SOP Data Request

Tags: SOP_Category Information_Governance_Category

Requests for participant counts only

1. All requests for participant counts based on a set of search criteria do not require approval.
2. Approval will not be required whether the request is from a source internal or external to the NIHR Leicester Cardiovascular Biomedical Research Unit.
3. The exact figure for requests that result in a participant count of less than 100 participants will not be released. Instead, the figure will be reported as ‘less than 100’.
4. Details of the request (including the requester, search criteria, query and results) should be recorded in the BRICCS Data Request Folder where the request is likely to be re-run or the criteria are non-trivial.

Requests by study staff for study administration and processing purposes

1. The requester must have the administrator role on the study delegation log.
2. Approval will not be required.
3. Details of the request (including the requester, search criteria, output fields, query and extract results) should be recordedin the BRICCS Data Request Folder where the request is likely to be re-run or the criteria are non-trivial.
4. Wherever possible data should be de-identified or psedonymised.
5. Where patient identifiable or sensitive data is extracted, the extracted data must be encrypted.

Requests by study staff for research purposes

1. The requester must have the researcher role on the study delegation log.
2. Approval will not be required for these requests
3. Details of the request (including the requester, search criteria, output fields, query and extract results) must be recordedin the BRICCS Data Request Folder.
4. Wherever possible data should be de-identified or psedonymised.
5. Where patient identifiable or sensitive data is extracted, the extracted data must be encrypted.

Requests of participant details by individuals outside of the study, whether internal or external to the NIHR Leicester Cardiovascular Biomedical Research Unit

1. These requests will require the requester to fill out an Application for Data or Samples from the NIHR Leicester Cardiovascular Biomedical Research Unit form. (available from the P.A. to the LCBRU Manager)
2. The completed application form should be submitted to the P.A. to the LCBRU Manager who will pass it on to the NIHR Leicester Cardiovascular Biomedical Research Unit Science Advisory Board for approval.
3. Governance approval must be sought from the LCBRU Research Governance manager.
4. Data should be supplied to the requester using the format and medium specified in the application form.
5. Details of the request’s fulfilment must be completed on the application form.
6. Details of the request (including the requester, search criteria, output fields, query and extract results) must be recordedin the BRICCS Data Request Folder.
7. Wherever possible data should be de-identified or psedonymised.
8. Where patient identifiable or sensitive data is extracted, the extracted data must be encrypted.

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