1. Update to the Study Status Log Submission Process and Excel Tips & Tricks to Report Study Activity Accurately Vikki Rawls Fiscal & Business Analyst, USF Health OCR October 6&7, 2011

2. Learning Objectives  Identify changes to the Study Status Log (SSL) submission process  Acquire and/or verify Excel skills to support submission of study activity to the USF Health Office of Clinical Research (OCR)  Integrate Excel tips and tricks into daily practice

3. Updated Study Status Log Submission Process

4. What Are Study Status Logs?  Mechanism to report study activity to the OCR  Includes study patient visits, screen failures, unscheduled visits  Also includes IRB submissions and other items to be invoiced  Applicable to non-Federally funded clinical research projects that are managed by the OCR

5. What Is the Big Deal About SSLs?  SSLs are how the OCR is notified of study activity, both participant visits and items to be invoiced  OCR invoices the sponsors on behalf of the study teams  No SSL = No $$

6. What About the Process Is Changing?  Going to100% electronic submission  Updated Excel workbook is sent to OCR by study team monthly  Printed and signed SSL are no longer required  PI must be copied on SSL submission email to OCR. Recommend cc your Dept Administrator  The PI has until the close of the next business day to notify OCR of any additions or deletions on the SSL  Clinical Trial Tracking Logs being deleted from process

7. What Is Not Changing?  SSL are still submitted to OCRFM@health.usf.edu OCRFM@health.usf.edu  Still due in OCR by COB on the first working day of the month  Items to be invoiced, as allowed by the contract, still noted on the Excel SSL –Supporting invoices should be scanned and emailed with the Excel SSL –Faxed copies accepted but must have PI name and protocol number on fax cover sheet

8. Email Notification

9. Must SSLs be Submitted Monthly?  Do not send a SSL if there is no activity

10. How to Submit a SSL Electronically  Open the SSL Excel workbook  Click on the “Office Button” in the upper left corner of the window  Click “Send”  Click “E-mail”  Enter email address OCRFM@health.usf.eduOCRFM@health.usf.edu  Copy the PI on the email  Subject line should include PI name and either Banner # or Project # as applicable

11. Missing a SSL?  For new studies in FAST contact Caroline Pittman and Vikki Rawls  All other studies contact Vikki  If lost SSL, contact Vikki for a replacement  If there has been patient activity and you have not received a SSL, contact Caroline and Vikki immediately

12. Excel Tips & Tricks to Report Study Activity Accurately

13. Making a Change to Reported Activity  Never delete activity dates from the SSLs  If a change must be made –Fill the cell color in bright yellow and –Add a note explaining why you are voiding that activity date  To add your explanation, select the cell being changed, right click, click on “Insert Comment” and type the note into the text box

14. Adding Items to the SSL  Do not add columns to the SSL  If an item to be invoiced is not on the SSL under the Misc Earnings tab, 1 st check the contract to see if it is allowable  If the item is in the contract, send the back up with the Banner or Project # written on it along with your SSL  If the item is not in the contract, contact your PL

15. Screen Failures  If a visit was recorded on the SSL and the participant subsequently screen fails, fill the cell color of the now void date in bright yellow  Record the screen fail in the screen fail column on the SSL  Do not delete any dates that were previously reported

16. Adjusting to Print  Select the “Page Layout” tab  Click the right lower corner of the “Page Setup” section and a dialogue box will open  Under “Scaling” increase the “adjust to” percentage to larger  Click on the “Sheet” tab within the dialogue box  At “Columns to repeat at left” click on the box then click on the “Initials” and “Random #” columns within the spreadsheet and click the “OK” button  Click the “Print Preview” button in the dialogue box

17. Statements and Invoices  Do not send statements to the OCR  Sponsors typically do not pay from statements  If you receive a statement, you should have already received and submitted the invoice(s) that make up that statement  If an invoice has not been paid it is probably because the sponsor has not yet paid it

18. More Fun Excel Tips & Tricks  Want to see how many subjects have been enrolled or how many study visits have been done? Use the Count function: –Select the range of cells in your spreadsheet that interest you –The number of cells with data in them is displayed at the bottom of the workbook –Cells containing no data are not Counted –Cells containing numerical data also display the Average and the Sum

19. Print a PDF Contract for PI Signature  Select “File” → “Print” from the top menu bar  A dialogue box will pop up  From the “Comments and Forms” drop down box, select “Document and Stamps”  Click “OK” to print  Changing this setting will set it as the default for future print jobs in Adobe Acrobat

20. Print a PDF Contract for PI Signature

21. Questions?