Other important Information

Ethical review for CPRD Protocols

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The CPRD Group holds research ethics has obtained ethical approval from a National Research Ethics Service Committee (NRECS) for all purely observational research using anonymised CPRD data. S; namely, studies requiring which do not include patient involvement (which is the vast majority of CPRD studiesie. Interventional research require patient consent. ISAC is responsible for reviewing protocols for scientific quality, but may recommend that study-specific ethical approval is sought if ethical issues arise in relation to an individual study. Separate ethical approval will be required for any study which includes any form of direct patient involvement.

Voluntary registration of ISAC approved studies

Epidemiological studies are increasingly being included in registries of research around the world, including those primarily set up for clinical trials. To increase awareness amongst researchers of ongoing research, ISAC encourages voluntary registration of epidemiological research conducted using MHRA databases. This will not replace information on ISAC approved protocols that may be published in its summary minutes or annual report. It is for the applicant to determine the most appropriate registry for their study. Please inform the ISAC secretariat that you have registered a protocol and provide the location.

Guidance on resubmissions to ISAC

Some protocols submitted to ISAC require resubmission before approval is given. Feedback will be provided by ISAC on the points to be addressed upon resubmission. Applicants should use the feedback form provided to respond to the points made by the reviewers and should highlight all changes they have made to the protocol (please do not use "track changes").