= 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

* Standard timeline:
  * Enrol / Open Case

* Recruited 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 
    * Consent Q1 Y/N
    * Consent Q2 Y/N
    * Consent Q3 Y/N
    * Consent Q4 Y/N
    * Consent Q5 Y/N
    * Consent Q6 Y/N
    * Date of consent
    * !BioResource recruitment ID (must be last for barcode scanning)
  * 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      * NOT WITHDRAWN (default)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, and a Study Enrolment creatd with status 'Recruitment pending'. If there is no response, a report can be generated of participants with status 'Recruitment pending' 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. The Study Enrolment should be updated to status 'Recruited', 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. There are initial option sets in the questionnaire, but during the initial data entry period, any forms with answers in these categories should be retained, so a decision can be made regarding coding the data.

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? How can matrix fields be used to help here?

==== GO LIVE ====

The NIHR BioResource questionnaire in REDCap was set to production status on 25 November 2013. There will need to be some ongoing maintenance of the option groups as above, but it is cleared for data entry.