Standard Application Form For The Ethical Review Of Health-Related Research Studies, Which Are Not Clinical Trials Of Medicinal Products For Human Use As Defined In S.i. 190/2004 Page 10

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Version 5.5
May 2011
Office Use:
-
REC Reference No:__________
D10. Will the research participant's hospital consultant be informed
the research participant is taking part in the study (if appropriate)?
Yes / No / Non-applicable
SECTION E
DATA PROTECTION
SECTION E IS MANDATORY
IMPORTANT NOTE:
This application form permits the applicant to delete
individual questions within each section depending on their response to the
preceding questions. Please respond to each question carefully and refer to the
accompanying Guidance Manual for more in-depth advice prior to deleting any
question.
SECTION E1
DATA PROCESSING - CONSENT
E1.1 (a) Will consent be sought for the processing of data?
Yes / No
E1.1 (b) If no, please elaborate.
Answer
SECTION E2
DATA PROCESSING - GENERAL
E2.1 Who will have access to the data which is collected?
Answer
E2.2 What media of data will be collected?
Answer
E2.3 (a) Would you class the data collected in this study as
anonymous,
irrevocably
anonymised,
pseudonymised,
coded
or
identifiable data?
Answer
E2.3 (b) If ‘coded’, please confirm who will retain the ‘key’ to re-
identify the data?
Answer
E2.4 Where will data which is collected be stored?
Answer
10 |
P a g e

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