Presented by The Division of AIDS (DAIDS) Regulatory Compliance Center (RCC) Training
Post on 23-Feb-2016
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Transcript
Presented by
The Division of AIDS (DAIDS) Regulatory Compliance Center (RCC)
Training
Welcome to the DAIDS-ES Protocol Registration System Training
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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.
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
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Creates and Submits Electronic RegistrationPacket
Triages Submission and assigns to Protocol Registration Specialist (PRS)
Review approvalsand documents
Review and Provide resolution
Provide Investigatorof Record (IoR) Approval decision
Resolve discrepancies
Respond to Materials requested
Prepare and Review Registration Decision
Request additional materials as required
Receives Approval or Disapproval Notification
Protocol Registration Office (PRO)
Clinical Research Site (CRS)
OPCRO Protocol RegistrationTeam (PRT)
Terms we will use in this training
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Term DefinitionDesignated 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 track the status of a submission
The system supports
Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registration.
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?
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User Role AbilityCTU 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
How do you get started?
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Enter username and password on Login screen If you have not received your username and password, contact DAIDS
at the email address or telephone number provided onscreen.
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Opening Screen
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Submission Screen
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On the left side of the home page you can view all outstanding submissions for sites you are associated with
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
From home page, click New Submission
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Select site (if not already correct) Enter protocol number or click icon
to select
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Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations
Select proper protocol version number Identify correct IoR
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Check appropriate box (e.g. Initial) Click “Next” button
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Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations
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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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Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations
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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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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Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations
After documents are saved and you receive a “Save Successful” message, click Submit
Click ‘OK’ to submit form.
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Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations
* Confirm Protocol Number to complete submission
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Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations
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
From home page, click New Submission
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Insert new IoR name (if applicable)
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New/Change IoR, FDA 1572/IoR Agreements, Updated CVs
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New/Change IoR, FDA 1572/IoR Agreements, Updated CVs
Check appropriate box (e.g. Updated CV) Click “Next” button
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New/Change IoR, FDA 1572/IoR Agreements, Updated CVs
Click the icon to upload 1572/IoR Agreement or updated CV.
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Save your work.
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New/Change IoR, FDA 1572/IoR Agreements, Updated CVs
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New/Change IoR, FDA 1572/IoR Agreements, Updated CVs
After documents are saved and you receive a “Save Successful” message, click Submit
Click ‘OK’ to submit form.
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New/Change IoR, FDA 1572/IoR Agreements, Updated CVs
* Confirm Protocol Number to complete submission
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New/Change IoR, FDA 1572/IoR Agreements, Updated CVs
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
From home page, click New Submission
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Required Corrections, Disapproval reversals, Requested documents/information
Check appropriate box (e.g. Corrected Materials) If Corrected Materials, select submission from menu. Click “Next” button
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Required Corrections, Disapproval reversals, Requested documents/information
Upload documents and save.5
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Required Corrections, Disapproval reversals, Requested documents/information
After documents are saved and you receive a “Save Successful” message, click Submit
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* Confirm Protocol Number to complete submission
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Required Corrections, Disapproval reversals, Requested documents/information
Click ‘OK’ to submit form.
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Required Corrections, Disapproval reversals, Requested documents/information
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?
To track a protocol registration packet that has already been saved in the system, click Search Submission from the Home page.
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Enter any of the information requested. Click Search
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How do I….track submissions?
View status in the Status column.
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How do I….track submissions?
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Status Term DefinitionEditing 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.
How do I….track submissions?
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 pop-up window
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How do I….track submissions?
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?
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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Enter any of the information requested. Click Search
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How do I…….edit submissions?
Click the icon in the Edit column.
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How do I…….edit submissions?
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Add notes or update documents
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How do I…….edit submissions?
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Save your work.
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How do I…….edit submissions?
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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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How do I…….edit submissions?
* Confirm Protocol Number to complete submission
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How do I…….edit submissions?
How do I…….edit submissions?
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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Enter any of the information requested. Click Search
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How do I ……view submissions documents?
Click the icon in the Document Library column.
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How do I……view submissions documents?
Click on hyperlink(s) to view submission document(s) in pop-up window.
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……view submissions documents?
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 DAIDS_ESSupport@niaid.nih.gov.
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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 DAIDS-ESSupport@niaid.nih.gov 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 e-
mail at protocol@tech-res.com, fax 1-800-418-3544 or 1-301-897-1701, or phone 1-301-897-1707.
Please complete the evaluation form found in your training packet, or online at http:// TBD
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