SCAD and CAE

Extension of the SCAD study to include patients with Coronary Artery Aneurysms / Ectasia funded by ​ Rare Diseases Translational Research Collaboration (​Website).

• RD-TRC Study Guidance​
• RD-TRC Data Day Agenda

Data Meeting

Roger James of the ​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 ...