Revised policy on lifespan of approved protocols

In response to a recent review of CPRD’s policy on approved protocols for studies using CPRD data, we will be introducing a 4-year lifespan on all protocols following approval by the Independent Scientific Advisory Committee (ISAC).

Once a protocol has been approved the research team will have a total of 3 years 11 months from approval date to submit any amendment requests for the protocol. Analyses can continue to be conducted on protocols after this date with a valid, approved data extension request. If however, an amendment to the protocol is needed after the 4-year period, then a new study application must be submitted to CPRD and treated as a new application.

This policy will be implemented from 3 February 2020 and also apply retrospectively to all protocols using CPRD data. If your protocol was approved before 3 February 2017, to allow for this transition then you will be able to submit any amendment up to 1 February 2021. After this time any amendments to the research protocol will have to be submitted as a new study application to CPRD and treated as a new application.

Please note this policy only applies for amendments to approved studies. Licence terms remain at 12 months and the data extension request process remains unchanged.

Find out more about approved study protocols.