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Purpose

A CDISC Library account allows a user to access the Data Standards Browser and view the data standards in the CDISC Library.  This Work Instruction details the steps to provision or deactivate a CDISC Library account.

Scope

The CDISC Library Support Technician and Azure Active Directory Administrator will use these Work Instructions to provision or deactivate a CDISC Library account.

Pre-Requisites

Access to the Azure Active Directory B2C Tenant will be required for steps performed by the Azure Active Directory Administrator.

Access to the clib-support-user-analytics.xlsm Excel file on SharePoint.

Definitions

List terms (abbreviations, acronyms, technical jargon) referenced in this Work Instruction useful at adding clarity. Put "Not applicable." if this section is not applicable.

TermDefinition
CDISC Library

The CDISC Library is a web-based solution providing a user with access to CDISC's data standards metadata.  The CDISC Library is accessible though the Data Standards Browser (DSB).

Data Standards Browser (DSB)

A CDISC product that provides an authenticated user with additional value-added tools for interacting with data from the CDISC Library, including interactive menus, search and scoping features, and the ability to filter by various criteria. 

Simply put, a user will use their CDISC Library credentials to visit the DSB and view data standards metadata provided by the CDISC Library.

JiraJira is a software created by Atlassian for tracking bugs and issues.  It is used by the CDISC Library Support Technician ("Support Technician") and the Azure Active Directory Administrator ("Azure Admin") to track CDISC Library accounts.
Azure Active Directory B2C Tenant

A business-to-consumer (B2C) tenant housed on a resource in Microsoft's Azure platform that provides identity management for CDISC Library accounts.  An Azure AD tenant is a specific instance of Azure AD containing accounts and groups. 

Simply put, the Active Directory houses the stored CDISC Library account data, including log-in information, for our users on a segmented chunk of our overall rented storage (or resource) from Azure.  This data is segmented for integrity and security purposes, which is why it requires "switching directories" in Azure to access.

CLIB Users SharePoint FileAn Excel file stored on SharePoint with the latest CDISC Library member information pulled from JIRA.

Roles & Responsibilities

Lists all roles and their responsibilities relevant to this Work Instruction.

RoleResponsibilities
CDISC Member Organization

The requesting CDISC Member Organization with an active CDISC Membership and CDISC.org account uses the Account Request Form to submit a request for a CDISC Library account.

CDISC Library Support Technician

Performs the steps to provision or deactivate a CDISC Library account.

Azure Active Directory Administrator

Accesses the Azure Active Directory B2C Tenant to complete the associated tasks.

CDISC Membership RepresentativeA representative from the CDISC Membership team who is knowledgeable about organization's membership status.
Account AdministratorThis contact will manage the account.
Account UserThe first account user. Additional requests can be made once the account is activated.
Technical ContactThe person to whom CDISC can communicate any technical aspects of the account.

Instructions

Describe each step to be taken to complete the scope of this Work Instruction in the prescribed sequence.  Note:  Use active verbs in the "Instructions" column.

Provisioning a CDISC Library Account

Step #RoleInstructionsNotes
1.0CDISC Library Support Technician

Receives a CDISC Library account creation request, either:

Note:  It is strongly preferred that all requests be submitted through the Account Request Form.  If an informal request is received, the CDISC Library Support Technician should direct the requesting party to the Account Request Form if appropriate.  Exceptions may be granted by CDISC Management.
2.0CDISC Library Support Technician

Reviews the account request to ensure the requestor is from a CDISC Member Organization listed on Our Members.

  • If they are, proceeds to the next step.
  • If the member is a volunteer, obtains approval from the Standards Development team.
  • If not, copies a CDISC Membership Representative for follow-up.

2.1CDISC Library Support Technician

Confirms the CDISC Member Organization will not exceed their account allowance with this request, referenced on the "Account Allowance" tab of the CLIB Users SharePoint file.  If the account will place the Member Organization over the account allowance, the CDISC Library Support Technician advises a CDISC Membership Representative of this, and inquires if the Member Organization would like to purchase an additional account, or remove a current account user.


2.2CDISC Library Support Technician

Determines if the requestor is adequately authorized to request a CDISC Library account. 

  • If this is the CDISC Member Organization's first account, no further approvals are required.
  • If the Account Request Form was submitted by someone other than the Member Organization's existing Account Administrator, approval from the Account Administrator is required.
  • Subsequent accounts should maintain the same IT/Technical Contact and Administrative Contact for all accounts created for a Member Organization, unless otherwise directed.

3.0CDISC Library Support TechnicianInputs the CDISC Library account request into Jira, creating a new customer profile for the CDISC Member Organization if one does not already exist.Note:  Input the member organization's name as shown in the "Company/Organization - Hidden Value" field at the bottom of the automated request, and not "Logged in as Organization," found at the top.
3.1CDISC Library Support TechnicianAdvises the Azure Active Directory Administrator of the Jira ticket.
4.0Azure Active Directory AdministratorProvisions the new account in Azure AD B2C and Azure APIM using the CDISC Library User Account Provisioning instructions.
4.1Azure Active Directory AdministratorAdvises the CDISC Library Support Technician of the account creation.
5.0CDISC Library Support TechnicianCommunicates a Welcome Package to the new Account User, copying applicable Account Administrators.
5.1CDISC Library Support TechnicianNotates the client was notified and that the issue is being resolved on the Jira ticket, and closes the ticket.

Deactivating a CDISC Library Account

Note:  Deactivated accounts on Azure AD B2C are not deleted, but rather, their associated credentials are blocked.

Step #RoleInstructions
1.0CDISC Library Support Technician

Receives a notification to deactivate a CDISC Library account.  

  • If received from a current Member Organization, follow 1.1.
  • If received from CDISC Membership Representative, skip to 2.0.
1.1CDISC Library Support TechnicianReviews the deactivation request to ensure it was sent by the Member Organization's Account Administrator.  If not, obtains approval from the Account Administrator.
2.0CDISC Library Support TechnicianBlocks the userAccount User's access to the cdisc-library-apim  resource on the CDISC.org directory within Azure.
3.0Azure Active Directory AdministratorBlocks the user's access to the Azure Active Directory B2C tenant (this blocks the authentication of the user's credentials).
4.0CDISC Library Support TechnicianUpdates the user's associated Jira ticket with a "deactivated" tag.

General Workflow

Include a general workflow diagram that summarizes this Work Instruction.


Provisioning a CDISC Library Account


Deactivating a CDISC Library Account


References

List references pertinent to this Work Instruction, e.g., COP-001.