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 email@example.com 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. Find out more about the COVID-19 data included in the CPRD primary care databases.
Access to CPRD data, including UK Primary Care Data, and linked data such as Hospital Episode Statistics, is subject to protocol approval via CPRD’s Research Data Governance (RDG) Process. Independent scientific and patient advice is provided by Expert Review Committees (ERCs) and the Central Advisory Committee (CAC).
For more information please contact the RDG Secretariat at firstname.lastname@example.org
All protocols to access CPRD data must be submitted via the Electronic Research Applications Portal (eRAP) at www.erap.cprd.com. Applicants, and all members of the research team, need an approved eRAP account in order to submit an application.
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
All protocol applications and resubmissions are to be made on eRAP (www.erap.cprd.com). The ability to submit amendments to approved protocols is not yet available via eRAP. We ask that applicants who wish to submit an amendment to an existing protocol discuss this with the RDG Secretariat by emailing email@example.com. Amendments submitted via email will not be processed or reviewed.
A feasibility study is a study where the intended purpose is to assess the feasibility of conducting a future study. This could include assessing the feasibility of a future observational study using CPRD data, or a prospective observational study involving enhanced data collection (questionnaires or bio-samples), or an interventional study (for e.g. pragmatic trial). Feasibility studies using CPRD data do not require submission of a full protocol via eRAP, provided they meet the definition and scope of a feasibility study, as set out in the Feasibility Study Application Guidance Notes.
Applicants wishing to submit a Feasibility Study must first contact firstname.lastname@example.org to discuss the study prior to submitting an application. Feasibility study applications must be submitted to the RDG 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 email@example.com
The Secretariat will provide a Feasibility Study number for use in future communications.
Exemptions and analyses for medicines regulatory bodies
Some uses of primary care data for submissions to medicines regulatory bodies have been pre-approved by CPRD and do not require a research application. Analyses under this exemption are limited to numerator or denominator counts and exclude rate estimation. Examples of counts that are pre-approved by CPRD include:
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.
If the above analyses require access to linked data sources, a research application must be submitted to obtain data access. Please contact firstname.lastname@example.org for further advice.