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Update to the Study Status Log Submission Process and Excel Tips

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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 – PowerPoint PPT presentation

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Title: Update to the Study Status Log Submission Process and Excel Tips


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 67, 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_at_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_at_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?
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