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課程介紹： 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: 課程大綱： ??????? 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