= The NIHR Bioresource = 

The NIHR Bioresource project was created under the Government's [http://www.nihr.ac.uk/about/Pages/Strategy_for_UK_Life_Sciences.aspx Strategy for UK Life Sciences] published in December 2011.

The NIHR is investing £2.5m pump-priming this year in a new national NIHR Bioresource. The Cambridge NIHR Biomedical Research Centre (BRC) is working with other NIHR BRCs in Oxford and London and with the NIHR Biomedical Research Unit in Leicester to develop this. The new capacity will help companies to recruit patients for stratified experimental medicine studies as well as providing the potential to study the molecular basis of disease, identify the most appropriate biomarkers for diagnosis and drug discovery, and to test the mechanism of action and effects of new drugs. 

In Leicester, the LCBRU is participating firstly by approaching participants in existing studies ([[BRICCS]], [[GENVASC]] and [[GRAPHIC]]) and inviting them to also register for the NIHR Bioresource.

NIHR Bioresource will use many of the LCBRU IT platform tools, in particular:

[[CiviCRM]]: For monitoring the invitation process and recruitment status of participants.[[BR]]
[[REDCap]]: For electronic data capture from the Bioresource questionnaire.[[BR]]
[[CaTissue]]: For sample management and inventory.[[BR]]


=== NIHR Bioresource !CiviCase object model ===


For the bioresource in CiviCRM, the following configurations will be needed.

* New Group for contacts: Bioresource

* Activity: Invitation letter (doesn't need to be !BioResource specific)

* Activity: Reminder letter (doesn't need to be !BioResource specific)

!CiviCase

* New Case Type: !Bioresource

* Activity standard timeline:
  * Check study consent
  * Check questionnaire * NEW ACTIVITY
  * Input questionnaire data * NEW ACTIVITY

* Other activities:
  * Send replacement questionnaire * NEW ACTIVITY
  * Send replacement consent form * NEW ACTIVITY

* Custom Fields for study enrollment:
  * NIHR !BioResource 
    * !BioResource recruitment ID
    * Consent Q1 Y/N
    * Consent Q2 Y/N
    * Consent Q3 Y/N
    * Consent Q4 Y/N
    * Consent Q5 Y/N
    * Consent Q6 Y/N
  * NIHR !BioResource Withdrawal: 
    * NIHR !BioResource Withdrawal status
      * NOT WITHDRAWN (default)
      * WITHDRAW - KEEP SAMPLES AND DATA
      * WITHDRAW - DESTROY SAMPLES AND DATA

=== Process ===

Groups of participants in BRICCS, GENVASC and other studies will be identified as being suitable for the NIHR Bioresource, and a bulk mailing despatched inviting them to participate. This will be recorded in CiviCRM as an 'activity', and the participant will be added to the Bioresource group, but not at this point a Study Enrollment. If there is no response, a report can be generated of participants with the bioresource invitation, but no study enrollment, and a reminder can be sent to the result set.

Where a response is received, a Bioresource ID label should be attached to both the questionnaire and the consent form. A Study Enrollment should be created, with the activities and custom data completed as required.


=== Bioresource ID generation ===

The Bioresource will need each recruited participant to have a Bioresource ID. These do not need to be randomised, but they do need to be unique. IDs will be in the form "BRxxxxxxxx"

Labels will be printed with the ID in barcode and human-readable form. One to be attached to the consent form, and one to the questionnaire. 

Labels will be printed in advance, attached to the paper forms on receipt and entered into CiviCRM and REDCap when the recruitment and questionnaire data is submitted.

The label module zipfile is attached to this page.

=== Bioresource REDCap questionnaire ===

The current version of the questionnaire paper form is attached to this page. This is represented in REDCap. The questionnaire was initially built in the Online Designer, then downloaded for additional fields to be added in Excel as a data dictionary, and finally re-uploaded. As of 20th March 2013, the questionnaire development was complete and the questionnaire was ready for testing.

Remaining issues are:

[[bioresource_qaire_medications|Medications]], [[bioresource_qaire_dose|dose]], [[bioresource_qaire_freq|frequency]], [[bioresource_qaire_cancer|cancer]], [[bioresource_qaire_neuro|neurological disorders and operations]], and the [[bioresource_qaire_cancer|fh_cancer]] questions all need enumerated answers.

The family history section poses a problem - could we have a single row of data to collect FH, with a drop down for 'relation', and then the option to 'add more'? Or a question 'how many positive FH do you need to enter?' and then a set of data for each tick?