Study Management System

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The Study Management module in Active Steward provides a solution to maintain efficient project management of studies. Study records in Active Steward are used throughout the lifecycle of a study. There are various tools which aid the use of these records, such as;

• Costs & Invoicing - Detailed cost breakdowns, managing Consortium fees and cost sharing between companies.
• Invoicing tracking, invoice generation and payment status.
• Document storage and folder structure setup specifically for study related files. Generating Meeting Documents.
• Study planning, schedules, timelines and project status tracking.
• Storage of Laboratory /CRO details.
• Track test substances.

Studies can be connected to other records in Active Steward (Constituents, Products, Entities etc.). Some study information can be presented on campaign pages for external customers to view (How to Create a Study Page in Campaigns).

Follow the guide below for a walk through of everything study related and find links to more specific tutorials.

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List All Studies

Study records are listed in the "List Studies" screen which can be found by going to "Studies" in the top navigation bar.

This page can be used to filter through all studies in the current partition. Select the study status and/or use the column headers to search. Each study project is given a unique identifying code - How to Create a Study.

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The Study Record

A study record is composed of multiple tabs, each with a different function explained in the below sections:

Overview Tab

The Overview tab provides general high level information about the study. The aim is so any users that view the record have enough information to hand. If the user has permission, these study details can be edited (Edit User Permissions).

Study Monitors and Mangers can be assigned to the project. Assigning a monitor/manager involves selecting a user of the system and the date from which they are responsible. This helps with organisation and clearly indicates who is the relevant go-to person for a study. It also tracks who historically worked on it.

On the Overview there is a section for the “Study Narrative” – this is where comments / notes can be left. The comments added are usually the latest updates on the progress of a study. See Comments in Active Steward for more information.

Testing Laboratory / CRO Tab

The Testing Laboratory / CRO tab holds information such as;

• Study Phases (called "Activities" in Active Steward).
• Displays relevant Lab/CRO documentation (Contacts, Protocols and Amendments).
• Laboratory / CRO details and their specific contacts.

The CRO / lab used and the contact person(s) for this study can be selected in drop-down fields. The laboratory and contacts assigned must already exist in the system as those records will hold further useful information, some of which is pulled through and displayed on this page (Create Entity and Contacts).

The "Activities" section on this tab is used to show the separate phases of a study. For example, the phases could be:

1. Analytical Method Development and Validation
2. Dose-Range Finding Developmental Toxicity Study
3. Oral Developmental Toxicity Study
4. Tolerability Study

For each activity created, a corresponding payment schedule will be created in the timeline tab (Create Study Activities and Set up the Timeline).

Each activity can capture the CRO Study Number and Contract Reference.
Study documents are uploaded and displayed in the section below so relevant documents can be quickly located. It is good practise to make the "Contract Reference" in the activity correspond to one of the documents names here (How to Create a Document).

CRO Evaluation

This tab is used to obtain metrics and rate the working relationships with Labs/CROs. It can help determine future Lab choices and can store information for clients on how the experience was if requested.

Costs & Invoicing Tab

The Cost & Invoicing tab is a tool used in study financing. It includes multiple subtabs to aid invoicing and the cost sharing process. See the function of each explained below.

Payment Details

This tab stores cost information relating to the study. The Purchase Order and External Reference numbers are noted here, so it can be referred back to and used during invoice or document creation for example. The Currency field sets the currency of the Payment Schedule and study costs.

Payment Schedule

The payment schedule keeps track of planned, actual and published costs. A payment schedule outlines the costs and estimated dates of when these amounts are expected to be paid. The costs are split into types;

• Management Costs - These are the service provider (our) costs for organising, monitoring and managing a study.
• Study Related Costs - These are the costs for the study to take place at the laboratory.
• Other Costs - This is usually contingency costs to cover any unforeseen issues.
• Planned costs are filled out before a study commences. At the planned stage the study costs are usually an estimate based on the study type and CRO/laboratory used.

The planned costs will need updating once the study becomes active and more financial information becomes available. The updated costs are filled out on the "actual" costs section - once the study status changes to active, the planned tab cannot be edited. The payment milestones on the "Actual Costs" tab represents the cost breakdown in further detail.

The costs and payment schedule can be "Published" once it is finalised / agreed by the study manager. Published costs cascade throughout the system to be used in other areas of Active Steward such as the cost overview or campaigns (How to Create a Payment Schedule and Publish Costs).

Invoicing

The invoicing tab displays all invoices associated with a study. It helps keep track of the current total study value and balance. The tab is split into two; "Received" invoices and "Outgoing" invoices.

Received invoices are from the CRO / laboratory for the study activity costs. Outgoing invoices are from the service provider (us) to clients for our services.

The tables help keep track of finances by;

• Highlighting invoice rows with a symbol when an invoice becomes overdue. The number of days for an invoice to be marked as "overdue" is set up in the configuration menu.
• Marking invoices as "Paid". This is done by populating the "Date Paid" column with the relevant date.
• Displaying the entity(ies) that the invoice is being sent from and who it is sent to.
• The Total Value and Total Balance fields which give a quick overview of payment completeness.
• Using the "Add Invoice" button to directly upload invoices relevant to this study.
• Searching or using filter options to find specific invoices.

Cost Overview Tab

This tab provides a high level overview of a study's costs. The following information can be interpreted from the table and fields;

• Total Cost vs Total Paid
• Costs separated by Month, Quarter or Year
• How costs are shared between entities
• Costs over a specific timeline
• Costs separated by share (helpful when entities may be paying multiple shares)
• How much of the total has been invoiced out to entities so far
• Remaining balance to be paid by entities and the amount paid so far

Invoices can be generated from information held in the overview table - this involves using the "Create Invoices" button which relies on an integration - How to Set up and Use Integrations.

See the following examples of how the Cost Overview is used to draw conclusions:

Costs separated by Entity and Share:

• The entity "Seed Oils Incorporation" is responsible for 2 shares totaling €6000.
• The entity "The Heath and Safety Executive" is responsible for a share of €3000.
• The Total Cost of the study is €9000, which comes from the setup payment schedule (Create Payment Schedule and Publish Costs).
• The Total Paid so far towards the study costs is €2100.

Costs separated by Year:

• In 2024 the total cost shared (amount due) is €4000. In 2023, €4000 was due.
• In 2023, €2100 was paid to the CRO / lab.
• "Not Entered" refers to milestones in the payment schedule with no date assigned.

Cost Sharing

Entities

The "Entities" tab is where company cost sharing is set up. Here companies (called entities in Active Steward) are linked to a study either manually, automatically or by study group. See the following tutorials for more information:

• Automatically Link Entities to Study
• Manually Link Entities to Study
• Use Study Groups

Linking entities to studies is done to set up how the study costs are to be shared between companies. Not all entities linked to a study will be responsible for shares - it depends on the information assigned (their cost sharing roles and reason for interest). See the following example: Assign an Entity to Pay Shares Towards a Study.

Sharing Rules

The sharing rules tab lists payee roles that can pay shares towards a study. The list can be amended by editing the Study Configuration.
Alternatively, the study manager can override and customise this payee list for a specific study that they are assigned to, rather than updating the list for the whole partition.

Test Substance(s) Tab

A study requires samples of the substance being tested on. Obtaining samples can be a logistical issue. This tab provides a space to keep track of the necessary details. Notes can be left about the samples progress and supporting documentation can be uploaded. See Add a Test Substance for more instructions.

Timeline Tab

The Timeline tab is key for users to track projects progress. Each study has a "General" timeline by default. There are also specific study timelines that can be generated Create Study Activities and Set up the Timeline.

The page has "Planned" and "Completed" date fields for each activity/stage of the study. When an activity becomes overdue notifications can be sent to some users reminding them to provide a note/ update or change a planned date - see Notifications in Active Steward for more information.

The "Planned" dates are usually provided by Labs/CROs in their study plans - the planned schedule can be put into this tab, saving users from navigating into documents and manually checking due dates. Each activity/stage can have notes added against it, which is essential for keeping all users up to date on possible delays or changes.

The study specific timeline is more detailed, whilst the general timeline is more of an overview. The milestone points in study timelines can be amended by editing the study configuration.

Meeting(s) Tab

This tab is used to generate meeting documents. The document can include attendees, dates, subject, agenda, discussion points and actions. Using this feature means that the generated meeting documents will have similar formatting /layout each time they are created. This ensures consistency in files that are circulated to clients.

Statements Tab

This tab lists any Issues that are linked to the study. Study related Issues could be questions raised about testing methods, test substances or regulatory problems for example. Issues here can be used to keep track of questions raised by the client or CRO - See Create, Send and Link an Issue & Statement for more information.

Documents

Each study record has a specific folder structure for storing documents. Inside the study folders there are sub folders which help organise different types of study related document, such as; Contracts, Invoices, Reports and Quotes. Documents can be automatically saved into these folders via email - Automatically Save Emails (and Attachments) to Study Folders.

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Cost Overview

The Cost Overview in Active Steward is a useful tool that provides a high level overview of the current published financing status of all studies in the partition. This screen is also available on each study record.

The page shows costs that have been defined in published study payment schedules.

The overview has many options and filters to use, such as;

• Choose the type of cost to show; "Management", "Other" or "Scheduled Costs" (CRO Study Costs).
• Select a currency to display costs in.
• The option to separate rows by Year, Month or Quarter*.
• Choose a custom timeframe to view the costs over. Costs included are milestones from payment schedules that have an estimated date within the selected "From" and "To" date. It also includes management costs during that timeframe (the management costs are split evenly by month over the study duration).
• Split the table rows by "Entity"- So each row shows cost information for an entity by study, by timeframe (if one is selected*).
• Use the table headers to search - for example, search for a specific entity to only view their costs.

There are also cost overview screens located under entity and entity group records. These overviews show study costs by entity, or by a whole group of entities.

See the following examples on how to interpret the Cost Overview:

Separate By Year and Entity:

• The entity "Active Plant Protection SPRL 💻" is responsible for paying a total of €5225.50 in the year 2022 towards the study "0001-003-AF250-423-Powerplant 💻".

Separate By Constituent:

• The total study costs for the constituent Azoxystrobin is €11,750. €5000 has been paid so far. The total study costs for all constituents in the partition is €325,250.

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Study Groups

Study Groups are usually used when substances are assessed as a group. This is useful because multiple studies are able to "inherit" and use the same information from the group. Using study groups help cut down on admin time and makes it clear what studies are being run together - See Create a Study Group.

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