Dartmouth-Hitchcock Medical Center SITE OPERATION TOOLS ACRIN FALL MEETING 2009 Suzanne Lenz, M.A. – CCRP Dartmouth-Hitchcock Medical Center Lebanon, NH

Site Operation Tools Identify due or overdue forms & images Identify images/forms credited to calendar Track Z1 queries due or received/resolved

Site Operation Tools Searches can be completed for: a single study or all studies at site an individual case number Data can be copied to a spreadsheet allows site to track outstanding forms/images allows site to track data received by ACRIN

Site Operation Tools Future modules: opening a study recruiting and scheduling participants managing case report forms and images (treatment, screening, follow-up) maintaining compliance with regulatory requirements

From the home page of the ACRIN website (http://www. acrin From the home page of the ACRIN website (http://www.acrin.org/), click on “Site Operations Tool.”

Enter Login ID and your password (these are typically the same as your ACRIN Data Center Login).

Click on the desired Inst No. (in this case, there is only one).

Select Participant Form Calendar.

If you want to see all studies at your site, leave Study No Blank If you want to see all studies at your site, leave Study No Blank. Enter a study number to view data for just one ACRIN study. Leave Case No blank if you want to view data for all participants on a study. Enter a participant number for a specific case.

For the option “Select Form Occurrence,” choose “Multiple” only if a form can be submitted multiple times on the same due date (such as imaging that occurs more than one time on the same date). Most ACRIN forms are “Single.” If you are not sure, simply select “Both.”

Here, a search is beginning for all cases on ACRIN 6654 Here, a search is beginning for all cases on ACRIN 6654. Select “Query” to continue.

The initial query results in another screen in which the search will be narrowed down and defined in more detail.

You may select “All Forms” or choose a specific form for your selected study (studies) or case number.

You may choose to view forms that have already been submitted (Include Submitted) or only those that are still outstanding or due (Excluding Submitted Forms).

You must then choose how you wish to have the data sorted from the “Select Sort by:” drop-down menu.

In this search, all forms for ACRIN 6654, excluding forms already submitted, for the date range of 06/01/2009 through 09/30/2009 have been selected. They will be sorted by the due date. Once all choices have been made, select “Retrieve.”

Data are displayed as indicated by the selected parameters Data are displayed as indicated by the selected parameters. Yellow text denotes forms “overdue” between 30 – 60 days; red more than 60 days. NOTE: refer to your study protocol. For example, in ACRIN 6654, these forms are not truly overdue as the site has a “window” in which to submit the them.

At the bottom of the data set, you may choose to print the output, begin a new search (Clear or Cancel), or exit the system.

Selecting “Clear” at the end of the previous search will allow you to begin another query with the same initial parameters. In this example the search was for Study No 6654, ALL 6654 Cases, Form Occurrence – Both.

Choosing “Cancel” from the options at the end of the previous search allows you to begin an entirely new query with completely different parameters.

Selecting “Main Menu” returns you back to the initial screen and may add an extra step if you wish to begin a new search.

This is a search for outstanding data queries, i. e This is a search for outstanding data queries, i.e. Z1 queries that are typically sent to sites via e-mail. In this case, the search will look for both Z1s submitted as well as any that are due or outstanding.

The output shows the Z1 queries that have been received by ACRIN.

This query will search for outstanding forms to copy to a spreadsheet for site tracking and disposition purposes.

The results of the query.

The columns were highlighted and “copied.”

Data were “pasted” into an Excel spreadsheet, the column “Lock Status” was removed, and a new column “RA Comments” added for site tracking purposes.

This query shows how the tool can be used to determine if images (“Form” C5) due for this case number were received by ACRIN for the time period specified – in this case from enrollment date to current date.

The results show that all images due have been received to date.