Once you have created a Project, you must submit the Project s first Package to the ORA.

Transcription

1 CREATING, SIGNING, AND SUBMITTING PACKAGE #1 Once you have created a Project, you must submit the Project s first Package to the ORA. CREATE PACKAGE #1 1. Go to the Designer page. This is where an IRB or ORA Package is prepared for submission. When you create a Project, the Designer page automatically opens. You may also access this page from the left side navigation bar. 2. Go to Step 1 and download the ORA Research Review Application. a) Select the ORA library. b) Select ORA Research Review Application. c) Click Download to download the document to the location the department currently saves ORA and IRB documents. This will allow you to fill out the form and later attach it to the package. d) Save the form to the location (computer drive or FH shared drive) where the department currently saves ORA and IRB documents. This will allow you to fill out the form and later attach it to the package. Use the filename format: IRBNet ID #, Document Description, Version (if applicable), and Date (if applicable). Page 1 of 6

2 Reminder: For any forms that require signature(s), when complete, print, sign, scan, and save them as a PDF file that may be attached during the next step. 3. Once the ORA Research Review Application and supporting documents are ready to be submitted to the ORA, upload the documents to the Package. a) Go to Step 2 on the Designer page, and click Add New Document. i) Select Document Type (see Appendix A for a list of Document Types). ii) Select File: click Browse, choose the file for the document that has been saved on the computer drive and is ready to be submitted, and click Open. iii) Leave Description blank the document s filename will automatically populate this field. iv) Click Attach. H:\44701Study File\44701 Research Review Application.doc b) Uploaded documents will appear under Documents in this Package. Repeat steps i-iv above to attach additional documents. Page 2 of 6

3 SIGN PACKAGE #1 At this time, only the person submitting a Package to the IRB or ORA is required to sign electronically in IRBNet. (All other required signatures must be handwritten signatures and present on the attached PDF documents.) 1. On the left side navigation bar, click Sign this Package. 2. Select the role of the person submitting the Package. 3. Click Sign. An IRBNet Signature Notification will be sent to the user that signed the package. A confirmation will be displayed to indicate the time the package was signed. Page 3 of 6

4 NOTE: IRBNet will allow anyone with Project access (Read, Write, or Full) to sign a package. However, only those with Full access may Submit a package. It will be up to your department Standard Operating Procedure to decide who may Sign and who may Submit packages for your department, and you should grant levels of access appropriately. SUBMIT PACKAGE #1 1. On the left side navigation bar, click Submit this Package. 2. Select Florida Hospital Office of Research Administration (ORA), Orlando, FL, and click Continue. 3. Select Submission Type [Package 1 should always be New Funding (even if it is a non-funded Project) to alert the ORA that this Package is for a new project]; provide package explanation, requests, or special instructions (i.e., deadline dates, contract language requirements, etc.) in the Your Comments space; and click Submit. Page 4 of 6

5 4. You will be automatically directed to a Submission Confirmation displaying the date the package was submitted and to whom it was submitted.. 5. On the left side navigation bar, click Reviews to see the up-to-date status of the submission s review. APPENDIX A: Document Types Page 5 of 6

6 Forms Case report forms Change Request Form Check or proof of payment Delegation of Responsibilities Log Determination letters from cooperative review Determination letters from other IRB to which you have directly applied for this study Device manual Documentation of other committee review FDA letter with assigned IND or IDE number Financial Disclosure Forms Form 1572 Informed consent Investigator Brochure IRB Application Major Deviation Report or Minor Dev. Log Media Release Monitor letter Progress Report Protocol Questionnaires, surveys, phone scripts, interview questions, etc. Recruitment material Reviews Prep to Research forms Sponsor's letter of Non-Sig Risk determination IRBNet Document Types Data Collection Cover Sheet Conflict of Interest - Disclosure Consent Form Investigator Brochure Application Form Protocol Deviation/Violation Report Publication Material Continuing Review/Progress Report Protocol Questionnaires/Surveys Advertisement Page 6 of 6