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Designing Data Capture Tools

The collection (capture) of data in a research study can be achieved through various methods that may include, but are not limited to : paper case report forms (pCRFs) completed at a site by member(s) of the study team as delegated; electronic Case Report Form (eCRFs) where data may be  entered directly into the electronic form  from source or transcribed/ scanned from source as delegated and /or paper forms completed by participants themselves (questionnaires/diaries).

Data capture tools should be designed to meet the specific requirements of the protocol and the statistical analysis plan. For clinical trials, the Chief Investigator should work with the trial statistician and other personnel as relevant (i.e other members of the study team / study oversight groups) to ensure that the data capture tools are: workable in the real life research situation for which they are intended; allow for consistent data collection across all sites (i.e all sites are to use the data capture tools as instructed);  collect the data required for end point analysis and where possible collect confirmatory compliance information to assist with central monitoring activities  (for example, where medical doctor is required to confirm eligibility  in a CTIMP ensure that this information is mandated within the data capture tool).

Where a Noclor partner has agreed to act as sponsor, they may request to review /approve the proposed data capture tools and any instructions/data management plan (Noclor may also request evidence of who has been involved in the CRF development process and specifications for systems to be used such eCRFs, database etc) prior to the study commencing. If this is a requirement it will be clearly communicated to the Chief Investigator following the initial/bespoke risk assessment (and documented in any subsequent study-specific monitor plans).

The Chief Investigator is responsible for checking consistency of the CRF version with the protocol, for example if there is amendment to the protocol, the Chief Investigator must ensure any necessary changes to CRF are also made and implemented.  Version control of data collection tools (CRFs) must be maintained and evidenced in the Study/Trial Master File (S/TMF).