Changes between Version 3 and Version 4 of SCAD and CAE Study

Timestamp:

01/29/15 11:32:53 (10 years ago)

Author:

Richard Bramley

Comment:

--

SCAD and CAE Study

@@ -1 +1 @@
 = 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]].
+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 ...