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.
Local samples
A local sample refers to a specimen (such as blood, urine or tissue) that is analysed at the trial site where the participant is being treated. The sample is not being sent away to be analysed.
Total number of samples for local labs
Enter the total number of local samples that have been collected over the entire trial period, this will need to include biobank samples. (Samples that are collected and stored for future research.)
Percentage of samples analysed
Enter the percentage of samples taken that are analysed during the trial.
If you are unsure of this number you can select 'Use approximate value' to use default data, however this will lower the confidence score rating on the results page.
Analysis type used
Here you have the following options for the type of analysis that is performed on the samples:
- Full blood examination
- Coagulation profile
- Urea and electrolytes
- C-reactive protein
- Arterial blood gases
- Sample Analysis
Local Storage
Percentage of samples stored locally
Here you need to enter the percentage of samples taken that are stored locally (not sent away from the trial site)
If you are unsure of this number you can select 'Use approximate value' to use default data, however this will lower the confidence score rating on the results page.
Average duration of storage in years
Here you need to enter the average number of years of frozen sample storage.
If you are unsure of this number you can select 'Use approximate value' to use default data, however this will lower the confidence score rating on the results page.
Frozen storage temperature
Here you can enter the temperature that the frozen samples are stored at. If you are unsure you can leave this field empty.
The options available in the dropdown are:
- Unknown
- -20°C
- -70°C
- -90°C
Central samples
A central sample refers to a specimen (such as blood, urine, or tissue) that is collected at the trial site and then sent away to a specialised external laboratory for analysis. The sample is not processed or analysed locally at the participant's treatment site.
Total number of samples for central labs
Enter the total number of central samples that have been collected over the entire trial period, this will need to include biobank samples. (Samples that are collected and stored for future research.)
Percentage of samples analysed
Enter the percentage of samples taken that are analysed during the trial.
If you are unsure of this number you can select 'Use approximate value' to use default data, however this will lower the confidence score rating on the results page.
Sample Countries
Here you can enter the countries that central lab samples are shipped to for storage, testing and analysis. Click in the text box and scroll down to find the country you require, alternatively you can start typing and select your desired country from the list as it updates. You can enter more than one country.
Frozen, Chilled and Ambient samples
Percentage of Frozen, Chilled and Ambient samples
Here you will need to enter the percentage of samples that will need to be shipped under frozen, chilled or ambient shipping conditions. If you are unsure of this number you can select 'Use approximate value' to use default data, however this will lower the confidence score rating on the results page.
Box Size
Here you are able to select the box size for samples that will need to be shipped under frozen, chilled or ambient shipping conditions.
- Unknown
- Small, Weight: 5kg, Sample Capacity: 1000 items
- Medium, Weight: 13kg, Sample Capacity: 3000 items
- Large, Weight: 25kg, Sample Capacity: 8000 items
- Custom
Central Storage
Percentage of samples stored centrally
Here you need to enter the percentage of samples taken that are stored centrally (sent away from the participant trial site)
If you are unsure of this number you can select 'Use approximate value' to use default data, however this will lower the confidence score rating on the results page.
Average duration of storage in years
Here you need to enter the average number of years of frozen sample storage.
If you are unsure of this number you can select 'Use approximate value' to use default data, however this will lower the confidence score rating on the results page.
Frozen storage temperature
Here you can enter the temperature that the frozen samples are stored at. If you are unsure you can leave this field empty.
The options available in the dropdown are:
- Unknown
- -20°C
- -70°C
- -90°C