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

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

Nov 18, 2022 7 likes •698 views

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

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SITE TE INITI TIATION V VISIT T

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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

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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

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PIs & Site Map

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Dr Roy Soiza & Dr Alison Donaldson Dr Vera Cvoro Professor Miles Witham Dr Helen May Research Nurses: Blinded & Unblinded

NHS Grampian NHS Fife Newcastle upon Tyne NHS FT Norfolk & Norwich NHS FT Tayside CTU

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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).

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Key Outcomes

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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
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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

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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

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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

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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

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PI PI R RESPONSIBLITIE IES

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UK Policy Framework / GCP

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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

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Participant Pathway Flowchart

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Centralised Invitation Letters & Pt Tracker

  • PCN
  • RN / Hospital Clinician
  • Poster Advert contact / Hosptial Clinician

Recruitment Tracker

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Protocol & Study Matrix

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RAINDroP Visits: PI Activities

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  • 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

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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)

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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

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PI: Deviations & Breaches

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  • 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
  • r 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.
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PI: Completion / Withdrawals

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  • Withdrawals – clinical judgement
  • CRF completion sign-off
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Monthly Logs & Essential Site Activities

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  • 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.
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Monitoring: Purpose

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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

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Monitoring Schedule

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Risk based / non-CTIMP

  • SIV
  • On-site / Remote
  • Close out visit
  • Informed Consent Forms
  • SAEs
  • Independent audit by Sponsor or REC
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Monitoring visit requirements

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  • 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
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RAINDroP PI Meetings

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  • Trial Management Group – First Tuesday each month @ 3pm
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PARTICIPANT P PATHWAY

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Participant Pathway Flowchart

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HIC: Search Validation

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HIC: Centralised Invitations

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Recruitment Tracker

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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 accounts will be provided for RNs.

  • RAINDroP Recruitment Tracker User Guide
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RN: Telephone Pre-screening

RAINDroP participation Confirm eligibility Mail / email PIS Taxi / travel costs Book V1 or thank / decline Screening Log Recruitment Tracker

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Study Matrix

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Visit 1: Informed Consent

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PI or RN / Delegated activity – suitably trained and qualified Copies Enrolment & Randomisation Log Medical notes CRF

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Visit 1: Informed Consent

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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

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Visit 1: Informed Consent

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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

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Data Collection: CRF

Completing the Case Report Form (CRF)

  • Ensure participant ID is entered at the top of each page
  • Write clearly within the boxes provided
  • No abbreviations
  • Instructions for completion of each page

are given on the facing page Source Data

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Visit 1: Screening & Baseline

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Approx 2 hours IC / EC – tick yes or no Demographics – DOB, gender, home circumstances, walking aids Height & Weight / BMI Concomitant Medications – Oral iron & Other tx

Medical History Blood Samples Physical Assessments Questionnaire Tools

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Visit 1: Concomitant Medications

  • Iron treatment name, dose, unit and frequency are captured at Visit 1
  • All other prescribed medications Concomitant Medication page of the CRF:
  • Generic name
  • Ingredients of combined medications should be listed separately
  • Abbreviations should not be used
  • Over-the-counter medications are not recorded.
  • Frequency code:
  • OD; BD; TID

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Visit 1:Medical History

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  • Relevant Medical History from medical

notes / participant – tick

  • ‘Other’ include:

currently active medical condition if con meds are taken

  • r past medical condition that impacts ADL
  • Please NO abbreviations
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Visit 1:Blood Samples

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Local lab 10ml venous blood:

  • Hb
  • Ferritin
  • C-reactive protein, *creatinine, *eGFR
  • Results - numbers
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Visit 1: Physical Assessments

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  • Requirement: stopwatch, chair, 3 metre walking course, 30 metre flat

walking area with 3m interval markings, marker, measuring tape, emergency equipment / facilities

  • Short Physical Performance Battery
  • 6 minute Walk Test – min/secs

3

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Questionnaire Tools: up to 1 hour

Participant refreshment Quiet space Table or Clipboard Pen SELF-REPORTED

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Visit1:Questionnaire Tools

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Visit 1: Participant Information

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  • Schedule Visit 2
  • Advise possible dates for Visit 3
  • Schedule Visit 4
  • Provide Study Participant Card
  • Participant Reported Anaemia Symptoms

Questionnaires for completion at end of Month 1 and Month 2

  • Provide copy of PIS and signed Informed Consent

Form.

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Visit 1: Medical Notes & Data

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Document in medical notes include for source data verification:

  • Copy of signed Informed Consent Form & PIS
  • Date of visit
  • Confirmation that the patient has had the PIS for at least 24 hours.
  • Confirmation of how patient identity was verified.
  • Details of any notable findings at the visit and any action taken.
  • Confirmation that all inclusion/exclusion criteria were met; any results

awaited.

  • Height and weight.
  • Confirmation that the visit was carried out as per protocol.
  • Name and Signature of Research Nurse completing the visit.
  • CRF
  • Iron Treatment Data / Excel Spreadsheet
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Adverse Events

AE definition: event requiring advice or treatment from a 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)

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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

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Visit 2: Randomisation

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PI final eligibility assessment & sign-off Unblinded RN TRuST:

  • Site codes:

ARI FIF NWC NUH

  • Haemoglobin result after 8 weeks of oral iron
  • Ferritin prior to starting oral iron
  • 6 minute walk test distance

Allocation:

  • Treatment as usual
  • Stop oral iron treatment
  • Stop oral iron and give IV iron (as per local formulary).
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Visit 2:Telephone Call

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Unblinded RN

Treatment Arm Instruction Group 1: Continue oral iron 1. Telephone participant and instruct to continue oral iron 1. Send recruited letter to GP informing Group 1 allocation Oral iron continuing for study duration Group 2: Stop oral iron 1. Telephone participant and instruct to stop oral iron 1. Send recruited letter to GP informing Group 2 allocation Oral iron stopping for study duration Group 3: Stop oral iron & give IV iron 1. Arrange appointment with Day Hospital / Clinical facility Following discussion with participant this may need to be re-arranged 1. Telephone participant, instruct to stop oral iron. 2. Advise and confirm appointment to attend for IV infusion IV infusion visit should be within 2 weeks of randomisation 1. Send recruited letter to GP informing Group 3 allocation Oral iron stopping & IV iron therapy for study duration and not to restart oral iron for 3 months

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Visit 2:Medical Notes & Data

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  • Date and time of visit
  • Treatment allocation / Print TRuST notification
  • GP letter – Recruited
  • Name and Signature of RN completing the visit.
  • CRF
  • Recruitment Tracker
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Visit 3:IV Iron Administration

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Within 2 weeks of V2 Approx 90 minutes Local Policy PI prescribe: dose, time & Hb Registered Nurse administer Unblinded RN attend Clinical Location & Emergency Facilities Record after V4 assessments – Iron Treatment Log & Excel spreadsheet

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V3:Medical Notes & Data

  • Date and time of visit
  • IV iron prescription filed as per local policy
  • Details of any notable events at the visit and any action taken.
  • Name and Signature of RN completing the visit.
  • NO CRF DATA
  • NO RECRUITMENT TRACKER
  • V3 treatment retrospective Iron Treatment Data / excel spreadsheet
  • AEs – retrospective @V4

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V4: Assessments

  • Approx 2 hours
  • Blinded RN
  • Blood samples: Hb & ferritin
  • Physical Assessments: SPPB. 6 minute walk
  • Questionnaire Tools (refreshment)
  • AE / con meds after assessments
  • Iron specific dietary advice
  • Inform participant to contact GP
  • Travel expenses
  • Oral iron pts – Unblinded RN call for Oral Iron Use Tool / Spreadsheet

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Visit 4: Concomitant Medications

  • Iron treatment name, dose, unit and frequency are captured following assessments:
  • Iron Treatment & Excel Spreadsheet.
  • Record all other prescribed medications on CRF Concomitant Medication page :
  • Generic name
  • Concomitant medication taken after Visit 1 and before Visit 4 are not recorded, e.g. antibiotics.
  • Over-the-counter medications are not recorded
  • Ingredients of combined medications should be listed separately
  • Abbreviations should not be used.

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V4:Medical Notes & Data

  • Date and time of visit
  • Details of any notable events at the visit and any action taken.
  • Confirmation that the visit was carried out as per protocol.
  • Name and Signature of RN completing the visit.
  • CRF
  • Recruitment Tracker
  • Quarantined Data
  • Iron Treatment excel spreadsheet
  • Oral Iron Use excel spreadsheet
  • Participant experience questionnarie

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SYSTEM EMS

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Monthly Logs & Essential Site Activities

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  • 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.
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Monthly RN Meetings

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  • Research Nurse Meeting
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Website

Public information / Potential Participants Staff Portal

  • Recruitment Tracker
  • TRuST
  • OpenClinica
  • LabKey
  • Trial Documents – generic and site specific
  • Recruitment / Accrual Numbers
  • Trial Announcements
  • Events Calendar

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Recruitment Tracker

  • Password Protected Training Site
  • RAINDroP Recruitment Tracker User Guide
  • Dummy Data
  • Password Protected Live Account
  • HIC DATA LINKAGE SERVICE - NHS FIFE

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TRuST: Randomisation

  • Unblinded RN
  • RAINDRoP TRuST User Guide
  • Password Protected Account

Randomisation Notification

  • Unblinded RN print and file in medical notes
  • No formal unblinding required

Emergency Randomisation

  • If no web-access at site telephone TCTU 01382 383581

Treatment allocation notified by telephone & email (print and file when access resumes)

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OpenClinica

  • Web-based Database
  • Web-based training to follow
  • RAINDroP OpenClinica User Guide
  • Dummy data
  • Training Certificate
  • Password Protected Account

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Quarantined Data

Maintain statistician & health economist blinding Data held at site until post-database lock TCTU will request upload via LabKey

  • Oral Iron Use Scale responses are entered on the Oral Iron Use Excel spreadsheet (to maintain blinding).
  • Iron Treatment Data will be entered on the Iron Treatment Data excel spreadsheet.
  • Patient Experience Questionnaire

Excel Spreadsheet SOP

  • System backups
  • Naming format

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LabKey

Password Protected Account RAINDroP User Guide – Folder Structure & Document Naming Convention Web-based Data Repository Excel Spreadsheets: Oral Iron Use & Iron Treatment Data Participant Experience Questionnaire Completed CRFs Data Query Resolutions

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Case Report Form: Review

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Investigator Site File: Review

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Next Steps

RAINDroP training GP invitations Recruitment Tracker Medical Notes Pre-screening / Clinician invitations FPFV

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