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