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

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 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

6

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

7

What can I do in the PRS?

8

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?

9

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

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

14

1

1

Select site (if not already correct) Enter protocol number or click icon

to select

15


Select proper protocol version number Identify correct IoR

2

3 4

5

2

3

4

5

Check appropriate box (e.g. Initial) Click “Next” button

16


6

6

7

7

NOTE: If you have the wrong entry or omit information, the PRS will highlight your error in red.

17


18


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


9

9

10

10

20


After documents are saved and you receive a “Save Successful” message, click Submit

Click ‘OK’ to submit form.

21


* Confirm Protocol Number to complete submission

1111

12

12

22


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



25

1

1

Insert new IoR name (if applicable)

26


2

2

2

27


Check appropriate box (e.g. Updated CV) Click “Next” button

3

4

4

3

28


Click the icon to upload 1572/IoR Agreement or updated CV.

5

5

Save your work.

29

6

6


7

7

30




31



88

9

9

32


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



35

1

1

36


Check appropriate box (e.g. Corrected Materials) If Corrected Materials, select submission from menu. Click “Next” button

2

3

3

2

4

4

37


Upload documents and save.5

5

38



6

6


39



7

7

8

8

40


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.

43

1

1

44

Enter any of the information requested. Click Search

2

3

2

3

How do I….track submissions?

View status in the Status column.

45

4

4


46

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.


View history by clicking the icon in the History column.

47

5

5


Submission history will display in a pop-up window

48


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.

50

1

1


51

2

3

3

2


Click the icon in the Edit column.

52


4

4

Add notes or update documents

53


5

5

Save your work.

54

6

6


55


7

7



56



88

9

9

57



To view a protocol registration packet that has already been saved in the system, click Search Submission from the Home page.

58

11


59

2

3

3

2

How do I ……view submissions documents?

Click the icon in the Document Library column.

60

4

4

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

61

5

5

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 [email protected].

62

mailto:[email protected]

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 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 e-

mail at [email protected], 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

65



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

Documents

protocol registration

protocol registration

protocol registration

registration materialstrack

registration reportsunderstand

notification of registration

protocol submission

electronic registration