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課程介紹： 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: 課程大綱： ??????? 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