Vikki Rawls Fiscal & Business Analyst, USF Health OCR October 6&7, 2011

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 • 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.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, 1st 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?