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)

传统的面对面授课方式。

 

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