09/08/2018 3 PIs & Site Map Dr Roy Soiza & Dr Alison Donaldson Dr Vera Cvoro Professor Miles Witham Dr Helen May NHS Grampian Tayside CTU NHS Fife Newcastle upon Tyne NHS FT Norfolk & Norwich NHS FT
Research Nurses: Blinded & Unblinded SIV V1 09/08/2018 4 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). SIV V1 09/08/2018 5 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
SIV V1 09/08/2018 6 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
SIV V1 09/08/2018 7 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 SIV V1 09/08/2018 8 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 SIV V1 09/08/2018 9 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 SIV V1 09/08/2018 10 PI RESPONSIBLITIES
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 SIV V1
V1 09/08/2018 15 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 SIV
V1 09/08/2018 16 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) SIV
V1 09/08/2018 17 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 SIV V1
09/08/2018 18 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. SIV
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. SIV V1 09/08/2018 21 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 SIV V1 09/08/2018 22 Monitoring Schedule Risk based / non-CTIMP SIV On-site / Remote Close out visit Informed Consent Forms
SAEs Independent audit by Sponsor or REC SIV V1 09/08/2018 23 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
SIV V1 09/08/2018 24 RAINDroP PI Meetings Trial Management Group First Tuesday each month @ 3pm 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 accounts will be provided for RNs. RAINDroP Recruitment Tracker User Guide SIV
V1 09/08/2018 30 RN: Telephone Pre-screening RAINDroP participation Confirm eligibility Mail / email PIS Taxi / travel costs Book V1 or thank / decline Screening Log Recruitment Tracker SIV
V1 09/08/2018 31 Study Matrix SIV V1 09/08/2018 32
Visit 1: Informed Consent PI or RN / Delegated activity suitably trained and qualified Copies Enrolment & Randomisation Log Medical notes CRF SIV V1 09/08/2018 33 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 SIV V1 09/08/2018 34 Visit 1: Informed Consent Common Errors Wrong version ICF / PIS
Ticked boxes Signed in wrong place Dates that dont match Missing information Illegible writing Researcher completing name and date for pt SIV V1 09/08/2018 35 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 SIV V1 09/08/2018 36 Visit 1: Screening & Baseline 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 SIV V1 09/08/2018 37
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 SIV V1 09/08/2018
38 Visit 1:Medical History Relevant Medical History from medical notes / participant tick Other include: currently active medical condition if con meds are taken or past medical condition that impacts ADL Please NO abbreviations SIV V1 09/08/2018
40 Visit 1: Physical Assessments 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 3 6 minute Walk Test min/secs SIV V1 09/08/2018
41 Questionnaire Tools: up to 1 hour Participant refreshment Quiet space Table or Clipboard Pen SELF-REPORTED SIV V1 09/08/2018
42 Visit1:Questionnaire Tools SIV V1 09/08/2018 43 Visit 1: Participant Information 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. SIV V1 09/08/2018 44 Visit 1: Medical Notes & Data 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 SIV V1 09/08/2018 45 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) SIV V1 09/08/2018 46 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 SIV V1 09/08/2018 47 Visit 2: Randomisation 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). SIV V1 09/08/2018
48 Visit 2:Telephone Call Unblinded RN Treatment Arm Group 1: Continue oral iron Instruction 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 SIV V1 09/08/2018 49 Visit 2:Medical Notes & Data o Date and time of visit o Treatment allocation / Print TRuST notification o GP letter Recruited o Name and Signature of RN completing the visit.
CRF Recruitment Tracker SIV V1 09/08/2018 50 Visit 3:IV Iron Administration 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 SIV V1 09/08/2018 51 V3:Medical Notes & Data oDate and time of visit o IV iron prescription filed as per local policy
oDetails of any notable events at the visit and any action taken. oName and Signature of RN completing the visit. NO CRF DATA NO RECRUITMENT TRACKER V3 treatment retrospective Iron Treatment Data / excel spreadsheet AEs retrospective @V4 SIV V1 09/08/2018 52 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 SIV V1 09/08/2018 53
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. SIV V1 09/08/2018
54 V4:Medical Notes & Data oDate and time of visit oDetails of any notable events at the visit and any action taken. oConfirmation that the visit was carried out as per protocol. oName and Signature of RN completing the visit. CRF Recruitment Tracker Quarantined Data Iron Treatment excel spreadsheet Oral Iron Use excel spreadsheet Participant experience questionnarie SIV V1
09/08/2018 55 SYSTEMS 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. SIV V1 09/08/2018 57
Monthly RN Meetings Research Nurse Meeting SIV V1 09/08/2018 58 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 SIV
V1 09/08/2018 59 SIV V1 09/08/2018 60 SIV
V1 09/08/2018 61 Recruitment Tracker Password Protected Training Site RAINDroP Recruitment Tracker User Guide Dummy Data Password Protected Live Account oHIC DATA LINKAGE SERVICE - NHS FIFE SIV V1
09/08/2018 62 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) SIV
V1 09/08/2018 63 OpenClinica Web-based Database Web-based training to follow RAINDroP OpenClinica User Guide Dummy data Training Certificate Password Protected Account SIV
V1 09/08/2018 64 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
SIV V1 09/08/2018 65 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 SIV
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