
- Verify that investigational staff is qualified
- Review the Investigators Brochure
- principles of risk based monitoring
- Ensure monitoring activities are conducted according to plan
- Escalate significant findings as appropriate
- Prepare, and/or participate in interim monitoring activities (including onsite, remote, and risk-based)
- project feasibility
- Evaluate study for feasibility (site determining ability to successfully conduct the study)
- considerations
- Ensure appropriate staff, facility, and equipment availability throughout the study
- Identify the safety and expected therapeutic effects of the investigational product using various study documents including the protocol and IB
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