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CRC认证培训
课程介绍：
Certified Clinical Research Coordinators (CCRCs) 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 Certified Clinical Research Coordinator (CCRC®) 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
• 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
• Prepare investigational product according to the protocol
• Dispense investigational product according to the protocol
• Retrieve investigational product and calculate subject compliance
• Maintain randomization and emergency codes of investigational product dispensing
• Prepare emergency use report
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
• Supplemental/rescue/comparator product
• Investigational product compliance (e.g., protocol, standard operating procedures, local governance)
• Accountability records
II. Protocol
• 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)
• Report required adverse events to regulatory authorities and/or IRB/IEC
• 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)
• Handle medical monitor oversight
• 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
• Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit progress reports to the IRB/IEC per requirements
• Review common laboratory values and alerts
• Determine and document the causality of adverse events
• Identify expected or unexpected results associated with investigational products
• Implement Investigator’s plan of action for management of adverse event (e.g., stop investigational product; call, retest, treat subject)
• Maintain follow‐up to determine resolution of adverse event
• Report serious adverse event to Sponsor/CRO and IRB/IEC
• Classify adverse events (i.e., serious, severe, moderate, mild, expected, unexpected)
• Record adverse event and relevant information on source document
• Document reasons for subject discontinuation (i.e., causes, contact efforts)
• Document follow‐up medical care for study subjects, as applicable
• Conduct safety monitoring/reporting activities
• Initiate un‐blinding procedures
Using knowledge of:
• Investigator’s Brochure
• Safety monitoring
• Safety and clinical databases
• Subject safety issues (e.g., toxicity, significant lab values)
• 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
• 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
• 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 close‐out monitoring visit(s)
• Prepare study summary and/or close‐out letter for IRB/IEC
• Document protocol deviations/violations
• Evaluate study for feasibility
• Schedule subjects
• Obtain informed consent and screen trial subjects
• Prepare study documents for IRB/IEC and/or sponsor review/approval
• Prepare study documentation (e.g., schedule of events, description of procedures)
• Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g., protocol procedures, EDC)
• Select the investigational staff and assign roles and responsibilities
• Develop a recruitment strategy and site study management plan
• Transmit CRFs to Data Management
• Review CRF queries from Data Management
• Coordinate study monitoring visits
• Select and manage local vendors (e.g., laboratory, x‐ray, MRI)
• Draft study specific tools (e.g., source document, tracking tools)
• Obtain, negotiate, and seek approval of study budgets and clinical trial agreement
• Conduct subject visits according to requirements
• Implement corrective actions plans
• Maintain trial master file (e.g., regulatory binder)
• Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO
• Maintain standards for handling hazardous goods (e.g., IATA)
• Manage study supplies (e.g., lab kits, case report forms)
• Maintain equipment (e.g., calibration and preventive maintenance)
• Manage study record retention and availability
• Manage financial agreements
• Comply with subject privacy regulations
• Prescreen telephone calls for eligibility requirements
• Maintain subject screening/enrollment log
• Collect, record, and report accurate and verifiable data
• Manage study issues
Using knowledge of:Site Activities
• Contract budget negotiations and approval process
• Monitoring guidelines/plan and tools
• 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
• 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)
• Regulatory documents
• Record retention
• Visit reports (e.g., initiation, close‐out)
• Final report
• Progress reports
Protocol Compliance
• Project feasibility
• Study project tools
• Sample collection, shipment, and storage
• Study management plan (e.g., timelines, data management)
• Good Clinical Practice
• Procedure manuals
• Protocol deviations
Subject Scheduling, Screening, Recruitment, and Retention
• Project timelines
• Recruitment plan/strategies
• Subject compliance
• Subject visit logistics
• Subject selection, screening, and recruitment
• Subject retention
• Subject discontinuation
• Clinical trial registry
PI Oversight/Qualifications
• Staff qualifications
• Staff roles and responsibilities
• Plan for staff oversight
• Investigator qualifications/site selection (e.g., therapeutic area, education, experience)
• Plan for ancillary staff education
CRF/Source Documents
• Data management activities
• Communication documentation (e.g., telephone, email)
• Data management plan
• Data query resolution
• Electronic data (e.g., electronic health records, electronic case report forms)
• Case Report Form
• Essential documentation, subject related and non‐subject related (e.g., past medical records, lab reports, protocol, IRB approvals)
• Source documentation
Consent/Assent
• Vulnerable subject populations
• Communication with subjects
• Protection of human subjects
• Subject reimbursement
• Subject privacy regulations
• Informed consent
• Indemnification/insurance
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
• 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 ICH‐GCP, 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
• 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
• Prepare investigational product according to the protocol
• Dispense investigational product according to the protocol
• Retrieve investigational product and calculate subject compliance
• Maintain randomization and emergency codes of investigational product dispensing
• Prepare emergency use report
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
• Supplemental/rescue/comparator product
• Investigational product compliance (e.g., protocol, standard operating procedures, local governance)
• Accountability records
II. Protocol
• 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)
• Report required adverse events to regulatory authorities and/or IRB/IEC
• 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)
• Handle medical monitor oversight
• 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
• Inform the sponsor and IRB/IEC of any changes to the protocol or safety concerns and submit progress reports to the IRB/IEC per requirements
• Review common laboratory values and alerts
• Determine and document the causality of adverse events
• Identify expected or unexpected results associated with investigational products
• Implement Investigator’s plan of action for management of adverse event (e.g., stop investigational product; call, retest, treat subject)
• Maintain follow‐up to determine resolution of adverse event
• Report serious adverse event to Sponsor/CRO and IRB/IEC
• Classify adverse events (i.e., serious, severe, moderate, mild, expected, unexpected)
• Record adverse event and relevant information on source document
• Document reasons for subject discontinuation (i.e., causes, contact efforts)
• Document follow‐up medical care for study subjects, as applicable
• Conduct safety monitoring/reporting activities
• Initiate un‐blinding procedures
Using knowledge of:
• Investigator’s Brochure
• Safety monitoring
• Safety and clinical databases
• Subject safety issues (e.g., toxicity, significant lab values)
• 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
• 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
• 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 close‐out monitoring visit(s)
• Prepare study summary and/or close‐out letter for IRB/IEC
• Document protocol deviations/violations
• Evaluate study for feasibility
• Schedule subjects
• Obtain informed consent and screen trial subjects
• Prepare study documents for IRB/IEC and/or sponsor review/approval
• Prepare study documentation (e.g., schedule of events, description of procedures)
• Train site personnel on Sponsor/CRO and regulatory requirements for study conduct (e.g., protocol procedures, EDC)
• Select the investigational staff and assign roles and responsibilities
• Develop a recruitment strategy and site study management plan
• Transmit CRFs to Data Management
• Review CRF queries from Data Management
• Coordinate study monitoring visits
• Select and manage local vendors (e.g., laboratory, x‐ray, MRI)
• Draft study specific tools (e.g., source document, tracking tools)
• Obtain, negotiate, and seek approval of study budgets and clinical trial agreement
• Conduct subject visits according to requirements
• Implement corrective actions plans
• Maintain trial master file (e.g., regulatory binder)
• Communicate laboratory/diagnostic results with Principal Investigator and Sponsor/CRO
• Maintain standards for handling hazardous goods (e.g., IATA)
• Manage study supplies (e.g., lab kits, case report forms)
• Maintain equipment (e.g., calibration and preventive maintenance)
• Manage study record retention and availability
• Manage financial agreements
• Comply with subject privacy regulations
• Prescreen telephone calls for eligibility requirements
• Maintain subject screening/enrollment log
• Collect, record, and report accurate and verifiable data
• Manage study issues
Using knowledge of:Site Activities
• Contract budget negotiations and approval process
• Monitoring guidelines/plan and tools
• 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
• 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)
• Regulatory documents
• Record retention
• Visit reports (e.g., initiation, close‐out)
• Final report
• Progress reports
Protocol Compliance
• Project feasibility
• Study project tools
• Sample collection, shipment, and storage
• Study management plan (e.g., timelines, data management)
• Good Clinical Practice
• Procedure manuals
• Protocol deviations
Subject Scheduling, Screening, Recruitment, and Retention
• Project timelines
• Recruitment plan/strategies
• Subject compliance
• Subject visit logistics
• Subject selection, screening, and recruitment
• Subject retention
• Subject discontinuation
• Clinical trial registry
PI Oversight/Qualifications
• Staff qualifications
• Staff roles and responsibilities
• Plan for staff oversight
• Investigator qualifications/site selection (e.g., therapeutic area, education, experience)
• Plan for ancillary staff education
CRF/Source Documents
• Data management activities
• Communication documentation (e.g., telephone, email)
• Data management plan
• Data query resolution
• Electronic data (e.g., electronic health records, electronic case report forms)
• Case Report Form
• Essential documentation, subject related and non‐subject related (e.g., past medical records, lab reports, protocol, IRB approvals)
• Source documentation
Consent/Assent
• Vulnerable subject populations
• Communication with subjects
• Protection of human subjects
• Subject reimbursement
• Subject privacy regulations
• Informed consent
• Indemnification/insurance
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
• 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 ICH‐GCP, 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
