In response to the coronavirus outbreak, CPRD is expediting processing of protocols relating to COVID-19 research. To ascertain whether your protocol is eligible for rapid review please email firstname.lastname@example.org before you submit your application and include a clear impact statement in terms of public health, safety or policy. To understand how the current situation may impact on data processing and access requests see here.
To help coordinate activities and avoid duplication of research effort, see information on COVID-19 studies underway.
Access to CPRD data is subject to protocol approval by an Independent Scientific Advisory Committee (ISAC). Approval is required if access to anonymised patient level data is being requested for research purposes.
This includes access to the following:
For further clarifications please contact the ISAC Secretariat at email@example.com
All protocols must be submitted to the ISAC Secretariat using the Protocol Application Form. Applicants should ensure that the latest version of the forms are used. Applications for data access will not be accepted in any other format. In addition, a brief curriculum vitae and conflict of interest statement for each researcher named on the application should be included using the template provided.
The Protocol Application Form, CV template, guidance on completion of the application form and on the content of protocols can be downloaded below.
Completed applications should be sent to the ISAC Secretariat at firstname.lastname@example.org.
The Secretariat will provide a Protocol Number for use in future communications. Applicants will also be provided with CV numbers, which can be used in any future applications.
We will use personal data provided as part of an application for studies using CPRD data, both to arrange, support, and control use of that information under contract or licence and to vet applications for access to CPRD and related data (particularly CVs and past experience for chief and principal investigators). Please look here for more information about your legal rights and how to complain to the Information Commissioner’s Office.
Resubmissions and amendments
Applicants wanting to resubmit an ISAC Protocol Application, or request and amendment to an approved ISAC protocol, should follow the Guidance on Resubmissions and Amendments below. Resubmissions and amendments should be sent to the ISAC Secretariat at email@example.com.
Please check our revised policy on lifespan of approved protocols.
Applicants wishing to submit a Feasibility Study must contact firstname.lastname@example.org to discuss the study prior to submitting an application. Feasibility study applications must be submitted to the ISAC Secretariat using the Feasibility Studies Application Form. Applications will not be accepted in any other format. In addition, a brief curriculum vitae (CV) and conflict of interest statement for each researcher named on the application should be included.
The Feasibility Study Application Form, Application Guidance Notes, and CV template can be downloaded below.
Completed Feasibility Study applications should be sent to the ISAC Secretariat at email@example.com.
The Secretariat will provide a Feasibility Study number for use in future communications.
Some uses of data, such as conducting analyses for submissions to regulatory bodies, are exempt from ISAC review.
Analysis for regulatory bodies
In general, ISAC approval is required prior to release of CPRD data to any third party, so as to ensure that the standard of studies carried out using CPRD data is maintained. However, there are some types of aggregate data necessary for regulatory work that is suitable for exemption from this requirement, such as:
- Counts of patients receiving prescriptions for a certain substance;
- Counts of prescriptions for a certain substance / substances;
- Distribution of number of prescriptions per patient (mean, median, minimum, maximum, interquartile range etc…);
- Distribution of prescription duration;
- Distribution of patient time at risk;
- Counts of patients with a particular clinical event.