Changes between Version 10 and Version 11 of SCAD and CAE Study


Ignore:
Timestamp:
10/02/15 11:27:23 (9 years ago)
Author:
Richard Bramley
Comment:

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  • SCAD and CAE Study

    v10 v11  
    1 = SCAD and CAE
     1= SCAD Study
    22
    33Tags: [[LCBRU Study Category]]
     4
     5== Overview
    46
    57Extension 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]]).
    … …  
    810- [[attachment:NIHR RD-TRC Data Day Agenda (pm) 28th Jan 2015.docx|RD-TRC Data Day Agenda]]
    911
    10 == Data Meeting
     12== Status
    1113
    12 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.
     14?
    1315
    14 === Data Requirements
     16== Contacts
     17
     18 Principle Investigator:: Dave Adlam
     19 Investigator:: Abi Al-Hussaini
     20 RDCIT Training:: ?
     21 RDCIT Director:: Roger James
     22
     23== IT
     24
     25- [[REDCap Summary]] (Questionnaire: {{{Link}}})
     26
     27=== Upload of Data to RDCIT OpenClinica Instance
    1528
    1629- 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).
    … …  
    1932- These data definitions (CRF) are published on the RDCIT OpenClinica site and reuse and collaboration are encouraged.
    2033
    21 === OpenClinica useage
    22 
    23 - OpenClinica allows you to define sets of study data to be entered by clinicians.
    24 - 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.
    25 - Data can be entered manually into OpenClinica or it can be imported from a spreadsheet.
    26 - 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.
    27 - 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.
    28 
    29 === Infrastructure
    30 
    31 - The RDCIT instance of OpenClinica currently sits on a server in Cambridge this instance is '''not secure for storing Patient Identifiable Data''' and so is called OC Anonymous.
    32 - RDCIT have commissioned a server in a data centre in Liverpool that will comply with various security requirements and so will be suitable for patient identifiable data.  This will be called OC Secure and should be ready in June.
    33 - Both servers are visible on N3 and the equivalent university network.
    34 
    35 === Remaining Issues
    36 
    37 After the presentation several questions and issues were raised, some of which require further clarification:
    38 
    39 - Ethics and Consent: It may be necessary to re-consent patients to put their data on the RDCIT OpenClinica instance.  GEL has ethics policy that should be reusable for this project.
    40 - Data Sharing: There seemed to be no consensus on whether Data Sharing Agreements would have to be created for all involved organisations.  It was put forward that as long as a responsible clinician entered or approved each individual data entry, it should be OK.  Whether the Trsusts would be OK with this is another matter.  RDCIT was going to seek clarification from the Department of Health.
    41 - Responsibility for the coding and mapping of the data lies with the study team, although technical assistance may be available from RDCIT through the Theme coordinator.
    42 - Funding for IT should be covered by the BRU budget as this is an amendment to the BRU contract.
    43 - Requests for new users, groups and permissions should be made to RDCIT.  There is no devolved user / permissions admin.
     34**We are waiting for the requirements of data to be uploaded from Dave and Abi**
    4435
    4536[[BackLinks]]