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CRA认证培训
课程介绍：
Certified Clinical Research Associates (CCRAs) are expected to have general knowledge of:
• laboratory terminology, tests, and procedures
• basic math, including adding, subtracting, multiplying, dividing, and calculating percentages
As defined by the 2010 ACRP Job Analysis Survey, a CCRA® shall have proficiency in the following areas of clinical research:
课程对象：
课程长度：72学时
最新时间：定制课程(内训)，人满开班(公开课)
课程大纲：
I. Investigational Product Management
• Develop and update the instructions for use of investigational product
• Initiate shipment of investigational product to site
• Ensure adequacy of investigational product and other supplies at site
• Ensure randomization and emergency codes of investigational product have been maintained
• Ensure proper storage, dispensing, handling, and disposition of investigational product and other supplies
• Reconcile investigational product and other supplies
• Maintain accountability of investigational product
• Retrieve investigational product and calculate subject compliance
• Maintain randomization and emergency codes of investigational product dispensing
Using knowledge of:
• Investigational product (e.g., package insert, report of prior investigations, Investigator's Brochure)
• Investigational product inventory
• Investigational product accountability
• Investigational product storage
• Packaging and labeling
• Product Development
• Supplemental/rescue/comparator product
• Investigational product compliance (e.g., protocol, standard operating procedures, local governance)
• Accountability records
II. Protocol
• Review product development plan
• Identify study objective/design
• Develop the protocol (e.g., inclusion/exclusion criteria, procedures, schedule of events, safety and efficacy parameters)
• Evaluate protocol for scientific soundness
• Evaluate protocol for feasibility
• Evaluate congruence of data collection tools (e.g., case report form (CRF), electronic data capture (EDC) with the study protocol
• Verify the eligibility of potential trial subjects
• Contribute to protocol development
• Coordinate protocol approval process
• Review protocol for feasibility
• Review protocol during Investigator’s meeting
• Execute study per protocol
• Recommend and Implement protocol amendments
Using knowledge of:
• Protocol development
• Protocol submission and approval procedures
• Clinical trial phase
• Study design characteristics (e.g., double‐blind, crossover, randomized)
• Study objective
• Description of procedures
• Amendment submission and approval procedures
• Inclusion/exclusion criteria
• Statistical plan
III. Safety
• Assess safety during trial participation
• Minimize potential risks to subject safety
• Oversee safety risks (e.g., clinical holds, product recalls)
• Ensure adverse events reporting is documented (e.g., serious, severe, moderate, mild, expected, unexpected)
• Ensure reasons for subject discontinuation are documented (i.e., causes,contact efforts)
• Conduct study‐related procedures and monitor the safety of the trial subjects and investigational staff
• Manage and motivate the investigational staff and other disciplines involved,and take measures to minimize any potential risks
• Review common laboratory values and alerts
• Identify expected or unexpected results associated with investigational products
• Maintain follow‐up to determine resolution of adverse event
• Conduct safety monitoring/reporting activities
Using knowledge of:
• Investigator’s Brochure
• Safety monitoring
• Safety and clinical databases
• Subject safety issues (e.g., toxicity, significant lab values)
• Vulnerable subject populations
• Adverse events reporting
• Serious adverse events reporting
• Safety reporting requirements
IV. Trial Management
• Verify investigator/site feasibility
• Develop timelines for conducting and completing the clinical trial
• Prepare and conduct initiation activities
• Ensure appropriate training of the investigational staff
• Develop a recruitment strategy and study management plan
• Follow a recruitment strategy and study management plan
• Review, clarify, and obtain data changes from sites
• Schedule and coordinate pre‐study site visit
• Identify minimum regulatory document requirements for site trial master file (e.g., country‐specific regulatory documents)
• Ensure IRB/IEC review/approval of study and study documents
• Facilitate site budget/contract approval process
• Develop Case Report Forms (e.g., CRFs, eCRFs)
• Develop CRF completion guidelines
• Develop monitoring guidelines/plans
• Develop project tools
• Submit documents to regulatory authorities
• Document and communicate site visit findings
• Ensure clinical trial registry requirements are met
• Ensure timely review of study data (e.g., laboratory results, x‐rays)
• Maintain current vendor credentials (e.g., lab certification/licensure and normal ranges)
• Prepare and conduct interim monitoring visit(s)
• Prepare and conduct close‐out monitoring visit(s)
• Reconcile payments to sites per contract
• Document protocol deviations/violations
• Reconcile safety and clinical databases
• Conduct co‐monitoring/training visits
• Perform remote monitoring activities
• Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g., protocol procedures, EDC)
• Transmit CRFs to data management
• Review CRF queries from data management
• Coordinate study monitoring visits
• Draft study specific tools (e.g., source document, tracking tools)
• Implement corrective actions plans
• Maintain trial master file (e.g., regulatory binder)
• Manage study supplies (e.g., lab kits, case report forms)
• Comply with subject privacy regulations
• Manage study issues
Using knowledge of:Site Activities
• Contract budget negotiations and approval process
• Project feasibility
• Project timelines
• Monitoring guidelines/plan and tools
• Study project tools
• Staff qualifications
• Staff roles and responsibilities
• Data management activities
• Plan for staff oversight
• Investigator qualifications/ site selection (e.g., therapeutic area, education, experience)
• Disposition of unused study‐related materials (e.g., CRF at end of study, destruction of lab kits)
• Equipment and supplies (e.g., x‐ray, computer, lab kits) and storage
• Study management plan (e.g., timelines, data management)
• Communication documentation (e.g., telephone, email)
• Pre‐study site visit
• Investigator's meeting
• Site initiation
• Monitoring visit
• Close‐out visit
• Site monitoring visit log
• Site signature log
• Delegation listing
• Trial master file (e.g., site, sponsor)
• Data management plan
• Data query resolution
• Electronic data (e.g., electronic health records, electronic case report forms)
• Recruitment plans/strategies
• Subject compliance
• Subject visit logistics
• Protection of human subjects
• Subject selection, screening, and recruitment
• Subject retention
• Subject discontinuation
• Subject reimbursement
• Good Clinical Practice
• Regulatory documents
• Record retention
• Subject privacy regulations
• Case Report Form
• Visit reports (e.g., initiation, close‐out)
• Final report
• Progress reports
• Essential documentation, subject related and non‐subject related (e.g., past medical records, lab reports, protocol, IRB approvals)
• Informed consent
• Procedure manuals
• Source documentation
• Protocol deviations
• Indemnification/insurance
• Clinical trial registry
V. Trial Oversight
• Ensure consistency between the sites’ standard operation procedures (SOPs) and the study requirements
• Ensure investigator/site protocol compliance
• Facilitate investigator/site corrective actions
• Oversee vendors {e.g. Contract Research Organizations (CROs)}
• Ensure compliance with electronic data requirements (e.g., electronic health records, eCRF)
• Ensure adequate site management
• Prepare the study site for audits and inspections
• Respond to or facilitate response to audit/inspection findings
• Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation of slides, freezing, refrigeration)
• Ensure proper adverse event reporting by the investigator
• Escalate problems to appropriate in‐house management
• Investigate potential fraud and misconduct
• Report potential fraud and misconduct
• Ensure follow‐up medical care for study subjects is documented, as applicable
• Ensure adequate consent and documentation
• Ensure staff, facility, and equipment availability throughout the study
• Ensure compliance with study requirements and regulations
• Prepare for audits, inspections, and follow up
• Ensure access to source data by authorized parties, in accordance with ICHGCP, and protect confidentiality by limiting unauthorized access
• Ensure that IRB/IEC documentation is adequate and that details of the IRB/IEC composition are on file
Using knowledge of:
• Issues management (e.g., escalation)
• Audit preparation
• Regulatory standards
• Audit documents
• Project monitoring guidelines
• Project investigator supervision requirements
• Develop and update the instructions for use of investigational product
• Initiate shipment of investigational product to site
• Ensure adequacy of investigational product and other supplies at site
• Ensure randomization and emergency codes of investigational product have been maintained
• Ensure proper storage, dispensing, handling, and disposition of investigational product and other supplies
• Reconcile investigational product and other supplies
• Maintain accountability of investigational product
• Retrieve investigational product and calculate subject compliance
• Maintain randomization and emergency codes of investigational product dispensing
Using knowledge of:
• Investigational product (e.g., package insert, report of prior investigations, Investigator's Brochure)
• Investigational product inventory
• Investigational product accountability
• Investigational product storage
• Packaging and labeling
• Product Development
• Supplemental/rescue/comparator product
• Investigational product compliance (e.g., protocol, standard operating procedures, local governance)
• Accountability records
II. Protocol
• Review product development plan
• Identify study objective/design
• Develop the protocol (e.g., inclusion/exclusion criteria, procedures, schedule of events, safety and efficacy parameters)
• Evaluate protocol for scientific soundness
• Evaluate protocol for feasibility
• Evaluate congruence of data collection tools (e.g., case report form (CRF), electronic data capture (EDC) with the study protocol
• Verify the eligibility of potential trial subjects
• Contribute to protocol development
• Coordinate protocol approval process
• Review protocol for feasibility
• Review protocol during Investigator’s meeting
• Execute study per protocol
• Recommend and Implement protocol amendments
Using knowledge of:
• Protocol development
• Protocol submission and approval procedures
• Clinical trial phase
• Study design characteristics (e.g., double‐blind, crossover, randomized)
• Study objective
• Description of procedures
• Amendment submission and approval procedures
• Inclusion/exclusion criteria
• Statistical plan
III. Safety
• Assess safety during trial participation
• Minimize potential risks to subject safety
• Oversee safety risks (e.g., clinical holds, product recalls)
• Ensure adverse events reporting is documented (e.g., serious, severe, moderate, mild, expected, unexpected)
• Ensure reasons for subject discontinuation are documented (i.e., causes,contact efforts)
• Conduct study‐related procedures and monitor the safety of the trial subjects and investigational staff
• Manage and motivate the investigational staff and other disciplines involved,and take measures to minimize any potential risks
• Review common laboratory values and alerts
• Identify expected or unexpected results associated with investigational products
• Maintain follow‐up to determine resolution of adverse event
• Conduct safety monitoring/reporting activities
Using knowledge of:
• Investigator’s Brochure
• Safety monitoring
• Safety and clinical databases
• Subject safety issues (e.g., toxicity, significant lab values)
• Vulnerable subject populations
• Adverse events reporting
• Serious adverse events reporting
• Safety reporting requirements
IV. Trial Management
• Verify investigator/site feasibility
• Develop timelines for conducting and completing the clinical trial
• Prepare and conduct initiation activities
• Ensure appropriate training of the investigational staff
• Develop a recruitment strategy and study management plan
• Follow a recruitment strategy and study management plan
• Review, clarify, and obtain data changes from sites
• Schedule and coordinate pre‐study site visit
• Identify minimum regulatory document requirements for site trial master file (e.g., country‐specific regulatory documents)
• Ensure IRB/IEC review/approval of study and study documents
• Facilitate site budget/contract approval process
• Develop Case Report Forms (e.g., CRFs, eCRFs)
• Develop CRF completion guidelines
• Develop monitoring guidelines/plans
• Develop project tools
• Submit documents to regulatory authorities
• Document and communicate site visit findings
• Ensure clinical trial registry requirements are met
• Ensure timely review of study data (e.g., laboratory results, x‐rays)
• Maintain current vendor credentials (e.g., lab certification/licensure and normal ranges)
• Prepare and conduct interim monitoring visit(s)
• Prepare and conduct close‐out monitoring visit(s)
• Reconcile payments to sites per contract
• Document protocol deviations/violations
• Reconcile safety and clinical databases
• Conduct co‐monitoring/training visits
• Perform remote monitoring activities
• Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g., protocol procedures, EDC)
• Transmit CRFs to data management
• Review CRF queries from data management
• Coordinate study monitoring visits
• Draft study specific tools (e.g., source document, tracking tools)
• Implement corrective actions plans
• Maintain trial master file (e.g., regulatory binder)
• Manage study supplies (e.g., lab kits, case report forms)
• Comply with subject privacy regulations
• Manage study issues
Using knowledge of:Site Activities
• Contract budget negotiations and approval process
• Project feasibility
• Project timelines
• Monitoring guidelines/plan and tools
• Study project tools
• Staff qualifications
• Staff roles and responsibilities
• Data management activities
• Plan for staff oversight
• Investigator qualifications/ site selection (e.g., therapeutic area, education, experience)
• Disposition of unused study‐related materials (e.g., CRF at end of study, destruction of lab kits)
• Equipment and supplies (e.g., x‐ray, computer, lab kits) and storage
• Study management plan (e.g., timelines, data management)
• Communication documentation (e.g., telephone, email)
• Pre‐study site visit
• Investigator's meeting
• Site initiation
• Monitoring visit
• Close‐out visit
• Site monitoring visit log
• Site signature log
• Delegation listing
• Trial master file (e.g., site, sponsor)
• Data management plan
• Data query resolution
• Electronic data (e.g., electronic health records, electronic case report forms)
• Recruitment plans/strategies
• Subject compliance
• Subject visit logistics
• Protection of human subjects
• Subject selection, screening, and recruitment
• Subject retention
• Subject discontinuation
• Subject reimbursement
• Good Clinical Practice
• Regulatory documents
• Record retention
• Subject privacy regulations
• Case Report Form
• Visit reports (e.g., initiation, close‐out)
• Final report
• Progress reports
• Essential documentation, subject related and non‐subject related (e.g., past medical records, lab reports, protocol, IRB approvals)
• Informed consent
• Procedure manuals
• Source documentation
• Protocol deviations
• Indemnification/insurance
• Clinical trial registry
V. Trial Oversight
• Ensure consistency between the sites’ standard operation procedures (SOPs) and the study requirements
• Ensure investigator/site protocol compliance
• Facilitate investigator/site corrective actions
• Oversee vendors {e.g. Contract Research Organizations (CROs)}
• Ensure compliance with electronic data requirements (e.g., electronic health records, eCRF)
• Ensure adequate site management
• Prepare the study site for audits and inspections
• Respond to or facilitate response to audit/inspection findings
• Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation of slides, freezing, refrigeration)
• Ensure proper adverse event reporting by the investigator
• Escalate problems to appropriate in‐house management
• Investigate potential fraud and misconduct
• Report potential fraud and misconduct
• Ensure follow‐up medical care for study subjects is documented, as applicable
• Ensure adequate consent and documentation
• Ensure staff, facility, and equipment availability throughout the study
• Ensure compliance with study requirements and regulations
• Prepare for audits, inspections, and follow up
• Ensure access to source data by authorized parties, in accordance with ICHGCP, and protect confidentiality by limiting unauthorized access
• Ensure that IRB/IEC documentation is adequate and that details of the IRB/IEC composition are on file
Using knowledge of:
• Issues management (e.g., escalation)
• Audit preparation
• Regulatory standards
• Audit documents
• Project monitoring guidelines
• Project investigator supervision requirements
