CDISC 资源库使用链接的数据和一个 REST API 以便向自动化标准为本流程的软件应用交付 CDISC 标准元数据。 CDISC 资源库提供各标准之间的新关系,并大幅度增加了版本化 CDISC 标准和受控术语包的数量。

CDISC 资源库是 CDISC 标准的单个、可靠和具权威的资源,并代表一种创建、操作和发表元数据的新方法。


其他效益包括:


CDISC Library - Benefits

下列为可用的 CDISC 标准和术语。 此页面将定期更新以反映新发布内容。

CDASH/CDASHIG

  • CDASH Model v1.0, v1.1, v1.2
  • CDASHIG v2.0, v2.1, v2.2
  • CDASH v1.1/CDASHUG v1.0

SDTM

  • SDTM v1.2, v1.3, v1.4, v1.5, v1.6, v1.7, v1.8, v2.0

SDTMIG

  • SDTMIG v3.1.2, v3.1.3, v3.2, v3.3, v3.4
  • SDTMIG-AP v1.0
  • SDTMIG-MD v1.0, v1.1
  • SDTMIG-PGx v1.0

SENDIG

  • SENDIG v3.0, v3.1, 3.1.1
  • SENDIG-DART v1.1
  • SENDIG-AR v1.0

ADaMIG

  • ADaMIG v1.0, v1.1, v1.2, v1.3
  • ADaM ADAE v1.0
  • ADaM BDS for TTE v1.0
  • ADaM OCCDS v1.0, v1.1
  • ADaMIG NCA v1.0
  • ADaMIG MD v1.0

QRS

  • Functional Test
    • SIX MINUTE WALK v1.0
  • Questionnaire
    • CGI v2.1
    • PGI v1.1

Controlled Terminology

  • P19 (2014-09-26) to P49 (2022-03-25): 31 quarters

CDISC Library is available to all employees of our Member Organizations as a benefit of membership.


If you work for a CDISC Member Organization, CREATE AN ACCOUNT* using your organization email address to begin using Library.


*A CDISC Library account is different from an account on the CDISC website.


If you have never logged into CDISC Library or are unsure, please use the Sign up now link on the login page.


If you are interested in using the Library API, please continue to sign up for CDISC Library. Instructions for API access will be sent to you within a few hours of sign up.


If you have an existing CDISC Library account and are receiving a notice to contact CDISC Membership, please confirm your organization is CDISC Member on our Membership page. Once confirmed, please log out of CDISC Library and then log back in to see if your access is updated. If you continue to receive a notice to contact CDISC Membership,  please reach out to our Membership Team via the Contact us form. 


What are the URLs for CDISC Library?

You can access the following sites via the links provided and add them to your bookmarks:

 

How many CDISC Library accounts is each member organization allowed?

CDISC Library is available to all employees of our Member Organizations.

How do I access the CDISC Library data standards browser?

You can access the data standards browser with your existing CDISC Library credentials here https://library.cdisc.org/browser.

Can I use my CDISC WIKI or CDISC website credentials to access the CDISC Library?

No. You must create a CDISC Library account.

I have a CDISC Library account. Where can I find how-to articles to get started?
What is available in the CDISC Library?

A product catalog is posted on https://www.cdisc.org/cdisc-library#cdisc__library__content

CDISC Library API customers can obtain a product catalog electronically by submitting /mdr/products.

Does metadata in CDISC Library match those in the publications? Does it contain corrections?

CDISC requires metadata in CDISC Library to match what is originally published. CDISC uses automated tools to take the metadata from the specifications in the publications and put it into CDISC Library. The CDISC Library Release Notes describe where there are exceptions and/or limitations. CDISC is working to ensure that known issues in the published standards are addressed.

Which part of a published standard is available in CDISC Library?

CDISC Library contains highly structured content such as domain specification tables from the SDTM, SENDIGs and SDTMIGs, metadata tables from CDASH and CDASHIG, data structure variables from ADaMIGs, and Controlled Terminology quarterly publications.

Why does this query fail /mdr/sdtm/1.6?

CDISC Library uses dashes for version. There is no v or V. /mdr/sdtm/1-6 is the correct query construct.

Why does this query fail /mdr/sdtmig/3-2/classes/?

The trailing forward slash is extra, which causes the error. /mdr/sdtmig/3-2/classes is the correct query construct.

Why does this query fail /mdr/SDTM/3-3?

Path parameters are case sensitive. /mdr/sdtm/3-3 is the correct query construct.

What information can I use to help diagnose a failed query?

An HTTP status code is always returned after the server finished processing a request. CDISC Library API generally follows HTTP/1.1's guidelines for status code. For example, 200 indicates a successful request. When a query is not successful, with status code in the 4xx and 5xx series, a message will appear in the response body. For example, when requesting a fictitious version of SDTMIG, sdtmig-5-0:

HTTP/1.1 404
status: 404
Date: Wed, 29 May 2019 23:46:19 GMT
Content-Type: application/json
{
   "message": "Service resource error.",
   "detail": "Requested resource [http://library.cdisc.org/sdtmig-5-0/Product] does not exist."
}

For a list of supported HTTP status codes, visit https://wiki.cdisc.org/display/LIBSUPRT/HTTP+Status+Codes.

Are there additional technical resources available?

Release Notes are accessible here: https://wiki.cdisc.org/display/LIBSUPRT/Release+Notes. Additionally, CDISC continues to expand the knowledge base in the CDISC WIKI here: https://wiki.cdisc.org/display/LIBSUPRT/How-to+articles.

Is there documentation for CDISC Library API?

Yes. Visit the API Documentation on the CDISC website, at https://www.cdisc.org/cdisc-library/api-documentation.


CDISC Library Benefits Summary


Membership License Maximum Allocated Bandwidth (Per Organization) Maximum # of Accounts (Per Organization)
Platinum Member 2 GB/month 3
Platinum Commercial 3 GB/month 4
Gold Member 1.5 GB/month 2
Gold Commercial 2.5 GB/month 3

Account Bundle Options

If your organization would like to obtain additional CDISC Library accounts, please review the options below and email CDISC Library Support for additional details.

Bundle Option Bundle Cost* Bandwidth Allocation % (per bundle)**
10 accounts $2,500/year 4 GB/month
20 accounts $3,500/year 8 GB/month
30 accounts $5,000/year 20 GB/month

*The cost of account bundles is on-top of existing CDISC membership benefits. It will be invoiced accordingly based on bundling option selected. CDISC Library accounts will not be created until invoice is paid in full by the requesting organization.

**Exceeding bandwidth allocation can result in overage fees.



Upgrades & Overage Fees
Additional Account Cost per Year (Per Organization)* Bandwidth Overage Fee per Month (Per Organization)**
$300/account $1.00/GB

*Additional accounts are billed at time of membership fee dues.

**Overage fees incurred per given calendar month beyond existing benefit limits. Bandwidth overage fees are billed on a monthly basis.


The following form is for inquiries about CDISC Library. For other questions related to CDISC, please use the CDISC Contact page.
 

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