Watch-Standards
Watch-Standards
ICH, CDISC, OHDSI 문서를 표준과 컨소시엄 축으로 따로 정리합니다.
Sources
출처 요약
CDISC · 36
ICH · 9
OHDSI · 6
Topics and years
주제 / 연도 요약
Submission Standards · 35
Methods / Network · 5
OMOP / Data Model · 5
Clinical Trials / GCP · 3
RWE Strategy · 3
Unknown · 44
Current · 7
Filter
Structured table
논문 표
| 국가 | 저널 / 출처 | 주제 | 연도 | 제목 | 설명 | 링크 |
|---|---|---|---|---|---|---|
| Global | OHDSI | Methods / Network | Current | OHDSI Home | 커뮤니티 발표, 오픈소스 도구, 네트워크 업데이트를 따라가기 위한 OHDSI 메인 페이지입니다. | 원문 |
| Global | OHDSI | OMOP / Data Model | Current | OHDSI Data Standardization | OMOP CDM과 표준화 전략을 따라가기 위한 OHDSI의 핵심 페이지입니다. | 원문 |
| Global | ICH | Clinical Trials / GCP | Current | Search the Index of ICH Guidelines | ICH 가이드라인 전체를 검색하고 현재 어떤 문서가 어떤 카테고리에 있는지 확인하는 기본 허브입니다. | 원문 |
| Global | ICH | RWE Strategy | Current | ICH Multidisciplinary Guidelines | M 계열 문서와 함께 RWD/RWE, 전자자료, 혁신적 평가 주제가 모일 가능성이 높은 ICH 허브입니다. | 원문 |
| Global | ICH | Clinical Trials / GCP | Current | ICH Efficacy Guidelines | 임상시험 설계와 평가 관련 ICH E 계열 가이드라인을 추적하는 허브입니다. | 원문 |
| Global | CDISC | Submission Standards | Current | CDISC Standards | CDISC 표준 전반을 보는 기본 허브로, SDTM, ADaM, Define-XML 등 제출 표준의 출발점입니다. | 원문 |
| Global | CDISC | RWE Strategy | Current | CDISC Real-World Data | CDISC가 RWD와 observational studies를 어떤 표준 언어로 연결하는지 추적할 수 있는 허브입니다. | 원문 |
| Global | OHDSI | OMOP / Data Model | Unknown | ↓ Skip to Main Content Who We Are Mission, Vision & Values Areas of Focus Who We Serve Collaborators Titan Awards Regional Chapters Website Privacy Policy Notice Updates & News Community News & Update | ↓ Skip to Main Content Who We Are Mission, Vision & Values Areas of Focus Who We Serve Collaborators Titan Awards Regional Chap... | 원문 |
| Global | OHDSI | OMOP / Data Model | Unknown | Website Privacy Policy Notice | Home › Website Privacy Policy Notice Website Privacy Policy Notice This privacy policy notice discloses the privacy practices f... | 원문 |
| Global | OHDSI | RWE Strategy | Unknown | Updates & News | Home › OHDSI News and Updates OHDSI News and Updates Feb. 10 Update: MS Teams, Email Access Restored We are pleased to share th... | 원문 |
| Global | OHDSI | Methods / Network | Unknown | Home › Subscribe To Our Newsletter Subscribe To Our Newsletter Subscribe * indicates required Email Address * First Name Last Name | Home › Subscribe To Our Newsletter Subscribe To Our Newsletter Subscribe * indicates required Email Address * First Name Last Name | 원문 |
| Global | ICH | Methods / Network | Unknown | Skip to main content Log in Primary tabs ••• Log in Reset your password Primary tabs ••• Log in Reset your password Username Password | Skip to main content Log in Primary tabs ••• Log in Reset your password Primary tabs ••• Log in Reset your password Username Pa... | 원문 |
| Global | ICH | Clinical Trials / GCP | Unknown | Safety Guidelines | Main Content Widgets Content Widget Text ICH has produced a comprehensive set of safety Guidelines to uncover potential risks l... | 원문 |
| Global | ICH | Methods / Network | Unknown | Reset your password | Username or email address Password reset instructions will be sent to your registered email address. User login Username Passwo... | 원문 |
| Global | ICH | Methods / Network | Unknown | Quality Guidelines | Main Content Widgets Content Widget Text Harmonisation achievements in the Quality area include pivotal milestones such as the... | 원문 |
| Global | ICH | Submission Standards | Unknown | Multidisciplinary Guidelines | Main Content Widgets Content Widget Text Those are the cross-cutting topics which do not fit uniquely into one of the Quality,... | 원문 |
| Global | ICH | Submission Standards | Unknown | Main Content Widgets Layout 25-75 Content Left Widgets Images Files The CTD Triangle Content Right Widgets Title M4 : The Common Technical Document Text The agreement to assemble all the Quality, Safe | Main Content Widgets Layout 25-75 Content Left Widgets Images Files The CTD Triangle Content Right Widgets Title M4 : The Commo... | 원문 |
| Global | CDISC | Submission Standards | Unknown | cdiscID Help | CDISC is pleased to announce the launch of cdiscID, which allows Single Sign-On to our website, CDISC Library, and the CDISC Le... | 원문 |
| Global | CDISC | Submission Standards | Unknown | What are CDISC Foundational Standards? CDISC Foundational Standards are the basis of the complete suite of standards, supporting clinical and non-clinical research processes from end to end. Foundatio | What are CDISC Foundational Standards? CDISC Foundational Standards are the basis of the complete suite of standards, supportin... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Volunteering at CDISC | Benefits of Volunteering CDISC harnesses the vision and insights of each volunteer to define a focused approach for capturing a... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Therapeutic Areas | Therapeutic Area User Guides (TAUGs) extend the Foundational Standards to represent data that pertains to specific disease area... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Terminology | CDISC Terminology is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within the... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Real World Data | Overview FHIR-CDISC Observational Studies Guide BRIDG Real world data (RWD) plays an increasingly important role in clinical re... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Questionnaires, Ratings & Scales | Description QRS Supplements New QRS Supplements FAQ QRS Resources CDISC develops SDTMIG (tabulation) and ADaMIG (analysis) QRS... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Published User Guides | Therapeutic Area User Guides (TAUGs) extend the Foundational Standards to represent data that pertains to specific disease area... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Overview What is the USDM Participate Webinars Versions and Conformance Rules Education FAQ Call for Nominations - CDISC USDM Governance Group Contact Us Welcome to Digital Data Flow (DDF) for Clinica | Overview What is the USDM Participate Webinars Versions and Conformance Rules Education FAQ Call for Nominations - CDISC USDM G... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Non Standard Variables | NSVs Fragments The Non-Standard Variables (NSV) Registry serves as a reference for using or creating non-standard variables to... | 원문 |
| Global | CDISC | Submission Standards | Unknown | News and Media Webinar Recap: Accelerating Medical Device Trials with Data Harmonization New Study Demonstrates Strong Alignment Between CDISC Standards and Alzheimer’s Disease Research Data, Highligh | News and Media Webinar Recap: Accelerating Medical Device Trials with Data Harmonization New Study Demonstrates Strong Alignmen... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Mission & Roadmap | Strategy and Roadmap 2024 Webinars on Strategic Plan & Roadmap In the ever-evolving and complex clinical research landscape, CD... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Medical Devices | Description Versions Education Knowledge Base The Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-... | 원문 |
| Global | CDISC | Submission Standards | Unknown | ICH Controlled Terminology | This page provides access to the official ICH-controlled terminologies developed to support ICH technical specifications and gu... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Guiding Principles | " Guiding Principles " describe a broad philosophy of beliefs and values to direct an organization's operations, goals and stra... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Global Regulatory Requirements | Required by the world’s leading regulatory authorities , CDISC plays a critical role in streamlining the drug development and r... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Get Involved | CDISC Membership: CDISC convenes a global community of research experts, each representing a diverse range of experiences and b... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Foundational | CDISC Foundational Standards are the basis of a complete suite of data standards, enhancing the quality, efficiency and cost ef... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Description Versions TIG Submission Pilot In-progress Tobacco industry experts are invited to adopt TIG v1.0 standards within their organizations as part of a pilot project with CDISC resources to sup | Description Versions TIG Submission Pilot In-progress Tobacco industry experts are invited to adopt TIG v1.0 standards within t... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Description Versions Knowledge Base Public Review Archive Primer Guiding Principles Where the SDTM provides a standard model for organizing and formatting data for human and animal studies, the SDTMIG | Description Versions Knowledge Base Public Review Archive Primer Guiding Principles Where the SDTM provides a standard model fo... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Description Versions Knowledge Base Public Review Archive Primer Guiding Principles SEND is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present | Description Versions Knowledge Base Public Review Archive Primer Guiding Principles SEND is an implementation of the SDTM stand... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Description Versions Education Knowledge Base Public Review Archive Primer Guiding Principles SDTM provides a standard for organizing and formatting data to streamline processes in collection, managem | Description Versions Education Knowledge Base Public Review Archive Primer Guiding Principles SDTM provides a standard for orga... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Description Versions Education Knowledge Base Archive Primer Guiding Principles CDASH establishes a standard way to collect data consistently across studies and sponsors so that data collection format | Description Versions Education Knowledge Base Archive Primer Guiding Principles CDASH establishes a standard way to collect dat... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Description Versions Education Knowledge Base Archive ODM is a vendor-neutral, platform-independent format for exchanging and archiving clinical and translational research data, along with their assoc | Description Versions Education Knowledge Base Archive ODM is a vendor-neutral, platform-independent format for exchanging and a... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Description Versions Education Knowledge Base Archive Guiding Principles Define-XML transmits metadata that describes any tabular dataset structure. When used with the CDISC Foundational Standards, it | Description Versions Education Knowledge Base Archive Guiding Principles Define-XML transmits metadata that describes any tabul... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Description Versions Education Knowledge Base Archive Guiding Principles ADaM defines dataset and metadata standards that support: efficient generation, replication, and review of clinical trial stati | Description Versions Education Knowledge Base Archive Guiding Principles ADaM defines dataset and metadata standards that suppo... | 원문 |
| Global | CDISC | OMOP / Data Model | Unknown | Description Knowledge Base Archive Access Glossary v20.0 Here The Glossary effort was launched in 2002 to support other CDISC standards by clarifying and disambiguating key concepts in clinical resear | Description Knowledge Base Archive Access Glossary v20.0 Here The Glossary effort was launched in 2002 to support other CDISC s... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Dataset-JSON | Description Versions Archive Dataset-JSON is a data exchange standard for sharing tabular data using JSON. It is designed to me... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Data Exchange | Data Exchange Standards facilitate the sharing of structured data across different information systems. Data Exchange Standards... | 원문 |
| Global | CDISC | Submission Standards | Unknown | CDISC Primer | Image Welcome to CDISC Primer! The CDISC Primer brings together a series of short, animated videos as well as helpful links to... | 원문 |
| Global | CDISC | Submission Standards | Unknown | CDISC History | Partner with CDISC as we transform the next 25 years. We invite you to be a part of our next chapter. Support our mission, beco... | 원문 |
| Global | CDISC | OMOP / Data Model | Unknown | CDISC Controlled Terminology | Description Education Knowledge Base Public Review CDISC, in collaboration with the National Cancer Institute's Enterprise Voca... | 원문 |
| Global | CDISC | Submission Standards | Unknown | By Disease Area | Therapeutic Area User Guides (TAUGs) extend the Foundational Standards to represent data that pertains to specific disease area... | 원문 |
| Global | CDISC | Submission Standards | Unknown | Analysis Results | Description Versions Education Large trials generate many analysis results in the form of tables, figures, and written reports,... | 원문 |