Guideline:
Completion of a Personal Data Notification
Form for a clinical research database
Introduction
This guideline is set up to support clinical researchers in how to complete the University of
Birmingham Personal Data Notification Form for their clinical research databases. Please note that
this form also needs to be completed for any database, file or set containing personal data other than
clinical research databases.
Definitions:
Chief Investigator The person who takes overall responsibility for the design, conduct and
reporting of a study if it is at one site; or if the study involves researchers at
more than one site, the person who takes primary responsibility for the design,
conduct and reporting of the study, whether or not that person is an investigator
at any particular site.
Note that for CTIMPs the Chief Investigator must be an authorised health
professional.
UoB Lead
The UoB Lead is a (senior) person in the UoB who takes responsibility for the
conduct and delivery of those parts of the study which are either carried out at
or managed/overseen by the UoB. Normally this would be an academic
researcher, but in some cases it may be a senior member of a UKCRC
registered UoB CTU.
Guideline:
1. Access the form via the web: http://www.dpa.bham.ac.uk/index.asp
2. Fill in the form – follow instructions as indicated on the example below:
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Guideline:
Completion of a Personal Data Notification
Form for a clinical research database
A data store can be paper
or electronic. The CRFs
can be a data store if it
contains personal data.
Complete one form for
each data store.
Complete details
of the CI, or if CI
is external, the
UoB Lead.
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Guideline:
Completion of a Personal Data Notification
Form for a clinical research database
Location of data – specify as applicable
‘<name of building> within University’ and/or if
outside the University ‘within UK’, ‘within EEA’
or ‘elsewhere in the world, i.e....’
E.g. locked filing cabinet, encrypted memory
stick, password protected computer document
Purpose = clinical research
E.g. from NHS Trust(s), directly
from patients, ...
This should be in line with information
captured in IRAS form and described
in the information sheet/consent form.
Consider data being sent e.g. for
statistical analysis or to funding bodies.
3. Ensure the Data Protection Officer is kept informed if the requirements change.
References

University of Birmingham University of Birmingham Intranet, Legal Services, Data Protection:
https://intranet.birmingham.ac.uk/legal-services/Data-Protection/Data-Protection.aspx

University of Birmingham Personal Data Notification Form:
http://www.dpa.bham.ac.uk/index.asp
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