Governance relating to the use of CPRD for research

What needs ISAC approval?

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ISAC approval is required if access to anonymised patient level data is being requested for research purposes.

This includes access to the following:

  • UK primary care data
  • Linked data such as Hospital Episode Statistics

Patient level data used in the generation of aggregated data, intended for publication, also requires approval. This includes the production of prevalence and incidence rates.

The Confidentiality Advisory Group (CAG), an expert advisory group hosted by the Health Research Authority (HRA), provides advice to ISAC in relation to patient confidentiality. In line with CAG guidance, ISAC will publish summaries of approved protocols that require linkage between CPRD data and other data sources.

Please click below to download the latest declaration of ISAC linkage approvals

Declaration of ISAC Linkage Approvals

Researchers requiring bespoke linkage to any of the data sources available through the CPRD will also require ISAC approval. Please note that all such requests must be within the context of a proposed study or programme of research.

ISAC approval is also required in order to obtain access to additional patient information including:

  • Anonymised patient records including hospital letter and paper based records
  • Questionnaires/surveys to be completed by practice staff or patients

ISAC Exemptions

The following requests are exempted from ISAC approval:

  • The use of patient level data to generate aggregated data not destined for publication. Publication here is defined as circulation to third parties outside of the institution requesting the data.
  • The use of patient level data to produce simple descriptive information in support of regulatory submissions/requests.

Please see ISAC Exemption - Requests from Regulators.

Publication of Research Findings

For protocols approved from 01 April 2014 onwards, applicants are required to include the ISAC protocol in their journal submission with a statement in the manuscript indicating that it had been approved by the ISAC (with the reference number) and made available to the journal reviewers. If the protocol was subject to any amendments, the last amended version should be the one submitted.

Applicants must submit a copy of all peer-reviewed publications based on CPRD data to the ISAC Secretariat. Please also notify the ISAC Secretariat should it become clear that an ISAC-approved study will not be completed.

It is essential that consideration is given to preserving confidentiality at the reporting stage. The possibility of unintentional (deductive) disclosure arises when cells with small numbers of patients are quoted. Applicants should note that, when reporting the data, CPRD policy is that no cell should contain <5 events.

Please note that the ISAC reserves the right to audit the concordance between approved study protocols and published research.