Transcript Slide 1

Welcome to the DAIDS-ES Protocol
Registration System Training
Presented by
The Division of AIDS (DAIDS) Regulatory Compliance Center (RCC)
Training
Protocol Registration Office (PRO)
 The Protocol Registration Office (PRO) at the
Regulatory Compliance Center (RCC)
implements and manages the day-to-day
operations of the Protocol Registration Process.
 All required protocol registration documents are
submitted to the PRO.
 RCC personnel, under DAIDS oversight, review
the registration materials.
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What is the Protocol
Registration System (PRS)?
 Official source of information for all protocol
registrations performed by the Protocol
Registration Office (PRO)
 Centralized repository to capture, track and view
protocol registration information
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Training Objectives
 Electronically submit registration materials
 Track and monitor progress of submissions
 View and update submission documents and
registration reports
 Understand how to maintain your site users
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Protocol Registration Process
Review and
Provide resolution
OPCRO
Protocol
Registration
Team (PRT)
Protocol
Registration
Office (PRO)
Clinical
Research
Site (CRS)
Review approvals
and documents
Resolve
discrepancies
Triages Submission and
assigns to Protocol
Registration Specialist (PRS)
Request additional
materials as required
Creates and Submits
Electronic Registration
Packet
Respond to
Materials requested
Provide Investigator
of Record (IoR)
Approval decision
Prepare and Review
Registration Decision
Receives Approval or
Disapproval Notification
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Terms we will use in this training
Term
Definition
Designated Site
Site is designated to participate on the study (applicable only for site
restricted studies).
Initial Registration
The first protocol registration request from the site to register to a study.
Amendment Registration
Subsequent requests from the site to register to a new study version.
Approval with Required
Corrections
The site is registered to a study, but corrections or additional materials
are required.
Third Party Submissions
Materials submitted to the PRO by someone other than the site that will
be conducting the protocol.
Submission Type
The general purpose for submitting a submission packet to the PRO
(e.g. Initial, Change of IoR, Updated 1572/IoR Agreement, Continuing
Reviews etc).
Submission Packet
A collection of documents submitted to the PRO for the purpose of
initiating or updating the registration for a specific site and protocol
Packet Number
A unique number assigned to a submission packet that can be used to
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track the status of a submission
The system supports
 Initial & Amendment registrations, LOA & IRB/EC
Continuing review, Revised site ICs and Deregistration.
 New/Change IoR, FDA 1572/IoR Agreements,
Updated CVs
 Required Corrections, Disapproval reversals,
Requested documents/information
 Network / Non-Network studies, Sub-studies
 Domestic and International sites
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What can I do in the PRS?
User Role
Ability
CTU Study Coordinator
Create submissions, Track and Modify existing submission,
Respond to materials request, View Reports
CTU Site Leader
Create submissions, Track and Modify existing submission,
Respond to materials request, View Reports
Site Protocol Registration Data
Manager
Create submissions, Track and Modify existing submission,
Respond to materials request, View Reports
Site Protocol Registration Data
Submitter
Create submissions, Track and Modify existing submission,
Respond to materials request, View Reports
Site Coordinator
Create submissions, Track and Modify existing submission,
Respond to materials request, View Reports
Investigator of Record
Create submissions, Track and Modify existing submission,
Respond to materials request, View Reports
Site Leader
Create submissions, Track and Modify existing submission,
Respond to materials request, View Reports
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How do you get started?
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2
 Enter username and password on Login screen
2 If you have not received your username and password, contact DAIDS
1
at the email address or telephone number provided onscreen.
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Opening Screen
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Submission Screen
 On the left side of the
home page you can
view all outstanding
submissions for sites
you are associated
with
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Alert Screen
 On the right side of
the home page, you
can receive alerts for:
• Applications requiring
correction,
• Request for additional
materials
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How do I….?
 Submit:
• Initial & Amendment registrations
• LOA & IRB/EC Continuing review
• Revised site ICs
• De-registrations
 Same process for all in the PRS
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Initial & Amendment registrations, LOA &
IRB/EC Continuing review, Revised site ICs
and De-registrations
1
 From home page, click
1
New Submission
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Initial & Amendment registrations, LOA &
IRB/EC Continuing review, Revised site ICs
and De-registrations
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3
4
5
2 Select site (if not already correct)
3 Enter protocol number or click icon
 Select proper protocol version number
5 Identify correct IoR
4
to select
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Initial & Amendment registrations, LOA &
IRB/EC Continuing review, Revised site ICs
and De-registrations
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7
6 Check appropriate box (e.g. Initial)
7 Click “Next” button
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Initial & Amendment registrations, LOA &
IRB/EC Continuing review, Revised site ICs
and De-registrations
NOTE: If you have the wrong entry or omit
information, the PRS will highlight your error in red.
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Initial & Amendment registrations, LOA &
IRB/EC Continuing review, Revised site ICs
and De-registrations
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8 Click the
icon to upload the documents required in
accordance with the DAIDS Manual.
NOTE:
The PRS only accepts the .DOC, .PDF, and
.JPG file types
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Initial & Amendment registrations, LOA &
IRB/EC Continuing review, Revised site ICs
and De-registrations
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9 Save your work.
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Initial & Amendment registrations, LOA &
IRB/EC Continuing review, Revised site ICs
and De-registrations
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 After documents are saved and you receive a “Save
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Successful” message, click Submit
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Initial & Amendment registrations, LOA &
IRB/EC Continuing review, Revised site ICs
and De-registrations
 Click ‘OK’ to submit form.
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11
12
12
* Confirm
Protocol
Number to
complete
submission
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Initial & Amendment registrations, LOA &
IRB/EC Continuing review, Revised site ICs
and De-registrations
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What if…?
 I am entering data into the PRS and discover I am
missing the 1572 Form. Should I continue, or will I need
to start all over again when I have the 1572 Form?
 Answer:
The PRS will save files and data until you are
ready to submit them. Enter what you have now and
click ‘Save’ at the bottom of the form. When you receive
the 1572 go back into the record and add it before
submitting your materials.
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How do I….?
 Change the IoR
 Add or change FDA 1572/IoR Agreements
 Update CVs
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New/Change IoR, FDA 1572/IoR
Agreements, Updated CVs
1
 From home page, click
1
New Submission
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New/Change IoR, FDA 1572/IoR
Agreements, Updated CVs
2
2
 Insert new IoR name (if applicable)
2
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New/Change IoR, FDA 1572/IoR
Agreements, Updated CVs
3
4
3 Check appropriate box (e.g. Updated CV)
4 Click “Next” button
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New/Change IoR, FDA 1572/IoR
Agreements, Updated CVs
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5 Click the
icon to upload 1572/IoR Agreement or
updated CV.
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New/Change IoR, FDA 1572/IoR
Agreements, Updated CVs
6
6 Save your work.
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New/Change IoR, FDA 1572/IoR
Agreements, Updated CVs
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7 After documents are saved and you receive a “Save
Successful” message, click Submit
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New/Change IoR, FDA 1572/IoR
Agreements, Updated CVs
8 Click ‘OK’ to submit form.
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* Confirm
Protocol
Number to
complete
submission
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9
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New/Change IoR, FDA 1572/IoR
Agreements, Updated CVs
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What if…?
 I am attempting to update materials for a
submission and the system keeps logging me off
as I upload, how can I avoid this?
 Instead of uploading all your submission
materials in one file, break it into multiple files.
Smaller files take less time to upload, making it
less likely the system will time out and log you
off.
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How do I…?
 Respond to:
• Required corrections
• Disapproval reversal
• Requested documents/information
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Required Corrections, Disapproval reversals,
Requested documents/information
1
 From home page, click
1
New Submission
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Required Corrections, Disapproval reversals,
Requested documents/information
2
3
4
2 Check appropriate box (e.g. Corrected Materials)
3 If Corrected Materials, select submission from menu.
4 Click “Next” button
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Required Corrections, Disapproval reversals,
Requested documents/information
5
5 Upload documents and save.
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Required Corrections, Disapproval reversals,
Requested documents/information
6
6 After documents are saved and you receive a “Save
Successful” message, click Submit
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Required Corrections, Disapproval reversals,
Requested documents/information
7 Click ‘OK’ to submit form.
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* Confirm
Protocol
Number to
complete
submission
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8
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Required Corrections, Disapproval reversals,
Requested documents/information
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Network / Non-Network
studies, Sub-studies
 Sites are only able to enroll in studies associated
with their affiliated network.
 Non-network sites may submit materials for
appropriate protocols.
 Sub-study registration materials are submitted
independently following the same PRS process
as main studies.
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Domestic and International sites
 The system supports the unique requirements of
domestic and international sites as defined in
the Protocol Registration Manual.
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How do I.…track submissions?
1
 To track a protocol
1
registration packet that
has already been
saved in the system,
click Search
Submission from the
Home page.
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How do I….track submissions?
2
3
2 Enter any of the information requested.
3 Click Search
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How do I….track submissions?
4
4 View status in the Status column.
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How do I….track submissions?
Status Term
Definition
Editing
Another user is accessing this submission.
Pending
Registration materials are saved in the PRS, but have not yet been submitted.
In Progress
Registration materials are in the process of being reviewed by the PRO.
Paused
Materials have been requested by the PRO for a submission packet that are required to
complete registration.
Registered
The site has met the DAIDS protocol registration requirement(s) and the PRO has issued
an approval or approval with required corrections notification for a study
Acknowledged
The PRO has issued an acknowledgement notification indicating that all required materials
have been verified for completeness. An acknowledged status indicates that the site has
completed the protocol registration process for the specific study and version.
Disapproved
The site has not met the DAIDS protocol registration requirement(s) and the PRO has
issued a disapproval notification.
Discontinued
A site’s submission review has been cancelled due to study closure, request by the site,
DAIDS, Operations Center, etc.
Deregistered
The site is no longer registered to a study.
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How do I….track submissions?
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5 View history by clicking the icon in the History column.
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How do I….track submissions?
 Submission history
will display in a popup window
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What if…?
 I wanted to show a co-worker that we have been
approved for a study. However, the record is no
longer available. Was our approval revoked?
 Answer: No, the approval is still valid unless you
receive formal notification stating otherwise.
The PRS only displays approval records for 3
days on the home page. They are still
accessible afterwards via the search screen.
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How do I…….edit
submissions?
1
1
To edit a protocol
registration packet that
has already been saved
in the system, click
Search Submission from
the Home page.
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How do I…….edit
submissions?
2
3
2 Enter any of the information requested.
3 Click Search
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How do I…….edit
submissions?
4
4 Click the icon in the Edit column.
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How do I…….edit
submissions?
5
5 Add notes or update documents
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How do I…….edit
submissions?
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6 Save your work.
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How do I…….edit
submissions?
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7 After documents are saved and you receive a “Save
Successful” message, click Submit
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How do I…….edit
submissions?
 Click ‘OK’ to submit form.
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8
9
9
* Confirm
Protocol
Number to
complete
submission
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How do I…….edit
submissions?
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How do I…….edit
submissions?
1
1 To view a protocol
registration packet
that has already
been saved in the
system, click Search
Submission from the
Home page.
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How do I ……view submissions
documents?
2
3
2 Enter any of the information requested.
3 Click Search
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How do I……view submissions
documents?
4
4 Click the icon in the Document Library column.
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How do I……view submissions
documents?
5 Click on hyperlink(s)
to view submission
document(s) in popup window.
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NOTE: After registration
for a specific
protocol, only the
PRO approved
documents will be
available on the PRS
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How do I…enroll additional /
new users at my site?
 When adding new users to the PRS, visit the
enrollment webpage at: http:// TBD
• All users must be trained by DAIDS or a DAIDS
trained colleague
 NOTE: If you are removing users from the PRS,
email [email protected].
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What if…?
 The protocol I am
trying to register to
states “ Restricted
study, Cannot
participate”.
 You must contact
your Operations
Center so that they
may designate your
site as eligible to
participate in the
protocol.
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Congratulations!
 You have completed the DAIDS-ES Protocol
Registration System Training
 You are now trained to provide training to your
peers.
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Thank You
 If you have any questions, please contact:
•
For technical questions
– Please e-mail questions or comments about User Name or Login to [email protected] or call or fax your request to:
•
•
Phone: 1 (866) 337-1605 (USA toll-free) or 1 (240) 499-2239 (Outside USA)
•
Fax: 1 (866) 337-1606 (USA toll-free) or 1 (301) 948-2242 (Outside USA)
For Registration related questions:
– Should you have any questions, please contact the Protocol Registration Office via email at [email protected], fax 1-800-418-3544 or 1-301-897-1701, or phone 1301-897-1707.
 Please complete the evaluation form found in your training packet, or online
at http:// TBD
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