Project Update June 2017

1)      ETHICS/GOVERNANCE

All consent forms and information sheets have now completed final approvals from REC and ready for use when recruitment begins. All updated documents can be accessed via Dropbox.

The project has received local R&D approval at the both Cambridge and SGUL sites.

This study has now been successfully added to the Clinical Research Network South London Portfolio.

2)      PARTICIPANT RECRUITMENT AND TESTING

Copies of the BDAE have been delivered to SGUL and Cambridge.  We will decide what subtests are going to be essential to demonstrate convergent validity with the MLSE. This will be added to the agenda of the next project meeting on Tuesday 18th July 2017.

We have data on the full set of items from the pre-norming stimuli from 27 controls so far. Cambridge has managed to recruit a further 2 volunteers for the pre-norming stimuli and hope to recruit a further 2 early next week which will see the tally pass the initial target of 30 participants.

We should aim for patient testing to start in the second half of July, after populating the test sections based on the pre-norming data. This will be slightly later than originally envisaged, but there hasn’t been too much slippage even given the slow and staggered start to the project. We can project to compensate for this towards the end of 2017.

SGUL and Cambridge have both applied for access to the Join Dementia Research (JDR) database for recruitment of healthy controls. With recent changes to the legislation for access to the JDR database, each site is required to set-up a Data Processing Agreement (DPA) with the Department of Health. The DPA has now been successfully processed and signed for SGUL and the study is ready to be opened on the JDR database for recruitment.  We await confirmation from the Cambridge site.

3)      DATABASE

Nikil and Peter discussed the REDCap proposal with SGUL’s Information Governance consultant and the SGUL Solicitor, and there is general agreement that, subject to a data sharing agreement being signed off by all collaborating centres, non-identifiable test data from patients and controls can be stored and shared using this web based solution.

SGUL’s data protection officer (Claire Morrissey) has drafted a data sharing agreement which has been sent for review by the Cambridge and Manchester groups and their respective Information Governance offices. The data sharing agreement has been reviewed by the Cambridge group and we await confirmation from the Manchester group.

SGUL are currently waiting on the IT department at SGUL to grant us with credentials for REDCap login to begin setting up the REDCap database. This will be processed first week of July.

SGUL will draft the REDCap database outline which will be presented at the July meeting.

4)      PROJECT IMPACTS

The project website has been updated. Please visit the website when you can and feedback/suggestions are welcome. This project update will have been archived in the Updates page.

Katie now has access to admin details and can add any updates that the Cambridge group wish to make. If Matt and/or Stefano think it would be useful to have someone with admin rights in Manchester and/or Pavia, please could they let Nikil and Peter know.

A paper on the control data from the Italian version of the pilot materials has been accepted for publication in Neurological Sciences. The paper or a link to it (depending on open access policy) will be posted on the website when production is complete. The paper can now be accessed via Dropbox.

5)      DATE OF NEXT PROJECT MEETING

This is set for Tuesday 18th July, from 14:30 to 17:30 at SGUL. Room 2.263 has been booked for the meeting which is located on the 2nd floor of the Jenner Wing (also referred to as the ‘Chrissie Fenske’ room). Please contact Nikil if you need assistance with locating the room on the day. An agenda for the next meeting will be circulated at the beginning of July.

A table has been reserved at Macellaio in Exmouth Market from 19:00 for a collaborators’ dinner. Thanks to all those who have so far confirmed that they will be coming.

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