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1. What are the different document types that can be submitted through the CDER DIRECT portal?
62061 views
|37|
|DOCUMENT TYPESFORMS
The following document types are currently availab.. (Read more)

2. How many users can my Organization have?
57985 views
|25|
|ADMINISTRATIONUSERS
There is no limit on how many users an Organizatio.. (Read more)

3. Can I have more than one user from my organization use the portal to submit SPLs?
57614 views
|22|
|USERS
There is no limit on how many users an Organizatio.. (Read more)

4. Can more than one person use a single login at the same time?
57406 views
|17|
|LOGIN
No. CDER DIRECT allows a person to login from only.. (Read more)

5. How can users be added to the Organization?
58008 views
|15|
|ADMINISTRATIONUSERS
Once a user has created an account with CDER DIREC.. (Read more)

6. What is the role of a general user in CDER DIRECT within the organization?
57080 views
|16|
|ADMINISTRATIONUSERS
A general user will have access to the forms/docum.. (Read more)

7. What is the role of an administrator in CDER DIRECT within the organization?
57207 views
|15|
|ADMINISTRATION
An organization Administrator has the ability to .. (Read more)

8. When I created my account with CDER DIRECT for my organization, I did not give myself access to the forms that I need. How can I give my organization access?
57589 views
|38|
|FORMSUSERS
Once the user is logged in as an Administrator, un.. (Read more)

9. What is HL7?
56708 views
|12|
|STANDARDS
Health Level Seven International is one of several.. (Read more)

10. What is an SPL message?
57204 views
|20|
|SPL
The Structured Product Labeling (SPL) is a documen.. (Read more)

11. What is a Root ID in an SPL?
57812 views
|19|
|SPL
The Root ID uniquely identifies a specific Submiss.. (Read more)

12. What is a Set ID in an SPL?
59939 views
|18|
|SPL
The Set ID uniquely identifies a group of versions.. (Read more)

13. How do versions work in an SPL?
56999 views
|14|
|SPL
The version number gives sequential order to the d.. (Read more)

14. How do I transfer admin rights from one user to another?
57437 views
|14|
|ADMINISTRATIONUSERS
Only a user with administrator access can modify t.. (Read more)

15. How do I remove an admin from an organization’s account?
57528 views
|15|
|ADMINISTRATIONUSERS
Only a user with administrator access can remove a.. (Read more)

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What is the role of an administrator in CDER DIRECT within the organization?
57207 views
|15|
An organization Administrator has the ability to 1. create Subaccounts and manage them 2. Change User roles 3. Add or remove form access to the user as well as organization 4. Inactive a user from having access to CDER Direct