PI -­‐ Managing IRB Applications/Protocols Application Form Program •
How to start an application On the main login page click [My Applications] or in the lower left corner click ”Contributor Home” Next, the PI will click on the form he/she wishes to fill out listed under the section “Currently Available Forms". Example 1 is in the process of being filled out and is in working status. • Miscellaneous Form Elements (see next page) 1) ? = tips on that field; cursor over the “?” to view the help tip text. 2) * = required field 3) Checkboxes are multiple select 4) Radio buttons are single selection and must be answered 5) Dropdown lists are single select except in the universal field set 6) Application numbers are assigned by the system. The letter after the number represents the current status of the form (e.g. W=Working, S=Submitted, F=Finalized, A=Approved, R=Returned) 7) Grayed out items (expiration date, submit date, etc) be filled out by the system or Compliance Office 8) “Universal Field Set” -­‐ first 20+ fields listed under the “General Information” section of every form 9) “Get PDF Version” or “Get Form PDF” link will generate a pdf version of your application; Get Packet PDF will give you a preview of the entire packet. 10) The “See letter + #” at the end of a question [e.g. Question 46 (See C6)] ties the question to “Section 17-­‐Submission Assistance” as well as to the IRB reviewer’s CARE form checklist. 1 Application to Use Human Subjects in Research (Expedited or Exempt) Example 1 (64-­‐W) -­‐ Workflow process from PI thru IRB Decision Note: see Appendix A for additional information on the type of reviews and categories. 2 Add, Edit (update), Remove, Attach Buttons Research and Approval Team Members To add a research and approval team member type in the person’s email address then press <Enter> so that the system can verify the address. If the email address is not valid to the system then an error will be displayed. After the system validates the email address it will populate the “Name” field. Type in the Phone#, Department, select the title from the drop down which will pre-­‐fill the order in which the team member will be notified and then click <Add New Member> to complete the action. 3 The order in which each research and approval team member is entered and the role that each plays, will determine the order in which the team member(s) receive email notifications and is able to take action on the application. Order 1 receives notification first then after all 1's have completed their approval then 2's and after 2's then 3's and so on. The default order is as follows: Co PI = 1 Faculty Advisor = 2 Department Head = 3 Research Assistants = 0 (they are identified as part of the team but won’t go through the approval process or receive emails; they are automatically listed as having approved the application. Other can be assigned any number (say 4) and represents some other role that may be played. To update or remove a research and approval team member click the <Update> button to update the information or click the <Remove> button to remove the member from your research and approval team. To add/attach or edit a certificate(s) to your application choose from the certificate dropdown for the person listed and then click <Attach Certificate>. To remove a certificate from your application for a person click the <Remove> button next to the certificate you wish to remove. To add attachments to your application click the <Browse> button then select the file you wish to attach then click the <Open> button. When the file appears in the “File:” textbox click the <Attach> button to attach it to your application. 4 NOTE: The current file size limit is 10MB. Please email [email protected] if your attachment is larger than this limit or if you have problems attaching your file. To remove an attachment from your application click the <Remove> button next to the file you wish to remove. 5 6 7 8 9 10 Adaptation of the Submission Checklist NOTE: These items correspond to the IRB reviewer CARE form checklist items that will be used to add comments to an application for the PI during the review process when further clarification is needed or if items are missing. 11 NOTE: To Finalize your Form and have it sent to your research and approval team you must click the checkbox certifying that the information provided is correct and accurate and that the proposed research conforms with NMSU policy and that you are familiar with the federal regulations. The PI can clear, reset, save, or finalize a form. Click <Save form> or [Quick Save] periodically to save the form in case your browser encounters a timeout. The following message is displayed after saving and indicating that your form was saved. Click <Continue Working> if you wish to continue editing your form or click <Return to Forms List> to go to the main forms menu. 12 * Saving a form will trigger the app to be assigned an IRB Application Number Example: PI’s Form List (lists available form templates & PI’s Current Forms by state) 13 14