Update to the Study Status Log Submission Process and Excel Tips & Tricks to Report Study Activity Accurately

Vikki RawlsFiscal & Business Analyst, USF Health OCR

October 6&7, 2011

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

Updated Study Status Log Submission Process

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

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 $$

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

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

Email NotificationDear Coordinator(s):

****CHANGE IN PROCESS****

INSTRUCTIONS

(Updated 10/20/11)

IF YOU HAD ACTIVITY:

Email the updated Excel status log to OCRFM@health.usf.edu

o PI must be copied on email to the OCR

o **IMPORTANT NOTE:** PI has until the close of the next business day to notify OCR of any additions or deletions on the study status log

Items to be Invoiced - (advertising, IRB amendments, phone charges, etc.) allowed by the contract should be noted on the Excel study status log.

o Supporting invoices should be scanned and emailed with the Excel status log to OCRFM. FAX copies of supporting invoices will be accepted, but must have the PI Name and protocol number on the FAX cover sheet.

MISSING A STATUS LOG? o For new studies in FAST please contact Caroline Pittman. For all other studies contact Vikki Rawls. o If you simply lost your status log you can contact Vikki for a replacement.

OCTOBER 2011 LOGS DUE BY COB TUESDAY, NOVEMBER 1, 2011

Must SSLs be Submitted Monthly?

Do not send a SSL if there is no activity

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

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

Excel Tips & Tricks to Report Study Activity Accurately

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

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

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

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

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

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

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

Print a PDF Contract for PI Signature

Questions?