📄️ 2.2.1 General Section
In this section you will input general information about the trial.
📄️ 2.2.2 Countries Trial Undertaken In
This section allows you to enter country specific data for your trial, this includes information such as number of patients and the number of site visits expected in each country.
📄️ 2.3 Investigational Product (IP)
In this section of the calculator you will be adding information about investigational product (IP) also known as investigational medical product (IMP), this is the substance or treatment being studied for its potential therapeutic effects in a clinical trial.
📄️ 2.4 Lab Kits
A lab kit, also referred to as a test kit, is a pre-assembled package containing all necessary components for collecting, processing, and transporting biological samples or conducting specific procedures during a clinical trial.
📄️ 2.5 Other Participant Or Site Devices/Equipment
Use this section to define the devices or hardware provided to participants in the trial. Please indicate the number of Smartphones, Tablets, or Smartwatches needed per participant.
📄️ 2.6 Procedures
This section is used to document the diagnostic procedures involved in the trial. You will need to provide the total count per participant for MRI scans, CT scans, and other imaging tests, alongside the number of surgical procedures, if any, and their average duration.
📄️ 2.7 Participant Travel
In this section you need to enter information about patient travel including the distance that they travel for trial visits and the modes of transport used.
📄️ 2.8 Trial Sites
A trial site is the specific physical location that trial participants are treated, these are often Hospitals, Medical Centres or Dedicated Research Clinics. This section
📄️ 2.9 Trial Management
In this section, enter information about the number of trial management staff, travel information such as trips made to the trial site, proportion of staff working from home, and time spent on-site per staff visit.
🗃️ 2.10 Trial Meetings
5 items
📄️ 2.11 Local Consumables
In this section, please record the total number of local consumables used per participant, per visit.
📄️ 2.12 Samples
In this section you need to enter information about local and central laboratory samples, this will include information on storage and analysis.