지디에프아이 브레인셀연구소

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Data Management

국제법령과 글로벌 임상표준화를 충족하는 GDFI Braincell Laboratory

국제법령(FDA의 CFR Part11 등)과 글로벌 표준화(GCDMP등)를 충족하는 Clinical Data Management 시스템을 도입 운영, 전자 방식의 임상 데이터 수집, 처리 및 관리를 적용하고 있습니다.

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다국가, 다기관, 장기간 소요 임상시험의 보안성, 무결성, 편리성 및 적합성을 유지하여 임상 데이터 신뢰성을 제고할 수 있도록 지원하고 있습니다.

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모든 SAE, AE 약물은 전문약사와 Medical Director에 의한 Cross Checking으로 확인검토 업무를 제공하게 됩니다.

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병용약물 및 질환분류를 위한 Medical Coding(MedDRA, WHOART, ATC Code) Support System을 지원하고 있습니다.

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5-1. Data Coordinator (DC)

  • Providing guidance to Clinical Database Administrator
  • Coordinate, lead and manage all activities from study start-up to study close-out.
  • Create and maintain the study Data management Plan and associated DM documents
  • Communicate project status and recognize possible risks/issues discovered during execution of data management processes to PMs
  • Champion the use and implementation of SOPs, guidelines and standards.
  • Provide input to enhance or update process and procedure.
  • Train and mentor Clinical Data Coordinators, Data Entry and Database Designers.
  • Creation and tracking of DM timelines, relaying study risks/concerns to the Manager, CDM in a timely manner.
  • Monitor DM study budget, relaying risks/concerns to the manager, CDM in a timely manner.
  • Communicate resourcing needs to Manager, CDM.
  • Providing guidance to Clinical Database Administrator
  • Coordinate, lead and manage all activities from study start-up to study close-out.
  • Create and maintain the study Data management Plan and associated DM documents
  • Communicate project status and recognize possible risks/issues discovered during execution of data management processes to PMs
  • Champion the use and implementation of SOPs, guidelines and standards.
  • Provide input to enhance or update process and procedure.
  • Train and mentor Clinical Data Coordinators, Data Entry and Database Designers.
  • Creation and tracking of DM timelines, relaying study risks/concerns to the Manager, CDM in a timely manner.
  • Monitor DM study budget, relaying risks/concerns to the manager, CDM in a timely manner.
  • Communicate resourcing needs to Manager, CDM.
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5-2. Clinical Data Management (CDM)

  • DM-related internal / external (customers) and Communication
  • Develop and maintain all DM-related documents
  • Plan, creation and review of all business processes for DM
  • DB Structure (DBS), DES (Data entry Server) and DVS (Data Validation Specification) Development
  • Medical Review and Create DCF (Data Clarification Form) and management
  • Medical coding (MedDRA, WHOART, ATC Code, etc.) and database review
  • DB quality check / if the paper CRF DBQC report writing and performing
  • SAE Reconciliation progress and results review
  • Blinded Meeting (Violation / Deviation List Report Review and Create)
  • Developed Data Management Plan
  • DM-related internal / external (customers) and Communication
  • Develop and maintain all DM-related documents
  • Plan, creation and review of all business processes for DM
  • DB Structure (DBS), DES (Data entry Server) and DVS (Data Validation Specification) Development
  • Medical Review and Create DCF (Data Clarification Form) and management
  • Medical coding (MedDRA, WHOART, ATC Code, etc.) and database review
  • DB quality check / if the paper CRF DBQC report writing and performing
  • SAE Reconciliation progress and results review
  • Blinded Meeting (Violation / Deviation List Report Review and Create)
  • Developed Data Management Plan
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5-3. Data Base Management (DBM/IT)

  • Web CRF development in consultation
  • Global standards such as GCDMP, CDISC Operations
  • DB development, data and systems management
  • Clinical development of computerized data and security management
  • Clinical management system development and operational improvements
  • Web CRF & PMS development operations
  • Oracle OC / RDC solution operations management
  • IQ, OQ, PQ inspection and Validation
  • When performing DB Lock Data input is complete, SQL & RL / SQL Raw Data extraction and Extraction
  • Server Room and computer system operations management (Oracle System Server room management / IDC management)
  • Web CRF development in consultation
  • Global standards such as GCDMP, CDISC Operations
  • DB development, data and systems management
  • Clinical development of computerized data and security management
  • Clinical management system development and operational improvements
  • Web CRF & PMS development operations
  • Oracle OC / RDC solution operations management
  • IQ, OQ, PQ inspection and Validation
  • When performing DB Lock Data input is complete, SQL & RL / SQL Raw Data extraction and Extraction
  • Server Room and computer system operations management (Oracle System Server room management / IDC management)
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