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.
Note: A trial may involve multiple investigational products
Product type
From the dropdown box select the product type that best represents the product in your trial.
Info: The High, Medium, or Low ratings indicate the environmental impact of a medicine's active ingredients, as calculated by the ABPI’s standard tool. (The Association of the British Pharmaceutical Industry)
Product name
Enter a name here that will easily help you to tell your products or different scenarios apart.
To rename the product, just click in the text box, delete the existing name, and type your own.
Is the product supplied locally or centrally
From the distribution site you will need to select if the product is supplied Locally or Centrally.
Locally
Locally refers to the product being made on site, or very close by.
Centrally
Centrally refers to the product being supplied from a different country, please select the country from the alphabetised list, alternatively you can start typing the name of the country which will bring up matching options for you.
You are able to add in more than one Country here if required. To delete a country click on the cross on the right of the country name.
Total investigational product quantity unit (per trial, total per participant, total spend)
In this section you need to select one of the following options; per trial, per participant or total spend.
Per Trial
This is the total amount of product quantity needed for the whole trial period, including over supply.
Per participant
This is the total amount needed for each participant in the trial for the whole trial period, not including over supply.
Note: If you select per participant, you will manually need to enter the percentage of over supply for the product.
Over supply, also referred to as overage, is the term for a deliberate buffer of a product to cover variability in the demand for that product during a trial, which usually results in unused product.
Total spend
This is a monetary value, representing the spend across the whole trial from start to finish in the chosen currency. You need to round up to the closest whole number.
Note: We recommend only using 'Total Spend' data if you don't have 'Per Trial' or 'Per Participant' data available to enter.
Using 'Total Spend' to calculate emissions does not give as accurate a result as defining the quantity using 'Per Trial' or 'Per Participant'.
Total investigational product quantity
This is the total amount of the product used throughout the trial, covering everything shipped, used by patients, and left over.
Override Manufacture Emission Factor
To override the Manufacture Emission Factor, the value must represent a strictly "Cradle to Gate" boundary, focusing exclusively on the impact of producing a single unit, such as one tablet or one vial.
This figure must include the pro rata emissions associated with the primary and secondary packaging—like individual blister packs—relevant to that single item. Finally, the factor should only cover the manufacturing phase and must exclude any supply chain logistics or End-of-Life (EOL) emissions, as those components are managed through separate, independent calculations.
Calculate placebo factor
Selecting the Placebo Factor Calculation option creates a dedicated placebo product entry, which must be paired with a separate entry for the active investigational product (IP). This calculation automatically reduces the manufacturing emission for the base product type by 65%, an adjustment that reflects the significantly lower carbon impact associated with producing a placebo version. However, it is important to note that if you have elected to provide your own manufacture emission override, this manual figure will not be reduced and will be applied exactly as provided in the final calculation.
Kit quantity unit
If you have selected that the product is supplied centrally, you will be asked to add information about the kit that a trial participant would receive. The kit would include the box or outer packaging, any information leaflets and anything else that was provided alongside the product.
You will need to select whether the Kit quantity unit is Per Trial, Per Participant or Total Spend.
Note: If you select per participant, you will manually need to enter the percentage of over supply for the product.
Over supply, also referred to as overage, is the term for a deliberate buffer of a product to cover variability in the demand for that product during a trial, which usually results in unused product.
If you select Total Spend this is a monetary value, representing the spend across the whole trial from start to finish in the chosen currency. You need to round up to the closest whole number.
Note: We recommend only using 'Total Spend' data if you don't have 'Per Trial' or 'Per Participant' data available to enter.
Using 'Total Spend' to calculate emissions does not give as accurate a result as defining the quantity using 'Per Trial' or 'Per Participant'.
Kit quantity
This is the quantity of kits that are required for the duration of the trial.
Kit weight
Here you need to enter the weight of each kit in kilograms (kg.) Make sure the weight includes any outer packaging, leaflets and marketing material that is provided to the trial participant alongside the product.
Info: When you have entered all of the information per product you need to click on the 'Add New Record' button. Once the product has been added you will be able to see it in the table at the bottom of the page. From here you can either edit, duplicate or delete this product.
Alternatively you can scroll to the top of the page and start the process again to add in another product.