1. FIRE1000S - Self-Paced FIREBIRD Training Training on the Federal Investigator Registry of Biomedical Informatics Research Data (FIREBIRD) for Clinical Investigators and Registration Coordinators June 21, 2016

2. Session Details  Target Audience: – Clinical Investigators – Site/Study Registration Coordinators  Prerequisites: – You should be familiar with the process of registering for a clinical trial using the FDA form 1572  Training Session Format: – PowerPoint presentation

3. Session Details: Training Objectives  Upon successful completion of this session, you will be able to: – Describe the background and purpose of FIREBIRD. – Distinguish between the different roles and privileges, and obtain the appropriate account. – Demonstrate how to create an investigator profile. – Establish the key necessary to obtain a digital signature. – Demonstrate how to complete and sign all forms that comprise a registration packet.

4. Session Details: Lesson Plan  Background and Overview  Completing an Investigator Profile  Completing a Registration

5. Background and Overview  In this lesson, we will: – Describe the background and purpose of FIREBIRD. – List the features and benefits of FIREBIRD. – Describe the difference between the various roles and actions involved in the registration process. – Practice obtaining a FIREBIRD Account.

6. Background and Overview : Introduction to FIREBIRD  Interagency Oncology Task Force (IOTF) – A partnership of the National Cancer Institute (NCI) and the Food and Drug Administration (FDA) – Goal is to implement a common, electronic, secure, standards- based infrastructure to support the sharing of clinical research data for faster, more efficient development of new drugs  The Federal Investigator Registry of Biomedical Informatics Research Data (FIREBIRD) – The first module implemented within the IOTF vision – Developed for any investigator participating in government, academic, or industry trials wanting to register online with the National Cancer Institute (NCI) and other sponsors

7. Background and Overview: Features and Benefits  Features – Automates and centralizes the 1572 registration process including the 1572, Financial Disclosure Form (FDF), and Curriculum Vitae (CV) – Uses a single, web-based interface to a secure, central repository – Maintains a profile of accreditation information that you can automatically apply to multiple registrations for multiple Sponsors – Leverages Health and Human Services (HHS) standards for legally enforceable digital signatures  Benefits – Eliminates inefficiencies of paper-based, manual process and the need for wet signatures – Standardizes the collection of registration information across multiple sponsors and the Food and Drug Administration (FDA)

8. Background and Overview: Roles Overview  Investigators – Create and maintain a profile – Complete, digitally sign, and submit a registration packet  Sub Investigators – Optional (a registration may have a Sub Investigator. Must complete and sign FDF, CV, and Human Subjects Protection Training form before Investigator can submit that registration  Registration Coordinators – On behalf of an Investigator, can create and maintain their profile, and complete, but not sign, their registration packet  Registration Specialists/Sponsors – Compile and send registration packet with protocol details to Investigator – Edit, update, and review submitted registration packets  FDA – Monitor and enter inspection data, and abstract registration data  Curators – Curate new data entries, and grant digital signatures for Investigators

9. Background and Overview: Process Overview  Common Registration Workflow: – Investigator and coordinator registers for FIREBIRD account. – Investigator specifies primary organization and address, delegates coordinator if necessary, and requests digital signature key. – Sponsor creates a registration and notifies investigator. – Investigator or coordinator completes profile and registration packet. – Sub Investigator (if associated) signs and submits required forms. – Investigator digitally signs and submits registration packet. – Sponsor approves or disapproves registration packet.

10. Background and Overview: Registration Workflow by Role Investigator Request account Add primary address Request digital signature key Delegate coordinator Complete profile and complete registration Sign forms and submit registration Coordinator Request account Complete profile and complete registration Sponsor Invite investigator to complete registration Approve or disapprove registration

11. Background and Overview: Register for FIREBIRD Account Creates a ticket for NCICB Applications Support who will create your account https://firebird.nci.nih.gov

12. Investigator Profile  In this lesson, we will: – Explain the required first steps – Establish the Digital Signature Key – Demonstrate completing an Investigator profile

13. Investigator Profile: Investigator Login Log on

14. Investigator Profile: Welcome Page Investigator Investigator Profile

15. Investigator Profile: 3 Initial Steps  Add Primary Organization – Investigator’s primary address is required before proceeding in FIREBIRD  Delegate Coordinator (if applicable) – If the Investigator will have their Coordinator complete tasks on their behalf, they must first delegate them in FIREBIRD  Request Digital Signature – Digital signature is required for signing documents for registration submission; Request takes up to 48 hours

16. Investigator Profile: Step one - Primary Organization Required Investigator Click to search for and add Primary Organization Click Contact Data Tab

17. Investigator Profile: Search Screens Investigator Use % as Wildcard Select or Request New Organization

18. Investigator Profile: Request New Data Fill out required fields and click submit Investigator

19. Investigator Profile: Step two - Delegate Coordinator… Investigator

20. Investigator Profile: Delegate Coordinator… Step 1 - Search for Sponsor Organization and Select Investigator

21. Investigator Profile: Delegate Coordinator Step 2 - Search for Coordinator and Select Investigator

22. Investigator Profile: Digital Signature Key Investigator Create personal password (different from FIREBIRD account password)

23. Background and Overview: Digital Signature Key Process  Request digital signature key via FIREBIRD  Receive email with instructions for identity verification documentation  Verify and complete document in presence of notary, and mail to NCICBIIT Application Support  Application Support validates, approves request, and emails a one-time activation code  Enter activation code with password to unlock digital signature key

24. Background and Overview: Digital Signature Key Process Request Key Visit Notary to verify identity & sign documents; submit Validate & approve request; send activation code Enter activation code & use signature Investigator NCICB Application Support FIREBIRD Automatically sends instructions and mailing address

25. Investigator Profile: Coordinator Login Coordinator Note – bottom of slide will tell you which role can complete the task

26. Investigator Profile: T he Investigator Profile Who you are logged in as What you are working with Note - Be as expansive as possible – add any data you may want to apply to any future registration(s).

27. Investigator Profile: Practice Sites Investigator or Coordinator

28. Investigator Profile: Labs Investigator or Coordinator

29. Investigator Profile: Institutional Review Boards (IRBs) Investigator or Coordinator

30. Investigator Profile: Sub Investigators Investigator or Coordinator Search and Select 1 or more from list of investigators

31. Investigator Profile: Curriculum Vitae (CV) Investigator or Coordinator Data is pre- populated from Personal tab Enter required information Save changes Note – this automatically generated CV is required

32. Investigator Profile: Documents Update Document Investigator or Coordinator Launch Document View history Upload Document Note - Documents are not required

33. Completing a Registration  In this lesson, we will: – Practice completing and signing a 1572, CV, and Financial Disclosure Form (FDF) – Practice attaching the Human Subjects Protection Training Certification, Delegation of Responsibilities, and Lab Normal Forms

34. Completing a Registration: Search Registrations Investigator or Coordinator Search Registrations using drop downs View active registrations by clicking Protocol Number

35. Completing a Registration: Sponsor Registration Review Investigator or Coordinator Review status of each form

36. Completing a Registration: 1572 Step 1 – Confirm Investigator Investigator or Coordinator Proceed through Form Jump to Profile

37. Completing a Registration: 1572 Step 2 – CV Investigator or Coordinator

38. Completing a Registration: 1572 Step 3 – Practice Sites Investigator or Coordinator

39. Completing a Registration: 1572 Step 4 – Labs Investigator or Coordinator

40. Completing a Registration: 1572 Step 5 – IRBs Investigator or Coordinator Select 1 or more IRBs

41. Completing a Registration: 1572 Step 6 – Sub Investigators Investigator or Coordinator Sends automatic email to Sub Investigator inviting them to complete 3 forms as part of this registration

42. Completing a Registration: 1572 Step 7 – Confirm Protocol Investigator or Coordinator

43. Completing a Registration: 1572 Step 8 – Protocol Information Investigator or Coordinator

44. Completing a Registration: 1572 Step 9 - Commitments Coordinator stop here Investigator Investigator or Coordinator

45. Completing a Registration: Review Progress of Forms Track progress and jump to step Attach required forms Investigator or Coordinator Sub investigators must submit View and sign forms

46. Completing a Registration: Financial Disclosure Form Investigator or Coordinator Investigator or coordinator can submit FDF; only Investigator can sign

47. Completing a Registration: Sign Financial Disclosure Form Investigator Enter Digital Signature Key and click ‘Sign’ Successfully signed

48. Completing a Registration: Sign CV Form Investigator Enter Digital Signature Key and click ‘Sign’

49. Completing a Registration: Human Subjects Protection Training Certification Investigator or Coordinator Upload and submit document, then be sure to click ‘Attach Certificate’

50. Completing a Registration: Delegation of Responsibilities Investigator or Coordinator Browse for document, then click ‘Upload Document’ to attach.

51. Completing a Registration: Lab Normals Form Investigator Browse for document, then click ‘Upload Document’ to attach Lab Normals Form Note - Each lab used on a registration requires a Lab Normals form

52. Completing a Registration: Signing Inbox Investigator Complete Step 9 and sign Complete FDF and sign Launch CV and sign Investigators can go directly to signing inbox

53. Completing a Registration: Submit Registration

54. Session Review  Now that you have successfully completed this session, you should be able to: – Describe the background and purpose of FIREBIRD. – Distinguish between the different roles and privileges, and obtain the appropriate account. – Demonstrate how to create an investigator profile. – Establish the key necessary to obtain a digital signature. – Demonstrate how to complete and sign all forms that comprise a registration packet.

55. NCICB Application Support  Live Support: Monday – Friday 8 am – 8 pm Eastern Time – Telephone support is available Monday to Friday, 8 am – 8 pm Eastern Time, excluding government holidays. – You may leave a message, send an email or submit a support request via the Web at any time.  Email: ncicb@pop.nci.nih.gov  Phone: 301-451-4384  Toll-free: 888-478-4423  Web: http://ncicb.nci.nih.gov/NCICB/support