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.