## A1. Creating a new application and submission

1AFDC5FC-36E6-927-D73D-ED241369468 -- Original Submission Unit
(Sequence) applies to:

2BFDC5FC-36E6-927-D73D-ED241369469 -- Original Submission applies to

989898 - Application

## B1. Adding new files to a submission

The following files were submitted: 356h Form, Introduction, Study
report body, Protocol, Legacy Study Report

The following keywords was submitted: StudyID: 991245 and Study Title:
Super Duper Double blind

## B8. Adding one file to multiple logical documents 

Protocol is related to keyword: StudyID: 991245 and Study Title: Super
Duper Double blind and keyword: StudyID 554126 and Study Title: Wonder
Randomization

![](media/image1.png){width="5.042361111111111in"
height="3.7284722222222224in"}

# A2. Providing additional submission units to an existing submission

ABB7ABA1-837C-43a8-ADFD-9D1847F39F87 -- amendment is applies to:

2BFDC5FC-36E6-927-D73D-ED241369469 -- Original Submission applies to

989898 - Application

# B2. Replacing a previously submitted file

Note: Replacing is the same regardless if the file is an addendum (B6),
or from another application (B12) or has multiple keywords associated to
it (b13)

Study report body replaces documentation in original submission

# B3. Removing a previously submitted file

The introduction file has been made obsolete

# B4. Replacing one file with multiple files

Legacy study report in original submission unit is replaced by both the
protocol and synopsis documentation

# B5. Adding an addendum to a file

The protocol has an addendum.

![](media/image2.png){width="5.072222222222222in"
height="3.1868055555555554in"}

![](media/image3.png){width="4.969444444444444in"
height="3.4902777777777776in"}

# A3. Creating a new submission to an application

50C25432-95AF-4fe7-AAA2-A0CECB8FAC50-- Efficacy Supplement Unit
(Sequence) applies to:

CA9FBD9B-0E6F-4572-BC6C-4D8867F5BA7E -- Efficacy Supplement applies to

989898 - Application

![](media/image4.png){width="5.186805555555556in" height="1.6875in"}

356H form and Introduction document was added

# A4. Modular Reviews

Currently GS Review can not have the extra hierarchy for Module Review
(Rolling Review)

# A5. Submitting one submission unit to multiple applications

Note: Submitting a submission unit to multiple submissions (A6) is the
same as submitting a submission unit to multiple applications. Note: GS
Review currently cannot process between applications.

189169D2-C12D-44a1-9398-E462E7A75584-- amendment (Sequence) applies to
both:

CA9FBD9B-0E6F-4572-BC6C-4D8867F5BA7E -- Efficacy Supplement and

2BFDC5FC-36E6-927-D73D-ED241369469 -- Original Submission applies to

989898 - Application

![](media/image5.png){width="5.156944444444444in"
height="2.3541666666666665in"}

# A7. Withdrawing a submission unit

Currently GS Review does not show a submission unit that has been
withdrawn -- we need more guidance from our clients.

# A8. Withdrawing a submission

Currently GS Review does not show a submission has been withdrawn -- we
need more guidance from our clients.

# B7. Replacing a file and an addendum

Note: This is the same as storyboard B14 -- replacing multiple files
with one file

The protocol document replaced the original protocol and the protocol
amendment

# B9. Adding files that were previously removed

Introduction was withdrawn then reactivated

# B10. Changing the category of a submitted file reference

An introduction document was added to introduction and was later
re-categorized as a quality overall summary introduction

![](media/image6.png){width="5.093055555555556in"
height="4.854861111111111in"}

79BA7731-81F1-47ea-A2CE-326C122C4D97 -- amendment is applies to:

2BFDC5FC-36E6-927-D73D-ED241369469 -- Original Submission applies to

989898 - Application

# B15. Replacing sections of a file

There is not real world case for this storyboard. This storyboard would
go in effect when we are in a XML authoring environment and you can
replace sections of a file. The coding in RPS word exactly like a
replace but have and update code instead of a replace code.

# B11. Referencing files from other applications

Same as referencing files within one application

# B12. Replacing files referenced from other applications

Not different from B2. Replacing a previously submitted file

# B13. Replacing one file referenced in multiple logical documents 

Not different from B2. Replacing a previously submitted file

# B14. Replacing multiple files with one file

Not different from B7. Replacing a file and an addendum