Sample Limits and Dates

Additional functions support Sampling, which is highly regulated and controlled. This includes PDMA compliance in the US and new regulations in the EU, for example, EFPIA 4x2 Code.

The additional functionality is available online and covers the following:

  • Ability to define a Sample Limit Template
  • Used for a specific combination of Account Type and Product
  • Used to automatically generate Sample Limit records
  • Ability to enable Sample Limits with rolling start and/or end dates
  • With split periods
  • With-out split periods

There are two conditions for Sample Limits and dates to consider - Fixed and Rolling Limits.

Fixed Limits means the start and end date do not change and calculations are done with the limits. If using the Sample Limit Product Templates, the system will copy the start and end date of the template to the generated sample limit record.

Rolling Limits means the start date is the date of the first disbursement of the product for that account. The End date is the start date plus the rolling period value (in number of months) minus one day. If Sample Limit Product Templates are in use, the system will not copy the template start and end dates but instead will generate dates based on the rules for Rolling Limits.

  • Account - if using Split Periods (meaning a pre-defined quantity of samples can be disbursed per year during the validity period defined by the Sample Limit template),  several records will be generated - one for each corresponding period (1 per valid year + 1 to restrict sampling after the 24 months period)

There are two ways to define the year duration for split periods:

  • Using the Gregorian calendar year logic (January 1 – December 31)
  • Using a 12-month logic – any 12 month period. For example, April 1 – March 31.

It is important to note the following:

  • Using the Gregorian calendar logic split periods for rolling limits requires the definition of a 24-month rolling period in the Sample Limit Template
  • If the Sample Limit Template is defined per call, then no splitting occurs and only one Sample Limit record generates