BIODEP Research Nurse Training - London Event

1. BIODEP Research Nurse Training Monday 15th June 2015 One Chapel Place London W1G 0BG 9:30-17:30

2. Attendees • Glasgow • Cathy Deith (Research Nurse) Catherine.Deith@ggc.scot.nhs.uk • Andrew McPherson (Research Nurse) Andrew.McPherson@ggc.scot.nhs.uk • Oxford • Akintayo Oladejo (Research Nurse) Akintayo.Oladejo@oxfordhealth.nhs.uk • Jithen Benjamin (Research Nurse) Jithen.Benjamin@oxfordhealth.nhs.uk • Helen Jones (Nurse Practitioner) Helen.Jones@oxfordhealth.nhs.uk • Cambridge • Amber Dickinson (CRN Clinical Studies Officer) Amber.Dickinson@cpft.nhs.uk • Clare Knight (CRN Clinical Studies Officer) Clare.Knight@cpft.nhs.uk • Barry Widmer (Database Operations Manager) bw215@cam.ac.uk • Linda Pointon (Research Project Manager) ljp22@medschl.cam.ac.uk

3. Training programme 09:30 Introduction and overview of study (Linda) 10:45 Payments to participants (Clare) 11:00 Tea 11:15 Cohort management System CMS and database (Barry) 12:15 Lunch 12:45 HAM-D and ATRQ administration (Akintayo) 13:45 SCID training (Clare and Amber) 15:00 Tea 15:15 SCID training continued (Clare and Amber) 16:45 Self-administered questionnaires (Amber) 17:15 Wrap up (Linda) 17:30 Close

4. NIMA The Neuroimmunology Consortium • Funded by the Wellcome Trust • Collaboration between 7 academic and 2 industry partners • University of Cambridge* • University of Oxford* • University of Glasgow* • University of Sussex* • King’s College London* • University of Southampton • University of Cardiff • Janssen • Lundbeck

5. NIMA Workpackages and timeline BIODEP!

6. BIODEP Background • Increasing evidence that inflammation may be causal in depression • Less clear that anti-inflammatory drugs will have an antidepressant effect • Goals is to identify the subset of depressed patients that is most likely to respond better to an anti-inflammatory drug than to a conventional antidepressant

7. BIODEP Study Design

8. Blood/corstisol Potential control Potential subject with MDDGP surgeryIAPTCRN n=50 n=200 + Referral to local study team CMS CMS Database CRP Result Screening Form ……………………………………………... Subject contacted by Research Nurse Breakfast Questionnaires SCIDinterview……………………………………………............................ Consent form(S) ……………………………………………... Eligible subjects: 100 DEP + MA + 50 DEP – MA + 50 DEP + Local laboratory Primary cohort Breakfast Questionnaires MRI/fMRI PET &/or lumbar puncture Blood samples Consent form(S) ……………………………………………... Low CRP Med CRP High CRP Controls Secondary cohort

9. Study preparation • Recruitment • Contact local Clinical Research Network • CRIS application (Cambridge, KCL, Oxford) • IAPT application (if necessary) • Local SOPs • Local SOPs should be in place for: • Lab staff and research nurses should agree procedure to ensure they are informed of each participant visit and lumbar puncture • Spinning and shipping routine bloods • Booking local clinic for visit • MRI scans • Lumbar punctures, including identifying clinician and arranging local clotting panel test • Aliquoting and freezing CSF • Payment of participants, either by cheque or by cash • Receive kits • Immunophenotyping (from Glasgow) • Routine bloods (from Quest) • Salivary cortisol kits (from KCL) • CSF processing (from Lundbeck)

10. Study recruitment • Potential participants may be identified from various sources: • Clinical Research Network (Primary Care) GP sources together with routine NHS clinics. • The Clinical Records Interactive Search (CRIS) database will be used to identify patients where available • Local NHS consultants who specialise in depression will be contacted • Local IAPT services will be contacted • Posters will be displayed in clinics, GP surgeries and Recovery Colleges • Advertising through local media, including newspapers • University counselling services • Volunteer registers • Web based resources, such as http://patientsactiveinresearch.org.uk/ • Social media (such as Facebook/Twitter) • Local Mind services • Local support groups • Recovery Colleges • Richmond Fellowship, • Scottish Association for Mental Health • Depression Alliance • Call/email to arrange screening. Patient information sheet should be sent in advance if possible

11. Study screening Anything that makes you very out of breath or sweaty Nothing but water from midnight

12. If in doubt, send for review Bring meds to the appointment

13. Must agree to all Primary cohort consent

15. Eligibility appointment

16. Assess eligibility using: HAM-D questionnaire ATRQ (to be reviewed later)

18. If eligible: • Arrange Fasting Blood Draw appointment for next morning (within 48 hours) • Inform lab contact to arrange pick-up of samples. • Remind about fasting and exercise! • Send participation letter and participant information sheet to GP (see link on CMS) • Enter information from consent form into CMS • Enter HAM-D and ATRQ data into REDCap • The SCID interview and self-administered questionnaire pack may be done at this appointment or at the Fasting Blood Draw appointment • Enter SCID data into REDCap while participant completes the questionnaire pack

20. Primary cohort - clinic visit (Fasting Blood Draw appointment) Before 10.30, then provide breakfast

22. Primary cohort - clinic visit (Fasting Blood Draw appointment) • Check consent has been signed, filed and that participant has a copy • Coordinate with lab for bloods to be collected immediately after they are drawn • Recheck current medications, including oral contraceptives • Collect booklet from participant, make a copy/scan to keep and put original into prepaid envelope to be returned to Cambridge • Post envelope to Cambridge in pre-paid envelope • Give out salivary cortisol kits and provide instructions (see link on website) – stick barcodes on the tubes • Arrange payment for participant (see link on CMS)

24. Research bloods All kits will be provided Arrange immediate collection/delivery to research lab

25. Routine safety labs Spin and aliquot serum into 3 x Quest tubes (ambient) Whole blood – no processing required Package and arrange DHL courier to Quest Refer to Quest Investigator Manual and slides for details

26. Salivary cortisol instructions

30. Recruitment for secondary cohort • Receive safety labs back by fax/email (2-3 days later) enter CRP result into CMS • CMS will tell you whether there is a slot in the secondary cohort • Contact participant to arrange appointments • Also: • Get lab report checked for clinical significance and signed by investigator • Send copy of signed lab result to GP – generate letter from CMS

31. Secondary cohort appointments CLINIC For fasting blood draw and brief questionnaires (early morning) MRI Arrange with local centre – morning appointment Lumbar Puncture Arrange with local centre – afternoon appointment SAME DAY IF POSSIBLE! PET scan Arrange with KCL (details to follow) – within 2 weeks before MRI and lumbar puncture

32. Optional Optional

33. Secondary cohort clinic visit • Fasting blood sample • Shorter version of questionnaire pack • Accompany to MRI • Accompany to lumbar puncture • Arrange for aliquoting and freezing of CSF

35. Regulatory Documents • In Study Manual: • Site file checklist • Contact sheet • Delegation log • SAE reporting form • To follow: • SAE SOP • Study documents • All protocols, amendments, PISs, ICFs, etc will be available on the website

36. Website http://www.neuroimmunology.org.uk/ ALWAYS DOWNLOAD THE LATEST INFORMATION SHEET AND CONSENT FORM! NEVER MAKE COPIES OR PRINT IN ADVANCE!

38. Wrap-up • Study Manual to be finalised • CMS • MRI • PET • LPs • Local study preparation checklist • Query re MTA • Regular calls • Weekly site calls • Monthly workgroup calls • Remote monitoring • Annual visit (ISF review)