Oracle Life Scrience

Oracle® Life Sciences InForm CRF
Submit
User Guide for Sponsors
Release 7.0.1.4
F92947-04
June 2024
Oracle Life Sciences InForm CRF Submit User Guide for Sponsors, Release 7.0.1.4
F92947-04
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Contents
Preface
Documentation accessibility vi
Related resources vi
Access to Oracle Support vi
Additional copyright information vi
1 For new users

About Oracle InForm CRF Submit 1-1
Access Oracle InForm CRF Submit to generate an archive or history report 1-1
Archive types and the files and subject data included 1-2
History report details 1-4
Subscribe to release announcements 1-5
What data is migrated across data centers? 1-5
2 Create an archive
Start with a Test Run 2-1
Submission PDF 2-2
Archival PDF 2-5
Blank Forms Only 2-9
Custom PDF 2-11
Custom Blank Forms 2-17
Download the PDF output for an archive 2-20
Create a custom template 2-21
Create a PDF archive from a template 2-21
PDF output options 2-22
How can I handle blank forms? 2-22
About Electronic Trial Master File (eTMF) 2-23
Can I generate archives and history report headers in Japanese? 2-24
How does the Include data as of date and time option affect the output? 2-24
How do I define the Export Selection Criteria? 2-25
How do I enter a large number of subjects? 2-25
Can I save a request? 2-26
iii
What do rights groups do? 2-26
How do I prevent hidden Oracle InForm data from appearing? 2-26
What PDF format is applied to PDF output? 2-27
Why should I create a custom template? 2-27
Can I create a ZIP file even if Oracle InForm CRF Submit encounters errors? 2-27
Transferred subject data 2-28
Are subject data transfers supported? 2-28
Where is subject transfer history included? 2-28
3 Create a history report

Audit Trail Report 3-1
User Assignment History report 3-4
Download a history report 3-7
4 Create other reports

Site Confirmation report 4-1
Download Log report 4-1
Not Yet Downloaded report 4-2
5 Manage archives and history reports

Display the options and settings 5-1
View request processing details 5-1
Resubmit a failed request 5-2
Delete an archive or report 5-2
Monitor request notices 5-3
Check how much storage has been used 5-4
Archives and reports shared by sponsors 5-4
Can I list the archives and reports shared with sites? 5-4
Is there a record of affidavits used to sign off on Oracle InForm data? 5-5
6 For administrators
Manage Trial and Sponsor Settings 6-1
Specify Trial Settings 6-1
Specify Sponsor Settings 6-2
Email notifications 6-2
About email notifications 6-2
Configure email notifications 6-5
Rights management 6-6
iv
Archival rights and descriptions 6-6
Where are rights controlled? 6-8
7 Revision History
v
Preface
Preface
This preface contains the following sections:
• Documentation accessibility
• Related resources
• Access to Oracle Support
• Additional copyright information
Documentation accessibility
For information about Oracle's commitment to accessibility, visit the Oracle Accessibility
Program website at http://www.oracle.com/pls/topic/lookup?ctx=acc&id=docacc.
Related resources
All documentation and other supporting materials are available on the Oracle Help Center.
Access to Oracle Support

Oracle customers that have purchased support have access to electronic support through
Support Cloud.
Contact our Oracle Customer Support Services team by logging requests in one of the
following locations:
• English interface Customer Support Portal (https://hsgbu.custhelp.com/)
• Japanese interface Customer Support Portal (https://hsgbu-jp.custhelp.com/)
You can also call our 24x7 help desk. For information, visit https://www.oracle.com/life-
sciences/support/ or visit http://www.oracle.com/pls/topic/lookup?ctx=acc&id=trs if you are
hearing impaired.
Additional copyright information

This documentation may include references to materials, offerings, or products that were
previously offered by Phase Forward Inc. Certain materials, offerings, services, or products
may no longer be offered or provided. Oracle and its affiliates cannot be held responsible for
any such references should they appear in the text provided.
vi
1
For new users
In this chapter
• About Oracle InForm CRF Submit
• Access Oracle InForm CRF Submit to generate an archive or history report
• Subscribe to release announcements
• What data is migrated across data centers?
About Oracle InForm CRF Submit

Using Oracle InForm CRF Submit, you can initiate PDF archive and history report requests
directly from the Oracle InForm user interface for UAT and LIVE studies. You can use the
output for:
• Interim study data analysis.
• Inclusion in submissions to regulatory authorities.
• Archiving study data for retention by sponsors and investigative sites.
Each PDF archive request includes casebooks or a set of unique forms that include.
• CRFs
• Visits
• Audit trails (including queries)
• Comments
• Signatures
Oracle allocates 1000 GB of storage server space for each customer, which is shared across
all studies. For more information, see Check how much storage you have used.
Access Oracle InForm CRF Submit to generate an archive or

history report
Access to Oracle InForm CRF Submit differs based on the version of Oracle InForm you
are using.
If you are using Oracle InForm 7.0 or higher:
1. Log into Oracle InForm.
2. On the toolbar, click Archives.
If you are using a version of Oracle InForm lower than 7.0:
1. Log into Oracle InForm.
2. Below the toolbar, click the Archives link.
1-1
Chapter 1
Access Oracle InForm CRF Submit to generate an archive or history report
How do I generate a study archive or history report?

After clicking Archives you are taken to the My Requests - Processing page.
• Use the links below to generate an archive containing study data or a set of blank forms.
– Submission PDF
– Archival PDF
– Blank Forms Only
– Custom PDF
– Custom Blank Forms
For additional information about each, see Archive types and the files and subject data
included.
• Use the links below to generate a history report.
– Audit Trail Report
– User Assignment History report
For additional information about each, see History report details.
• Archive types and the files and subject data included
• History report details
Archive types and the files and subject data included

Here's what's included with the output of each archive request
Each request produces a zip file that includes the following.
1-2
Chapter 1
Table 1-1 Archive request output details
Request type Description Included in the .zip file

Submission PDF Generate this type for submission to • One folder per site, each
the FDA and other regulatory containing one PDF per subject.
agencies at the conclusion of a • Table of Contents
study. The information is • Request Settings
automatically compiled and • Blank forms with active controls
formatted according to the for each study version.
regulators' requirements.
• Protocol Guide
• Study Design
Note:
The zip file includes
the protocol guide
and study design only
if the study
administrator made
them available on the
Documents tab on
the study’s home
page. The Visit
Calculator and
Sample Book are not
included. For more
information, see
What types of study
documentation are
there?.
Archival PDF Generate this type for mid-study data • One folder per site, each
analysis or to generate a final containing one PDF per subject.
archive of study data, which can then • Table of Contents
be made available to auditors, • Request Settings
sponsors, sites, and regulatory • Blank forms with active controls
agencies. for each study version.
Blank Forms Only Generate this type to view blank • Request Settings
forms with active controls for a study • Blank forms with active controls
version. for each study version.
1-3
Chapter 1
Table 1-1 (Cont.) Archive request output details
Request type Description Included in the .zip file

Custom PDF This type gives users access to all • One folder per site, each
settings, letting them control what to containing one PDF per subject.
include in the output. • Table of Contents
• Request Settings
• Protocol Guide
Note:
The zip file includes
the protocol guide
only if the study
administrator made it
available on the
Documents tab on
the study’s home
page and the
Request Setting,
Protocol Guide, is
set to Yes.
Custom Blank Forms Like the Custom PDF, the user can • Request Settings
access all available settings, but the • Blank forms with active controls
output only includes blank forms with for each study version.
active controls.
What subject data gets included in archive requests and history reports
The PDF layout does not differ between request types; only the data included in the output
does.
• For archive requests that include subject data (Submission, Archival, and Custom), Oracle
InForm CRF Submit provides a PDF that reflects each subject's casebook and includes
item, query, form, and visit details, audit trail information, and details for comments and
signatures.
• Oracle InForm CRF Submit relies on the Oracle InForm rights groups to determine what
data to include in the archive request and history report output. If a user assigned to a
rights group can't see specific information in the study, the output reflects that.
• The data included in the output gets determined by the selection from the Select the
rights group to control content setting. This setting is only available for sponsor users
on the Archival PDF and Custom PDF request types and for the Audit Trail Report.
Note:
The setting defaults to the rights group of the user generating the request.
History report details

As part of a study decommissioning package, some regulatory agencies require the following
history reports.
1-4
Chapter 1
Subscribe to release announcements
Table 1-2 History report details
Report name Description Included in the .zip file

Audit Trail Report This report includes traceability • One folder per site, each
details for item-level inserts and containing one CSV per
edits, query changes, form status subject.
changes, SV status changes, and • Table of Contents
comment and signature history. • Request Settings
This report is only available in • A cumulative CSV file
CSV format. containing details for all
subjects.
User Assignment History report This report includes an audit • One folder per site, each
history of changes made to each containing one CSV file with
user account. details for users at the site.
• User status changes, such • Table of Contents
as created, activated, • Request Settings
deactivated, and terminated.
• Query group changes
• Reporting group changes
• Rights group changes
• Signature group changes
• Site association changes
Subscribe to release announcements

1. Log in to Oracle Life Sciences Support Cloud.
2. In the upper-right corner, click the My Account icon ( ), then click Account Settings.
3. Enable Send email notifications when new announcements are posted at the bottom
of the Account Settings page, then click Save.
You'll receive an email notification whenever we post an Oracle InForm CRF Submit release
announcement on the Oracle Life Sciences Support Cloud.
Note:
You will also receive announcements from other industry-specific applications
developed by Oracle Life Sciences.
What data is migrated across data centers?

Oracle InForm CRF Submit includes the following features and a command line utility to
support migration across data centers (from GBUCS 1.0 to GBUCS 3.0) without impacting
regulatory data.
• Requests are migrated.
– Request Settings are available for migrated requests.
• Migrated requests:
1-5
Chapter 1
What data is migrated across data centers?
– Are displayed as part of the Completed Requests, and their status shows as Migrated.
Users cannot click on the Migrated request name, and therefore they cannot navigate
to the Request Details page.
– Always stay in the Completed Requests section regardless of their status, and do not
auto-purge.
– Cannot be downloaded.
• There is a new Migrated status for Requests and Audit Reports. The Request name must
be unique per study.
Command line utility

Oracle InForm CRF Submit supports a command line utility for migrating Regulatory and
Administration data for a study from the GBUCS 1.0 to GBUCS 3.0 data center. Prior to
migration, the PDFs and History Reports must be downloaded by the user.
The utility migrates the following information:
• Study settings (Sponsor settings are not migrated because they are not specific to a study)
• Regulatory data
– Download log
– Site Confirmation log
• Administration data
– CRFS Settings—Study Settings
– Admin Tool—Study Data
– CRF Submit rights for the study and the rights history
For Oracle InForm pre-6.2 studies, CRF Submit rights are migrated.
For Oracle InForm 6.2 and later studies, CRF Submit rights are not migrated.
All migration requests have a status of Migrated (instead of, for example, Completed or
Deleted).
Previously generated files (for example, PDFs or CSVs) in GBUCS 1.0 are not migrated and
there are no links to them in the Downloaded requests.
1-6
2
Create an archive
In this chapter
• Start with a Test Run
A test run is identical to a regular PDF request, except that a test run is limited to one
subject or study version, depending on the type of request selected.
• Submission PDF
At the conclusion of a study, generate this type of request for submission to the FDA and
other regulatory agencies. The information is automatically compiled and formatted
according to the regulators' requirements. The output contains data visible to the user who
creates it based on their assigned rights group.
• Archival PDF
Generate this type of request for mid-study data analysis or to create a final archive of
study data. The archive can be made available to auditors, sponsors, sites, and regulatory
agencies.
• Blank Forms Only
Generate this type of request to view a set of blank forms with active controls for each
study version. The output contains no subject data.
• Custom PDF
This request type gives you access to all settings, letting you control what to include in the
output.
• Custom Blank Forms
Like the Custom PDF, you have access to all available settings, but the output only
includes blank forms with active controls and no subject data.
• Download the PDF output for an archive
• Create a custom template
• Create a PDF archive from a template
• PDF output options
• Transferred subject data
Start with a Test Run

A test run is identical to a regular PDF request, except that a test run is limited to one subject
or study version, depending on the type of request selected.
Create a test run to confirm that your settings produce the desired output.
Follow the steps below to create a Test Run

Start by accessing Oracle InForm CRF Submit.
1. On the My Requests - Processing page, click Create Requests, then select Create Test
Run.
2. On the Study Information page, update the PDF Request Name if applicable, enter an
optional PDF Request Description, select the appropriate request type, and click Next.
2-1
Chapter 2
Submission PDF
Note:
The PDF Request Name defaults to the study name plus the current date and
time.
3. Depending on the request type selected, refer to the links below to complete the request.
• Submission PDF
• Archival PDF
• Blank Forms Only
• Custom PDF
• Custom Blank Forms
If you choose the Submission PDF, Archival PDF, or Custom PDF request, the system
prompts you to select a single subject.
If you choose the Blank Forms Only or Custom Blank Forms request, the system
prompts you to select a single study version.
Submission PDF
At the conclusion of a study, generate this type of request for submission to the FDA and other
regulatory agencies. The information is automatically compiled and formatted according to the
regulators' requirements. The output contains data visible to the user who creates it based on
their assigned rights group.
Tip:
You can generate a Test Run first to ensure the PDF output contains the correct data.
Here's what a Submission PDF request includes

• One folder per site, each containing one PDF per subject.
• A Table of Contents (TOC).
• A PDF containing the Request Settings.
• A set of blank forms with active controls for each study version.
Follow the steps below to create a Submission PDF

1. On the My Requests - Processing page, click Create Requests, then select Create New
PDF Request.
2. On the Study Information page, update the PDF Request Name (if applicable), enter an
optional PDF Request Description, select Submission PDF, and click Next.
Note:
The request name defaults to the study name plus the current date and time.
2-2
Chapter 2
Submission PDF
3. Complete the Form Options, then click Next.
Table 2-1 Submission PDF Form Options
Option Details
Header Text • Enter text up to 90 characters to appear at
the top of each page on the PDF.
• The study name is the default value.
Page Size • Letter: (default) 8-1/2" by 11"
• A4: European letter size: 210 x 297 mm
Blank Form Format • Unique Forms: One of each form in your
study.
• Casebook: (default) All forms, even those
that are repeated.
Note:
For more information, see How can I
handle blank forms?
Headings Language • Specify the language to use for labeling

bookmarks, headers, and footers.
• English is the default language.
Footer Text • Enter text up to 30 characters to appear in
the footer of each PDF page.
• ***Confidential*** along with page numbers
is the default.
Include Study Name in the Subject PDF File • Select Yes (default) for the Study Name to
name appear in the Subject PDF file name.
• Select No if the study name is not needed.
4. Complete the Request Settings, then click Next.
Table 2-2 Submission PDF Request Settings
Setting Details
Audit Location • Select After Each Form to place audit trail
data at the end of each form.
• Select End of PDF (default) to place it at the
end of the PDF.
2-3
Chapter 2
Submission PDF
Table 2-2 (Cont.) Submission PDF Request Settings
Setting Details
Include data as of date and time • Select Now (default) to include all data
available up to the date and time displayed.
• Select Select date/time to enter a specific
date.
Note:
The date cannot be before the
first subject’s study enrollment
date.
For more information, see How does the Include

data as of date and time option affect the
output?.
Export Selection Criteria Select to create PDFs for
• All Subjects (default)
• By Subject
• By Site
For more information, see How do I define the
Export Selection Criteria?, and How do I enter a
large number of subjects?
Candidate Queries • Select Yes to include Candidate Queries in
PDFs.
• Select No (default) to exclude them.
Generate Linking Blank Forms • Select Yes to link a copy of the blank form in
another language to this form.
• Select No (default) to not link a copy of the
blank form.
Note:
For multilingual studies.
Prevent Form Changes Not editable for this request type, displayed for
information purposes only.
Prevent Form Comments Changes • Select Yes to prevent comments and
annotations from being added to the output
PDF.
• Select No (default) to allow comments or
annotations.
Prevent Content Extracts and Copying • Select Yes to prevent content being copied
from the output PDF.
• Select No (default) to allow content to be
copied.
5. Review the request settings displayed on the Review and Submit page for accuracy.
• Click Save to save the request to the Saved tab under My Requests. You can access
this request later to make edits and generate it.
• Click Print to print a copy of the request settings. The zip file also includes a copy of
the request settings.
• Click Submit to generate the request.
2-4
Chapter 2
Archival PDF
6. The PDF Request Submitted window opens and presents the following options.
• Click Yes, Create Another to return to the Create New PDF Request page.
• Click No, Go to Processing Page to be taken to the My Requests - Processing
page.
7. On the My Requests - Processing page, click Refresh until the % Complete column
displays 100.
Note:
Completed requests are moved to the My Requests - Completed page.
8. You can now Download the PDF.
Archival PDF
Generate this type of request for mid-study data analysis or to create a final archive of study
data. The archive can be made available to auditors, sponsors, sites, and regulatory agencies.
Tip:
Here's what an Archival PDF request includes

Note:
Blank forms are included only when the Request Setting Generate Blank Forms
is Yes.
Follow the steps below to create an Archival PDF

PDF Request.
optional PDF Request Description, select Archival PDF, and click Next.
Note:
2-5
Chapter 2
Archival PDF
Table 2-3 Archival PDF Form Options
Option Details
study.
that are repeated.
Note:
handle blank forms?

is the default.
Table 2-4 Archival PDF Request Settings
Setting Details
Allow PDF request to be stored in eTMF For more information about this setting, see
About Electronic Trial Master File (eTMF).
Note:
This setting is only available when the
trial setting Enable eTMF Download
is enabled.
2-6
Chapter 2
Archival PDF
Table 2-4 (Cont.) Archival PDF Request Settings
Setting Details
Share with Sites • Select Yes (default) if you want to make the
PDFs made available for download by site
users.
• Select No if site users do not need to
Note: download this request.
Appears only if you belong to a rights
group with the Share Archives with
Sites right.
Site Confirmation Required • Select Yes (default) if you want site users to
confirm downloading a request shared with
them.
Note:
Appears only if Share with Sites is Note:
Yes.
For more information about the
site confirmation process, see
Confirm archives and reports.
• Select No if you do not require confirmation

from site users.
Select the rights group to control content • The rights group selected determines what
content gets included in the PDF output.
• The default is the logged-in user's rights
group
Allow any Site User to download this request • Select Yes to allow any site user with
Archives access to download the request.
• Select No (default) to allow only site users
assigned to the rights group selected for
Note: Select the Rights Group to Control
Content to download the request.
Appears only if Share with Sites is
Yes.
Notify CRFS Site Users • Select Yes to send site users the, PDF or
History Request is available for download
(Site user, when share with sites) notification
when a request is available for download.
Note:
Yes. Note:
The notification is only sent if it
has been enabled. For more
information, see About email
notifications. The setting displays
even if the notification is not
enabled.
• Select No (default) if the notification should

not be sent.
2-7
Chapter 2
Archival PDF
Table 2-4 (Cont.) Archival PDF Request Settings
Setting Details
end of the PDF.
date.
Note:
date.

output?.
• By Site
large number of subjects?
Candidate Queries • Select Yes (default) to include Candidate
Queries in PDFs.
• Select No to exclude them.
Generate Blank Forms • Select Yes (default) to include blank forms.
Prevent Form Comments Changes • Select Yes (default) to prevent comments
and annotations from being added to the
output PDF.
• Select No to allow comments or annotations.
Prevent Content Extracts and Copying • Select Yes (default) to prevent content being
copied from the output PDF.
• Select No to allow content to be copied.
2-8
Chapter 2
Blank Forms Only

page.
displays 100.
Note:
Blank Forms Only

Generate this type of request to view a set of blank forms with active controls for each study
version. The output contains no subject data.
Tip:
Here's what a Blank Forms Only request includes

Follow the steps below to create a Blank Forms Only request

PDF Request.
optional PDF Request Description, select Blank Forms Only, and click Next.
Note:
Table 2-5 Blank Forms Only Form Options
Option Details
2-9
Chapter 2
Blank Forms Only
Table 2-5 (Cont.) Blank Forms Only Form Options
Option Details
study.
that are repeated.
Note:
handle blank forms?

is the default.
Table 2-6 Blank Forms Only Request Settings
Setting Details
Include versions as of date and time • Select Now (default) to include all study
versions up to the date and time displayed.
date.
Study Version • Select All (default) to generate blank forms
for all study versions.
• Select Select from list to choose one or
more study versions.
PDF.
• Select No (default) to allow comments or
annotations.
Prevent Content Extracts and Copying • Select Yes to prevent content being copied
copied.
2-10
Chapter 2
Custom PDF
page.
displays 100.
Note:
Custom PDF
This request type gives you access to all settings, letting you control what to include in the
output.
Tip:
Here's what a Custom PDF request includes

Note:
Blank forms are included only when the Request Setting Generate Blank Forms
is Yes.
Follow the steps below to create a Custom PDF request

PDF Request.
optional PDF Request Description, select Custom PDF, and click Next.
Note:
2-11
Chapter 2
Custom PDF
Table 2-7 Custom PDF Form Options
Option Details
study.
that are repeated.
Note:
handle blank forms?.

is the default.
Display in the header By default, the PDF header includes, Header
Text, Form Name, Form Status, Subject No.,
Generated By, and Generated Time. You can
also include the following in the header.
• Form Version (default is Yes)
• Subject Initials (default is Yes)
• Visit Name and Number (default is Yes)
• Site Name and Number (default is Yes)
• Sponsor (default is No)
• Protocol (default is No)
2-12
Chapter 2
Custom PDF
Table 2-8 Custom PDF Request Settings
Setting Details
Allow PDF request to be stored in eTMF For more information about this setting, see
About Electronic Trial Master File (eTMF).
Note:
This setting is only available when the
trial setting Enable eTMF Download
is enabled.
Share with Sites • Select Yes if you want to make the PDFs
made available for download by site users.
• Select No (default) if site users do not need
to download this request.
Note:
Appears only if you belong to a rights
group with the Share Archives with
Sites right.
confirm downloading a request shared with
them.
Note:
Yes.

from site users.
group.
Archives access to download a request.
Yes.
2-13
Chapter 2
Custom PDF
Table 2-8 (Cont.) Custom PDF Request Settings
Setting Details
Note:
Yes. Note:
enabled.

not be sent.
Include Bookmark Prefixes • Select Yes to include prefixes (for example
CRF, Form, Visit, Study) in PDF bookmarks.
• Select No (default) if bookmark prefixes are
not needed.
end of the PDF.
date.
Note:
date.

output?.
• By Site
large number of subjects?.
2-14
Chapter 2
Custom PDF
Setting Details
Forms • Select All (default) to include all forms.
• Select Select from list to include selected
study forms in the output.
Note:
If you include selected forms, you
cannot limit the PDF to selected
visits.
Visits • Select All (default)

• Select Select from list to include selected
study visits in the output.
Note:
To include common forms across Note:
visits you must select the cross visit
entry or the forms will be missing from If you include selected visits, you
the output. cannot include selected forms.
Transferred Subjects in Current Site Only • Select Yes to create a PDF for a transfer
subject in just the current site.
• Select No (default) to create a PDF for both
the originating and the current site.
For more information, see Where is subject
transfer history included?.
Suppress Empty Clinical Forms • Select Yes to omit forms for which no data
has been entered.
• Select No (default) to include all forms, even
if they are empty.
Suppress Empty Clinical Visits • Select Yes to omit visits for which no data
has been entered.
• Select No (default) to include all visits, even
if they are empty.
Queries in PDFs.
Generate Blank Forms • Select Yes to include blank forms.
• Select No (default) to exclude them.
Study Version • Select All (default) to create blank forms for
all study versions.
• Select Select from list to choose specific
study versions.
Note:
Appears only if Generate Blank
Forms is Yes.
2-15
Chapter 2
Custom PDF
Setting Details
Generate Linking Blank Forms • Select Yes to link a copy of the blank form in
another language to this form.
• Select No (default) to not link a copy of the
blank form.
Note:
For multilingual studies.
Generate TOC • Select Yes (default) to include a table of

contents (TOC) with links to all generated
subject PDFs in the request.
• Select No to not include the TOC.
Protocol Guide • Select Yes to include the Protocol Guide
and the CRF Help in the PDF Request
output.
• Select No (default) to exclude the Protocol
Guide and CRF Help.
Prevent Form Changes • Select Yes to require a password to make
changes to the PDF.
Note:
When set to Yes a field appears
allowing you to define a
password.
• Select System-created : Hidden to

permanently prevent form changes to the
PDF.
WARNING:
This password cannot be
retrieved.
• Select No (default) to allow PDF output to be

modified.
PDF.
• Select No (default) to allow PDF comments
or annotations.
Prevent Content Extracts and Copying • Select Yes to prevent contents being copied
copied.
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Chapter 2
Custom Blank Forms
Setting Details
Password Specify a password to be used when Prevent
Form Comments Changes and Prevent Content
Extracts and Copying are set to Yes.
Note:
Appears only when Prevent Form WARNING:
Changes is set to Yes.
The password entered is not saved in
the application and must be retained
by the user.
Re-enter Password Re-enter the password exactly as entered in the

Password field.
• Click Save as New Template to save the request as a template for future use.
Templates are saved under Templates - Manage Templates.
page.
displays 100.
Note:
Custom Blank Forms

Like the Custom PDF, you have access to all available settings, but the output only includes
blank forms with active controls and no subject data.
Tip:
2-17
Chapter 2
Custom Blank Forms
Here's what a Custom Blank Forms request includes

• Request Settings
• Blanks forms with active controls for each study version.
Follow the steps below to create a Custom Blank Forms request

PDF Request.
optional PDF Request Description, select Custom Blank Forms, and click Next.
Note:
Table 2-9 Custom Blank Forms Form Options
Option Details
study.
that are repeated.
Note:
handle blank forms?.

is the default.
2-18
Chapter 2
Custom Blank Forms
Table 2-10 Custom Blank Forms Request Settings
Setting Details
group.
Include Bookmark Prefixes • Select Yes to include prefixes (for example
CRF, Form, Visit, Study) in PDF bookmarks.
• Select No (default) if bookmark prefixes are
not needed.
Include versions as of date and time • Select Now (default) to include all study
versions up to the date and time displayed.
date.
Study Version • Select All (default) to create blank forms for
all study versions.
• Select Select from list to select one or
more specific study versions.
Prevent Form Changes • Select Yes to require a password to make
changes to the PDF.
Note:
When set to Yes a field appears
allowing you to define a
password.
• Select System-created : Hidden to

permanently prevent form changes to the
PDF.
WARNING:
This password cannot be
retrieved.
• Select No (default) to allow PDF output to be

modified.
PDF.
• Select No (default) to allow PDF comments
or annotations.
Prevent Content Extracts and Copying • Select Yes to prevent contents being copied
copied.
2-19
Chapter 2
Download the PDF output for an archive
Table 2-10 (Cont.) Custom Blank Forms Request Settings
Setting Details
Password Specify a password to be used when Prevent
Form Comments Changes and Prevent Content
Extracts and Copying are set to Yes.
Note:
Appears only when Prevent Form WARNING:
Changes is set to Yes.
The password entered is not saved in
the application and must be retained
by the user.
Re-enter Password Re-enter the password exactly as entered in the

Password field.
page.
displays 100.
Note:
Download the PDF output for an archive

1. Perform one of the following:
• To download an entire request, on the My Requests - Completed page, select the
checkbox on the archive or history request you want and click Download.
• To download individual subjects or files, click the Request Name to go to the Request
Details page, then select the checkbox and click Download. You must download these
files one at a time.
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Chapter 2
Create a custom template
Note:
When a request fails, Oracle InForm CRF Submit creates a .zip file containing
those PDFs generated successfully. You can download all successfully
generated PDFs from the Completed page as well as a a failure report that lists
the failures (FailureReport.txt).
2. Open or Save the file(s). We recommend that you save the file(s) to a local machine and
then extract the output from the downloaded ZIP file.
Tip:
• The name of the ZIP file matches the request name.

• If the output exceeds 200 MB, Oracle InForm CRF Submit chunks the output
into 200 MB files.
• The Firefox browser presents users with an option to Save, while other
browsers like Edge and Chrome automatically save the files to the default
download folder.
3. Extract the output from the ZIP file. If you view files without extracting them in the ZIP tool,
the hyperlinks in the files might not work correctly.
Tip:
Archives are kept for 120 days after they are generated and then purged
automatically. You can manually delete archives if you wish.
Create a custom template

You can create a template from a custom archive request.
1. Follow steps 1 through 6 in Custom Request.
2. On the Review and Submit page, click Save as New Template.
3. Enter a unique name for the template and a description.
Tip:
The description tells other users what's in the template.
4. Click Save.
Create a PDF archive from a template

1. From the Create Requests drop-down menu on any My Requests page, select Create
from Templates.
2. Enter the PDF request name and description.
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Chapter 2
PDF output options
3. From the Select Custom Template drop-down list, select a template.

4. Click Next.
5. Step through the Forms Options and PDF Request Settings pages.
These have been prepopulated with the values from the template you selected. Note that
you cannot change the security options associated with adding comments to PDF output
and copying content.
6. Click Next.
7. On the Review and Submit page, click Submit.
Tip:
Manage templates from the Templates menu on the left. To save the changes to a
new template, on the Review and Submit page, click Save as New Template,
specify a new name and description, and click Save.
PDF output options

In this section
• How can I handle blank forms?
• About Electronic Trial Master File (eTMF)
• Can I generate archives and history report headers in Japanese?
• How does the Include data as of date and time option affect the output?
• How do I define the Export Selection Criteria?
• How do I enter a large number of subjects?
• Can I save a request?
• What do rights groups do?
• How do I prevent hidden Oracle InForm data from appearing?
• What PDF format is applied to PDF output?
• Why should I create a custom template?
• Can I create a ZIP file even if Oracle InForm CRF Submit encounters errors?
How can I handle blank forms?

You specify how to handle blank forms on the Form Options page.
• To include one of each form in alphabetic order, select Unique Forms. This option
produces blank forms more efficiently than by casebook.
• To include all forms within the visit structure, corresponding to the order in which the forms
appear in the study design regardless of whether the form was ever started, select
Casebook.
– Within a visit, all forms are represented, even if the same form is used in multiple visits.
For example, almost every visit includes a Date of Visit (DOV) form. If you select the
Unique Forms choice, the DOV form appears once. With the Casebook choice, the
DOV form appears under each visit in which the form is used.
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PDF output options
– It is also not uncommon to see what appears to be the same form repeated. These are
separately defined forms with the same form name.
About Electronic Trial Master File (eTMF)

Use this feature to send Archival PDF (sponsor) and Custom PDF archive requests to the
Oracle sFTP server, where they can be programmatically retrieved for import into an eTMF
system.
About eTMF
The primary purpose of this feature is to allow you to programmatically transfer archives from
the Oracle sFTP server to your eTMF system.
Downloading files manually from the sFTP server, while it can be done, is not recommended
as no data protections are applied to the content on the Oracle sFTP server, like in Oracle
InForm CRF Submit.
Also, archives manually downloaded from the sFTP server are not tracked in the Download
Log or the Site Confirmation report.
eTMF setting and archive retention

• To enable this feature, see Specify trial settings
• Once the feature is enabled, the setting, Allow PDF request to be stored in eTMF, is
available for the following archive types:
– Archival PDF (sponsor user)
– Custom PDF
• When the setting Allow PDF request to be stored in eTMF is set to Yes, archives are
delivered to the sFTP server and are available in the Oracle InForm CRF Submit user
interface. When set to No, archives are only available in the user interface.
• Deleting an archive from one location (sFTP or the user interface) does not delete it from
the other.
• Archives are automatically deleted from the sFTP server after 60 days and from the user
interface after 120 days.
Named sFTP account details

The username and password of this account are used to access the Oracle sFTP server to
retrieve requests programmatically. The email address, first name, and last name of an
individual need to be included in the request to create this account.
WARNING:
The data included in a request is based on the rights group selected when the
request was generated. The person associated with the named sFTP account can
access the sFTP server and manually download requests. This could result in
unblinding if the request contains data that the sFTP user should not have access to.
Request a named sFTP account

Follow these steps to create a request for a named sFTP account.
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Chapter 2
PDF output options
1. Log into Oracle Life Sciences Support Cloud.

2. Click Create Request in the upper-right corner, then select Change Request.
3. Click the Maintain an application tile.
4. Click the Request user access tile, then complete the following fields.
• Summary: (Ex.) Requesting the creation of an sFTP named account.
• Severity: Medium
• Description: Grant <enter first name, last name, and email> Read Only access to the
sFTP directory defined in this request.
• Category: Change-Cloud Infrastructure > Infrastructure Services > SFTP > User >
Add
• Customer: Select your company's name
• Product: CRF Submit
• Business Service: CRF Submit-customer name
• Environment: Prod/Live
• Implementation Window: Make a selection
• Action: Leave set to No Value
• sFTP: Reach out to your Oracle Services contact to get the sFTP path.
• Date Required: Enter a date
Error handling
If errors are encountered while copying files to the sFTP server, the request is marked as
Failed in the user interface, and the reason captured (in the FailureReport.txt file) is Request
output could not be copied to the sFTP location.
Note:
An archive can still be downloaded in the user interface even if an error is
encountered copying files to the sFTP server.
Can I generate archives and history report headers in Japanese?

Oracle InForm CRF Submit is Unicode-based and supports PDF and history report generation
for multilingual studies.
You can specify a submission language in the Headings Language field on the Form Options
page. The chosen language is applied to the structure of the PDF file or history report,
including headers, headings, and labels. The study content remains in the language it was
entered into the Oracle InForm study.
You also have the option to generate linking blank forms in a different study language than the
one selected as the submission language. A reviewer not fluent in the original language can
link to the associated blank form in a different language.
How does the Include data as of date and time option affect the output?
You specify an as-of date on the Request Settings page.
2-24
Chapter 2
PDF output options
The default is Now. The data export includes all eCRF data available at the current date and
time (displayed in the browser time zone). Use the Include data as of date and time option to
include data up to (as of) the date and time you enter. The earliest date you can select is the
enrollment date of the first subject.
When you select subjects using the Export Selection Criteria option, only subjects enrolled
prior to the as-of date appear in the selection list.
How do I define the Export Selection Criteria?

You define the Export Selection Criteria on the Request Settings page. The default for PDF
requests is All Subjects. That choice includes everything in the study. The default for history
reports is All Sites.
If you select By Subject or By Site, a page opens for you to make your selections.
To select subjects:
You can select subjects from multiple sites or import subject identifiers from a file.
1. (Optional) From the Select a site to filter drop-down list, limit the subjects shown to the
selected site.
2. (Optional) In the Select subjects from list below text box, search for subjects by typing
at least three characters of the subject ID.
Only subjects enrolled prior to the as-of date appear in the list.
3. Using the Shift and CTRL keys, highlight the subjects you want to include, and click the
right arrow to move the selected subjects to the Selected List.
4. To select subjects from another site, from the Select a site to filter drop-down list, select
the site.
5. Follow the instructions in steps 2 through 4.
6. Click Save.
To select site:
1. (Optional) In the Select sites from list below text box, search for a site by typing at least
three characters of the site name.
Only sites enrolled prior to the as-of date appear in the list.
2. Using the Shift and CTRL keys, highlight the sites you want to include, and click the right
arrow to move the sites to the Selected List.
3. Continue selecting sites.
4. Click Save.
How do I enter a large number of subjects?
Tip:
• This option is available for Submission, Archival, and Custom PDF requests.
• To use the import feature, you must use Microsoft Edge, Google Chrome, or
Firefox browsers.
2-25
Chapter 2
PDF output options
To use the import feature:

1. On the PDF Request Settings page, in the Export Selection Criteria field, select By
Subject.
2. In the Select Subjects dialog box, click the Import Subjects tab.
3. Select the CSV (comma-separated value) file to import from your directory by clicking
Browse and locating the file. The CSV file cannot be greater than 1MB.
4. Click Import.
5. Click Save.
6. Complete the PDF request.
To create the CSV file:

1. Use Microsoft Excel and save it as file type .csv.
2. Enter each entry on a separate line.
3. Separate the fields by commas.
4. Save the file with the extension .csv.
For example, an entry that includes Subject ID and Subject number string is, as follows:
• 100012,LLL
Shown below are entries from a CSV file generated from an Oracle InForm study:
• 11510,2333
• 2333,012-001
• 22486,012-003
Can I save a request?

A saved-but-not-submitted PDF request is visible only to the user who created it and persists
across sessions.
• On the Review and Submit page, instead of Submit, click Save.
What do rights groups do?

The rights group controls what data will and will not appear on the PDF. Items hidden from
sites will not be added to the PDF if a site user rights group is selected.
Your organization might have set up one or more specific rights groups in the Oracle InForm
application for use with the Oracle InForm CRF Submit application. Select the appropriate
rights group.
How do I prevent hidden Oracle InForm data from appearing?

When you create Archival, Custom, and Custom Blank Forms archives or an Audit Trail report
and share the output with sites, the PDF Request Settings page includes the option of
choosing a different rights group than the one to which you belong.
This creates a subset of the items your rights group and the selected rights group are able to
see in the PDF output.
2-26
Chapter 2
PDF output options
Note:
Only site users that belong to the rights group selected will be able to download the
PDFs once generated. The PDFs will not be visible to users belonging to other rights
groups.
To include all data items, you must be logged in with a rights group that has been set up to see
all items present in the study design. The rights group needs Read-Only or Editable display
overrides to any item that is hidden by design default.
When a rights group has a display override assigned to it, a user who is a member of the rights
group has the type of access defined by the display override to the items in the item group.
Display overrides overrule the access rights of the rights group and the access rights
determined by item definitions (design defaults).
For example, if an item group contains an item called dose_missed_rsn, and that item group is
assigned to the CDMGrp with a hidden override, a member of the CDMGrp rights group cannot
see the dose_missed_rsn item even if the design default is Read-Only or Editable.
What PDF format is applied to PDF output?

The Oracle InForm CRF Submit application produces PDF output that conforms to PDF format
version 1.7.
Page orientation—By default, output is printed in portrait orientation. Oracle InForm CRF
Submit automatically creates line-wraps in most text data. If the form data requires more space
than the width of the page, the font is reduced by up to 70% of the initial font size.
Margins—Left and top margins are at least 0.98 inches. Bottom is at least 1.26 inches. The
right margin is at least 0.59 inches.
Fonts—Fonts are embedded and restricted to 9 to 12 points.
Text color—Text is presented in black type.
Hyperlinks—Both visited and non-visited hyperlinks are blue.
Optimized output—Output is optimized for fast web view.
Compression—Oracle InForm CRF Submit compresses individual PDF files to fit within
regulatory standards.
Why should I create a custom template?

Creating templates for Custom PDF requests saves time and increases consistency. Templates
are especially useful when a dataset is used by multiple people. You can make the templates
you create most useful by providing descriptive names and documenting for others why you
made the choices you did. All saved templates appear on the Manage Templates page.
Can I create a ZIP file even if Oracle InForm CRF Submit encounters
errors?
If a request results in a Failed status, Oracle InForm CRF Submit still generates a ZIP file
containing all successfully generated PDFs. You can download this ZIP file from the My
Requests - Completed page. The ZIP file contains a report, FailureReport.txt, which contains
2-27
Chapter 2
Transferred subject data
details for any file that failed. You can use the details in this report to generate a new request. If
the failure continues, provide the report to Oracle Support.
Transferred subject data

In this section
• Are subject data transfers supported?
• Where is subject transfer history included?
Are subject data transfers supported?

Oracle InForm allows you to transfer a subject's information from one site to another; that is,
the subject data associated with the originating site is transferred to the destination site.
Note:
The data in the PDF for every previous site to which the subject was associated
represents a snapshot of the subject data at the moment the subject was most
recently transferred from that site. This ensures that the originating site does not
receive confidential subject data that was entered at a more recent site. The
destination (current) site for the subject contains complete data for the subject.
Where is subject transfer history included?

If a study includes subjects who have moved from one site to another site, a document named
the Subject Record Transfer History is generated in the folder for each of the sites. This
document contains information about all transfers that the subject has undergone.
The file name containing the transfer history is the subject number with -prth appended to it.
For example, for Subject 01-001, the PDF file is named <studyname>-01-001-prth.pdf.
Links to the Subject Record Transfer History are in the crftoc.pdf file.
Tip:
If a subject has been associated with more than one site, time zone information
corresponds to the time zone of the site where the data was entered. This might
cause an audit trail to appear to be out of order.
2-28
3
Create a history report
In this chapter
• Audit Trail Report
• User Assignment History report
• Download a history report
Audit Trail Report

The Audit Trail Report includes traceability for item-level inserts/edits, query changes, form
status changes, SV status changes, and comment and signature history. This report is only
available in CSV format.
The report also includes audit trail information for the following Oracle InForm form and SV
statuses:
• Date Form Started
• Date Form Frozen / Unfrozen
• Date Form Locked / Unlocked
• Date Form Signed / Unsigned
• Date Form Deleted / Undeleted
• Date Form is marked SDVReady, SDVPartial, & SDVComplete
• Date SDVReady, SDVPartial, & SDVComplete are deleted
Follow the steps below to generate the Audit Trail Report

1. On the My Requests page, select Create History Request from the Create Requests
drop-down.
2. On the Study Information page, accept the default Request Name (comprised of the
study name plus the current date and time) or enter a different name.
3. Enter an optional Description.
4. Select Audit Trail Report, and click Next.
5. Enter the Request Settings, then click Next.
Table 3-1 Audit Trail Report - Request Settings
Setting Description
headers.
Include Study Name in the Subject CSV File • Select Yes (default) to include the study
name name in the output file.
3-1
Chapter 3
Audit Trail Report
Table 3-1 (Cont.) Audit Trail Report - Request Settings
Setting Description
Share with Sites • Select Yes if you want to make the report
made available for download by site users.
• Select No (default) if site users do not need
to download this report.
Site Confirmation Required • Select Yes if you want site users to confirm
downloading the report shared with them.
Note:
Note:
Yes. For more information about the
Confirm archives and reports
• Select No (default) if you do not require

confirmation from site users.
group.
Archives access to download this request.
Yes.
Note:
Yes. Note:
enabled.

not be sent.
contents (TOC).
Queries.
3-2
Chapter 3
Audit Trail Report
Table 3-1 (Cont.) Audit Trail Report - Request Settings
Setting Description
Select Date Range The date range entered determines the audit trail
data included in the report.
Selection Criteria Use the following filters to generate an Audit Trail
Report for an entire trial or site or for a specific
subject or form.
• Sites
• Subjects
• Visits
• Forms
• Modification Type
• Rights Group
• Usernames
6. Review the request settings on the Review and Submit page for accuracy.
• Click Submit to generate the report.
• Click Yes, Create Another to return to the Create History Request page.
page.
displays 100.
Note:
9. You can now Download a history report.
Table 3-2 Audit Trail Report (ATR) Output Details
Output Column Output Column Description

Study Name InForm study name
Site ID InForm site number
Site Name InForm site name
SubjectID InForm subject number
Abbreviated Visit Name InForm visit refname
Abbreviated Form Name InForm form refname
Form Index This number uniquely identifies the instance of
the repeating form within a subject visit, starting
from 1.
Itemset Index This number uniquely identifies the instance of a
repeating section (i.e. itemset) within a subject
form.
Item Question InForm question text
3-3
Chapter 3
User Assignment History report
Table 3-2 (Cont.) Audit Trail Report (ATR) Output Details

Modification Type Indicates the type of modification made to the
Item Question. Modification Types: Initial Entry,
Association Added, Association Removed, Form
Comment, Form Deleted, Form Frozen, Form
SDV Complete, Form SDV Partial, Form SDV
Ready, Form Started, Form Undeleted, Form
Unfrozen, Item Comment, Modification, Query,
BOOK Signature, and CRF Signature
Entered Reason Reason entered in InForm for the modification
made to the Item Question. This could be an
option from a drop down, i.e., Transcription Error
or the text entered by the InForm user.
Current Value Value currently visible in the Item Question in the
InForm study UI
Current Value Date/Time Date/Time the value was updated to the Current
Value
Current Value Date/Time (UTC) Date/Time in Coordinated Universal Time (UTC)
the value was updated to the Current Value
Query Text The query text associated with the Current Value
Previous Value The value present in the Item Question prior to
the change
Previous Value Date/Time Date/Time the Previous Value was entered
Previous Value Date/Time (UTC) Date/Time in Coordinated Universal Time (UTC)
the Previous Value entered
Rights Group InForm Rights Group of the user that made the
change
Username InForm Username of the user that made the
change
User Type InForm user type of the user that made the
change

This report includes an audit history of changes made to each user account.
• User status changes, such as created, activated, deactivated, and terminated.
• Query group changes
• Reporting group changes
• Rights group changes
• Signature group changes
• Site association changes
Follow the steps below to generate the User Assignment History report
1. On the My Requests page, select Create History Request from the Create Requests
drop-down.
2. On the Study Information page, accept the default Request Name (comprised of the
study name plus the current date and time) or enter a different name.
3-4
Chapter 3
3. Enter an optional Description.

4. Select User Assignment History, and click Next.
5. Enter the Request Settings, then click Next.
Table 3-3 User Assignment History Report - Request Settings
Setting Description
headers.
Share with Sites • Select Yes (default) if you want to make the
report made available for download by site
users.
• Select No if site users do not need to
download this report.
confirm downloading the report shared with
them.
Note:
Yes.
Confirm archives and reports

from site users.
Note:
Yes. Note:
enabled.

not be sent.
contents (TOC).
3-5
Chapter 3
Table 3-3 (Cont.) User Assignment History Report - Request Settings
Setting Description
Include data as of date and time • Select Now to include all data up to the date
and time displayed.
• Choose Select date/time to enter a specific
date and time.
Note:
The earliest date you can select is the
enrollment date of the first subject. For
more information, see How does the
Include data as of date and time
option affect the output?
Export Selection Criteria • Select All Sites to include data for all sites.
• Select By Site to select the sites to include
in the report.
Note:
For more information, see How
do I define the Export Selection
Criteria?
6. Review the request settings on the Review and Submit page for accuracy.
• Click Submit to generate the report.
• Click Yes, Create Another to return to the Create History Request page.
page.
displays 100.
Note:
9. You can now Download a history report.
Table 3-4 User Assignment History (UAH) Output Details

Study Name InForm study name
3-6
Chapter 3
Download a history report
Table 3-4 (Cont.) User Assignment History (UAH) Output Details

Site ID InForm site number
Site Name InForm site name
Username Username of the user to whom changes were
applied
Change Type The type of change made to the user Change
Types: Group or Status.
Change Time Date/Time the change was submitted
Change Time (UTC) Date/Time in Coordinated Universal Time (UTC)
the change was submitted
User Change The high-level change made to the user User
Change Types: User Created, User Activated,
User Deactivated, Added to Group & Removed
from Group.
Change Rights Group Type The group change made for the user Change
Rights Group Types: Site, Rights Group,
Reporting Group, Query Group, and Signature
Group
Group Name The specific group name that was changed
Changing Username The username of the person who made the
change
Example of a Reporting Group change applied to a user.

• Change Type: Group
• User Change: Added to Group
• Change Rights Group Type: Reporting Group
• Group Name: Sponsor Users Reporting Group
Download a history report

1. On the My Requests - Completed or a Request Details page, select the report checkbox
and click Download.
The browser prompts you to Open or Save the file. We recommend that you save the
file(s) to a local machine and then extract the output from the downloaded ZIP file.
2. Click Save to save the output to your local machine at the designated location.
3. Extract the output from the ZIP file.
• The name of the ZIP file matches the request name.
• The file is in CSV format for import into MS Excel. One ZIP file is created and includes
all sites.
Tip:
If you view files without extracting them in the ZIP tool, the hyperlinks in the files
might not work correctly.
3-7
4
Create other reports
In this chapter
• Site Confirmation report
• Download Log report
• Not Yet Downloaded report
Site Confirmation report

Download this report to view a list of all requests shared with sites where site confirmation was
required.
Note:
For more information about the confirmation process, see Confirm archives and
reports.
The report includes the confirmation status (Confirmed or Not Confirmed), who confirmed the
request, and when it was confirmed.
Archive rights needed to access the report

• Sponsor users with the View Download Confirmation right can download this report.
Download the Site Confirmation report

1. From the Reports section on the left, click Site Confirmation.
2. Use the Search filters to locate specific requests or click Download as CSV or Download
as PDF to download a report that includes all requests.
3. When prompted, save the report locally.
Download Log report

Download this report to view a log of downloads performed by sponsor and site users in the
Oracle InForm CRF Submit user interface.
This report does not include requests downloaded from the Oracle sFTP server. For more
information, see About Electronic Trial Master File (eTMF).
The recommended practice is to download this report as a part of the study decommissioning
processes, ensuring you have an audit trail of all downloads.
4-1
Chapter 4
Not Yet Downloaded report
Note:
After decommissioning the study, you cannot retrieve this report.

• Sponsor users with the Administer Archives right can download this report.
Download the Download Log

1. From the Reports section on the left, click Download Log.
2. Use the Search filters to locate specific requests or click Download as CSV to download a
report that includes all requests.
3. When prompted, save the report locally.

Download this report to track requests created by site users and requests and history reports
created by sponsor users and shared with sites that have not yet been downloaded. From the
same page, you can also send reminder email notifications.
The report includes the following requests and reports

Requests and history reports generated by a sponsor user and shared with sites include.
• Archival PDF requests
• Custom PDF requests
• Audit Trail Report (ATR)
• User Assignment History (UAH)
Requests generated by site users.
• Site Requests
Requests are added to this report once successfully generated and remain here until the site
downloads them.
Once downloaded, it is removed from this report and tracked in the Download Log.

• Sponsor users with the Administer Archives right can download this report.
Download the Not Yet Downloaded report

1. From the Reports section on the left, click Not Yet Downloaded.
2. Use the Search filters to locate specific requests.
3. Clicking the checkbox for one or more requests enables the Send Reminder button.
4-2
Chapter 4
Note:
You can select all requests on a page by selecting the check box at the top of the
first column.
The Not yet downloaded PDFs or History Requests (Site user) email notification is sent
when Send Reminder is clicked. For more information, see About email notifications.
4-3
5
Manage archives and history reports
In this chapter
• Display the options and settings
• View request processing details
• Resubmit a failed request
• Delete an archive or report
• Monitor request notices
• Check how much storage has been used
• Archives and reports shared by sponsors
Display the options and settings

Why do this? When reviewing a test run or archive or report, it is useful to see the request
details.
1. On the My Requests - Processing, My Requests - Completed, My Requests - Saved, or My
Requests - Deleted page, select the request checkbox and click Show Settings.
2. Review the request details:
• If you selected specific subjects, sites, or visits, you can click a link to see your
selections.
• To print the settings, click Print.
3. To return to the My Requests page, click Close.
View request processing details

Why do this? Follow these steps if you need information about when an archive or history
report was processed.
1. On the My Requests - Completed or My Requests - Deleted page, click the Request
Name to get to the Request Details page.
The following information about the archive and report requests appears. All times are in
the time zone of the current browser.
• Start Time—Date and time processing started.
• Complete Time—Date and time processing completed.
• File Type—Type of information included in the output.
• File Name—Name of the file generated.
• State—Status of the archive or report request.
2. To return to the My Requests page, click Return.
5-1
Chapter 5
Resubmit a failed request
Resubmit a failed request

When a request fails, its status shows Failed on the My Requests - Completed page. A ZIP
folder is still created and contains files for any subjects for which the request was successful.
The ZIP folder also includes a failure report. You can correct the errors and resubmit the
request.
If available storage space is exceeded, requests continue to fail with the status of Failed-out
of storage space. For more information, see Check how much storage you have used.
Tip:
You can manually delete outdated or downloaded archives and reports to free up
space.
1. On the My Requests - Completed page, locate a request with a Failed status.

2. Click the Request Name.
On the Request Details page, you can see which files failed and why, files that succeeded
and are ready for download, and a failure report.
• The reason for failure appears in red in the State column. You can click the reason to
see more information.
• Files that were successfully created are labeled Ready for Download in green.
3. To download a successful file, click its check box, then click Download.
4. To resubmit a failed file:
• Try resubmitting the file as is by selecting its check box and clicking Resubmit.
Sometimes, just resubmitting the request works.
• Understand why some files failed by reviewing the details in the failure report. Each
line of the report describes a single file failure. To view the failure report, select it from
the Reports menu in the navigation pane at the left. You cannot download the report.
• Create a new request based on fixing the errors and submit it.
Delete an archive or report

Requests over 120 days old are automatically deleted to maintain the storage servers.
Note:
The Deleted By column on the My Requests - Deleted page (under My Requests)
displays the user name of the person who deleted the request. System is displayed
for auto-deleted requests.
1. On the My Requests - Completed or My Requests - Saved page, click the check box to the
left of a request, then click Delete.
The Select Requests page opens.
5-2
Chapter 5
Monitor request notices
2. Select the requests you want to delete from the list on the left, then use the arrows to move
your selections to the Selected List table on the right. In some cases, the request has
already been moved.
Tip:
Click the double arrow to move all requests.
3. Click Delete.
WARNING:
Deleting a request permanently removes all data files associated with the
request. These cannot be retrieved after deletion. This is also true for requests
automatically deleted after 120 days.
4. Click OK to confirm the deletion.

• Deleted requests are moved to My Requests - Deleted.
• Requests shared with sites are also deleted from the Site Archives page.
5. Clicking the check box to the left of the Request Name enables the Show Settings button,
which when clicked, displays the settings used to generate the request. This page can be
printed.
6. Click the request name to open the Request Details page. Here, you can view the files
(and associated details) generated for the request. These files can no longer be
downloaded.
Monitor request notices

Why should I do this? View notifications to see when archive and report requests have
completed, failed, or been downloaded.
Tip:
You must activate this feature on the Settings page.
1. In the Notifications section on the left, click Request Notices.

2. (Optional) Filter the information within each column heading:
• Request Name—Default or user-defined name for the request. Click the Request
Name to display the request on the My Requests-Completed page.
• Notification Type—Status or action with which the email notification is associated (for
example, Completed or Failed).
• Email Sent—The date and time when the email notification was sent (in GMT).
• Email Status—Message status. For example: Sent means the email notification was
sent successfully.
3. To view the notification details, click the Details link in the Details column to see:
• Subject—Subject line of the email message.
5-3
Chapter 5
Check how much storage has been used
• Body—Content of the message.

• Email Sent—Date and time the notification was sent.
• Sender—The email address of the sender.
• Recipient—The email address of the person who received the message.
• Sent—Status of the notification. For example, Sent or Failed.
4. To close the Details window, click the X in the upper right corner.
Check how much storage has been used

Oracle allocates 1000 GB of storage server space for each customer, which is shared across
all studies. Review the Request Overview report to see server usage details for all your
studies.
1. From the Reports section on the left, select Request Overview.
A storage meter in the upper right corner indicates the allocated storage status and shows
the total Storage Allocated and Storage Used.
• Green indicates that storage is still available.
• Yellow indicates that between 75% and 90% of the allocated storage has been used.
• Red indicates that >90% of the allocated storage has been used.
Note:
Email notifications are sent when the storage server exceeds 75%. To configure
the storage warning email address, see Specify sponsor settings.
2. Use the filters in the Search section to locate details based on a date range and study
name.
3. Click a column header to sort the requests further.
4. Requests can be manually deleted to free up space. Click the help icon to the right of the
storage meter for additional details.
Archives and reports shared by sponsors

In this section
• Can I list the archives and reports shared with sites?
• Is there a record of affidavits used to sign off on Oracle InForm data?
Can I list the archives and reports shared with sites?

The Site Notices page lists requests created by sponsors and downloaded by sites.
1. From the Notifications section on the left, click Site Notices.
2. (Optional) Filter the information within each column heading:
• Request Name—Default or user-defined name for the archive or report request.
• Notification Type—Action the notification is about (for example, Create or Download).
5-4
Chapter 5
Archives and reports shared by sponsors
• Site Name—Site that initiated the request or performed the download.

• Site User—User name of the person who generated the request.
• Email Status—Notification status (for example, Sent or Failed).
• Source—Whether this was a Site or Sponsor request.
• Details—A link to display the email message.
3. To view the notification details, click the Details link in the Details column to see:
• Subject—Subject line of the email message.
• Body—Content of the message.
• Sender—The email address of the sender.
• Recipient—The email address of the person who received the message.
• Sent—Status of the notification (for example, Sent).
4. To close the Details window, click the X in the upper right corner.
Is there a record of affidavits used to sign off on Oracle InForm data?

Why is this important? After a trial has been decommissioned, you might need to see the
affidavit used during a particular Oracle InForm casebook or form signing.
Affidavit text can be changed at any time. The Submission, Archival, and Custom PDF output
shows the affidavit text that was in effect at the time the casebook or form was signed. This
may be different than the affidavit text currently being used.
The affidavit text appears in the language that was in use when the affidavit was signed.
5-5
6
For administrators
Here, you can define Trial Settings and Sponsor Settings, enable and customize Email
Notifications, view Request Overview details, and view and download the Site Confirmation
report, Download Log, and Not Yet Downloaded Report.
• Manage Trial and Sponsor Settings
• Email notifications
• Rights management
Manage Trial and Sponsor Settings

• Specify Trial Settings
• Specify Sponsor Settings
Specify Trial Settings

Select Settings from the Manage section in the left-side panel, then click Trial Settings to
change the default configuration for the following trial-level settings.
Table 6-1 Trial Settings and their descriptions
Setting Description
Maximum Subjects per PDF Request by site user Enter the maximum number of subjects (between 1
and 50,000) a site user can include in a single PDF
request. The setting default is five (5).
Note:
This controls the
Export Selection
Criteria site request
setting.
Default Email Address Enter an email address to receive email

notifications when,
• A request shared with a site has been
downloaded.
• A a request has been generated by a site.
For more information, see About email notifications.
Enable eTMF Download When enabled, the setting Allow PDF request to
be stored in eTMF is made available when
creating Archival (sponsor) and Custom requests.
For more information, see About Electronic Trial
Master File (eTMF)
6-1
Chapter 6
Email notifications
Table 6-1 (Cont.) Trial Settings and their descriptions
Setting Description
Give priority to InForm Limit the concurrent data generation of output for
the trial so that InForm activities take priority.
Specify Sponsor Settings

Sponsor users with the Administer Archives right can access Settings under the Manage
section on the left side panel to enter a valid email address to receive email notifications when
allocated storage limits are reached and customize the confirmation text displayed to site users
when download confirmation has been requested.
Storage Warning Configuration

When specified, Storage Warning emails are only sent to this address. If an email address is
not entered, sponsor users with any of the following permissions receive them: Generate
Archives, Delete Archives, Administer Archives, and View All Completed Archives.
1. Enter a valid email address or distribution list.
Note:
This is a sponsor-level setting and only needs to be defined in one of your
studies. This covers both your LIVE and UAT studies.
2. Click Save.
Confirmation Text configuration

During request creation, a sponsor user can require site users to confirm they have
downloaded and reviewed a request shared by a sponsor.
The confirmation text is presented to the site user when they confirm the request output. Site
confirmation actions are captured in the Site Confirmation report.
1. Remove the check mark next to Use default text to unlock the text boxes.
2. Update the text, then click Save.
Email notifications
• About email notifications
• Configure email notifications
About email notifications

Required permissions
Sponsor users assigned to a Rights Group with the Administer Archives right can manage
email notifications. For more information, see Configure email notifications.
6-2
Chapter 6
Email notifications
Who can receive notifications

Sponsor and site users with access to Archives can receive email notifications. See the table
below for specific details about each notification.
Note:
Notifications are set to Yes by default for new studies.
Available languages
Each notification includes default text in both English and Japanese, which you can edit. For
more information, see Configure email notifications.
6-3
Chapter 6
Email notifications
Available Notifications
Table 6-2 Notification Details
Notification Details Notes

PDF or History Request is CRF Submit sends a notification n/a
available for download (Sponsor to the email address of the
user) requester (Sponsor user) when a
PDF or History Report is
available for download.
No
te:
Hist
ory
Req
uest
her
e
and
in
the
cell
s
belo
w
refe
rs to
the
Aud
it
Trail
Rep
ort
and
the
Use
r
Assi
gnm
ent
Hist
ory
rep
ort.
PDF or History Request is CRF Submit sends a notification This notification is sent to site
available for download (Site user, to the email address of site users users with Archive rights who are
when shared with sites) when a PDF or History report, associated with the rights group
shared with sites, is available for selected under, Select the
download. It is sent only when Rights Group to Control
Yes is selected for Notify Site Content. If the setting Allow any
Users during request creation. Site User to download this
request is set to Yes it is sent to
all site users with Archive rights.
6-4
Chapter 6
Email notifications
Table 6-2 (Cont.) Notification Details
Notification Details Notes

PDF or History Request shared CRF Submit sends a notification See Specify trial settings to see
with sites has been downloaded to the Default Email Address how to define the Default Email
(Default Email Address). when a request generated by a Address.
sponsor user and shared with
sites has been downloaded.
PDF or History Request has been CRF Submit sends a notification This notification is sent to the
confirmed (Sponsor user). to the email address of the Default Email Address if there is
requester (Sponsor user) when a no email address associated with
request shared with and the sponsors user account. See
downloaded by sites has been Specify trial settings to see how
confirmed. to define the Default Email
Address.
PDF or History Request CRF Submit sends a notification See Specify trial settings to see
submitted by a site user (Default to the Default Email Address how to define the Default Email
Email Address). when a site user has submitted a Address.
PDF or History Request.
PDF or History Request is CRF Submit sends a notification n/a
available for download (Site user). to the email address of the
requester (Site user) when a PDF
or History Request is available for
download.
Not yet downloaded PDFs or Sent to remind site users they n/a
History Requests (Site user). have not yet downloaded PDF or
History Report requests. This
notification is sent based on
actions taken in the Not Yet
Downloaded report.
PDF or History Request has CRF Submit sends a notification n/a
failed (Site user). to the email address of the
requester (Site user) when a PDF
or History Request has failed.
PDF or History Request has CRF Submit sends a notification n/a
failed (Sponsor user). to the email address of the
requester (Sponsor user) when a
PDF or History Request has
failed.
Configure email notifications

To manage notifications sponsor users need to belong to a Rights Group that includes the
Administer Archives right.
For more information about email notifications, see About email notifications
1. Log in to your study and click Archives in the top navigation bar.
2. Click Notifications under Manage in the left navigation panel.
You are presented with nine (9) email notifications set to Yes by default.
Note:
To define the Default Email Address, see Specify trial settings
6-5
Chapter 6
Rights management
3. Click No to disable the notifications you do not want to utilize.
4. Click the expand button ( ) to edit the email text for each notification to be used. You
can only expand one notification at a time.
The setting Use default notification body if enabled by default.
5. Uncheck the setting Use default notification body.
The default English and Japanese email text is now editable. You can enter custom text up
to 2000 characters.
6. Update the text and click Save.
7. Repeat these steps for each notification.
Rights management
In this section
• Archival rights and descriptions
• Where are rights controlled?
Archival rights and descriptions

The following Oracle InForm CRF Submit archival rights can be added to Oracle InForm rights
groups in Oracle InForm User Management Tool (UMT):
Table 6-3 Description of Archival Rights
Archival Right For sponsor users For site users

Generate Archives Allows sponsor users to generate Allows site users to generate the
the following PDF archives and following PDF archives and
history reports. history reports.
PDF Archives PDF Archives
• Submission PDF • Site Request
• Archival PDF For more information, see Create
• Blank Forms Only an archive of study data.
• Custom PDF History Reports
• Custom Blank Forms • Audit Trail Report
History Reports • User Assignment History
• Audit Trail Report For more information, see What
• User Assignment History reports are available.
For more information, see Access
Oracle InForm CRF Submit to
generate an archive or history
report.
6-6
Chapter 6
Rights management
Table 6-3 (Cont.) Description of Archival Rights

Administer Archives Allows sponsor users to specify This right is for sponsor users
trial and sponsor settings, only.
configure email notifications, and Adding this right to a site Rights
generate reports. Group does not grant site users
• Specify trial settings administrative access.
• Specify sponsor settings
• Define email notifications
• Request Overview report
• Download Log report
• Not Yet Downloaded Report
If you are using an Oracle InForm
version lower than 7.0 and need
to manage rights, see Where are
rights controlled?
Delete Archives Allows sponsor users to: Allows site users to delete PDF
• Delete PDF and history and history report requests that
report requests generated by they generated on the Site
them and other sponsor Archives page, as well as
users on the My Requests— requests generated by sponsors
Completed page. and site users assigned to the
• Delete their saved PDF same sites.
requests on the My For more information, see Delete
Requests—Saved page. a site archive or report.
For more information, see Delete
an archive or report.
View All Completed Archives Allows sponsor users to view all By default, site users can view
sponsor-generated PDF archive PDF requests and history reports
and history report requests on the on the Site Archives page that
My Requests—Completed page they generated, ones shared by
generated for any site in a study. sponsor users, and requests
If you do not include this right, generated by other site users
sponsor users can only see belonging to the same site.
requests they generated. Not including or removing this
right does not change what a site
user can view.
Manage Templates Allows sponsor users to create a This right is for sponsor users
template based on the Custom only.
PDF archive type. Adding this right to a site Rights
Sponsor users can then select Group does not allow site users
Create from Templates under to manage templates.
Create Requests.
For more information, see Why
should I create a custom
template?.
6-7
Chapter 6
Rights management
Table 6-3 (Cont.) Description of Archival Rights

Share Archives with Sites Controls the setting Share with This right is for sponsor users
Sites, which is available when only.
generating the following PDF Site users cannot share requests.
requests and history reports.
• Archival PDF
• Custom PDF
• Audit Trail Report
• User Assignment History
This right also controls the setting
Site Confirmation Required,
which is linked to Share with
Sites. You cannot require a site to
confirm a request that was not
shared.
Confirm Archives Download This right is for site users only, as This right controls access to the
only site users can confirm an Confirm link made available to
archive or history report shared site users for archive and history
by a sponsor user. report requests shared by
sponsors where site confirmation
was required.
For more information, see
View Download Confirmation Allows sponsor users to generate Site users can also generate the
the Site Confirmation report Site Confirmation report for their
under the Reports section. sites. Adding or removing this
For more information, see Site right does not change access to
Confirmation report. this report for site users.
Download for eTMF Starting with Oracle InForm CRF n/a

Submit 7.0.1 this right is no longer
relevant but is still present in the
Oracle InForm user interface. This
will be removed in a future
release.
Where are rights controlled?

For Oracle InForm versions 7.0 and later:
Access is controlled by the Oracle InForm User Management Tool administrator in the Oracle
InForm User Management Tool (UMT) interface. For more information, see Archival rights and
how to assign them.
Note:
Work with your Oracle point of contact if you have questions about how to best
assign rights.
6-8
Chapter 6
Rights management
For Oracle InForm versions before 7.0:

1. Log into Oracle InForm as a CRFAdmin.
2. On the InForm Home page, click the Archives link below the Oracle InForm icons.
3. From the Manage section on the left, click Rights Group.
4. Select the radio button of the rights group you want to update.
5. Click Edit.
6. Select and deselect the check boxes of the Archival rights as desired.
7. Click Save.
6-9
7
Revision History
Date Part number Description
05 June 2024 F92947-04 A broken link was fixed on
Archive types and what files and
subject data are included in the
Submission PDF row.
04 June 2024 F92947-03 The Submission PDF and
Custom PDF, listed on Archive
types and what files and subject
data are included, were updated
with additional details about the
Protocol Guide and Study
Design.
31 May 2024 F92947-02 The Submission PDF, listed on
Archive types and what files and
subject data are included, was
updated by adding Protocol
Guide as one of the output files.
28 May 2024 F92947-01 Original version of this document.
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1 For new users

3 Create a history report

4 Create other reports

5 Manage archives and history reports

Access to Oracle Support

Additional copyright information

About Oracle InForm CRF Submit

Access Oracle InForm CRF Submit to generate an archive or

How do I generate a study archive or history report?

Archive types and the files and subject data included

Table 1-1 Archive request output details

Request type Description Included in the .zip file

Table 1-1 (Cont.) Archive request output details

Request type Description Included in the .zip file

History report details

Table 1-2 History report details

Report name Description Included in the .zip file

Subscribe to release announcements

What data is migrated across data centers?

Command line utility

Start with a Test Run

Follow the steps below to create a Test Run

Here's what a Submission PDF request includes

Follow the steps below to create a Submission PDF

3. Complete the Form Options, then click Next.

Table 2-1 Submission PDF Form Options

Headings Language • Specify the language to use for labeling

4. Complete the Request Settings, then click Next.

Table 2-2 Submission PDF Request Settings

Table 2-2 (Cont.) Submission PDF Request Settings

For more information, see How does the Include

8. You can now Download the PDF.

Here's what an Archival PDF request includes

Follow the steps below to create an Archival PDF

3. Complete the Form Options, then click Next.

Table 2-3 Archival PDF Form Options

Headings Language • Specify the language to use for labeling

4. Complete the Request Settings, then click Next.

Table 2-4 Archival PDF Request Settings

Table 2-4 (Cont.) Archival PDF Request Settings

• Select No if you do not require confirmation

• Select No (default) if the notification should

Table 2-4 (Cont.) Archival PDF Request Settings

For more information, see How does the Include

• Click No, Go to Processing Page to be taken to the My Requests - Processing

8. You can now Download the PDF.

Blank Forms Only

Here's what a Blank Forms Only request includes

Follow the steps below to create a Blank Forms Only request

3. Complete the Form Options, then click Next.

Table 2-5 Blank Forms Only Form Options

Table 2-5 (Cont.) Blank Forms Only Form Options

Headings Language • Specify the language to use for labeling

4. Complete the Request Settings, then click Next.

Table 2-6 Blank Forms Only Request Settings

8. You can now Download the PDF.

Here's what a Custom PDF request includes