Presented by The Division of AIDS (DAIDS) Regulatory Compliance Center (RCC) Training Welcome to the DAIDS-ES Protocol Registration System Training

2 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 3

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 4

Protocol Registration Process 5 Creates and Submits Electronic Registration Packet Creates and Submits Electronic Registration Packet Triages Submission and assigns to Protocol Registration Specialist (PRS) Triages Submission and assigns to Protocol Registration Specialist (PRS) Review approvals and documents Review approvals and documents Review and Provide resolution Review and Provide resolution Provide Investigator of Record (IoR) Approval decision Provide Investigator of Record (IoR) Approval decision Resolve discrepancies Resolve discrepancies Respond to Materials requested Respond to Materials requested Prepare and Review Registration Decision Prepare and Review Registration Decision Request additional materials as required Request additional materials as required Receives Approval or Disapproval Notification Receives Approval or Disapproval Notification Protocol Registration Office (PRO) Clinical Research Site (CRS) OPCRO Protocol Registration Team (PRT)

Terms we will use in this training 6 TermDefinition Designated SiteSite is designated to participate on the study (applicable only for site restricted studies). Initial RegistrationThe first protocol registration request from the site to register to a study. Amendment RegistrationSubsequent 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 SubmissionsMaterials submitted to the PRO by someone other than the site that will be conducting the protocol. Submission TypeThe general purpose for submitting a submission packet to the PRO (e.g. Initial, Change of IoR, Updated 1572/IoR Agreement, Continuing Reviews etc). Submission PacketA collection of documents submitted to the PRO for the purpose of initiating or updating the registration for a specific site and protocol Packet NumberA 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 7

What can I do in the PRS? 8 User RoleAbility CTU Study CoordinatorCreate submissions, Track and Modify existing submission, Respond to materials request, View Reports CTU Site LeaderCreate 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 CoordinatorCreate submissions, Track and Modify existing submission, Respond to materials request, View Reports Investigator of RecordCreate submissions, Track and Modify existing submission, Respond to materials request, View Reports Site LeaderCreate submissions, Track and Modify existing submission, Respond to materials request, View Reports

How do you get started? 9  Enter username and password on Login screen  If you have not received your username and password, contact DAIDS at the address or telephone number provided onscreen

Opening Screen 10

Submission Screen 11  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 12

How do I….?  Submit: Initial & Amendment registrations LOA & IRB/EC Continuing review Revised site ICs De-registrations  Same process for all in the PRS 13

Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations  From home page, click New Submission

 Select site (if not already correct)  Enter protocol number or click icon to select 15 Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations  Select proper protocol version number  Identify correct IoR

 Check appropriate box (e.g. Initial)  Click “Next” button 16 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. 17 Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations

18 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 8 8

 Save your work. 19 Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations 9 9

10 20 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. 21 Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations * Confirm Protocol Number to complete submission 11 12

22 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. 23

How do I….?  Change the IoR  Add or change FDA 1572/IoR Agreements  Update CVs 24

New/Change IoR, FDA 1572/IoR Agreements, Updated CVs  From home page, click New Submission

 Insert new IoR name (if applicable) 26 New/Change IoR, FDA 1572/IoR Agreements, Updated CVs 2 2 2

27 New/Change IoR, FDA 1572/IoR Agreements, Updated CVs  Check appropriate box (e.g. Updated CV)  Click “Next” button

28 New/Change IoR, FDA 1572/IoR Agreements, Updated CVs  Click the icon to upload 1572/IoR Agreement or updated CV. 5 5

 Save your work New/Change IoR, FDA 1572/IoR Agreements, Updated CVs

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. 31 New/Change IoR, FDA 1572/IoR Agreements, Updated CVs * Confirm Protocol Number to complete submission

32 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. 33

How do I…?  Respond to: Required corrections Disapproval reversal Requested documents/information 34

Required Corrections, Disapproval reversals, Requested documents/information  From home page, click New Submission

36 Required Corrections, Disapproval reversals, Requested documents/information  Check appropriate box (e.g. Corrected Materials)  If Corrected Materials, select submission from menu.  Click “Next” button

37 Required Corrections, Disapproval reversals, Requested documents/information  Upload documents and save. 5 5

38 Required Corrections, Disapproval reversals, Requested documents/information  After documents are saved and you receive a “Save Successful” message, click Submit 6 6

* Confirm Protocol Number to complete submission 39 Required Corrections, Disapproval reversals, Requested documents/information  Click ‘OK’ to submit form

40 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. 41

Domestic and International sites  The system supports the unique requirements of domestic and international sites as defined in the Protocol Registration Manual. 42

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

44  Enter any of the information requested.  Click Search How do I….track submissions?

 View status in the Status column How do I….track submissions?

46 Status TermDefinition EditingAnother user is accessing this submission. PendingRegistration materials are saved in the PRS, but have not yet been submitted. In ProgressRegistration materials are in the process of being reviewed by the PRO. PausedMaterials have been requested by the PRO for a submission packet that are required to complete registration. RegisteredThe 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 AcknowledgedThe 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. DisapprovedThe site has not met the DAIDS protocol registration requirement(s) and the PRO has issued a disapproval notification. DiscontinuedA site’s submission review has been cancelled due to study closure, request by the site, DAIDS, Operations Center, etc. DeregisteredThe site is no longer registered to a study. How do I….track submissions?

 View history by clicking the icon in the History column How do I….track submissions?

 Submission history will display in a pop- up window 48 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. 49

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

 Enter any of the information requested.  Click Search How do I…….edit submissions?

 Click the icon in the Edit column. 52 How do I…….edit submissions? 4 4

 Add notes or update documents 53 How do I…….edit submissions? 5 5

 Save your work How do I…….edit submissions?

55  After documents are saved and you receive a “Save Successful” message, click Submit 7 7 How do I…….edit submissions?

 Click ‘OK’ to submit form. 56 How do I…….edit submissions? * Confirm Protocol Number to complete submission

57 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

 Enter any of the information requested.  Click Search How do I ……view submissions documents?

 Click the icon in the Document Library column 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 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: TBD All users must be trained by DAIDS or a DAIDS trained colleague  NOTE: If you are removing users from the PRS, 62

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. 63

Congratulations!  You have completed the DAIDS-ES Protocol Registration System Training  You are now trained to provide training to your peers. 64

Thank You  If you have any questions, please contact: For technical questions –Please questions or comments about User Name or Login to DAIDS- or call or fax your request to:DAIDS- Phone: 1 (866) (USA toll-free) or 1 (240) (Outside USA) Fax: 1 (866) (USA toll-free) or 1 (301) (Outside USA) For Registration related questions: –Should you have any questions, please contact the Protocol Registration Office via e- mail at fax or , or phone 1-  Please complete the evaluation form found in your training packet, or online at TBD 65