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