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Presented by The Division of AIDS (DAIDS) Regulatory Compliance Center (RCC) Training

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).

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Presented by The Division of AIDS (DAIDS) Regulatory Compliance Center (RCC) Training

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

  3. 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

  4. 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

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

  6. Terms we will use in this training

  7. 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

  8. What can I do in the PRS?

  9. How do you get started? • 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. 1 2 1 2

  10. Opening Screen

  11. Submission Screen • On the left side of the home page you can view all outstanding submissions for sites you are associated with

  12. Alert Screen • On the right side of the home page, you can receive alerts for: • Applications requiring correction, • Request for additional materials

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

  14. Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations • From home page, click New Submission 1 1

  15. Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations • Select site (if not already correct) • Enter protocol number or click icon to select 2 3 4 5 2 4 • Select proper protocol version number • Identify correct IoR 3 5

  16. Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations • Check appropriate box (e.g. Initial) • Click “Next” button 6 7 6 7

  17. 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.

  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

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

  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 10 10

  21. Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations • Click ‘OK’ to submit form. 11 11 12 * Confirm Protocol Number to complete submission 12

  22. Initial & Amendment registrations, LOA & IRB/EC Continuing review, Revised site ICs and De-registrations

  23. 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.

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

  25. New/ChangeIoR, FDA 1572/IoR Agreements, Updated CVs • From home page, click New Submission 1 1

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

  27. New/Change IoR, FDA 1572/IoR Agreements, Updated CVs • Check appropriate box (e.g. Updated CV) • Click “Next” button 3 4 3 4

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

  29. New/Change IoR, FDA 1572/IoR Agreements, Updated CVs • Save your work. 6 6

  30. New/Change IoR, FDA 1572/IoR Agreements, Updated CVs • After documents are saved and you receive a “Save Successful” message, click Submit 7 7

  31. New/Change IoR, FDA 1572/IoR Agreements, Updated CVs • Click ‘OK’ to submit form. 8 8 * Confirm Protocol Number to complete submission 9 9

  32. New/Change IoR, FDA 1572/IoR Agreements, Updated CVs

  33. 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.

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

  35. Required Corrections, Disapproval reversals, Requested documents/information • From home page, click New Submission 1 1

  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 2 3 4 2 3 4

  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

  39. Required Corrections, Disapproval reversals, Requested documents/information • Click ‘OK’ to submit form. 7 7 * Confirm Protocol Number to complete submission 8 8

  40. Required Corrections, Disapproval reversals, Requested documents/information

  41. 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.

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

  43. 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. 1 1

  44. How do I….track submissions? • Enter any of the information requested. • Click Search 2 3 2 3

  45. How do I….track submissions? • View status in the Status column. 4 4

  46. How do I….track submissions?

  47. How do I….track submissions? • View history by clicking the icon in the History column. 5 5

  48. How do I….track submissions? • Submission history will display in a pop-up window

  49. 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.

  50. 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. 1 1

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