= SCAD and CAE

Extension of the [[SCAD]] study to include patients with '''Coronary Artery Aneurysms / Ectasia''' funded by [[http://www.nihr.ac.uk/about/rare-diseases-translational-research-collaboration.htm | Rare Diseases Translational Research Collaboration]] ([[http://rd.trc.nihr.ac.uk/|Website]]).

- [[attachment:Study guidance.doc|RD-TRC Study Guidance]]
- [[attachment:NIHR RD-TRC Data Day Agenda (pm) 28th Jan 2015.docx​|RD-TRC Data Day Agenda]]

== Data Meeting

Roger James of the [[http://diligenti.net/rdcit.org/|Rare Diseases Clinical Infrastructure Team]] (RDCIT) gave an introduction to OpenClinica and data requirements for the RD-TRC.

=== Data Requirements

- There are no specific data requirements for the RD-TRC, except that patient identifiable study data is stored in the RDCIT instance of OpenClinica by the end of the funding period (approx September 2016).
- There is a proposed data structure that is based on the data requirements of GenomicsEngland (GEL).  This includes patient identiable details, consent, medical / family history, genetic / clinical tests, medication and more.  There is, however, no formal link between RD-TRC and GEL and all fields that are mandatory in GEL are not mandatory for RD-TRC.
- To this we can create a data definition (CRF) to facilitate our study data.
- These data definitions (CRF) are published on the RDCIT OpenClinica site and reuse and collaboration are encouraged.

=== OpenClinica useage

- OpenClinica allows you to define sets of study data to be entered by clinicians.
- The definitions are recorded in Excel spreadsheets and are version controlled.  So that when data is extracted you can tell the particular version of a question the clinician was asked and what options they were give.
- Data can be entered manually into OpenClinica or it can be imported from a spreadsheet.
- The import process requires you to map the column in the spreadsheet to a particular version of a question in a CRF.  (In the demonstration the column in the spreadsheet was renamed to be specific question ID from the CRF XML definition.  I don't know if this is necessary or helps with the mapping.)  The mapping can then be saved and reused with many spreadsheets.
- Importing seems to be done in 2 stages.  The first stage takes the input file and converts it to several mapped files. (So as not to be too large?)  The mapped files are then imported.

=== Infrastructure

- The RDCIT instance of OpenClinica currently sits on a server in Cambridge ...