SITE TE INITI TIATION V VISIT T Meet the Team Co-Sponsors - PowerPoint PPT Presentation

SITE TE INITI TIATION V VISIT T

Meet the Team Co-Sponsors University of Aberdeen & NHS Grampian CI Professor Phyo Myint Trial Co-ordinator Bolanle Birkinns TCTU Trial Manager Pauline Armory TCTU Trial Co-ordinator Fiona McLaren-Neil Statistician Professor Amanda Lee Health Economist Professor Paul McNamee Haematologist Dr Katherine Hands 2 SIV V1 09/08/2018

RAINDroP Team Emails CI, Prof Phyo Myint phyo.myint@abdn.ac.uk RAINDroP Trial Coordinator b.brikinns@abdn.ac.uk RAINDRoP Trial Manager raindroptm@dundee.ac.uk Sponsor p02gh3@adbn.ac.uk 3 SIV V1 09/08/2018

PIs & Site Map NHS Grampian Tayside CTU NHS Fife Dr Roy Soiza & Dr Alison Donaldson Dr Vera Cvoro Newcastle upon Tyne NHS FT Professor Miles Witham Dr Helen May Norfolk & Norwich NHS FT Research Nurses: Blinded & Unblinded 4 SIV V1 09/08/2018

Study Design Pilot Randomised Controlled Trial Non-CTIMP: routine care interventions 84 participants / 4 sites Three arms: • Treatment as usual • Stop oral iron treatment • Stop oral iron and give IV iron (as per local formulary). 5 SIV V1 09/08/2018

Key Outcomes The co-primary outcomes are: 1) the rate of randomisation per month across the pilot sites 2) the proportion recruited from each route of recruitment • how long it takes to recruit enough people to the study • which method(s) of recruitment (clinic, adverts or GP letters) is/are most efficient • Improvement in haemoglobin level (a measure of anaemia) in each treatment arm 6 SIV V1 09/08/2018

Secondary Outcomes 1) change in haemoglobin and ferritin levels at 3 months 2) number of eligible patients per site 3) proportion of eligible patients agreeing to take part and passing screening 4) feasibility of collecting primary (physical functioning and health- related and general quality of life) and secondary outcomes for main trial 7 SIV V1 09/08/2018

Recruitment: IC/EC searches Inclusion  ≥ 65 years  Oral Iron Prescribing – minimum 8 weeks tx  Haematology results: Before iron Hb ≥85g/L ≤110g/L  Hb after 8wks tx <20g/L improvement or still below lower limit of normal (male 130 / female 120)  Biochemistry results: Before iron ferritin <100ug/L Excluded × Ongoing anaemia investigations × Active GI cancers × Active peptic ulcer × Oral anticoagulants except antiplatelet agents (asprin, dipyridamole, clopidogrel) × eGFR <30 × Symptomatic chronic heart failure × Require human assistance to mobilise × Severe congnative impairment × Terminally ill × Another clinical trial 8 SIV V1 09/08/2018

Recruitment Channels & Accruals Database / Patient List Searches GP Practice lists / PCN search Hospital clinics / RN search Laboratory results lists / RN Research volunteer databases / RN Targeted local advertising / RN UKCRN Accruals ◦ In Scotland to NRSPCN ◦ In England to NIHR Ageing CRN. Screening Log / Data 9 SIV V1 09/08/2018

RAINDroP Training & SOPs • Protocol • Operations Manual • User Guides – Recruitment Tracker, TRuST, OpenClinica, LabKey • Sponsor agreed SOPs • Laminate Pack – WPGs for Physical Assessments • Approved Study Documents • Delegation Log • Study Specific Training Log & SOP Sign-off Sheet 10 SIV V1 09/08/2018

PI PI R RESPONSIBLITIE IES

UK Policy Framework / GCP Investigator and site staff qualifications Site agreements Adequate resources to conduct the study Medical care of trial subjects Compliance with the protocol Knowledge of interventions / SmPC including Reference Safety Information Randomisation Procedures (and Unblinding) Informed consent of trial subjects Records and Reports Safety Assessment & Reporting ICH GCP section 4 details the investigator responsibilities: http://ichgcp.net/4-investigator 12 SIV V1 09/08/2018

Participant Pathway Flowchart 13 SIV V1 09/08/2018

Centralised Invitation Letters & Pt Tracker  PCN  RN / Hospital Clinician  Poster Advert contact / Hosptial Clinician Recruitment Tracker 14 SIV V1 09/08/2018

Protocol & Study Matrix 15 SIV V1 09/08/2018

RAINDroP Visits: PI Activities  Visit 1 Informed Consent: PI or RN / Delegated activity  Pre & Visit 2 Pre-Randomisation Lab results & Final Eligibility Assessment & Sign-off Post-Telephone Call - IV Iron Prescribing; V3 appt date/time  Visit 3 Arrange / provide medical oversight  Visit 4 Lab results review and sign-off 16 SIV V1 09/08/2018

PI: Adverse Events AE definition: event requiring advice or treatment from a Health Care Professional (HCP) Duration: Informed Consent – End Visit 4.  Collect @ V2 & after V4 assessments (V3 retrospective)  Recording: AE Log & Medical Notes  PI assess: severity, causality, expectedness and seriousness  PI review and sign each AE  Follow-up: till resolution or until V4 + 30 days (whichever is first) 17 SIV V1 09/08/2018

PI: Serious AEs  Definition – Related and Unexpected and not exempt  Report to CI (cc TM) within 24 hours  Email form  Exceptions are recorded on AE log 18 SIV V1 09/08/2018

PI: Deviations & Breaches • Breach is a departure from the approved protocol, research project documentation, SOPs or any other information relating to the conduct of the trial • Deviation is a minor deviation from an SOP or a planned event. • Signalling  Reporting: Deviations on Log; Breaches on Log and Report  Monthly log to trial coordinator  Breaches to CI and RAINDroPTM; CI inform/report to Sponsor. 19 SIV V1 09/08/2018

PI: Completion / Withdrawals  Withdrawals – clinical judgement  CRF completion sign-off 20 SIV V1 09/08/2018

Monthly Logs & Essential Site Activities  Monthly Email Logs:  Screening  Enrolment & Randomisation  Data Verification (Visual Verification)  Deviations  Delegation (if any team changes)  Recruitment Tracker – live tool and event capture  OpenClinica data entry – within 2 weeks of study visit  Lab Key  Completed CRF pages  Data queries / cleaning  Quarantined Data Uploads:  Oral Iron Use  Iron Treatment Data  Pt Experience Questionnaire  ISF filing – printed documents; correspondence. 21 SIV V1 09/08/2018

Monitoring: Purpose To verify that the rights and well-being of participants are protected To ensure that reported trial data is accurate, complete and verifiable from source data To ensure that the trial is compliant with the protocol, Research Governance Framework /Good Clinical Practice (GCP), SOPs and regulatory requirements 22 SIV V1 09/08/2018

Monitoring Schedule Risk based / non-CTIMP  SIV  On-site / Remote  Close out visit  Informed Consent Forms  SAEs  Independent audit by Sponsor or REC 23 SIV V1 09/08/2018

Monitoring visit requirements  Email to arrange visit date – PI and RN  Access to Investigator Site File  Patient notes / source data  Completed Informed consent forms  OpenClinica and Excel spreadsheets: Oral Iron Use, Iron Treatment  Actions sent to site for completion within 4-8 weeks 24 SIV V1 09/08/2018

RAINDroP PI Meetings  Trial Management Group – First Tuesday each month @ 3pm 25 SIV V1 09/08/2018

PARTICIPANT P PATHWAY

Participant Pathway Flowchart 27 SIV V1 09/08/2018

HIC: Search Validation 28 SIV V1 09/08/2018

HIC: Centralised Invitations 29 SIV V1 09/08/2018

Recruitment Tracker The Recruitment Tracker has three primary functions : • Management and Mailing of Participant Invitations • Management of Participant Visits • Collection and Reporting of Screening Activity. Access is via https://hicservices.dundee.ac.uk/Recruitment/ Training site, dummy data and then live  RAINDroP Recruitment Tracker User Guide accounts will be provided for RNs. 30 SIV V1 09/08/2018

RN: Telephone Pre-screening RAINDroP participation Confirm eligibility Mail / email PIS Taxi / travel costs Book V1 or thank / decline Screening Log Recruitment Tracker 31 SIV V1 09/08/2018

Study Matrix 32 SIV V1 09/08/2018

Visit 1: Informed Consent PI or RN / Delegated activity – suitably trained and qualified Copies Enrolment & Randomisation Log Medical notes CRF 33 SIV V1 09/08/2018

Visit 1: Informed Consent PIS and Consent – Approved version & Headed paper Fully informed participant Adequate time to read and consider participation Opportunity to ask questions / encourage Prior to any trial related activity Pt initial boxes; signed and dated by both on same day 34 SIV V1 09/08/2018

Visit 1: Informed Consent Common Errors Wrong version ICF / PIS Ticked boxes Signed in wrong place Dates that don’t match Missing information Illegible writing Researcher completing name and date for pt 35 SIV V1 09/08/2018