Data collection and Case Report Forms (CRFs)
How data is collected and analysed should be considered in the
initial phases of study design and data collection methods, and
systems should be designed to collect and store data in a
proportionate way. Electronic systems to be used as part of data
collection and storage require a validation process which is
proportionate to the systems used. All research staff
undertaking UH Bristol sponsored research who process data are
responsible for ensuring the applicable data management standards
are met as described in SOP 012 Study Data.
Documentation detailing the requirements and processes:
SOP_012 Study data
SOP_011 Validation and backup of computer systems used
in research
GD_007 CRF design Key elements to
consider
GD_008 Source data Key elements to
include
TMPL_041 Template Data Management Plan
Access
the SOPs, guidance documents and templates here.