ACRP-CCRC Exam Information and Guideline
ACRP Certified Clinical Research Coordinator
Below are complete topics detail with latest syllabus and course outline, that will help you good knowledge about exam objectives and topics that you have to prepare. These contents are covered in questions and answers pool of exam.
- 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
- roles of various clinical trial entities (e.g., CROs, sponsors, regulatory authority, etc.)
- Verify that investigational staff is qualified
- Escalate significant findings as appropriate
- Coordinate protocol and/or protocol amendments through appropriate approval processes (e.g., IRB/IEC, sponsor, regulatory authority)
- site close-out activities
- Prepare and/or participate in close-out monitoring visit(s)
- Prepare study summary and/or close-out letter for IRB/IEC
- Manage study records retention and availability
- site initiation activities
- Prepare and/or participate in study initiation activities
- Develop or participate in protocol training
- Facilitate site budget/contract approval process
- site selection criteria
- Ensure appropriate staff, facility, and equipment availability throughout the study
- Verify that investigational staff is qualified
- Ensure consistency between the sites’ standard operating procedures (SOPs) and the study requirements
- staff oversight
- Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation of slides, freezing, refrigeration)
- Ensure appropriate staff, facility, and equipment availability throughout the study
- Ensure investigator/site protocol compliance
- staff qualifications (site and monitor)
- Verify that investigational staff is qualified
- Develop or participate in protocol training
- Follow standards for handling hazardous goods (e.g., International Air Transport Association (IATA)
- staff training requirements
- Develop or participate in protocol training
- Follow standards for handling hazardous goods (e.g., International Air Transport Association (IATA)
- Plan, conduct and/or participate in training of the investigational staff
- study close-out activities
- Prepare and/or participate in close-out monitoring visit(s)
- Submit documents to regulatory authorities
- Reconcile investigational product and related supplies
- communication documentation requirements (e.g., telephone, email)
- Collect, record, and report accurate and verifiable data
- Maintain study related logs (e.g., site signature log, screening log)
- Develop source document templates
- contract budget negotiations and approval process
- Participate in budget development
- Facilitate site budget/contract approval process
- Reconcile payments per contract (e.g. stipend payments)
- elements of a study budget
- Participate in budget development
- Facilitate site budget/contract approval process
- Ensure appropriate staff, facility, and equipment availability throughout the study
- equipment and supplies use and maintenance
- Perform and/or verify equipment calibration and maintenance
- Ensure proper collection, processing, and shipment of specimens
- centrifuge
- preparation of slides
- freezing
- refrigeration
- Ensure adequacy of investigational product and other supplies at site
- investigational product accountability and documentation requirements
- Maintain accountability of investigational product
- Reconcile investigational product and related supplies
- Monitor investigational product expiration and/or manage resupply
- investigational product characteristics (e.g., mechanism of action, stability, product attributes, etc.)
- Review the Investigators’ Brochure
- Identify the safety and expected therapeutic effects of the investigational product using various study documents including the protocol and IB
- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies
- investigational product labeling requirements
- Prepare investigational product
- Dispense investigational product
- Monitor investigational product expiration and/or manage resupply
- investigational product packaging
- Instruct subjects on proper use of investigational product
- Assess subject compliance
- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies
- investigational product shipment
- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies
- Maintain accountability of investigational product
- Maintain study related logs (e.g., site signature log, screening log)
- investigational product storage
- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies
- Ensure appropriate staff, facility, and equipment availability throughout the study
- Maintain accountability of investigational product
- non-compliance management
- Escalate significant findings as appropriate
- Oversee the management of safety risks at the site (e.g., clinical holds, product recalls)
- Assess subject compliance
- project timelines (e.g. data lock, enrollment period, etc)
- Follow a study plan (e.g., management plan, monitoring plan, etc.)
- Transmit data to Data Management
- Schedule subjects
- purpose of and process(es) for protocol compliance
- Identify issues requiring protocol amendments
- Conduct subject visits
- Assess subject compliance
- sample collection, shipment, and storage requirements
- Ensure appropriate staff, facility, and equipment availability throughout the study
- Manage study supplies (e.g., lab kits, case report forms)
- Follow standards for handling hazardous goods (e.g., International Air Transport Association (IATA)
- subject compliance assessment
- Assess subject compliance
- Develop trial management tools (e.g. subject study calendar, source documents, retention material)
- Maintain accountability of investigational product
- subject responsibilities for study participation
- Instruct subjects on proper use of investigational product
- Ensure adequate consent and documentation of the informed consent process
- Assess subject compliance
- subject visit activities
- Schedule subjects
- Conduct subject visits
- Participate in and document the informed consent process(es)
- vendor management
- Manage vendors (Obtain/verify vendor credentials,lab certification/licensure)
- Manage investigational product recall
- Ensure access to source data by authorized parties, and confidentiality by limiting unauthorized access
- data management activities
- Review completed eCRF/CRF
- Transmit data to Data Management
- Manage study records retention and availability
- data privacy principles
- 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
- Comply with subject privacy regulations
- elements and purposes of data collection tools (e.g., eCRF, EDC)
- Develop trial management tools (e.g. subject study calendar, source documents, retention material)
- Develop source document templates
- Evaluate data collection tools (e.g., case report form (e/CRF), electronic data capture (EDC)) for consistency with protocol
- elements of a final study report
- Manage study records retention and availability
- Prepare study summary and/or close-out letter for IRB/IEC
- Prepare and/or participate in close-out monitoring visit(s)
- elements of and process for data query
- Perform query resolution
- Collect, record, and report accurate and verifiable data
- Review completed eCRF/CRF
- elements of pharmacovigilance (e.g., CIOMS, IDMC/DSMB, safety databases)
- Ensure timely review of safety data
- Collect, record, and report accurate and verifiable data
- Minimize potential risks to subject safety
- essential documents for the conduct of a clinical trial (e.g., paper/electronic, trial master file)
- Identify and/or maintain Essential Documents required for study conduct
- Manage study records retention and availability
- Maintain study related logs
- site signature log
- screening log
- record retention and destruction practices and requirements
- Manage study records retention and availability
- Maintain study related logs (e.g., site signature log, screening log)
- Ensure consistency between the sites’ standard operating procedures (SOPs) and the study requirements
- source data review (SDR) and source data verification (SDV) purpose and process
- Collect, record, and report accurate and verifiable data
- Perform query resolution
- Ensure and document follow-up medical care for study subjects, as applicable
- source documentation requirements
- Develop source document templates
- Collect, record, and report accurate and verifiable data
- Evaluate data collection tools (e.g., case report form (e/CRF), electronic data capture (EDC)) for consistency with protocol
- study documentation practices (accurate, complete, timely, legible, dated, and identify the trial)
- Develop source document templates
- Evaluate data collection tools (e.g., case report form (e/CRF), electronic data capture (EDC)) for consistency with protocol
- Collect, record, and report accurate and verifiable data