Reporting

The Reporting module gives you access to your study data in a concise manner with extensive filtering.

Reporting is an add-on that gives you access to your study data in a way that previously was only achievable with an export. It allows you to browse data in your study through powerful filtering.

Currently there is one ‘Report’ within the module called ‘Verification’.

Table of contents

Getting Started

Common Use Cases

Using Filtering
How to use reporting effectively

How syncing works

Not included in Verification

 

Verification Report

Getting started

To get started with Reporting, first the add-on must be enabled in the study builder. 

When enabled, the system will perform its first full sync. This can take anywhere from 5 to 45 minutes, depending on the amount of data in your study. But after the initial sync, data will be updated as actions happen in the study.

Next, add the “Reporting” permission to the collaborators who should have access.

It can be found all the way to the right on the permission list.

 

Meaning if a user only has permissions to site ‘London’, they will not be able to see data from site ‘Aalborg’.

Now a new side menu tab has been added, in the left side menu called “Reports” where you can find the “Verification” report.

The verification report contains three different tables or ‘tabs’, with various levels of granularity.

Data points

Presents data points in your study, each being a row. Combined with an answer status column, it is possible to get an overview of e.g. why important endpoints are missing, or see the values of primary end points across the entire study.

Note: Table questions are not presented. They will have to be seen within the form.

Forms

Gives an overview of forms, their completion status, verification status, and the amount of visible data points in the form.

Data events

Presents data events (including Adverse events and Unscheduled events), their completion status, verification status, sign off and lock status.

Customize your table

Each verification tab contains a lot of columns with various information. In case some are not relevant for your work, they can be hidden using the “column” selector on the right hand side of the table.

Each column can also be dragged around and reordered.

The setup will be saved, and is unique to your profile and study, so it looks the same when you come back next time.

Currently it is not possible to share table setup with collaborators.

Who can use this report?

Everyone who wants to look at the data, see what is missing, and what the status of certain forms/data events is. Below is a collection of potential uses, divided by study roles.

Sponsor

• Get an overview of unscheduled event forms (e.g. protocol deviations or device deficiencies)
  • Forms
    • Filter for the specific form, to see completion and verification status
    • Filter for specific forms to quickly see number of reported (protocol deviations or device deficiencies)
  • Form Answers
    • Filter for specific form to see all questions and their answers
    • Filter on specific questions within the form, to get a quick overview of the most important values.
• Check the Verification status/progress of the study. Check that monitors are on track with their monitoring of:
  • Critical variables 
  • Forms
  • Data events
• Prepare for interim analysis / database lock. Ensure the relevant data events/forms have been prepared and are ready for export. 
• Easily filter for Data events that does not have the correct:
  • Sign off status
  • Lock status
  • Verification status
• Allowing you to quickly find what has yet to be done by the site personnel/monitors.
• Check values of critical endpoints without having to export the data, or easily export the relevant endpoints so you can perform a quick analysis in e.g. excel.

Monitor / CRO

• Get an overview of unscheduled event forms (e.g. protocol deviations or device deficiencies)
  • Forms
    • Filter for the specific form, to see completion and verification status
    • Filter for specific forms to quickly see number of reported (protocol deviations or device deficiencies)
  • Form Answers
    • Filter for specific form to see all questions and their answers
    • Filter on specific questions within the form, to get a quick overview of the most important values.
• Check the Verification status/progress of various elements to ensure you are on track.
  • Critical variables 
  • Forms
  • Data events
• Check event timing to see if date of visits/procedures etc have been conducted after e.g. informed consent signature time.
  • If subject questionnaires were answered before the scheduled visit, as per protocol
  • Visit windows (not automatically calculated)
• Find missing data ahead of a site visit or important study time points.
  • Critical variables
    • Check why it is missing with the form answer status containing missing codes
  • Completion status of data events or important forms

Site personnel

• Find missing data / ‘work to be done’ ahead of monitoring visits.
  • Via Forms
  • Critical endpoints

Find what is important via Filtering

Reporting has a lot of filtering available to narrow down the table to look at specific items.

It is well worth spending time creating good filters than can be re-used at a later time.

Filtering options

Different columns have different filtering options. Please see below for a brief description of possible filtering options.

Filtering	Description
Contains	The filter value can be found anywhere in the cell
Equals	Filter value must match the cell exactly
Starts with	The filter value matches with the initial letters
Ends with	The filter value matches with the ending letters
is empty	The cell must be empty
is not empty	The cell must NOT be empty
is any of	Functions as a multi selector, where several filter values can be selected by searching for them.  Use this: If you want to e.g. filter for several questions, forms or data events at the same time!
is not any of	The inverse of 'is any of'
is	Only show values that is/equals filter value
is not	Only show values that is not equal to filter value
Numeric operators: =, !=, <, >, >=, <=	Regular mathematical operators used in combination with a number, e.g. " Verify 1 <70%"

Do note that the filters applied will interact with ‘AND’, meaning that only the rows that fulfills all the filter criteria will be presented.

If you are looking to filter for e.g. several questions, forms or data events, use the “is any of”

 

The filter dropdowns for Questions, Data Events and Forms, will only show unique values.

E.e. if you have three questions called “Date of Visit”, in the study, only one entry will be shown in the questions filter “is any of” drop down.

Selecting it will show responses from all these date of visits. Must be 100% the same for it to be  merged together under the same.

Sites are not treated in this manner.

Quick filtering

Save your most used filtering combinations as a “Quick Filter”! That will allow you to quickly apply the filter at a later time, and easily switch between several filters.

As quick filters are created, they will be added to the quick filter drop down, please ensure you give it a descriptive name.

Existing filters can be updated, or used as a template for a new quick filter. 

Edit quick filter:

Apply the quick filter you wish to edit. Click on “Filters”, perform the changed required, and press “Update”

Re-use quick filter for new filter

Apply the quick filter. Click on “Filters”, perform the changes required, and change the filter name. This will allow the filter to be saved as new.

Quick Filters will be associated with your profile, the specific study you created it on, and the table where you created it. 

You will have to create quick filters each of your studies currently.

 

 

How/when does data get updated?

Data is synced to the reporting module within a few seconds of an action happening in the study, due to our event-based approach. 

Which means only the initial sync when the add-on is enabled on the study for the first time will take a little while.

The table will have to be refreshed, either by applying a filter, or using the ‘refresh’ button, for the newest data to be presented in the table.

Is anything not synced currently?

Medication

Any risks?

The data show in the reporting module is a copy of your regular study data, and as such there is no risk with the data being shown in the reporting module. You will not be able to affect your existing data directly from the tables in version 1. 
To edit/verify/create queries etc. you must use the "go to" button and perform actions within the form.