Caldicott Approval Form – for SAMBA PROJECT data transfer

SAMBA – Society for Acute Medicine Benchmarking Audit
Description of proposal:
National benchmarking exercise using a 24 hour cross-section of patient data from UK Acute Medicine Units
About SAMBA
The aim of this project is to describe the severity of illness of patients in the Acute Medicine Unit (AMU, or equivalent), the speed of their assessment and their progress after three days and to provide a comparison for each unit with the national average (or ‘benchmark’). Each unit is asked to collect data on all patients presenting to the AMU within a specified 24 hour period for inclusion in the national dataset.
Indicate which data items have been requested:
No patient identifiable data is to be requested.
Forename, Surname, DoB, Age, Sex, Address, Postcode, NHS number:
None of the data items above will be requested.
Other: A copy of the Data Collection forms to be used is attached, showing the data items that will be requested for each patient
Name of organisation receiving data: Society for Acute Medicine
Person responsible for release of data:
Name: Job title:
Person responsible for receipt of data:
Name: Dr Christian P Subbe Job title: Consultant Acute, Respiratory & Critical Care Medicine
For what time period is data transfer required
Start date: 25/06/2015 End date: 29/06/2015 (24 hour admission period, 3-day follow up)
Please state regularity; Single occasion – data from one 24-hour period of admissions
Contact details in relation to this form:
Name:
Address:
Telephone:
Email:
How will the data be transferred?
Paper records ⬜
Computer record x
Clinical staff in the Acute Medicine Unit [amend for local unit name]will complete paper data collection forms first. Data will be transferred by a annoymised secure online questionnaire. (Note – No Patient identifiable data will be transferred)
Who else will have access to the data?
(If data recipients are not employed by the NHS please state whether NHS honorary contracts are in place. If not – detail confidentiality agreements.)
No-one outside the [insert Trust name] clinical team will have access to patient identifiable data
Where will the data be stored?
No patient identifiable data will be stored outside the [insert Trust name]
How will data be protected? (Please detail security measures to be taken)
Data will be protected at source in accordance with the [insert Trust name] local procedures: [refer to the specific local data protection policy/procedures]
Anonymised coded data transferred for the project will be stored during data analysis in the Ysbyty Gwynedd, Bangor: paper files will be stored by the local team in a locked cupboard with access only for the clinical team and electronic data will be held on the [insert name of organization that will hold study data] computer server, in a password protected file, with similarly restricted access.
At completion of the project, all data and documents will be transferred to the custody and control of Dr Chris Subbe at Ysbyty Gwynedd, Bangor, who will have custody and control of the data at the end of the project, and who will archive the material securely either on the premises or in a secure commercial archive facility.
If the data is on a computer is there access via a network?
Patient identifiable data will not be stored on a computer.
How long will the data be stored?
Patient identifiable data will not be stored. The anonymised-coded data transferred for the project will be stored for one year following the date of the last publication arising from the project.
At the end of this period how will the data be disposed?
N/A as patient identifiable data will not be stored.
Who will be responsible to ensure that the data is disposed of in a confidential manner?
N/A as patient identifiable data will not be stored.
Other supporting information e.g. Ethics approval, correspondence etc
This project does not require Research Ethics Committee (REC) approval for its conduct as it is primarily a Quality Improvement project, not a formal research study. Furthermore it involves only the use of anonymised pre-collected patient data which does not require REC review (see ref).
Ref - Governance Arrangements for Research Ethics Committees (GAfREC) 2011. Available at:
(accessed 13.3.13)

I confirm that the data will be held and used according to the conditions and information

given as described within this approval from.

Name: ……………………………………..….. (local investigator)

Title: ………………………………………..….

Signature: ……………………………………….

Date: ………………………………………….....

For Office Use Only

The release and use of data as described above: approved / not approved

Caldicott guardian/deputy:……………………..……………Date:…………………….

  1. The data will be treated as confidential.
  2. The data will be used only for the purposes described.
  3. In the case of anonymised or confidential aggregated data, no attempt will be made to identify or contact individuals or organisations identified through these data.
  4. The data may be disclosed to staff of the above organisation but only for the purposes described.
  5. The data may not be disclosed to any third party.
  6. The data will be stored in secure condition at all times whether held on computer medium or as a printed copy.
  7. The organisation to which the data are released will maintain and comply with a Data Protection Registration which encompasses the data and data usage described.
  8. The data will be destroyed when the work is completed: any printed copies will be destroyed, and files deleted from computer systems (including any copies held on backup or archive media).

9. All staff given access to the data will be made aware of these conditions

Please return the completed and signed form to

Dr Christian P Subbe

c/o Lisa Mirrlees

Ysbyty Gwynedd

Department of Acute Medicine

Penrhosgarnedd

Bangor, LL57 2PW

SAMBA Caldicott form 1