webIRB and Post-Approval Report Update

Bette L Okeya PharmDAssistant Director OHRPP

Learn at Lunch June 2 2011

Creating a Post-Approval Report (PAR) in webIRB

2

In the study workspace you

will click on New Post-Approval Report or

Single Subject

Exception

Initial Information

3

The SmartForm will branch out

depending on the type of report

chosen

Short Title or Study Participant

Number will appear in the

correspondence

Initial or Follow-up Report

Submission Criteria

4

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 ViolationsDeviation and

Incident Reports

Evaluation of Information

5

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

IRB Determinations

6

No Further Action

Additional Information Required

Amendment Required

Full Board Required

webIRB PAR Correspondence

7

The type of correspondence (Acknowledgement or Additional Action

Required)The IRB determination (No Further

Action Additional Information Required or Amendment Required)

The ldquoShort Titlerdquo will appear in the IRB correspondence

Type of Review

Does not meet submission criteria

8

Write descriptionof event in Item 4

AEs that do not meet the IRBrsquos

prompt reporting criteria will result with No Report Required page

Instructions to withdraw PAR is in

Item 3

Withdrawing an AE PAR

9

Click Withdraw PAR for Adverse

Events that do not meet

the IRBrsquos prompt

submission criteria

Record Keeping for Withdrawn AE PARs

10

Select Category for withdrawal

Enter additional comments which be

viewed in the History tab of the study

PAR Recordkeeping

11

Short Title of withdrawn PAR

Withdrawn PARs will be available in the PAR tab

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

Creating a Post-Approval Report (PAR) in webIRB

2

In the study workspace you

will click on New Post-Approval Report or

Single Subject

Exception

Initial Information

3

The SmartForm will branch out

depending on the type of report

chosen

Short Title or Study Participant

Number will appear in the

correspondence

Initial or Follow-up Report

Submission Criteria

4

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 ViolationsDeviation and

Incident Reports

Evaluation of Information

5

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

IRB Determinations

6

No Further Action

Additional Information Required

Amendment Required

Full Board Required

webIRB PAR Correspondence

7

The type of correspondence (Acknowledgement or Additional Action

Required)The IRB determination (No Further

Action Additional Information Required or Amendment Required)

The ldquoShort Titlerdquo will appear in the IRB correspondence

Type of Review

Does not meet submission criteria

8

Write descriptionof event in Item 4

AEs that do not meet the IRBrsquos

prompt reporting criteria will result with No Report Required page

Instructions to withdraw PAR is in

Item 3

Withdrawing an AE PAR

9

Click Withdraw PAR for Adverse

Events that do not meet

the IRBrsquos prompt

submission criteria

Record Keeping for Withdrawn AE PARs

10

Select Category for withdrawal

Enter additional comments which be

viewed in the History tab of the study

PAR Recordkeeping

11

Short Title of withdrawn PAR

Withdrawn PARs will be available in the PAR tab

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

Initial Information

3

The SmartForm will branch out

depending on the type of report

chosen

Short Title or Study Participant

Number will appear in the

correspondence

Initial or Follow-up Report

Submission Criteria

4

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 ViolationsDeviation and

Incident Reports

Evaluation of Information

5

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

IRB Determinations

6

No Further Action

Additional Information Required

Amendment Required

Full Board Required

webIRB PAR Correspondence

7

The type of correspondence (Acknowledgement or Additional Action

Required)The IRB determination (No Further

Action Additional Information Required or Amendment Required)

The ldquoShort Titlerdquo will appear in the IRB correspondence

Type of Review

Does not meet submission criteria

8

Write descriptionof event in Item 4

AEs that do not meet the IRBrsquos

prompt reporting criteria will result with No Report Required page

Instructions to withdraw PAR is in

Item 3

Withdrawing an AE PAR

9

Click Withdraw PAR for Adverse

Events that do not meet

the IRBrsquos prompt

submission criteria

Record Keeping for Withdrawn AE PARs

10

Select Category for withdrawal

Enter additional comments which be

viewed in the History tab of the study

PAR Recordkeeping

11

Short Title of withdrawn PAR

Withdrawn PARs will be available in the PAR tab

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

Submission Criteria

4

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 ViolationsDeviation and

Incident Reports

Evaluation of Information

5

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

IRB Determinations

6

No Further Action

Additional Information Required

Amendment Required

Full Board Required

webIRB PAR Correspondence

7

The type of correspondence (Acknowledgement or Additional Action

Required)The IRB determination (No Further

Action Additional Information Required or Amendment Required)

The ldquoShort Titlerdquo will appear in the IRB correspondence

Type of Review

Does not meet submission criteria

8

Write descriptionof event in Item 4

AEs that do not meet the IRBrsquos

prompt reporting criteria will result with No Report Required page

Instructions to withdraw PAR is in

Item 3

Withdrawing an AE PAR

9

Click Withdraw PAR for Adverse

Events that do not meet

the IRBrsquos prompt

submission criteria

Record Keeping for Withdrawn AE PARs

10

Select Category for withdrawal

Enter additional comments which be

viewed in the History tab of the study

PAR Recordkeeping

11

Short Title of withdrawn PAR

Withdrawn PARs will be available in the PAR tab

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

Evaluation of Information

5

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

IRB Determinations

6

No Further Action

Additional Information Required

Amendment Required

Full Board Required

webIRB PAR Correspondence

7

The type of correspondence (Acknowledgement or Additional Action

Required)The IRB determination (No Further

Action Additional Information Required or Amendment Required)

The ldquoShort Titlerdquo will appear in the IRB correspondence

Type of Review

Does not meet submission criteria

8

Write descriptionof event in Item 4

AEs that do not meet the IRBrsquos

prompt reporting criteria will result with No Report Required page

Instructions to withdraw PAR is in

Item 3

Withdrawing an AE PAR

9

Click Withdraw PAR for Adverse

Events that do not meet

the IRBrsquos prompt

submission criteria

Record Keeping for Withdrawn AE PARs

10

Select Category for withdrawal

Enter additional comments which be

viewed in the History tab of the study

PAR Recordkeeping

11

Short Title of withdrawn PAR

Withdrawn PARs will be available in the PAR tab

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

IRB Determinations

6

No Further Action

Additional Information Required

Amendment Required

Full Board Required

webIRB PAR Correspondence

7

The type of correspondence (Acknowledgement or Additional Action

Required)The IRB determination (No Further

Action Additional Information Required or Amendment Required)

The ldquoShort Titlerdquo will appear in the IRB correspondence

Type of Review

Does not meet submission criteria

8

Write descriptionof event in Item 4

AEs that do not meet the IRBrsquos

prompt reporting criteria will result with No Report Required page

Instructions to withdraw PAR is in

Item 3

Withdrawing an AE PAR

9

Click Withdraw PAR for Adverse

Events that do not meet

the IRBrsquos prompt

submission criteria

Record Keeping for Withdrawn AE PARs

10

Select Category for withdrawal

Enter additional comments which be

viewed in the History tab of the study

PAR Recordkeeping

11

Short Title of withdrawn PAR

Withdrawn PARs will be available in the PAR tab

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

webIRB PAR Correspondence

7

The type of correspondence (Acknowledgement or Additional Action

Required)The IRB determination (No Further

Action Additional Information Required or Amendment Required)

The ldquoShort Titlerdquo will appear in the IRB correspondence

Type of Review

Does not meet submission criteria

8

Write descriptionof event in Item 4

AEs that do not meet the IRBrsquos

prompt reporting criteria will result with No Report Required page

Instructions to withdraw PAR is in

Item 3

Withdrawing an AE PAR

9

Click Withdraw PAR for Adverse

Events that do not meet

the IRBrsquos prompt

submission criteria

Record Keeping for Withdrawn AE PARs

10

Select Category for withdrawal

Enter additional comments which be

viewed in the History tab of the study

PAR Recordkeeping

11

Short Title of withdrawn PAR

Withdrawn PARs will be available in the PAR tab

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

Does not meet submission criteria

8

Write descriptionof event in Item 4

AEs that do not meet the IRBrsquos

prompt reporting criteria will result with No Report Required page

Instructions to withdraw PAR is in

Item 3

Withdrawing an AE PAR

9

Click Withdraw PAR for Adverse

Events that do not meet

the IRBrsquos prompt

submission criteria

Record Keeping for Withdrawn AE PARs

10

Select Category for withdrawal

Enter additional comments which be

viewed in the History tab of the study

PAR Recordkeeping

11

Short Title of withdrawn PAR

Withdrawn PARs will be available in the PAR tab

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

Withdrawing an AE PAR

9

Click Withdraw PAR for Adverse

Events that do not meet

the IRBrsquos prompt

submission criteria

Record Keeping for Withdrawn AE PARs

10

Select Category for withdrawal

Enter additional comments which be

viewed in the History tab of the study

PAR Recordkeeping

11

Short Title of withdrawn PAR

Withdrawn PARs will be available in the PAR tab

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

Record Keeping for Withdrawn AE PARs

10

Select Category for withdrawal

Enter additional comments which be

viewed in the History tab of the study

PAR Recordkeeping

11

Short Title of withdrawn PAR

Withdrawn PARs will be available in the PAR tab

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

PAR Recordkeeping

11

Short Title of withdrawn PAR

Withdrawn PARs will be available in the PAR tab

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

Description of Event for Your Records

12

Description of withdrawn AE PAR will be

stored permanently in your records

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

PAR Amendments in webIRB

13

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

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

When is an Amendment Needed

14

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 Investigatorrsquos Brochure Adverse Event

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

Amendment with Concurrent PAR

15

Item 9 Is a Post-Approval Report included in this

amendmentCheck ldquoYESrdquo and the application

will branch with the PAR questions

Create an Amendment

16

Important update application and documents in the original study space

Amendment with Concurrent PAR

Linked Amendment

Use Create Linked Amendment if an Amendment has notbeen created for this PAR

UseLink to Existing Amendment if an Amendment has been created

17

IRB DeterminationCompleted Amendment Required

You must be in the PAR workspace to Create a Linked Amendment or Link to

Existing Amendment

Create a Linked Amendment

Use the Create a Linked Amendment activity from the

PAR workspace

18

Enter the Amendment Title click OK and you will be taken to the

Amendment workspace

Create a Linked Amendment

19

When in the Amendment workspace check NOto Item 9

Reminder you will only check Yes to Item 9 when an Amendment is submitted concurrently with a PAR

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

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

PARs Linked to an Amendment

22

You can link multiple

PARs to an Amendment if applicable

PAR will be in Completed state after linked to Amendment

PARs Linked to an Amendment

23

PAR will change state from Completed Amendment

Required to Completed after the PAR is linked to an Amendment

PARs Linked to an Amendment

24

Under the Amendments tab in the PAR workspace you will

see the Amendment the PAR is linked to

PARs Linked to an Amendment

25

In the study workspace the PAR will appear as

ldquoCompletedrdquo under the PAR tab

Single Subject Exception

26

When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject

Examples waiver of inclusionexclusion criteria a change in study procedure schedule

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

Linked Amendment

Use Create Linked Amendment if an Amendment has notbeen created for this PAR

UseLink to Existing Amendment if an Amendment has been created

17

IRB DeterminationCompleted Amendment Required

You must be in the PAR workspace to Create a Linked Amendment or Link to

Existing Amendment

Create a Linked Amendment

Use the Create a Linked Amendment activity from the

PAR workspace

18

Enter the Amendment Title click OK and you will be taken to the

Amendment workspace

Create a Linked Amendment

19

When in the Amendment workspace check NOto Item 9

Reminder you will only check Yes to Item 9 when an Amendment is submitted concurrently with a PAR

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

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

PARs Linked to an Amendment

22

You can link multiple

PARs to an Amendment if applicable

PAR will be in Completed state after linked to Amendment

PARs Linked to an Amendment

23

PAR will change state from Completed Amendment

Required to Completed after the PAR is linked to an Amendment

PARs Linked to an Amendment

24

Under the Amendments tab in the PAR workspace you will

see the Amendment the PAR is linked to

PARs Linked to an Amendment

25

In the study workspace the PAR will appear as

ldquoCompletedrdquo under the PAR tab

Single Subject Exception

26

When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject

Examples waiver of inclusionexclusion criteria a change in study procedure schedule

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

Create a Linked Amendment

Use the Create a Linked Amendment activity from the

PAR workspace

18

Enter the Amendment Title click OK and you will be taken to the

Amendment workspace

Create a Linked Amendment

19

When in the Amendment workspace check NOto Item 9

Reminder you will only check Yes to Item 9 when an Amendment is submitted concurrently with a PAR

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

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

PARs Linked to an Amendment

22

You can link multiple

PARs to an Amendment if applicable

PAR will be in Completed state after linked to Amendment

PARs Linked to an Amendment

23

PAR will change state from Completed Amendment

Required to Completed after the PAR is linked to an Amendment

PARs Linked to an Amendment

24

Under the Amendments tab in the PAR workspace you will

see the Amendment the PAR is linked to

PARs Linked to an Amendment

25

In the study workspace the PAR will appear as

ldquoCompletedrdquo under the PAR tab

Single Subject Exception

26

When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject

Examples waiver of inclusionexclusion criteria a change in study procedure schedule

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

Create a Linked Amendment

19

When in the Amendment workspace check NOto Item 9

Reminder you will only check Yes to Item 9 when an Amendment is submitted concurrently with a PAR

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

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

PARs Linked to an Amendment

22

You can link multiple

PARs to an Amendment if applicable

PAR will be in Completed state after linked to Amendment

PARs Linked to an Amendment

23

PAR will change state from Completed Amendment

Required to Completed after the PAR is linked to an Amendment

PARs Linked to an Amendment

24

Under the Amendments tab in the PAR workspace you will

see the Amendment the PAR is linked to

PARs Linked to an Amendment

25

In the study workspace the PAR will appear as

ldquoCompletedrdquo under the PAR tab

Single Subject Exception

26

When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject

Examples waiver of inclusionexclusion criteria a change in study procedure schedule

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

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

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

PARs Linked to an Amendment

22

You can link multiple

PARs to an Amendment if applicable

PAR will be in Completed state after linked to Amendment

PARs Linked to an Amendment

23

PAR will change state from Completed Amendment

Required to Completed after the PAR is linked to an Amendment

PARs Linked to an Amendment

24

Under the Amendments tab in the PAR workspace you will

see the Amendment the PAR is linked to

PARs Linked to an Amendment

25

In the study workspace the PAR will appear as

ldquoCompletedrdquo under the PAR tab

Single Subject Exception

26

When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject

Examples waiver of inclusionexclusion criteria a change in study procedure schedule

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

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

PARs Linked to an Amendment

22

You can link multiple

PARs to an Amendment if applicable

PAR will be in Completed state after linked to Amendment

PARs Linked to an Amendment

23

PAR will change state from Completed Amendment

Required to Completed after the PAR is linked to an Amendment

PARs Linked to an Amendment

24

Under the Amendments tab in the PAR workspace you will

see the Amendment the PAR is linked to

PARs Linked to an Amendment

25

In the study workspace the PAR will appear as

ldquoCompletedrdquo under the PAR tab

Single Subject Exception

26

When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject

Examples waiver of inclusionexclusion criteria a change in study procedure schedule

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

PARs Linked to an Amendment

22

You can link multiple

PARs to an Amendment if applicable

PAR will be in Completed state after linked to Amendment

PARs Linked to an Amendment

23

PAR will change state from Completed Amendment

Required to Completed after the PAR is linked to an Amendment

PARs Linked to an Amendment

24

Under the Amendments tab in the PAR workspace you will

see the Amendment the PAR is linked to

PARs Linked to an Amendment

25

In the study workspace the PAR will appear as

ldquoCompletedrdquo under the PAR tab

Single Subject Exception

26

When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject

Examples waiver of inclusionexclusion criteria a change in study procedure schedule

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

PARs Linked to an Amendment

23

PAR will change state from Completed Amendment

Required to Completed after the PAR is linked to an Amendment

PARs Linked to an Amendment

24

Under the Amendments tab in the PAR workspace you will

see the Amendment the PAR is linked to

PARs Linked to an Amendment

25

In the study workspace the PAR will appear as

ldquoCompletedrdquo under the PAR tab

Single Subject Exception

26

When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject

Examples waiver of inclusionexclusion criteria a change in study procedure schedule

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

PARs Linked to an Amendment

24

Under the Amendments tab in the PAR workspace you will

see the Amendment the PAR is linked to

PARs Linked to an Amendment

25

In the study workspace the PAR will appear as

ldquoCompletedrdquo under the PAR tab

Single Subject Exception

26

When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject

Examples waiver of inclusionexclusion criteria a change in study procedure schedule

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

PARs Linked to an Amendment

25

In the study workspace the PAR will appear as

ldquoCompletedrdquo under the PAR tab

Single Subject Exception

26

When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject

Examples waiver of inclusionexclusion criteria a change in study procedure schedule

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

Single Subject Exception

26

When an investigator anticipates the need to deviate from the previously IRB approved protocol for a single subject

Examples waiver of inclusionexclusion criteria a change in study procedure schedule

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

Single Subject Exception

27

The following information will be requested

Information regarding the sponsorrsquos 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 subjectrsquos condition differs constituting an exception to the protocol

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

Single Subject Exception

28

An explanation why the deviationexception is appropriate or necessary

An explanation of how the deviationexception affects the riskbenefit 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 ndash IRB Review of Modifications to Previously Approved Research

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

29

IRB DeterminationbullRequest ApprovedbullRequest Does Not Meet the Criteria for Exception

webIRB Correspondence Single Subject Exception

Recommendation use short title space for ldquoSingle Subject Exceptionrdquo plus subjectrsquos study numberinitials

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

Study Close-Out

30

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 Closureas the type of report being submitted

Report within 30 days of study close-out

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

Study Close-Out

31

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

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

Submission of PARs at Continuing Review

32

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 AErsquos and Updated Study Safety Information ndashSection 11 Item 5Violations Deviations Incidents ndash Section 10 Item 1 include in event description)

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

Miscellaneous Tid Bits

33

In webIRB do not upload the paper PAR form as documentation

Do not use the ldquoSubmit Responserdquo activity to send messages to the IRB Please use the ldquoSend Inquiryrdquo activity

Pre-Review changes are requested to help facilitate IRB review of the PAR

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu

Questions

34

Call or e-mail Bette Okeya OHRPP Assistant Director at (310) 206-2040 bokeyaresearchuclaedu

OHRPP website at httpohrppresearchuclaedu