User s Guide. Biomedical Research Alliance of New York

Transcription

1 Using IRBManager to Maintain Your BRANY Studies User s Guide Biomedical Research Alliance of New York Institutional Review Board 1981 Marcus Avenue, Suite 210 Lake Success, NY P: (516) F: (516)

2 Investigator Access 1) GO Visit IRBManager s Internet home page by going to You can add this login page to your favorites for future visits. (Diagram 1) We recommend using Microsoft Internet Explorer or Mozilla Firefox to access IRBManager. Please note that MAC users may have difficulties when attempting to log in or generate documents using Safari. Diagram 1 BRANY IRB (Version 12/10/2009) Page 2 of 9

3 2) ENTER Enter the following login information: a) Login: your address alias (everything before sign in your address) from the address you have previously provided to BRANY IRB b) Password: your first name (all lower-case characters - until you change it upon your first login). Passwords are case sensitive! c) Client: BRANY (If you check the Remember Client box, this box will automatically indicate BRANY for all future visits to this webpage on the computer you are using now.) 3) VIEW Once your login is successful, you will be taken to the home screen, which will contain a list of all of your BRANY IRB studies. Each protocol will be listed as a hyperlink (blue and underlined) that you can click on for further information. The protocols on this page can be sorted according to Sponsor Protocol number or IRB File number. You can change this by toggling the Show Sponsor Protocol Codes button on the left-hand menu, which will switch to Show Protocol Codes when you click on the link. (Diagram 2) Diagram 2 BRANY IRB (Version 12/10/2009) Page 3 of 9

4 4) SUBHEADINGS Once you select which protocol you would like to view, clicking on the hyperlink for that protocol will bring you to a screen with the following subheadings: i) Protocol Information (details about the study itself) ii) Contacts for this Protocol (sponsor staff we may contact for information regarding this protocol) iii) Protocol Site Information (details specific to your site including approval and expiration dates) iv) Contacts (study staff who we may contact for information regarding the protocol) v) Attachments (supporting documents, which may be printed or saved locally) vi) Events (events relative to the review of the project) These events are input by BRANY IRB staff to show the progress of any given review. For all items submitted to BRANY IRB for review, an event is opened upon receipt of submission, and each event is updated as the status of the review changes. You can view these events by clicking on any hyperlink in the section entitled Events. (Diagram 3) Diagram 3 BRANY IRB (Version 12/10/2009) Page 4 of 9

5 Once you click on any hyperlink, you will be taken to the Event Details page. The Event Details page will show you what steps have been completed for each review and which step the review process is currently at for that item (See Diagram 4). The first event detail without an Actual completion date is where the review currently stands. For example, below you will see an event entitled Protocol Amendment 1 that has the last completed step recorded as Sent to Expedited Reviewer. Therefore the next step to be taken is Decision from Expedited Reviewer, which means that the submission is still currently under review. Once BRANY IRB staff receives a decision, a completion date will be input and the review status will be updated. Event attachments will be visible by clicking here. Event steps completed thus far are detailed here. Diagram 4 vii) Notes (notes relative to the project/site) viii) Generated Documents (IRB forms that you can generate from your own computer with study specific information automatically input by the database, which will save you time in completing them.) BRANY IRB (Version 12/10/2009) Page 5 of 9

6 Attachments relevant to a particular event will be located within the screen for that event. If the event has attachments associated with it, there will be a number in parentheses next to the event. You can click on the number, and it will bring you directly to the attachments for that event (see Diagram 5 and 5.1). If event has attachments, a number will appear here Diagram 5 BRANY IRB (Version 12/10/2009) Page 6 of 9

7 For each of these subheadings, a green triangle next to the subheading will indicate that there is further information for this section. You may click on the green triangle to either hide or show the detailed information for each section (see arrow #1 in Diagram 6). Diagram 6 5) CLICK - Anything that is hyperlinked may be clicked on for additional information (see arrow # 2 in Diagram 5). 6) SORT - Some columns may have yellow triangles pointing up and down (see arrow # 3 in Diagram 5). Wherever you see these yellow triangles, this means that you may sort the column under it by either ascending or descending order (such as Event Date, Event Name, etc.). 7) Generate a document From this option under Actions on the left hand menu (see arrow # 4 in Diagram 5), you may generate BRANY IRB forms with study specific information (such as IRB file number, protocol title, etc.) to be printed and/or saved. Once you click on Generate a Document, the following will come up: a) Template: Choose the document you would like to generate, such as an IRB Request for Review form, or SAE Reporting Form. BRANY IRB (Version 12/10/2009) Page 7 of 9

8 b) Name for Generated Doc: You can leave this field blank unless you want to give it a special name. If left blank, it will default with the file name. c) Click: Generate. The form will pop up on the screen. Please note that if you are using an older version of some web browsers (e.g., Internet Explorer), the generated document may not pop up on the screen. In this instance, you will need to go to the subheading Generated Documents on the protocol s main screen and click on the item s hyperlink in order to open the document. From here, you can modify and print. (See Diagram 6) Diagram 6 BRANY IRB (Version 12/10/2009) Page 8 of 9

9 Frequently Asked Questions 1) How do I get my user login information? You should have received BRANY IRB correspondence, notifying you of your login information. If you are an investigator who already has IRB approved projects through BRANY IRB, you can create your own account using your address alias as your username and using your first name as your temporary password. 2) What if I forget my password? You may contact BRANY IRB who can supply you with a temporary password, with which you can logon and change your password. 3) How can I change my password? You can change your password by clicking on My Settings at the top of the screen, and choosing Change My Password. 4) What if I have trouble generating a document? Due to the fact that IRBManager is a web-based system, you may have occasional troubles with generating documents. You should wait a few moments and try again. If that does not work, try logging out of your web browser and re-logging into IRBManager. If it still does not work, contact BRANY IRB staff at ) How do I enter in a new protocol for IRB review? At this time, only IRB staff will enter new projects. Any new protocols that are being submitted for IRB review still need to be submitted in hard copy or via to BRANY. 6) How can I enable my study staff to access IRBManager and view information for my studies? If you would like to delegate access to any of your study staff to view your projects, please the name, address, and phone number of the person to be activated to mrodrigu3@brany.com. We will facilitate this for you. BRANY IRB (Version 12/10/2009) Page 9 of 9