GS Release Notes v26.2.1

Benefits:

Technology upgrade for quality features and releases.

Features:

This ensures the software is upgraded to latest technology stacks enabling quicker and better feature deliveries.

Benefits:

Features:

Benefits:

Help users to see all files with links, create new links and related replace relationships, and make efficient relationship decisions.

Features:

Ability to choose links for related files and create replace relationships for the files with new destination links.

Benefits:

Help users use the filename as the title without manual edits if chosen on file upload.

Features:

Ability to have same file name and title on upload.

Benefits:

Help users know the validation codes and run reports.

Features:

Ability to run reports and view the codes (The list of codes implemented

as part of this release is below).

• SB-2744: eCTD4-001 - Message must be Well Formed XML based on XML 1.0

• SB-2745: eCTD4-002 - Message must be valid against the ICH specified version of the RPS schema

• SB-2751: eCTD4-003 - Submission Unit identifier is required (1..1)

• SB-2752: eCTD4-004 - Submission Unit id root must be a UUID

• SB-2754: eCTD4-006 - Submission Unit code value is required (1..1)

• SB-2755: eCTD4-007 - Submission Unit must have a valid code value

• SB-2756: eCTD4-008 - Submission Unit Code System value is required (1..1)

• SB-2757: eCTD4-009 - Submission Unit code must have a valid OID for the Code

System value

• SB-2758: eCTD4-010 - The Submission Unit status code requires the code

attribute "active"

• SB-2759: eCTD4-011 - The Submission Unit must have at least one Context of

Use element in the message

• SB-2761: eCTD4-012 - Sequence Number is required (1..1)

• SB-2762: eCTD4-013 - Sequence Number must be a whole number

• SB-2763: eCTD4-014 - Sequence Number for initial submission unit in the

application starts with the value of "1"

• SB-2764: eCTD4-015 - Sequence Number is unique in the application for the

applicant

• SB-2769: eCTD4-018 - Context of Use Priority Number must be a non-negative

real number

• SB-2770: eCTD4-019 - Context of Use Priority Number shall have one and only

one value

• SB-2972: eCTD4-047 - Document title is required

• SB-2977: eCTD4-052 - Keyword definition code is required (1..1)

• SB-2978: eCTD4-053 - Keyword definition code must have a valid value

• SB-2979: eCTD4-054 - Keyword definition value code is required (1..1)

• SB-2985: eCTD4-055 - Keyword definition value code must have a valid value

• SB-3000: eCTD4-056 - Keyword definition value is required (1..1)

• SB-3001: eCTD4-057 - Keyword definition value has one and only one value.item

element

• SB-3005: eCTD4-058 - Keyword definition display name value is required

• SB-3027: eCTD4-065 - File name length is met

• SB-3031: eCTD4-066 - Folder name length is met

• SB-3032: eCTD4-067 - Folder path length is met

• SB-3002: eCTD4-068 - Keyword definition display name value is as previously

submitted

• SB-3033: eCTD4-069 - Unassociated File

• SB-3003: eCTD4-073 - The Keyword Definition for a Study Id and Study Title

(ich_keyword_type_8) must follow the correct format

• SB-7524: eCTD4-078 - Keyword definition must exist and match v3.2.2 value

• SB-7525: eCTD4-083 - Keyword Definition code system is a valid OID

• SB-2746: US-eCTD4-501 - Descriptions should not exceed character limits

• SB-2766: US-eCTD4-503 - Sequence number matches the sequence number

folder name

• SB-2950: US-eCTD4-510 - Application number must contain 6 digits only

• SB-3004: US-eCTD4-515 - Email address is greater than 64 characters

• SB-3019: US-eCTD4-523 - Promotional Material Issue Date Format is incorrect

• SB-3038: US-eCTD4-528 - Folder contains no files or sub folders

• SB-3061: US-eCTD4-538 - Broken bookmark

• SB-3062: US-eCTD4-539 - Corrupt bookmark

• SB-3063: US-eCTD4-540 - Bookmark has non-existent named destination or page

• SB-3064: US-eCTD4-541 - Multiple action bookmark

• SB-3065: US-eCTD4-542 - External bookmark

• SB-3066: US-eCTD4-543 - Inactive bookmark

• SB-3067: US-eCTD4-544 - Non-relative bookmark

• SB-3068: US-eCTD4-545 - Bookmark does not 'Inherit Zoom'

• SB-3072: US-eCTD4-546 - Broken hyperlink

• SB-3073: US-eCTD4-547 - Corrupt link

• SB-3074: US-eCTD4-548 - Link has non-existent named destination or page

• SB-3075: US-eCTD4-549 - Multiple action hyperlink

• SB-3076: US-eCTD4-550 - External hyperlink

• SB-3077: US-eCTD4-551 - Inactive hyperlink

• SB-3078: US-eCTD4-552 - Non-relative hyperlink

• SB-3079: US-eCTD4-553 - Link does not 'Inherit Zoom'

GlobalSubmit Review (browser) Back and forward button not working in all cases (SB-10288, SB-10667): For scenarios where Back and forward button was not working, now the button works as expected and remembers users last location.

GlobalSubmit Review (browser) Links with embedded documents going to wrong

location (SB-11018): Clicking on links with embedded documents now works without any errors.

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