Frequently Asked Questions regarding BRAAN2
How do I access BRAAN2?
- The URL to access BRAAN2 is https://braanprod.louisville.edu.
I am having problems viewing BRAAN2 on my PC
I am having problems viewing BRAAN2 on my MAC
- How to make BRAAN2 work on Safari:
1. Launch Safari
2. Open Preferences under the Safari drop-down menu
3. Click on the Advanced tab
4. Check the box in front of Show Develop menu in menu bar
5. Close Advanced window
6. Pull down Develop menu and go to User Agent
7. Set User Agent as Internet Explorer 8.0
8. BRAAN2 now thinks your Mac is running Internet Explorer and it lets you sign in.
Please note: it may be necessary to repeat these steps each time you close out of the browser.
How do I login to BRAAN2?
- Your username is your UofL userid
- Your password is your UofL password.
I am having trouble logging in, what should I do?
- BRAAN2 checks your UofL userid/password when you log in. UofL IT maintains this information. If you are having problems logging in, please contact the IT Helpdesk at 502-852-7997 or at firstname.lastname@example.org.
What if I forgot my password?
- If you don’t remember your password, please contact IT at 502-852-7997 or at email@example.com.
What if I don't have a UofL Userid?
- A UofL Userid is required to access BRAAN2. To obtain a UofL Userid for research purposes, you will need to request a Sponsored Account. To do so, please complete the Sponsored Account Request Form
- E‐mail the completed form to: IRB Sponsored Accounts, Service Account (SPONACCT@louisville.edu)
- Or Fax: 502-852-2164.
- Or print and mail to:
Human Subjects Protection Program Office
MedCenter One, Suite 200
501 E. Broadway
Louisville, KY 40202
- Please allow at least 5-7 business days for processing to establish account. If you have questions or need assistance please send email to the IRB Sponsored Accounts, Service Account SPONACCT@louisville.edu or call the Human Subjects Protection Program at 502-852-5188
How do I set my pop-up blocker?
What Operating System and Web Browser can I use to access BRAAN2?
- Microsoft Windows 2000 or higher: Netscape 7.0; Internet Explorer 6.0*; Firefox 1.0
- MAC OS 10.4: Netscape 7.1; Safari 2.0
- MAC OS 10.3: Netscape 7.1; Safari 1.2
- MAC OS 9.2: Netscape 7.1
*You can download Internet Explorer 6.0 to use with BRAAN2 at Microsoft Office IE 6.0 Download Site.
I created a new IRB protocol in BRAAN2 and now I can't find it!
If you are the PI, please check the following:
- Do you have the filter set properly? Instructions for setting the filter.
- Are you looking under the "PI" activity list (not "Research Team" activity list)
- Did you add yourself to the protocol as the PI? If you are not listed on the protocol, it will not show up on your activity list.
If you are part of theResearch Team, please check the following:
- Do you have the filter set properly? Instructions for setting the filter.
- Are you looking under the "Research Team" activity list (not "PI" activity list)
- Did you add yourself to the protocol as the IRB Contact or Key Personnel? If you are not listed on the protocol, it will not show up on your activity list.
I have completed my protocol in BRAAN2. Now what?
“Verify” the IRB protocol to be sure there are no errors.
Each person listed as Key Personnel on the study needs to login individually to BRAAN2 and check off a box that says they do not have a conflict of interest with this study. Link to step by step instructions for this process: Key Personnel COI Checkoff
The PI opens the study details and clicks on "submit" in the "select an action" drop down list. At this point the study will be assigned a tracking number and the study status will change from "New" to "Awaiting Signatures". Link to step by step instructions for PI submission process: PI Submit
Once the submission process is completed the study will show up in Scientific Reviewer's "Signature Activity List". Link to step by step instructions for the Scientific Reviewer: How to review and sign protocol and send "signature memo"
Once the Scientific Reviewer completes and sends the "signature memo" the study will appear in the Department Chair's "Signature Activity List". Link to step by step instructions for the Department Chair: How to sign protocol and send "signature memo"
Once the Chair (or designee) completes and sends the "signature memo", the study status will change to "submitted" and the study will be routed to the HSPPO for processing. (If the status does not change to "submitted", then the study has NOT been submitted to the IRB and will not be processed)
When I tried to submit my IRB Protocol a box popped up listing all of the key personnel on my study and show their training and COI expiration dates. One or several of the key personnel shows that their COI or training is expired. How do they update these?
- Expired COI: When a PI tries to submit a protocol and is stopped by the pop-up box indicating that COI is expired, COI refers to the Disclosure of Significant Financial Interest Form located on the Office of Research Integrity Website. Link to form: Disclosure of Significant Financial Interest Form (Please note: Once the form is completed, it will take 24 hours for the Office of Research Integrity to update BRAAN2. To expedite this process or to ask questions, please contact the Office of Research Integrity at firstname.lastname@example.org or 502-852-2454.)
- Expired Human Subjects Training: Link to Online Human Subjects Protection Program Training. (Please note: Once the course is completed, it will take 24 hours for the Office of Research Integrity to update BRAAN2. To expedite this process or to ask questions, please contact the Office of Research Integrity at email@example.com or 502-852-2454.)
- Expired HIPAA Training: Link to Online HIPAA Training. (Please note: Once the form is completed, it will take 24 hours for the Office of Research Integrity to update BRAAN2. To expedite this process or to ask questions, please contact the Office of Research Integrity at firstname.lastname@example.org or 502-852-2454.)
My Department Chairperson has signed my study, but the status still says "Awaiting Signatures"
- Signing a protocol is a two step processes. The first step is to click on the action "Signature Memo" and sign, the second step is to click on the action "Send Signature memo" to actually submit it. This two step process is not ideal and we have asked the software company to combine to a one step process. In the meantime, we need to work with it as it is. The Department Chair should login to BRAAN2 and see if your protocol is still showing in his "Signature" Activity List. If it is he/she needs to complete steps 11-15 on the Department Chair Signature Instruction Sheet.
What is the difference between COI CHECK-OFF and COI EXPIRED??
COI CHECK-OFF: Each person listed as Key Personnel on the study needs to login individually to BRAAN2 and check off a box indicating that they do not have a conflict of interest with the particular study. When a PI tries to submit a protocol, and an individual listed on the study has not done their COI-Check-off, a box will pop up stopping the PI from submitting. Please click here for instructions on COI CHECK-OFF. )Note: Each individual's conflict of interest box will show up only when that individual is logged in to BRAAN2. No one has access to any other checkbox than their own.) If you have questions regarding COI CHECK-OFF please call the HSPPO at 502-852-5188.
COI EXPIRED: When a PI tries to submit a protocol a box pops up listing all the key personnel on the study and their Training/COI expiration dates. If one of the Key Personnel's COI is marked as Expired, then COI refers to the Disclosure of Significant Financial Interest Form located on the Office of Research Integrity Website. This form needs to be completed annually by all individuals involved in research at UofL. If an individual's COI is Expired, the PI will not be able to submit the protocol. Please click here for the Disclosure of Significant Financial Interest Form . (Note: When completing the form, please be sure to check yes to the question on the first page which asks if you are involved in research.) Once the form is completed, it will take 24 hours for the Office of Research Integrity to update BRAAN2. If you have questions regarding EXPIRED COI please contact the Office of Research Integrity 502-852-2454.
How do I find my stamped Consent/HIPAA forms?
1. Click on the plus sign to the left of the study #.
2. A box will open with a link titled Details. Click on the Details link. If there is more than one Details link, click on the bottom link.
3. The IRB Protocol - Details page will open up. In the bottom right hand corner of the screen is a drop down box titled Select an Action, select View History and press Go.
4. Once the history opens up, look in the Memo Column and you should see this link: IRB PROTOCOL-APPROVAL. Click on this link. Remember: you want the Memo NOT the Letter.
5. When the memo opens up you will see a button labeled Attachments/Forms. Click that button.
6. A new window will pop up, which will show a list of all of your attachments (stamped/approved forms). Click on the attachment that you want to open and a pdf version of the attachment will open up on your screen.
For illustrated instructions please click here.
How will people know there is something they need to do in BRAAN2?
- Research Team: You will need to let your research team know that they need to check off their COI. A COI Check-off Instruction Sheet is available that you can send the research team explaining exactly what they need to do.
- Principal Investigator: If you are filling out the protocol and someone else is the PI, you will need to let the PI know when the protocol is ready for submission. A PI Submit Instruction Sheet is available that you can send the PI explaining exactly what they need to do.
The automated signature notification emails are not working at the present time. If your study status is "Awaiting Signatures", please notify the person who needs to sign directly and ask him/her to login to BRAAN2 and "sign" your protocol.
Why do I and each key personnel participating in my research have to check the COI box in BRAAN2 for each study that is submitted when we are required by policy to complete the University’s annual Significant Financial Conflict of Interest (SFI) certification?
- University of Louisville Policy requires that all covered individuals involved in research complete the disclosure form at least on an annual basis. When completing the COI check in BRAAN2, study personnel are certifying that their SFI disclosure is current and there is no change in the current SFI statement due to participation in the study to be submitted for IRB review. By utilizing the COI check in BRAAN2, study personnel no longer have sign an individual COI form each time they participate in a new human subjects research study. This electronic process should help reduce the amount of time it takes to prepare a study for submission to the IRB because this can be done by each member of the research team from any location they have computer and internet access.
- Involved in research means: Having responsibilities that include the design, conduct, reporting or management of research. This may include enrolling research subjects (including obtaining subject’s informed consent) or making decisions related to eligibility to participate in research, or activities that include direct and significant access to research data with control over its collection, analysis, or reporting (including submission for publication).
- “Covered individual” includes any faculty member (whether fully-, partially-, or non-salaried), staff member, student, fellow, trainee, administrator or other employee who, under the aegis of the University, is involved in research, or pursuant to the review and approval of the University’s Institutional Review Board (IRB), conducts research involving human subjects, or is otherwise identified as involved in research by a principal investigator, chair or unit head, or other University administrative officer responsible for research activities.
Why are we are required to list the inclusion/exclusion criteria when the same information is located in the protocol and what do I do if the protocol is a protected document?
- The oversight agencies such as OHRP and our accrediting body AAHRPP expect that we document in our submissions and review documents that we (the investigator and the reviewer) have looked at these areas of the protocol. This is how we do it. You can ask the sponsor for a copy that will allow you to cut and paste. Sponsors are getting used to this type of request as so many institutions are going electronic. Aternatively, you can use Adobe Acrobat Professional to capture and copy from the document.
Why do I need to attach a CV for each person listed on study and does each CV need to be signed?
- AAHRPP Standards requires CVs to insure that each person is qualified to to conduct the research.
- It is common practice for a person to sign his or her CV, but not mandatory. The IRB does not require it.
What if I have a collaborator from another University or another Country?
- How to add key personnel from outside of UofL.
There are two options:
1. Obtain a sponsored account for the person and add them as Key Personnel in BRAAN2.
2. Create a document for the person containing their CV, training certifications and COI attestation. This document can be attached to the protocol under MISC. ATTACHMENTS.
How to know which option to choose:
If the individuals are external to UofL and they will not be on the UofL campus to conduct the research, you don't need to have a sponsored account for them (unless you want them to see the BRAAN2 documents). If they are local community people, whether or not they will need an account is based on the extent of their participation. As each situation may be different, please e-mail (email@example.com) or call the HSPPO at 852-5188. Someone will discuss and provide guidance.
When I add an individual to my study via a personnel change amendment, does the person need to log on to BRAAN2 to do their COI checkoff?
- BRAAN2 does not require the COI checkoff on amendments adding personnel, this is a bug in the system. Therefore, when personnel is added via an amendment, they do not need to log on and complete the COI checkoff in BRAAN2.
When I tried to submit my protocol, I received the error message "Signature plugin issue: A Scientific Review signatory was not found for the department selected in the protocol. Please contact your system administrator."
- If you tried to submit your protocol and you received the above error message, there is a problem with Section 14 of your protocol. Please click on the following link for instructions on how to complete Section 14: http://louisville.edu/research/braan2/signatures.html
Why do I have a study listed in my Research Team Activity list that I cannot open?
- There is a known bug in BRAAN2 that when someone is listed as key personnel on a study and is removed from that study. The study still shows up in their Activity List, but they don't really have access to it. That could be what is happening here. If you need access to the study, an amendment will need to be submitted by the PI adding you as key personnel.
BRAAN2 will not recognize key personnel that I am trying to add to my study.
- Please follow the process outlined in the following document to add the personnel to your study: Importing Key Personnel.
When I verify my study I keep getting an error related to Pregnant Women, Fetuses or Neonates in Section 6!
There is a bug in BRAAN2 related to selecting Pregnant Women, Fetuses or Neonates in Section 6. To get around this bug, please do the following:
- For the question titled: "Description of Population" select "other" and then save. A text box will appear with red text asking you to explain "other". In the text box explain that your population is neonates.
- For the question titled: "Age Ranges of Subjects", select "child"
- Do not select neonates for either question.
I have clicked on "submit" but my study still has a status of "New"
- If you have clicked on submit but your study still has a status of new, check your pop-up blocker settings to be sure you have allowed pop-ups from *.louisville.edu. Detailed instructions on setting the Pop-Up Blockers can be found at the following link: Setting the Pop-Up Blocker. Once you are sure your pop up blockers are set correctly, try and submit again.
I have clicked on "resubmit" but my study still has a status of "admin mods required" or "board mods required"
- If you have clicked on resubmit but your study still has a status of "admin mods required" or "board mods required", check your pop-up blocker settings to be sure you have allowed pop-ups from *.louisville.edu. Detailed instructions on setting the Pop-Up Blockers can be found at the following link: Setting the Pop-Up Blocker. Once you are sure your pop up blockers are set correctly, try and resubmit again.