PAGE 1. IRBManager. Instruction Manual For IRB members

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1 PAGE 1 IRBManager Instruction Manual For IRB members

2 IRBManager PAGE 2 What is IRBManager? IRBManager is a web-based system designed specifically for the IRB review process, all the way from submission to approval letters. Investigators are able to sign forms electronically, forward their new submissions to other signatories such as the Department Chair for electronic signature, and access the current status of the submission at any time. IRBManager uses smart forms called Xforms to direct the questions based on previous answers. For example, if you answer the question, Is this a VA study? as no then you will not see any further questions related to VA studies. This will enable the forms to be more tailored to your specific needs and help ensure more complete submissions. IRBManager will also speed up the review process, eliminating delays caused by routing time for submissions, reviewer forms, and approval letters. notifications will provide links with which you can access, review and update study material immediately. In fact, you ll have remote access capability from any computer with an internet connection. That means you ll also be able to collaborate with investigators at other institutions. In addition, IRB reviewers will have access to your study s entire history as they conduct their review, which will enable informed decisions quickly. How can I obtain access to this system? Register for training through the ETSU PlanIT or contact Theresia Cannon at Complete Request for Log-In and return the form to the ETSU IRB. You will be contacted with a date and time for training, after training you will receive your username and password. How do I log-in? 1. Go to 2. Enter your username and password. 3. Enter ETSU as the Client (check box 4. Remember Client to set the client permanently for the computer you are working on). 5. Click Login.

3 Passwords PAGE 3 What happens at first log-in? On your first log-in, you will be prompted to change your password. Your password must meet the following requirements: 1. Be 8 or more characters 2. Must contain any 2 of the following: upper case letter(s), lower case letter(s) or number(s) To change your password and proceed: Step 1: Enter old password. Step 2: Enter new password (see requirements above) and then enter new password again to confirm. Step 3: Click update. Tip: When you log-in in the future, be sure you know your username and password. As a security precaution, if you enter the wrong username/ password three times, IRBManager locks your account. If that happens, you will have to call an IRB staff member to reset your account. You can choose to use your ETSU password if you wish and update your IRBManager password when your ETSU password is updated. Tip: Once you log in with your username and password, you will be able to provide a required signature electronically simply by entering your password. Ok, I m in, now what? Once your password has been updated, you will be logged into the system. Your view will depend on your assigned role. As an IRB member, you will be able to view all studies assigned to your board. If you are also a researcher, you will also be able to access your own studies.

4 Navigating the Home Page PAGE 4 Dashboard view On the left side of the page, you will see 5 captions: 1. Actions 2. Recent Items 3. Messages 4. Useful Links 5. My documents and Forms

5 Navigating the Home Page PAGE 5 1. Actions Show Sponsor Protocol Codes allows you to see protocols listed by Sponsor Protocol Numbers rather than IRB numbers. Just click on Show Sponsor Protocol Codes link to toggle your view from IRB numbers to Sponsor Protocol Numbers (and vice-versa). Note: If you have multiple sponsors, the Sponsor Protocol Numbers view will show one line for each sponsor, so a study may have multiple listings in this view. Agendas & Minutes Links you to the information shown below. Use the arrows on the columns to sort data for your needs. Choose Action Icon to view specific information for that specific date. SEE PAGE 6 13 FOR SPECIFIC AGENDA/MEETING INSTRUCTIONS 2. Recent Items The hyperlinks under this heading will show the 7 most recent items you have viewed in IRBManager. You can just click on any link under recent items to go directly to that item. 3. Messages This heading is an area that the IRB will use for communication to all of the users within the system (for example, the next submission deadline for full studies). 4. Useful Links CITI Human Subjects Training CITI Instructions Form 129 (Is it Human Research?) IRB Member IRBManager Instructional Manual Researcher IRB Manager Instructional Manual 5. My Documents and Forms This heading shows how many attachments and xforms (smart forms) the user has submitted. User Attachments Xforms

6 Navigating Agendas & Minutes PAGE 6 IRB SPECIFIC AGENDA INSTRUCTIONS To Access IRBManager Website: Enter your Username & Password Client is etsu Check the box for Remember Client

7 Navigating Agendas & Minutes PAGE 7 IRB SPECIFIC AGENDA INSTRUCTIONS Full Continuation Reviews With and Without Waivers

8 Navigating Agendas & Minutes PAGE 8 IRB SPECIFIC AGENDA INSTRUCTIONS Instructions below are for locating Events by IRB Number Click on Study Number link.

9 Navigating Agendas & Minutes PAGE 9 IRB SPECIFIC AGENDA INSTRUCTIONS Select xforms to see the Form 107 To Review Narrative: If the study has an actual narrative form, it will be on the attachment of the Event called Continuing Review. If the study was initially submitted on an xform, the narrative questions are part of the New Protocol Submission xform. To view, scroll down the page and select New Protocol submission Event. Then select xform New Protocol Submission.

10 Navigating Agendas & Minutes PAGE 10 IRB SPECIFIC AGENDA INSTRUCTIONS To Review Attachments

11 Navigating Agendas & Minutes PAGE 11 IRB SPECIFIC AGENDA INSTRUCTIONS Return back to Member Agenda

12 Navigating Agendas & Minutes PAGE 12 IRB SPECIFIC AGENDA INSTRUCTIONS Meeting Minutes & Other Meeting Documents

13 Navigating Agendas & Minutes PAGE 13 IRB SPECIFIC AGENDA INSTRUCTIONS Closing out of Meeting Minutes

14 Navigating Find Protocol PAGE 14 As an IRB member, you can search by one of seven functions. 1. To search by IRB number, enter the IRB number (protocol code) in the Protocol box and click find it. 2. To search by board, choose the appropriate IRB from the drop-down box at IRB Committee, and click find it. (Note: you can only see the studies belonging to the board you belong to, and any studies that you may have with the other board as a researcher). 3. To search by Site, choose East Tennessee State University (for campus), or if you are a medical IRB member, choose from any of the 3 options: ETSU, MSHA or the VA, and click find it. 4. To search by Sponsor, make your selection of sponsor from the drop-down menu, and click find it. 5. To search by the sponsor code, enter the sponsor protocol code in the Sponsor s Protocol box and click find it. 6. To search by Investigator, either select the PI from the drop-down menu, or type his/ her name in the Investigator box and click find it. 7. To search by Keyword, enter your desired word in the keyword(s) box and click find it. (note: keyword searches within the title and the comments entry, which is typically the primary objective of the research. Note: If you return to this screen using the back arrow, be sure to click clear to remove previous search criteria.

15 Navigating the Home Page PAGE 15 In the example below, Dr. Test Investigator has 2 studies. The headings on the home page show: 1. IRB Number (called Protocol Code). 2. Site (ETSU unless the study is a Mountain States Health Alliance (MSHA) or James H. Quillen VA study (VA) 3. PI (Investigator) 4. Study Title 5. Expiration Date 6. Status (at most recent continuing review) To access any study, just click on the blue link in Protocol Code. Tip #1:The data is sorted by the column highlighted in blue. To sort by another column, just click on the arrow in the column header. For example, you might want to list the studies by upcoming expirations so just click the arrow by Expiration Date to sort by that date.

16 Navigating the Home Page PAGE 16 Tip #2: You can sort your data by clicking in one of the boxes. To view your exempt studies, click in to view your ex- Then you can see a sub-set of only the exempt studies. (sub-sets are always highlighted in yellow). To go back to the view of all your studies, just click in the box again.

17 Navigating the Home Page PAGE 17 At the top of the page, there are 3 important headings: 1. Home tab 2. My Settings 3. Sign off Please note: the Help button is not functional at this time. 1. Home tab This tab will always bring you back to your home page the page you see when you log in. My Settings Sign Off 2. My settings Clicking on My settings will bring up this view: Under my settings you can: 1. Change your password 2. Update your user settings 3. Update your address information 4. View last 25 logins 5. Create an signature 3. Sign Off

18 Navigating My Settings PAGE 18 A. Change password Step 1: Click on change password link. You will then see this view: Step 2: Enter old password. Step 3: Enter new password that meets requirements and then enter new password again to confirm. Your password must meet the following requirements: Be 8 or more characters Contain any 2 of the following: upper case letter(s), lower case letter(s) or number(s) Step 4:Click update. B. Update your user settings. Step 1: Click on user settings link. You will then see this view: Step 2: Update your name, phone number or address. Step 3: Click update.

19 Navigating My Settings PAGE 19 C. Update your address information Step 1: Click on address information link. Step 2: Click add address. You will then see this view: Step 3: Enter information. Step 4: Click add address. (If you need to edit an address, click on the hand icon). D. View last 25 log-ins. This view shows the date, time, source IP address and status of the last 25 log ins or log-in attempts. E. Set signature. Step 1: Click on signature link. You will then see this view:

20 Navigating the Home Page PAGE 20 E. Set signature continued... Step 1: Click on signature link. You will then see this view: Step 2: Enter your desired signature. Step 3: Click on save. F. Sign off Click on this link to sign-off from IRBManager. Then close your browser window. Next section: Navigating the Study Protocol Page.

21 Navigating the Protocol Page PAGE 21 From the home page, you can access a protocol page for each of the IRB studies. Use the search function and then click on a blue-linked Protocol Code to access an individual protocol page of your choice. On the protocol page there are multiple study items that can be viewed. There are 7 main sections for a protocol home page. 1. Protocol 2. Protocol Site 3. Contacts for this Protocol 4. Attachments 5. Events 6. Notes 7. Generated Documents In addition, note the same sections on the right hand side, Actions, Recent Items, Messages and My Documents and Forms. Tip: Notice that the sections can be condensed or expanded by clicking the green arrow beside the section name.

22 Navigating the Protocol Page PAGE 22 Section 1: Protocol This section accesses all sorts of basic information about the protocol, such as: IRB number Sponsor Sponsor protocol number (if there is one) Title of the study Type of IRB review IRB assignment You can click on any blue link; in this section, you can click to view more information on the sponsor. Section 2: Protocol Site This section accesses all sorts of basic information about the protocol site, such as: Site (ETSU, MSHA or VA) PI name Status (From last continuing review; for example, closed to accrual, data analysis only, etc) Most recent approval date Expiration date Initial approval date In this section, you can click on the following blue links for additional information Click on status to view the history of the status of this study Click on approval to view the approval history (example below) (click done to return) Click on investigator to view the investigator history Click on location to view the specific location information

23 Navigating Protocol Page PAGE 23 Section 3: Contacts for the Protocol Site This section lists the names of all study staff members. These staff members have access to this protocol as an IRBManager user, if they have attended training and obtained a username and password from the IRB Office. Their role on the study is included in this section. Tip: IRBManager allows assignment to the following study staff roles: co-investigator, coordinator, research assistant, faculty advisor, and cc recipient. One person in each role can be designated as primary. Section 4: Attachments This section lists the attachments that have been attached to the main protocol page. If there are attachments listed, click on the name to open the attachment. This section also identifies the type of the attachment, the date it was attached, and which user attached it. The Currently approved consent documents will be posted here. Section 5: Events This section lists all the IRB events or reviews that have been or are being conducted for this protocol. The event line contains the following sections: A. Type of event B. Attachments C. Child Events D. Event Instance E. Start Date F. Complete Date G. Primary and Secondary Reviewers (not displayed) A. Type of Event Some examples are continuing review, modification, or initial new submission. The event type is in blue (more to come about this link) B. Attachments Next to the blue event name are either one or two red numbers. The first red number is the number of attachments tied to that event. You can click on this number and go directly to the attachments.

24 Navigating Event Screen PAGE 24 C. Child Events If there is a second number on your event, this is the number of child events. Child events are events related to the original event for example, requested changes from an approval pending action. You can click on this number and then click on the name of the child event to view. (the example on previous page does not have a child event). D. Event Instance This is a summary of the event to help you identify specific events. E. Start Date This is the date the submission was received by the ETSU or ETSU/VA IRB. F. Complete Date This is the date the event was completed by the IRB. G. Primary and Secondary Reviewers This data is not displayed for investigators. IRB members can view this section. Section 6: Notes This section includes notes posted on the mail protocol page. Section 7: Generated Documents This section includes generated documents (for example, approval letters) posted on the main protocol page.

25 Frequently Asked Questions PAGE 25 I forgot my password. How do I obtain a new password? Contact the IRB office at (IRB IRT) or (medical coordinator) during regular business hours. Although IRB staff can not look up your password, they can assign a temporary password. You will then be required to update your password when you log in. How do I find a protocol? Click on the Home tab at the top of any screen. Use your choice of search criteria. How do I change my password? From any screen in IRBManager: Click the link My Settings (top right) Click the link Change my Password You will then be prompted to enter your old password, followed by your new password and confirmation of your new password (remember passwords must be 8 or more characters, and contain any 2 of the following 3: lower case letters, upper case letters, numbers. Click update. How do I change my contact information (name, phone number or address)? From any screen in IRBManager: Click the link My Settings (top right) Click the link Users Settings This will take you to the screen where you can make the necessary changes. Click update. How do I change my address? From any screen in IRBManager: Click the link My Settings (top right) Click the link Address Information This will take you to the screen where you can make the necessary changes. To add an address, click add address. To edit an address, click the hand icon (first icon on left). Enter the address information and click update. How can I check on the status of a submission? Log into the system and click the blue protocol link for the appropriate study protocol page. Once on the study protocol page, click the blue event link for the event that you wish to check. The event page will open up and within the Steps section, you can see which steps have been completed by the yes or no answers in the completed column.

26 IRB Staff Information PAGE 26 Institutional Review Board (IRB) Staff Janine Olive, IRB Director Hazel Robinson, IRB Coordinator (Medical Board) Amber Anderson, IRB Coordinator (Campus Board) Linda Zerby, IRB IRT VA R&D Administrative Staff Owen Murnane, Ph.D Associate Chief of Staff for Research To be announced Research Administrative Officer

27 Office Information PAGE 27 Office for the Protection of Human Research Subjects East Tennessee State University PO Box Johnson City, TN Fax: Website: an AAHRPP Accredited University Accredited since December 16, 2005