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Study Staff User Guide

for Principal Investigators, Co-PI’s,

Regulatory Coordinators,

Study Coordinators,

Faculty Sponsors, and

Other Key Personnel

eIRB Home: http://eIRB.mc.duke.edueIRB Support: [email protected]

Institutional Review Board

Duke University Medical Center

IRB Office: http://irb.mc.duke.edu

Phone: (919) 668-5111

Table of ContentsIntroduction for Study Staff 2

How to Log In to eIRB 2How to Select the Study Staff Role 2How to Log Out of eIRB 2

Creating a New Study 2How to Create a New Study 2How to Complete the Study Pages 3

Submitting for Signatures and Review 10How to Submit a New Study, Personnel Change Request, Study Amendment, Safety Event or Continuing Review 10How to Complete the Investigator Electronic Signature 10How to Return to Presubmission 11

Editing Study Personnel for Approved Studies 11How to Modify Existing Study Personnel 11How to Create a Personnel Change Request 12

Creating a Study Amendment 12How to Create a Study Amendment 12How to Complete the Modified Study Pages 13

Creating a Safety Event 13How to Create a Safety Event 13How to Complete the Safety Event Pages 14

Creating a Continuing Review (Progress Report or Final Report) 16How to Create a Continuing Review (Progress Report or Final Report) 16How to Complete the Continuing Review Pages 17

Creating a Request to Re-Open a Closed Study 18How to Create a Request to Re-Open a Closed Study 18How to Complete the Request to Re-Open Pages 19

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Navigating a New Study, Personnel Change Request, Study Amendment, Safety Event or Continuing Review 19

How to Save Study Pages 19How to View an Approval Letter 19How to View Approved Consent Forms 20

Responding to Requests 20How to Respond to a Request for Changes 20

Withdrawing a Submission from IRB Review 21How to Withdraw a New Study, Personnel Change Request, Study Amendment, Safety Event or Continuing Review 21

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Introduction for Study StaffThis User Guide contains detailed, step by step instructions for activities Study Staff can do in the eIRB. In the eIRB, the Study Staff includes all study personnel, including PI, Co-PI, Primary Regulatory Coordinator, Primary Study Coordinator, Faculty Sponsor and other Key Personnel. Study Staff can create and submit new studies and their related personnel change requests, study amendments, safety events and continuing reviews in the eIRB.

For a general introduction to the eIRB, including information about how to log in and how to navigate the different workspaces, please first see the General Reference Guide in the User Guides section of the eIRB Home page.

How to Log In to eIRB1. In your internet browser, go to the eIRB Home page at:

http://eIRB.mc.duke.edu.

2. Log in using your Net ID and Net ID password.Your personal workspace displays with the title “Workspace for” and your name.

To return to your personal workspace at any time, click the My Home link in the top blue banner.

For help, see the General Reference Guide in the User Guides section of the eIRB Home page.

How to Select the Study Staff RoleClick Study Personnel under the My Roles heading in the column at the left. The selected role, Study Personnel, displays under the Current Workspace heading in the red banner and also appears bold under the My Roles heading.

How to Log Out of eIRBClick the white Logoff link in the far right of the top blue.

Creating a New Study

How to Create a New Study1. Log in and verify that the selected role is correct.

Click the My Home link in the top blue banner. The red Study Personnel banner displays at the top of the column at the left.

2. Click the New Study button under the Create heading in the toolbar on the left.The first page of the study displays.

3. Enter the Study Title and Research Personnel information. Complete all of the required fields marked by a red asterisk.

4. Click the Save button at the top of the study page.The study is created with a unique Protocol number, the Pro0000xxx number showing at the top right of the study page.

5. To go to the next study page, click Continue to save the current page and proceed.

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The second page of the study displays.

6. To save your work and exit the study pages, click the gray Exit link at the top of page.

For detailed information about each study page, see the How to Complete the Study Pages section below.

How to Complete the Study PagesThis section includes step by step instructions for each study page.

01. Study Title and Research Personnel1. Type a short title for the study, including any keywords or phrases that can be used

to quickly identify the study.The short title displays in summary views of the study.

2. Type the full title of the study.

3. Select the Study Organization.This selection determines the division, department, and/or school or center to which the study is routed for approval if no SBR is selected.If your organization does not appear on this list, email eIRB Support at: [email protected].

4. Answer the Site-Based Research Group (SBR) questions, and select an SBR if applicable.In an SBR is selected, the study is routed to the SBR for approval.

5. Select the Principal Investigator (PI).People with the PI role appear on the list. This includes full time, regular rank Duke Faculty members, according to Duke policy. For more information, see: http://irb.duhs.duke.edu/wysiwyg/downloads/Who_May_Serve_as_PI_in_the_Duke_HRPP_12-6-07.pdf. The PI has edit rights and receives email notifications for the study.

6. Select the Primary Regulatory Coordinator.This person is the primary IRB contact for the study. This is the person who, prior to June 1, was in the Study Coordinator role. The Primary Regulatory Coordinator has edit rights and receives email notifications for the study.

7. Select the Primary Study Coordinator.

This is a new role, added June 1. The Primary Study Coordinator has edit rights and receives email notifications for the study.

8. The IRB no longer allows assignment of a Faculty Sponsor.

For approved studies, you can submit a Personnel Change Request to remove the Faculty Sponsor. At continuing review, removal of the Faculty Sponsor is required.

9. Click the Add button to add the Co-Principal Investigators (Co-PI’s).

People with the PI role appear on the list. This includes full time, regular rank Duke Faculty members, according to Duke policy. For more information, see: http://irb.duhs.duke.edu/wysiwyg/downloads/Who_May_Serve_as_PI_in_the_Duke_HRPP_12-6-07.pdf.

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http://irb.duhs.duke.edu/wysiwyg/downloads/Who_May_Serve_as_PI_in_the_Duke_HRPP_12-6-07.pdf




mailto:[email protected]

The Co-PI’s have edit rights and receive email notifications for the study. If this is not desired, move the person to the Other Key Personnel list.

To add additional people, click OK and Add Another. When you are finished adding people, click OK.

10. Click the Add button to add Other Key Personnel. For each member of the key personnel, select the Person, the Role on Study, and the Edit Rights and Receive Email notifications options.People with a Net ID appear on the list. If someone does not appear on the list, email eIRB Support at: [email protected].

To add additional people, click OK and Add Another. When you are finished adding people, click OK.

11. Click Continue to save your work and proceed to the next page.

For more information, see the “How to Select People” section of the General Reference Guide.

02. Study Personnel Outside Duke1. Download, complete and attach the Outside Duke Key Personnel Form.

To find the form, click the here link in the help text to the right or go to the Download eIRB Forms section of the eIRB Home page.


For information, see the “Tips for Attaching Documents” section of the General Reference Guide.

03. Protocol Application Type1. Click the radio button to select New Study, Application for Exemption from IRB

review, or Trainee Research while away from Duke.New studies will receive expedited or full committee review. This determination will be made by the IRB Office. Applications for exemption must meet criteria established in the Exempt Policy on the IRB Office web site: http://irb.mc.duke.edu.

2. For studies that include FDA regulated drugs or biologics, select the Protocol Phase.

Choose only one.

3. Click Continue to save the page and proceed.

For regular new study applications, skip the following section.

e(1) Exempt ApplicationFor applications for IRB Exemption, this page displays.

1. Attach the Project Summary.

2. Click the radio button to answer the activity question.If Yes, click the appropriate check boxes and type an explanation.

3. Click Finish to save and exit the study application pages.

You have created the application for exemption. The study workspace displays.

To return to the study pages, click the View/Edit Study button

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The Current State of the study is Presubmission. You must submit and the PI must electronically sign the protocol. For more information, see the “Submitting for Signatures and Review” section of this document.

Trainee ResearchFor Trainee Research while away from Duke, this page displays.

1. Attach the requested information.

2. Enter the date the site IRB approval expires..

3. Click Finish to save and exit the study application pages.

You have created the application for trainee research. The study workspace displays.

To return to the study pages, click the View/Edit Study button

The Current State of the study is Presubmission. You must submit and the PI must electronically sign the protocol. For more information, see the “Submitting for Signatures and Review” section of this document.

04. Sponsor and Funding Source1. Click the Add button to add the funding sources.

For each funding source, type all or part of the name in the first box, or type the acronym in the second box. Press the Enter key or click the Find button to the right to display the list of matches.For department-funded studies, type “depart” and press Enter to find “Department/Division/PI”.Click the check box in front of the name, and click OK.If a funding source is not on the list, send a request to add it to the database, to eIRB Support at: [email protected].

2. Click the radio button to answer the Sponsor question.

If the Sponsor is different from the funding source, select the Sponsor:Type all or part of the name in the first box, or type the acronym in the second box. Press the Enter key or click the Find button to the right to display the list of matches.If applicable, type “depart” and press Enter to find “Department/Division/PI”.Click the check box in front of the name, and click OK.If a funding source is not on the list, send a request to add it to the database, to eIRB Support at: [email protected].

3. Click the radio button to answer the samples/data transferred question.

4. Click the radio button to answer the grant from the federal government question.

If applicable, enter the sponsor grant number and attach the documentation. Grants can be exported from the Sponsored Projects System (SPS) as a PDF or XPDF file. If your study is an exception, create and attach a Word document explaining the exception.

5. Click the Continue button to save your work and proceed to the next page

For help attaching documents see the “Tips for Attaching Documents” section of the General Reference Guide.

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05. Multi-site Research1. Click the radio button to answer the multi-site study question.

If this is a multi-site study, click the radio buttons to answer the detail questions, and click the Add button to add detail about the sites.

If the multi-site detail answers are all “No” and there are no other sites where the Duke PI will be responsible for the research, you do not need to add detail about Duke as a site.


If this is not a Multi-Site Study, skip to section 06. Research Summary and Abstract.

05.1 Research at Sites External to Duke University Medical Center1. Click the radio button to answer the multi-site study question.

If this is a multi-site study, click the radio buttons to answer the detail questions, and click the Add button to add detail about the sites.

If the multi-site detail answers are all “No” and there are no other sites where the Duke PI will be responsible for the research, you do not need to add detail about Duke as a site.


If this is not a Multi-Site Statistical Center, skip the next section.

05.2 Multi-site Statistical Center1. Enter text to answer all the questions.

If you are entering a lot of text, you might want to use Word to create and edit the text, then copy and paste it on this page.


If this is not a Multi-Site Coordinating Center, skip the next section.

05.3 Multi-Site Coordinating Center1. Enter text to answer all the questions.



06. Research Summary & Abstract1. Attach the research summary.

A summary of the research is required for all new study submissions to the IRB. See the Research Summary Template in the Download eIRB Documents section of the eIRB Home page for the information that must be included in the summary.

2. Enter text in the Research Abstract text box.

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3. Click the Continue button to save your work and proceed to the next page.


07. Full Protocol1. Check the protocol source.

Select only one choice. If the protocol has joint authorship, select the primary author.

2. Attach a copy of the full protocol, and any related study documents.In addition to the protocol, attach related documents such as questionnaires, surveys, and collaboration agreements. This section is not required. If you do not have a full protocol, do not attach another copy of the research summary here.

3. Click the Continue button to save the page and proceed.

08. Drugs, Biologics, and Other SubstancesInvestigational New Drug (IND) Provided

Add all that are applicable:

1. Click the Add button.

2. Enter all of the detail information for each substance.

3. Click OK to exit the Drug/Biologic/Substance details box.

Investigational New Drug (IND) Not Provided

Add every other drug, biologic or other substance for which side effects are described in the consent form.


2. enter all of the detail information for each substance.

3. Click OK to exit the Drug/Biologic/Substance (Other) details box.

Investigational Drugs, Biologics, or Other Substances:

1. Click the radio buttons and enter text to answer the detail questions.


09. DevicesInvestigational Device Exemption (IDE) Provided

For all that are applicable:


2. Enter all of the detail information for each device.

3. Click OK to exit the Device details box.

Investigational Device Exemption (IDE) Not Provided

For all that are applicable:

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2. Enter all of the detail information for each device.

3. Click OK to exit the Device (Other) details box.

Devices:

1. Enter text to answer the detail questions.


10. Subject Population Groups and Enrollment1. Click the check box in front of all population groups that apply.

Studies with Minors selected will be routed to Pediatrics for the Pediatric Risk Assessment.

2. Click the check box in front of all populations groups to be excluded from the study.

3. Type the maximum number of subjects to be consented at Duke.Enter a single number. Do not enter a range of numbers. You can enter 0 for studies that do not involve consent, if applicable.

4. Type the total maximum number to be consented at all sites, including Duke.

Enter a single number. Do not enter a range of numbers. You can enter 0 for administrative blanket protocols, if applicable.


10.1. Subject Procedures and Costs1. Click the check box in front of all procedures that apply.

2. Click the radio button to answer if blood will be drawn and if yes, enter the maximum amount of blood to be drawn in an 8-week period.

3. Click the radio button to answer if the operating room will be used and if yes, enter the anesthesia time required.

4. Click the radio button to answer if there will be costs to the subject, and compensation, and if yes, the subject compensation.


11. Subject Recruitment MaterialsMaterials are reviewed as part of the study submission. They do not require separate signature.


2. Type a name that identifies the material.

3. Attach the material.

4. Click the Category arrow and select the category from the drop down list.

5. Enter the specific locations where the advertisement will be used. For Duke buildings, include the room numbers.

6. Click the IRB approved arrow and select the answer to the question.

7. Click the Notice of Privacy arrow and select the answer to question.

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8. Click OK on the Edit Subject Recruitment Materials page. If you want to add additional subject recruitment materials, click OK and Add Another.


12. Privacy and Confidentiality1. Enter text to answer the privacy and confidentiality questions.


13. Protected Health Information (PHI)1. Click the radio button to indicate how you plan to use Protected Health Information.


13.1 Review Preparatory to ResearchThis page displays because you selected the first choice on page 13. Protected Health Information (PHI). If this is not what you intend, click the Back button to return to page 13, select a different choice and click Continue.

1. Enter the description in the text box.

2. Click the check boxes in front of the boxes that apply.


13.2 Waiver of Consent and HIPAA AuthorizationThis page displays because you selected the second or fourth choice on page 13. Protected Health Information (PHI). If this is not what you intend, click the Back button to return to page 13, select a different choice and click Continue.

1. Attach the completed Waiver of Consent and HIPAA Authorization or the appropriate waiver (e.g. Decedent Research Notification.To find the form, click the here link in the help text to the right or go to the Download eIRB Forms section of the eIRB Home page.



14. Consent Process1. For each different consent form, click the Add button and attach the document.

To find the eIRB consent form template, click the here link in the help text to the right or go to the Download eIRB Forms section of the eIRB Home page. Save a local copy of the template, complete the consent form, and attach it to this page.

2. Enter text to answer the consent form process questions


For help attaching revised versions of consent forms, see the “How to Respond to Requests for Changes” section of this document.

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15. Specialty Committee Reviews1. Click the check box in front of each specialty committee review required.

The study will be routed to each specialty committee for approval. Submit supporting documentation directly to the specialty committee, as needed, to meet their specific requirements. For example, submit site specific documentation to Durham Regional Hospital.To avoid delay in the review of your study, see the Important Note: in the help text box on this page.


16. Departmental ReviewThis page has been removed from the application. All studies will route to an administrator for management of the departmental/SBR review

Clinical Trials Memo1. Review this notice for information about required registration of studies in

ClinicalTrials.gov.

2. Click the Finish button to save and exit the study pages.

You have created the study and continued through all of the study pages. The study workspace displays. The Current State of the study is Presubmission. The PI still must submit the study for IRB review.

To return to the study pages, click the View / Edit Study button.

For more information about the study workspace, see the “Exploring the Study Workspace” section of the General Reference Guide.

Submitting for Signatures and ReviewStudy Staff with edit rights can submit items for Investigator signatures. New studies and Continuing Reviews must be signed by the PI and all of the Co-PI’s and approved by the Faculty Sponsor, if applicable. Amendments and Safety Events must be signed by the PI.

How to Submit a New Study, Personnel Change Request, Study Amendment, Safety Event or Continuing Review

1. Log in and verify that the selected role is correct.Click the My Home link in the top blue banner. The red Study Personnel banner displays at the top of the column at the left.

2. Click the name link in the “Items in Presubmission” section of the Tasklist. The workspace displays. The title appears at the top of the workspace.

3. Click the Submit activity in the left column.

An entry is added to the History folder tab with your name and the date and time submitted. The state changes to Awaiting Investigator Signatures.

How to Complete the Investigator Electronic Signature1. Log in and verify that the selected role is correct.

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Click the My Home link in the top blue banner. The red Study Personnel banner displays at the top of the column at the left.

2. Click the name link in the “Items Requiring Your Electronic Signature” section of the Tasklist.The workspace displays. The title appears at the top of the workspace.

3. Review the study.For more information, see the General Reference Guide.

4. Click the Electronically Sign Protocol activity in the left column.

5. Click each drop down box in the Conflict of Interest section and select Yes or No to answer the question.

6. Click the check box to agree to the certification and click OK.An entry is added to the History folder tab with your name and the date and time signed. When all investigator signatures are obtained, the study moves forward t the next reviewer.

How to Return to PresubmissionSubmissions that have been submitted but do not have all of the required investigator signatures can be returned to the Presubmission state for changes. When the study is submitted again, all investigator signatures must be obtained, even if some were complete before the study was returned to Presubmission.

1. Click the Studies link in the top blue banner.

2. Find the study and click on the name link. To find related submissions, click on the Amendments, Safety Events or Continuing Reviews folder tab and click on the name link. For more information, see the “Tips for Finding Studies” section of the General Reference Guide.

3. Click the Return to Presubmission activity in the left column and click OK.The study returns to the Presubmission state and is open for editing by Study Staff.

Editing Study Personnel for Approved StudiesFor approved studies, there are two ways to change research personnel. You can use the Modify Existing Study Personnel to change the study role and the edit rights and email recipient properties of people on the Key Personnel list. To add people to or remove people from a study, you must create, submit, and receive approval of a Personnel Change Request. A study Amendment is necessary when you need to change the approved study application or attached documents. You can have one Personnel Change Request and one study Amendment in progress at the same time.

The Personnel Change Request only allows selection of people whose research training certification is current in the eIRB. It takes 2-4 days from course completion to update all of the involved systems. If you have a time-sensitive need to have a person’s certification updated in the eIRB, please email [email protected] and request a manual update.

Note: As soon as you remove yourself from the study, you no longer have view or edit rights.

How to Modify Existing Study Personnel1. Click the Studies link in the top blue banner.

2. Find the study and click on the name link.

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3. Click the Modify Existing Study Personnel activity in the left column.

4. Change the role, edit rights or email recipient properties and click OK.To avoid confusion, it is advisable to limit the number of people with edit rights and receivers of email. The PI, Co-PI’s, Primary Regulatory Coordinator and Primary Study Coordinator have edit rights and receive email notifications.

For more information, see the “Tips for Selecting People” section of the General Reference Guide.

How to Create a Personnel Change Request1. Click the Studies link in the top blue banner.

2. Click the Personnel Change Request under the New heading in the column at the left.

3. Enter a description of the personnel change you are requesting and click Continue.

4. Make the personnel changes and click Finish.To avoid confusion, it is advisable to limit the number of people with edit rights and receivers of email. The PI, Co-PI’s, Primary Regulatory Coordinator and Primary Study Coordinator have edit rights and receive email notifications.

5. Submit the Personnel Change Request as described in the “Submitting for Review and Electronic Signature” section of this document, above.

Creating a Study AmendmentFor approved studies, you must create, submit and receive approval of a study amendment to change the approved study application and documents. Only one amendment can be in process at a time. An existing amendment must be approved before another can be created. If you have submitted an amendment and find you need to submit another before the first one is approved, you can withdraw the first amendment and submit all proposed changes in a new amendment. If this is causing problems for you, please contact eIRB Support at: [email protected].

Note: You no longer use a study amendment to change study personnel on an approved study. See the “Editing Study Personnel for Approved Studies” section of this document, above.

How to Create a Study Amendment1. Click the Studies link in the top blue banner.

2. Find the study and click on the name. For help, see the “Tips for Finding Studies” section of the General Reference Guide.

3. Click the New Amendment button under the Create heading in the column at the left.The Amendment Request Form displays.

4. Enter the amendment information. Complete the required fields marked by a red asterisk.

5. Click the Save link in the light blue banner at the top of the Amendment Request Form page.The amendment is created with the amendment ID number showing at the top right of the page. The amendment ID number, AMD#_Pro00000xxx, shows the amendment sequence number and the approved protocol ID number.The amendment has 2 parts:

The Amendment Request Form, the one-page amendment application with the explanation of the proposed changes, and

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The Modified Study, a copy of the approved study where you make the changes proposed in the amendment.

6. Click the Exit link in the light blue banner at the top of the Amendment Request Form page to exit the Amendment Form page and go to the Amendment workspace.

For more information, see the “Exploring the Amendment Workspace” section of the General Reference Guide.

How to Complete the Modified Study Pages1. Go to the Amendment workspace.

Click the Studies link in the top blue banner. Find the study and click on the name link. Click on the Amendments folder tab, and then click on the amendment name link. For help, see the “How to Create an Amendment” section above.

2. Click the To Modified Study button in the column at the left.You go from the Amendment workspace to the Modified Study workspace.

3. Click the Edit Modified Study button in the column at the left.

4. Make the changes to the Modified Study pages that you propose in the amendment.For help with each study page, see the “How to Complete the Study Pages” section of this document.Be sure to use Track Changes to mark up all proposed changes to study documents and use the [Edit] link to attach revised versions. Do not attach clean copies of the documents until the proposed changes are reviewed. For help, see the “Tips for Attaching Documents” section of the General Reference Guide.All proposed changes are tracked in the Change Log folder tab. Click the Notepad icon next to each entry to view that page of the Approved study and the Modified Study.

5. When you are finished editing the Modified Study, click the Exit link in the light blue header at the top of the page and answer Yes to save the changes.

6. Click the To Amendment Workspace button to return to the Amendment workspace.

7. Submit the Amendment as described in the “Submitting for Review and Electronic Signature” section of this document.

Creating a Safety EventIn the eIRB, safety events include adverse events, protocol deviations and violations, correspondence, and other problems/events that require prompt reporting to the IRB.

How to Create a Safety Event1. Log in and verify that the selected role is correct.

Click the My Home link in the top blue banner. The red Study Personnel banner displays at the top of the leftmost column.

2. Click the white Studies link in the top blue banner, find the study and click on the name. For help, see the “Tips for Finding Studies” section of the General Reference Guide.

3. Click the New Safety Event button under the Create heading in the column at the left.

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The first page of the safety event, Safety Event Type, displays.

4. Select the Safety Event Type.

5. Enter the name and a brief description of the problem/event.

6. Click the Save button at the top of the page.The safety event is created with a unique event number, the SE# showing at the top right of the page.

7. Click Continue to save the current page and proceed.

8. To exit the safety event pages and return to the safety event workspace, click the gray Exit link at the top of page.

For detailed information about each page, see the How to Complete the Safety Event Pages section below.

How to Complete the Safety Event Pages

01. Safety Event Type1. Click a radio button to select the safety event type.

This selection will determine which pages you are routed to when you Continue.

2. Enter the name of the problem/event.

3. Enter a brief description of the event.

4. Click a radio button to answer the internal/external event question.


Adverse Events

02. Adverse Event Evaluation1. Click a radio button to answer each of the evaluation questions.

These selections will determine which pages you are routed to, Reportable or Non-Reportable problem/events, when you Continue.

2. If the event resulted in death, indicate the date of death.


03. Reportable Problem/EventThis page and those that follow are skipped if the problem/event is not reportable. Continue to the 05. Non-Reportable Safety Event section of this document below.

1. Click the check boxes to categorize the event and the harm resulting from the event.

2. Enter the dates the problem/event occurred and the Duke PI recognized/learned of the event.


03.1 Reportable Problem/Event Continued1. Click a radio button to answer the Initial report question.

If the answer is no, enter the related numbers as applicable and click the Select link to select the eIRB safety event of the initial report.

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2. Click the radio button to answer the sponsor judgment question.

If the relatedness is not specified, enter the sponsor evaluation.


03.1 Study Information1. Click the radio button to select the status of study and recruitment

2. Click the radio button to answer the DSMB question.

If the answer is yes, attach the most recent report or add the next scheduled meeting date. A date is required in this field, so if you do not know the exact date, enter an approximation.

03.3 Internal Problem/EventThis page is skipped for external events.

1. Click the radio button to answer the problem resolved question.

2. Click the radio button to answer the reporting questions and add explanation as applicable.

3. Use the last section of this page to describe or attach any other information relevant to the problem/event that should be reported to the IRB.


04. Corrective Action/Response1. Click the radio button to answer the corrective action question.

If the answer is no, enter a justification.


04.1 Corrective Action/Response by the Duke Investigator1. Click the check boxes to answer the corrective actions question.

2. Enter any other corrective actions.

3. Describe why corrective actions will decrease future problems.


See the Safety Event Complete section of this document below.

Protocol Deviation/Violations

02. Protocol Deviation/Violation Evaluation1. Click a radio button to answer each of the evaluation questions.


02.1 Protocol Deviation/Violation Report1. Enter the date of the problem/event.

2. Click the radio button to answer the subject death question.

If the event resulted in death, indicate the date of death.

3. Click the check boxes to categorize the event

If the category is lapse in approval, enter the details.

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If the category is Other, describe.


See the 04. Corrective Action/Response section of this document above.

Correspondence

02. Correspondence or Other Problem/Event Requiring Prompt Reporting to the IRB1. Click the check boxes to answer the correspondence/other problem/event type.

If the type is other, describe.

2. Enter the date o the problem/event.

3. Click the radio button to answer the safety, rights and welfare question.

4. Attach correspondence or documentation describing the problems/events.


For problems/events affecting safety, rights and welfare, see the 03. Reportable Adverse Event section of this document above.

See the Safety Event Complete section of this document below.

Other Problem/Event Requiring Prompt Reporting to the IRBSee the Correspondence section of this document above.

05. Non-Reportable Safety Event1. Attach Documents

These reports will not be reviewed by the IRB. You can report multiple non-reportable events on this page.

2. Enter other information.


Safety Event Form CompleteClick the Finish button to save the page and return to the safety event workspace.

You have created the safety event and completed the safety event pages. The safety event workspace displays. The Current State is Presubmission. You must Submit and the PI must electronically sign the safety event to route it to the IRB for review. For details, see the How to Submit section of this document above.

Creating a Continuing Review (Progress Report or Final Report)In the eIRB, a continuing review can be a Progress Report to renew a study or a Final Progress Report to close a study.

How to Create a Continuing Review (Progress Report or Final Report)1. Go to the eIRB Home page at: http://eIRB.mc.duke.edu

1. Log in using your Net ID and Net ID password.


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3. Click the Studies link in the top blue banner, click on the Approved folder tab, and click on the study name to open the study workspace.

For help, see the “Tips for Finding Studies” section of the General Reference Guide.

4. Click the New Continuing Review or Final Progress Report button under the Create heading in the toolbar on the left.

The first page of the continuing review, Continuing Review Type, displays.

5. Click the radio button to select Progress Report or Final Progress Report.

6. Click the Save link in the light blue header at the top of the Continuing Review Type page.The continuing review is created with the ID number showing at the top right of the page. The continuing review ID for a renewal, Cr#_Pro00000xxx shows the continuing review sequence number and the approved protocol ID number. The continuing review ID for a final progress report is in the format, FR_Pro0000xxx.

For more information, see the “Exploring the Continuing Review Workspace” section of the General Reference Guide.

How to Complete the Continuing Review PagesThis section includes step by step instructions for each page..

01. Progress Report Type1. To renew the study, select Annual Progress Report. To close the study, select Final

Progress Report.

2. Click Continue to save the page and proceed. If you selected Final Progress report, go to section 07. Final Progress Report below.

02. Study Enrollment Status1. Select the current enrollment status.


03. Changes to Study Documents1. Click the radio button to answer the changes to study documents question. If Yes,

Summarize the changes. This is a summary of changes that have occurred since the last IRB review. If you are proposing changes that have not yet been reviewed by the IRB, you must create and submit an Amendment.


04. Audits1. Click the radio button to answer the audit question. If Yes, enter the audit entities and

attach a copy of the audit report.


05. Interim Reports1. Click the radio button to answer the interim reports question. If Yes, attach a copy of

the report.


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06. Funding Source1. Click the radio button to answer the funding source question. If federally funded,

attach the supporting documents.


07. Progress Report1. Download the Progress Report and Continuing Review Summary from the Download

Forms section of the eIRB Home page.

2. Complete and attach the Progress Report.

3. Click the Finish button to save the page and exit the continuing review pages.You have completed the continuing review pages.

9. Submit the Continuing Review as described in the “How to Submit” section of this document.

07. Final Progress Report1. Download the Final Progress Report for Closure of an IRB-Approved Study from the

Download Forms section of the eIRB Home page.

2. Complete and attach the Final Progress Report.

3. Click the Finish button to save the page and exit the continuing review pages.For more help, see the “Tips for Attaching Documents” section of the General Reference Guide. You have completed the continuing review pages.


Creating a Request to Re-Open a Closed StudyIn the eIRB, there is a special type of continuing review called a Request to Re-Open a Closed Study. This continuing review is only available when a study has been closed.

How to Create a Request to Re-Open a Closed Study1. Go to the eIRB Home page at: http://eIRB.mc.duke.edu

2. Log in using your Net ID and Net ID password.


3. Click the Studies link in the top blue banner, click on the Inactive folder tab, and click on the study name to open the study workspace.

For help, see the “Tips for Finding Studies” section of the General Reference Guide.

4. Click the Re-Open Request button under the Create heading in the toolbar on the left.The first page of the re-open request displays.

5. Click the radio button to select the reason for the re-open request, and type an explanation.

6. Click the Save link in the light blue header at the top of the Request to Re-Open page.

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The continuing review is created with the ID number showing at the top right of the page. The ID, Cr#_Pro00000xxx shows the continuing review sequence number and the approved protocol ID number.

For more information, see the “Exploring the Continuing Review Workspace” section of the General Reference Guide.

How to Complete the Request to Re-Open PagesThis section includes step by step instructions for each page.

01. Request to Re-Open a Closed Study1. Click the radio button to select the reason for the re-open request.

2. Type an explanation for the request.

3. Click Continue to save the page and proceed. If you selected Request to collect new data, go to section 02. Create a New Study below.

4. Click the Finish button to save the page and exit the continuing review. You have completed the continuing review pages.


02. Create a New StudyIf you want to re-open a closed study to collect new data, you must create a new study. The eIRB will make a copy of the closed study and assign the copy a new study ID number. You will edit, then submit and electronically sign the newly copied study.

1. Click the checkbox to confirm you want to create a new study.

2. Click Finish to save the page and proceed.

The new study is created, with a new Protocol ID number. The study is in the Presubmission state. Follow all of the instructions in this document for submitting and electronically signing a new study.

Navigating a New Study, Personnel Change Request, Study Amendment, Safety Event or Continuing Review

How to Save Study PagesIt is a good idea to save the page you are working on, as you work.

Click the Save link in the light blue header at the top of the page, to save the page of a new study, amendment request form, modified study, safety event or continuing review.

When you click the Continue button, the current page is saved.

How to View an Approval Letter1. Click the Studies link in the top blue banner, click on the Approved folder tab, and

click on the study name to open the study workspace.For help, see the “Tips for Finding Studies” section of the General Reference Guide.

2. Click the View link next to the Letter of Approval: label in the study header.

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The original approval letter does not change. Click the X in the top right corner to close the page.

3. To view approval letters for amendments, safety events and continuing reviews, click the appropriate folder tab in the study workspace, click the name link to open the workspace, and click the View link next to the Letter of Approval label in the header.

How to View Approved Consent Forms1. Click the Studies link in the top blue banner, click on the Approved folder tab, and

click on the study name to open the study workspace.For help, see the “Tips for Finding Studies” section of the General Reference Guide.

2. Click the name link in the Approved and Watermarked Consent Forms section with the light green background.

Responding to RequestsThere are different activities administrators and reviewers can use to request changes to a study:

During departmental or SBR review, reviewers can Send Comments to the study team

Administrators and reviewers can send requests for changes to the study team.

The IRB can send a Modifications Notice

In each case, an email notification is sent to the study team.

When changes to the study are needed, responding to the request is a two-step process.

First, the study team must make the changes to the study on the application pages

Next, the study team must do the Send Comments, Submit Changes, or Submit Modifications activity to notify the reviewer or the IRB that the changes are complete.

How to Respond to a Request for Changes1. Click the My Home link in the top blue banner, and open the study from the Tasklist

section of your personal workspace.

2. Look in the History folder tab to view the reviewer requested changes. If you are responding to a modifications notice, the modifications display in the Modifications section of the study workspace. To view details, click the [View] link in front of the modification.

3. Click the View/Edit or Edit button to go to the study, amendment, safety event, or continuing review pages.If the changes need to be made to an attached document, how you respond depends on how the request was made.

If the reviewer has suggested tracked changes only and you agree with all of the changes, make a local copy of the reviewer’s document, Accept All Changes in Word, and save the clean copy.

If the reviewer has added comments, or tracked changes you do not agree with, first make a local copy of the reviewer’s document. If the reviewer has not changed the study document, but has provided instructions for how to change it, make a local copy of the study document. In either case, make your revisions with Track Changes On and save the revised document.Attach the revised copy of the study document on the study page.

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Use the [Edit] link in front of the study document to replace the document with the revised version. Don’t use the Add button unless you are attaching an additional, different study document for review.Note for Continuing Reviews: Go to the Continuing Review workspace and use the Update Protocol Documents activity to attach revised copies of the Research Summary, Consent Form, Protocol or Waiver documents. If you need to make change to the study application pages or other study documents, create and submit an Amendment.

4. Save and Exit the study, amendment, safety event or continuing review pages.

5. Click the Submit Changes or Submit Modifications button to return the study for review.

Withdrawing a Submission from IRB ReviewWhen a study is in your workspace, you can remove it from IRB completely and permanently. This activity moves the study to the Withdrawn state. A Withdrawn study cannot be edited or submitted. If you want to submit the study for IRB review later, you must start over by creating a new study.

How to Withdraw a New Study, Personnel Change Request, Study Amendment, Safety Event or Continuing Review

1. Log in and verify that the selected role is correct.Click the My Home link in the top blue banner. The red Study Personnel banner displays at the top of the column at the left.

2. Click the name link of the study in your Tasklist.The workspace displays. The title appears at the top of the workspace.

3. Click the Withdraw activity in the left column.

An entry is added to the History folder tab with your name and the date and time withdrawn. The state changes to Withdrawn and the submission is permanently withdrawn from IRB review.

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