webirb and Post-Approval Report Update Bette L. Okeya, Pharm.D. Assistant Director, OHRPP Learn at Lunch: June 2, 2011

Transcription

1 webirb and Post-Approval Report Update Bette L. Okeya, Pharm.D. Assistant Director, OHRPP Learn at Lunch: June 2, 2011

2 Creating a Post-Approval Report (PAR) in webirb In the study workspace you will click on New Post- Approval Report or Single Subject Exception 2

3 Initial Information Short Title or Study Participant Number will appear in the correspondence The SmartForm will branch out depending on the type of report chosen Initial or Follow-up Report 3

4 Submission Criteria For AEs, the application will alert you when an event does not meet the submission criteria, and instruct you to withdraw the PAR Adverse Events and Violations/Deviation and Incident Reports 4

5 Evaluation of Information Adverse Events and Updated Study Safety Information If the event warrants a change to the study protocol or consent form, an amendment needs to be submitted for review and approval by the IRB 5

6 IRB Determinations No Further Action Additional Information Required Amendment Required Full Board Required 6

7 webirb PAR Correspondence The Short Title will appear in the IRB correspondence Type of Review The type of correspondence (Acknowledgement or Additional Action Required) The IRB determination (No Further Action, Additional Information Required or Amendment Required) 7

8 Does not meet submission criteria AEs that do not meet the IRB s prompt reporting criteria will result with No Report Required page Instructions to withdraw PAR is in Item 3 Write description of event in Item 4 8

9 Withdrawing an AE PAR Click Withdraw PAR for Adverse Events that do not meet the IRB s prompt submission criteria 9

10 Record Keeping for Withdrawn AE PARs Select Category for withdrawal Enter additional comments which be viewed in the History tab of the study 10

11 PAR Recordkeeping Withdrawn PARs will be available in the PAR tab Short Title of withdrawn PAR 11

12 Description of Event for Your Records Description of withdrawn AE PAR will be stored permanently in your records 12

13 PAR Amendments in webirb PAR submitted concurrently with Amendment At the same time PAR form embedded within application Amendment in Response to a PAR Completed Amendment Required Linked Amendment Link to an Existing Amendment 13

14 When is an Amendment Needed? The PAR results in a change to the study Change in study as a result of a reported event Example: Change in study status Temporary or Permanent Closure to Enrollment Suspension or hold on study Sponsor termination of study Example: Change in risk information Revised Investigator s Brochure Adverse Event 14

15 Amendment with Concurrent PAR Create an Amendment Item #9: Is a Post-Approval Report included in this amendment? Check YES and the application will branch with the PAR questions 15

16 Amendment with Concurrent PAR Important: update application and documents in the original study space!!! 16

17 Linked Amendment IRB Determination: Completed Amendment Required Use: Create Linked Amendment if an Amendment has not been created for this PAR Use: Link to Existing Amendment if an Amendment has been created You must be in the PAR workspace to Create a Linked Amendment or Link to Existing Amendment 17

18 Create a Linked Amendment Use the Create a Linked Amendment activity from the PAR workspace. Enter the Amendment Title, click OK and you will be taken to the Amendment workspace 18

19 Create a Linked Amendment When in the Amendment workspace, check NO to Item #9. Reminder: you will only check Yes to Item #9 when an Amendment is submitted concurrently with a PAR 19

20 Link to an Existing Amendment Use Link to an Existing Amendment activity from the PAR workspace Click Add to see all amendments for this study 20

21 Link to an Existing Amendment Put a checkmark next to the Amendment that correlates this PAR - click OK when done Click OK when you are done Linking to the Existing Amendment 21

22 PARs Linked to an Amendment You can link multiple PARs to an Amendment, if applicable PAR will be in Completed state after linked to Amendment 22

23 PARs Linked to an Amendment PAR will change state from Completed Amendment Required to Completed after the PAR is linked to an Amendment 23

24 PARs Linked to an Amendment Under the Amendments tab in the PAR workspace, you will see the Amendment the PAR is linked to 24

25 PARs Linked to an Amendment In the study workspace, the PAR will appear as Completed under the PAR tab 25

26 Single Subject Exception When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject Examples: waiver of inclusion/exclusion criteria a change in study procedure schedule 26

27 Single Subject Exception The following information will be requested: Information regarding the sponsor s approval of the exception. If the sponsor has approved the exception, documentation should be included. An explanation of the protocol criteria involved and how the subject s condition differs, constituting an exception to the protocol. 27

28 Single Subject Exception An explanation why the deviation/exception is appropriate or necessary. An explanation of how the deviation/exception affects the risk/benefit assessment for this subject. An explanation of whether the current IRB-approved consent form adequately covers this exception. If not, a revised consent form should be included. OHRPP Guidance and Procedure: IRB Review Process IRB Review of Modifications to Previously Approved Research 28

29 webirb Correspondence Single Subject Exception Recommendation: use short title space for Single Subject Exception plus subject s study number/initials IRB Determination: Request Approved Request Does Not Meet the Criteria for Exception 29

30 Study Close-Out If the study is approved on paper, use the Final Study Close-Out Report Form (HS-8) If the study is approved in webirb, use the Continuing Review activity and choose Study Closure as the type of report being submitted Report within 30 days of study close-out 30

31 Study Close-Out If it is discovered that there are PARs that were not submitted prior to the close-out, you must create and submit the PAR: if the study is approved in webirb, submit in webirb and reference the IRB # of the Continuing Review (study closure) if the study is approved on paper, submit a paper PAR form 31

32 Submission of PARs at Continuing Review Continuing Review application in webirb will no longer allow the submission of paper PAR forms, and will instruct submission through webirb PARs submitted as part of the Continuing Review should reference the Continuing Review AE s and Updated Study Safety Information Section 11, Item 5 Violations, Deviations, Incidents Section 10, Item 1, include in event description) 32

33 Miscellaneous Tid Bits In webirb, do not upload the paper PAR form as documentation Do not use the Submit Response activity to send messages to the IRB. Please use the Send Inquiry activity Pre-Review changes are requested to help facilitate IRB review of the PAR 33

34 Questions? Call or Bette Okeya, OHRPP Assistant Director at (310) ; OHRPP website at 34