Introduction to CGIRB Connexus® For Site Level Users Click here to begin: Version 1.0 Dated 9/1/2012 [email protected].
Download ReportTranscript Introduction to CGIRB Connexus® For Site Level Users Click here to begin: Version 1.0 Dated 9/1/2012 [email protected].
Slide 1
Introduction to CGIRB Connexus®
For Site Level Users
Click here to begin:
Version 1.0
Dated 9/1/2012
[email protected]
Slide 2
Using this training presentation:
The goal of this presentation is to give the Site Level user a basic overview of the CGIRB Connexus Web
Portal. You can also sign up for one of our weekly instructor led training courses here:
http://www.cgirb.com/cgirb-connexus/connexus-training/
This presentation is broken into separate modules. If at any
time you want to start over at the table of contents, click the
“Home” icon on the top right corner of each page.
Some lessons may take more than 1 slide. Use this icon to
move to the next page.
After each lesson there will be a link to the next lesson on
top of the page.
Click here to begin!
Slide 3
Table of Contents
What is CGIRB Connexus?
How do I register?
Workspace Concept
Viewing Documents
Submitting Documents
Managing Users
Troubleshooting
Contacting the Help Desk
Click this icon to learn more
about using this presentation:
Slide 4
Next Lesson: How Do I Register
What is CGIRB Connexus?
Connexus is a secure Web Portal that allows sites to submit and receive
regulatory documents to and from Copernicus Group IRB.
Users at the Site as well as at the Sponsor/CRO have access to all
regulatory documents the IRB maintains or creates for the entire life of
the study.
Connexus allows you to securely submit items like Advertisements,
Change Forms, Continuing Review and Safety Information to Copernicus
Group.
Copernicus Group will alert you via email as soon as new outcome
documents like Approval Letters or Informed Consents are available to
download.
Slide 5
Next Lesson: Workspace Concept
How do I register?
You can register for CGIRB Connexus here:
https://connexus.cgirb.com/cswp/Account/Register.aspx
Registration only needs to be completed once. If you already have an
account, you do not need to register again.
All staff at your site can register with their own credentials. An unlimited
number of users can access and collaborate on your site’s workspace.
Make sure you register with your “site email” address. Whichever email
address you would use on documents or forms sent to the IRB. You will
be validated based on this email address.
If you have any questions or issues regarding CGIRB Connexus, please
contact our helpdesk: [email protected]
Slide 6
Next Page
Workspace Concept
Connexus is broken into “Workspaces”. Each study and site that you have access to
represents a workspace. Always navigate to the workspace you want to take an action
in, then take the action.
When you first log in you will see a list of “Study Workspaces”. These are all of the
studies that you have access to. If you do not see your study listed, please contact us.
Click the “Protocol” number to move 1 level deeper into the system.
Slide 7
Next Page
Workspace Concept (Continued)
Once inside the Study Workspace:
Listed here are the main contacts for this Study
at CGIRB and the Sponsor/CRO. You can click
their names to send an email.
Study Sites table will show you all sites you have
access to. Click the “IRB Site” number to
navigate one level deeper to your site specific
workspace.
Slide 8
Next Lesson: Viewing Documents
Workspace Concept (Continued)
Once inside the Site Workspace:
Study and Site
Identifier, so you
always know where
you are in the
system.
Site Profile - This is a
live view into our
database with the
most up to date
contact information
on file for your site.
If you see any
information that
needs updating,
please contact the
study’s Point of
Contact.
Action Buttons- These buttons
perform actions on the site
workspace. Learn more about
them in the Viewing
Documents, Submitting
Documents and Managing
Users slides.
Submissions for this Site – This
table lists all site specific
submissions regardless of how
they were received. The color
coded status correlates to
where the submission is in
CGIRB’s process. Learn more
on the Submitting Documents
slide.
Slide 9
Next Page
Viewing Documents
The “View All Documents” section gives you access to all regulatory documents
for the life of the study at your site. All Approvals, ICFs, Ads and any other
documents are available here.
1.
To access this section, first navigate to the desired Study Workspace, then the
Site Workspace. Refer to Workspace Concept slide if needed.
2.
Click the
3.
This will open the “View All Documents” section for your site:
action button on the right side of the page.
Slide 10
Next Lesson: Submitting Documents
Viewing Documents (Continued)
Items are listed with the most recently approved first. Note that items may be displayed on
several pages. You also have the ability to search and sort this data.
Search – Enter your
search term in the
desired box:
Sort – Click the column
name you wish to sort.
Click once to sort
Ascending:
Then select search type
from drop down:
Click Twice to sort
Descending:
Click third time to
reset:
This will display only
items matching your
search terms.
To reset, select “No
Filter” from the drop
down
Slide 11
Next Page
Submitting Documents
Submitting documents to Copernicus Group IRB is one of the main functions of Connexus. You can
utilize Connexus to submit any documents to CGIRB you would have normally faxed, emailed or
mailed.
Think of a “Submission” as an envelope that contains 1 or more documents that you need CGIRB to
review. This could be several Ads, or a Change Form accompanied by an updated CV. You will create
1 submission but may upload multiple documents into it.
The steps below will walk you through submitting items after your site is approved. If you need to
submit your initial site submission packet to CGIRB please contact us.
To initiate a new Site Specific Submission:
1.
Navigate to the desired Study Workspace, then the Site Workspace. Refer to
Workspace Concept slide if needed.
2.
Select your submission type from the
the right side of the page.
3.
This will start the process of building the submission.
drop down on
Slide 12
Next Page
Submitting Documents (Continued)
Building your submission:
PI and Study
information is
prepopulated
for you
Commonly
submitted
document
types for this
submission.
You will have
the ability to
add additional
documents
later.
Enter comments
regarding the
entire submission
here. (This field is
optional)
Select a Submission Action:
Upload Now – Browse for the file that
is ready to upload
Upload/Fax/Email Later – Creates a
“placeholder” file to be updated at a
later date.
Click Submit to
build your
initial
submission
envelope.
Not Applicable – Only available for
optional documents. Use this to tell us
what you are not submitting if needed
Enter comments
regarding the
specific
document here.
(This field is
optional)
Slide 13
Next Page
Submitting Documents (Continued)
Once you have clicked the
button, you will receive a confirmation
email, and will be brought to the “Submission Upload Complete” screen.
Click “Next” to continue.
You will then be
brought back to your
Site Workspace,
where you will see
your new submission
listed. Click the
“Submitted Item” to
open the submission.
Slide 14
Next Page
Submitting Documents (Continued)
Once inside the Submission, you can add and update
documents as needed:
Add New
Documents to the
submission here
Items that
have been
submitted are
listed here
Update already
submitted documents
here.
Slide 15
Next Lesson: Managing Users
Submitting Documents (Continued)
Tracking your submissions, regardless of how they were sent.
After submissions are reviewed
and approved they go to
“Complete” status.
When a Submission reaches
“Complete” all Workspace
Managers and Submitters are
notified via email.
As your submission moves
through the review process,
you can track it here.
This email alert will note whether
or not paper copies will be mailed
to you.
The Sponsor/CRO makes the
decision on paper copies being
shipped for your study or not.
If you have questions please
contact us.
Slide 16
Next Page
Managing Users
Connexus offers sites 3 access levels to choose from:
1. Read Only – Cannot Submit or Update Documents
2. Submit – Submit and update Documents
3. Manager – Can submit documents and manage participants.
There is no limit to how many workspace managers there can be
To view Workspace users or add new users to the Workspace:
1.
Navigate to the desired Study Workspace, then the Site Workspace. Refer to
Workspace Concept slide if needed.
2.
Click the
3.
This will open the Site Participants section displaying who already has access
to the workspace, and the ability to add new users. (Only Workspace
Managers can add new users)
action button on the right side of the page.
Slide 17
Next Lesson: Troubleshooting
Managing Users (Continued)
Workspace Managers
can use this page to add
new users.
Enter the email, who
they represent and the
desired access level then
click “Add Participant”.
An email will be sent to
the user notifying them
they have been granted
access to a new site
workspace.
You can edit the details of current users by
selecting the pencil to the left of their name
Workspace users can be deleted by clicking
the trash can to the right of their name
Slide 18
Next Page
Troubleshooting
Connexus allows you to troubleshoot and resolve most
password/login related issues yourself. See table below for
common issues and solutions.
Problem
Solution
Forgot Username
You can login with your
username or email address
Forgot Password
Reset Password
Locked out due to 3 or more
incorrect password attempts
Reset Password
Forgot answers to security
questions
Contact Helpdesk
I do not see my study listed
Contact Helpdesk
Slide 19
Next Lesson: Contact Help Desk
Troubleshooting (Continued)
To reset your password from the main login screen:
Click the forgot password link
and follow the prompts.
On top of all Connexus pages, you will see a “Need Help” bar with links to
answer common questions. These links are dynamic and change as you move
through the system
If these links do not answer your
question, contact the Help Desk here:
Slide 20
Contacting the Help Desk
We have a dedicated Help Desk here at Copernicus Group IRB to assist with
any issues within CGIRB Connexus. Study specific questions should be
directed to the study Point of Contact. (See Workspace Concept)
Our Help Desk hours are Mon-Fri 8:30 AM – 5:00 PM EST
You can contact us 3 ways:
1. Email – [email protected] or select the
icon on the
right corner of the page.
2. Live Chat - Click the live chat icon on top of all Connexus pages to
instantly be connected to one of our support staff.
3. Phone Call - 888-303-2224 ask for the Connexus Help Desk
Introduction to CGIRB Connexus®
For Site Level Users
Click here to begin:
Version 1.0
Dated 9/1/2012
[email protected]
Slide 2
Using this training presentation:
The goal of this presentation is to give the Site Level user a basic overview of the CGIRB Connexus Web
Portal. You can also sign up for one of our weekly instructor led training courses here:
http://www.cgirb.com/cgirb-connexus/connexus-training/
This presentation is broken into separate modules. If at any
time you want to start over at the table of contents, click the
“Home” icon on the top right corner of each page.
Some lessons may take more than 1 slide. Use this icon to
move to the next page.
After each lesson there will be a link to the next lesson on
top of the page.
Click here to begin!
Slide 3
Table of Contents
What is CGIRB Connexus?
How do I register?
Workspace Concept
Viewing Documents
Submitting Documents
Managing Users
Troubleshooting
Contacting the Help Desk
Click this icon to learn more
about using this presentation:
Slide 4
Next Lesson: How Do I Register
What is CGIRB Connexus?
Connexus is a secure Web Portal that allows sites to submit and receive
regulatory documents to and from Copernicus Group IRB.
Users at the Site as well as at the Sponsor/CRO have access to all
regulatory documents the IRB maintains or creates for the entire life of
the study.
Connexus allows you to securely submit items like Advertisements,
Change Forms, Continuing Review and Safety Information to Copernicus
Group.
Copernicus Group will alert you via email as soon as new outcome
documents like Approval Letters or Informed Consents are available to
download.
Slide 5
Next Lesson: Workspace Concept
How do I register?
You can register for CGIRB Connexus here:
https://connexus.cgirb.com/cswp/Account/Register.aspx
Registration only needs to be completed once. If you already have an
account, you do not need to register again.
All staff at your site can register with their own credentials. An unlimited
number of users can access and collaborate on your site’s workspace.
Make sure you register with your “site email” address. Whichever email
address you would use on documents or forms sent to the IRB. You will
be validated based on this email address.
If you have any questions or issues regarding CGIRB Connexus, please
contact our helpdesk: [email protected]
Slide 6
Next Page
Workspace Concept
Connexus is broken into “Workspaces”. Each study and site that you have access to
represents a workspace. Always navigate to the workspace you want to take an action
in, then take the action.
When you first log in you will see a list of “Study Workspaces”. These are all of the
studies that you have access to. If you do not see your study listed, please contact us.
Click the “Protocol” number to move 1 level deeper into the system.
Slide 7
Next Page
Workspace Concept (Continued)
Once inside the Study Workspace:
Listed here are the main contacts for this Study
at CGIRB and the Sponsor/CRO. You can click
their names to send an email.
Study Sites table will show you all sites you have
access to. Click the “IRB Site” number to
navigate one level deeper to your site specific
workspace.
Slide 8
Next Lesson: Viewing Documents
Workspace Concept (Continued)
Once inside the Site Workspace:
Study and Site
Identifier, so you
always know where
you are in the
system.
Site Profile - This is a
live view into our
database with the
most up to date
contact information
on file for your site.
If you see any
information that
needs updating,
please contact the
study’s Point of
Contact.
Action Buttons- These buttons
perform actions on the site
workspace. Learn more about
them in the Viewing
Documents, Submitting
Documents and Managing
Users slides.
Submissions for this Site – This
table lists all site specific
submissions regardless of how
they were received. The color
coded status correlates to
where the submission is in
CGIRB’s process. Learn more
on the Submitting Documents
slide.
Slide 9
Next Page
Viewing Documents
The “View All Documents” section gives you access to all regulatory documents
for the life of the study at your site. All Approvals, ICFs, Ads and any other
documents are available here.
1.
To access this section, first navigate to the desired Study Workspace, then the
Site Workspace. Refer to Workspace Concept slide if needed.
2.
Click the
3.
This will open the “View All Documents” section for your site:
action button on the right side of the page.
Slide 10
Next Lesson: Submitting Documents
Viewing Documents (Continued)
Items are listed with the most recently approved first. Note that items may be displayed on
several pages. You also have the ability to search and sort this data.
Search – Enter your
search term in the
desired box:
Sort – Click the column
name you wish to sort.
Click once to sort
Ascending:
Then select search type
from drop down:
Click Twice to sort
Descending:
Click third time to
reset:
This will display only
items matching your
search terms.
To reset, select “No
Filter” from the drop
down
Slide 11
Next Page
Submitting Documents
Submitting documents to Copernicus Group IRB is one of the main functions of Connexus. You can
utilize Connexus to submit any documents to CGIRB you would have normally faxed, emailed or
mailed.
Think of a “Submission” as an envelope that contains 1 or more documents that you need CGIRB to
review. This could be several Ads, or a Change Form accompanied by an updated CV. You will create
1 submission but may upload multiple documents into it.
The steps below will walk you through submitting items after your site is approved. If you need to
submit your initial site submission packet to CGIRB please contact us.
To initiate a new Site Specific Submission:
1.
Navigate to the desired Study Workspace, then the Site Workspace. Refer to
Workspace Concept slide if needed.
2.
Select your submission type from the
the right side of the page.
3.
This will start the process of building the submission.
drop down on
Slide 12
Next Page
Submitting Documents (Continued)
Building your submission:
PI and Study
information is
prepopulated
for you
Commonly
submitted
document
types for this
submission.
You will have
the ability to
add additional
documents
later.
Enter comments
regarding the
entire submission
here. (This field is
optional)
Select a Submission Action:
Upload Now – Browse for the file that
is ready to upload
Upload/Fax/Email Later – Creates a
“placeholder” file to be updated at a
later date.
Click Submit to
build your
initial
submission
envelope.
Not Applicable – Only available for
optional documents. Use this to tell us
what you are not submitting if needed
Enter comments
regarding the
specific
document here.
(This field is
optional)
Slide 13
Next Page
Submitting Documents (Continued)
Once you have clicked the
button, you will receive a confirmation
email, and will be brought to the “Submission Upload Complete” screen.
Click “Next” to continue.
You will then be
brought back to your
Site Workspace,
where you will see
your new submission
listed. Click the
“Submitted Item” to
open the submission.
Slide 14
Next Page
Submitting Documents (Continued)
Once inside the Submission, you can add and update
documents as needed:
Add New
Documents to the
submission here
Items that
have been
submitted are
listed here
Update already
submitted documents
here.
Slide 15
Next Lesson: Managing Users
Submitting Documents (Continued)
Tracking your submissions, regardless of how they were sent.
After submissions are reviewed
and approved they go to
“Complete” status.
When a Submission reaches
“Complete” all Workspace
Managers and Submitters are
notified via email.
As your submission moves
through the review process,
you can track it here.
This email alert will note whether
or not paper copies will be mailed
to you.
The Sponsor/CRO makes the
decision on paper copies being
shipped for your study or not.
If you have questions please
contact us.
Slide 16
Next Page
Managing Users
Connexus offers sites 3 access levels to choose from:
1. Read Only – Cannot Submit or Update Documents
2. Submit – Submit and update Documents
3. Manager – Can submit documents and manage participants.
There is no limit to how many workspace managers there can be
To view Workspace users or add new users to the Workspace:
1.
Navigate to the desired Study Workspace, then the Site Workspace. Refer to
Workspace Concept slide if needed.
2.
Click the
3.
This will open the Site Participants section displaying who already has access
to the workspace, and the ability to add new users. (Only Workspace
Managers can add new users)
action button on the right side of the page.
Slide 17
Next Lesson: Troubleshooting
Managing Users (Continued)
Workspace Managers
can use this page to add
new users.
Enter the email, who
they represent and the
desired access level then
click “Add Participant”.
An email will be sent to
the user notifying them
they have been granted
access to a new site
workspace.
You can edit the details of current users by
selecting the pencil to the left of their name
Workspace users can be deleted by clicking
the trash can to the right of their name
Slide 18
Next Page
Troubleshooting
Connexus allows you to troubleshoot and resolve most
password/login related issues yourself. See table below for
common issues and solutions.
Problem
Solution
Forgot Username
You can login with your
username or email address
Forgot Password
Reset Password
Locked out due to 3 or more
incorrect password attempts
Reset Password
Forgot answers to security
questions
Contact Helpdesk
I do not see my study listed
Contact Helpdesk
Slide 19
Next Lesson: Contact Help Desk
Troubleshooting (Continued)
To reset your password from the main login screen:
Click the forgot password link
and follow the prompts.
On top of all Connexus pages, you will see a “Need Help” bar with links to
answer common questions. These links are dynamic and change as you move
through the system
If these links do not answer your
question, contact the Help Desk here:
Slide 20
Contacting the Help Desk
We have a dedicated Help Desk here at Copernicus Group IRB to assist with
any issues within CGIRB Connexus. Study specific questions should be
directed to the study Point of Contact. (See Workspace Concept)
Our Help Desk hours are Mon-Fri 8:30 AM – 5:00 PM EST
You can contact us 3 ways:
1. Email – [email protected] or select the
icon on the
right corner of the page.
2. Live Chat - Click the live chat icon on top of all Connexus pages to
instantly be connected to one of our support staff.
3. Phone Call - 888-303-2224 ask for the Connexus Help Desk