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课程大纲
   
 
  • 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

 

 

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