SITE INITIATION VISIT Meet the Team CoSponsors University
- Slides: 69
SITE INITIATION VISIT
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 Mc. Laren-Neil Statistician Professor Amanda Lee Health Economist Professor Paul Mc. Namee Haematologist Dr Katherine Hands SIV V 1 09/08/2018 2
RAINDro. P Team Emails CI, Prof Phyo Myint phyo. myint@abdn. ac. uk RAINDro. P Trial Coordinator b. brikinns@abdn. ac. uk RAINDRo. P Trial Manager raindroptm@dundee. ac. uk Sponsor p 02 gh 3@adbn. ac. uk SIV V 1 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 V 1 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 V 1 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 V 1 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 healthrelated and general quality of life) and secondary outcomes for main trial SIV V 1 09/08/2018 7
Recruitment: IC/EC searches Inclusion ü ≥ 65 years ü Oral Iron Prescribing – minimum 8 weeks tx ü Haematology results: Before iron Hb ≥ 85 g/L ≤ 110 g/L ü Hb after 8 wks tx <20 g/L improvement or still below lower limit of normal (male 130 / female 120) ü Biochemistry results: Before iron ferritin <100 ug/L Excluded × × × × × Ongoing anaemia investigations Active GI cancers Active peptic ulcer Oral anticoagulants except antiplatelet agents (asprin, dipyridamole, clopidogrel) e. GFR <30 Symptomatic chronic heart failure Require human assistance to mobilise Severe congnative impairment Terminally ill Another clinical trial SIV V 1 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 V 1 09/08/2018 9
RAINDro. P Training & SOPs • Protocol • Operations Manual • User Guides – Recruitment Tracker, TRu. ST, Open. Clinica, Lab. Key • Sponsor agreed SOPs • Laminate Pack – WPGs for Physical Assessments • Approved Study Documents • Delegation Log • Study Specific Training Log & SOP Sign-off Sheet SIV V 1 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 / Sm. PC 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 V 1 09/08/2018 12
Participant Pathway Flowchart SIV V 1 09/08/2018 13
Centralised Invitation Letters & Pt Tracker ØPCN ØRN / Hospital Clinician ØPoster Advert contact / Hosptial Clinician Recruitment Tracker SIV V 1 09/08/2018 14
Protocol & Study Matrix SIV V 1 09/08/2018 15
RAINDro. P Visits: PI Activities ØVisit 1 Informed Consent: PI or RN / Delegated activity ØPre & Visit 2 Pre-Randomisation Lab results & Final Eligibility Assessment & Sign-off Post-Telephone Call - IV Iron Prescribing; V 3 appt date/time ØVisit 3 Arrange / provide medical oversight ØVisit 4 Lab results review and sign-off SIV V 1 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. ØCollect @ V 2 & after V 4 assessments (V 3 retrospective) ØRecording: AE Log & Medical Notes ØPI assess: severity, causality, expectedness and seriousness ØPI review and sign each AE ØFollow-up: till resolution or until V 4 + 30 days (whichever is first) SIV V 1 09/08/2018 17
PI: Serious AEs ØDefinition – Related and Unexpected and not exempt ØReport to CI (cc TM) within 24 hours ØEmail form ØExceptions are recorded on AE log SIV V 1 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 ØReporting: Deviations on Log; Breaches on Log and Report ØMonthly log to trial coordinator ØBreaches to CI and RAINDro. PTM; CI inform/report to Sponsor. SIV V 1 09/08/2018 19
PI: Completion / Withdrawals ØWithdrawals – clinical judgement ØCRF completion sign-off SIV V 1 09/08/2018 20
Monthly Logs & Essential Site Activities ØMonthly Email Logs: Ø Screening Ø Enrolment & Randomisation Ø Data Verification (Visual Verification) Ø Deviations Ø Delegation (if any team changes) ØRecruitment Tracker – live tool and event capture ØOpen. Clinica data entry – within 2 weeks of study visit ØLab Key Ø Completed CRF pages Ø Data queries / cleaning Ø Quarantined Data Uploads: Ø Oral Iron Use Ø Iron Treatment Data Ø Pt Experience Questionnaire ØISF filing – printed documents; correspondence. SIV V 1 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 V 1 09/08/2018 22
Monitoring Schedule Risk based / non-CTIMP ØSIV ØOn-site / Remote ØClose out visit ØInformed Consent Forms ØSAEs ØIndependent audit by Sponsor or REC SIV V 1 09/08/2018 23
Monitoring visit requirements ØEmail to arrange visit date – PI and RN ØAccess to Investigator Site File ØPatient notes / source data ØCompleted Informed consent forms ØOpen. Clinica and Excel spreadsheets: Oral Iron Use, Iron Treatment ØActions sent to site for completion within 4 -8 weeks SIV V 1 09/08/2018 24
RAINDro. P PI Meetings ØTrial Management Group – First Tuesday each month @ 3 pm SIV V 1 09/08/2018 25
PARTICIPANT PATHWAY
Participant Pathway Flowchart SIV V 1 09/08/2018 27
HIC: Search Validation SIV V 1 09/08/2018 28
HIC: Centralised Invitations SIV V 1 09/08/2018 29
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. Ø RAINDro. P Recruitment Tracker User Guide SIV V 1 09/08/2018 30
RN: Telephone Pre-screening RAINDro. P participation Confirm eligibility Mail / email PIS Taxi / travel costs Book V 1 or thank / decline Screening Log Recruitment Tracker SIV V 1 09/08/2018 31
Study Matrix SIV V 1 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 V 1 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 V 1 09/08/2018 34
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 SIV V 1 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 V 1 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 V 1 09/08/2018 37
Visit 1: Concomitant Medications ØIron treatment name, dose, unit and frequency are captured at Visit 1 ØAll other prescribed medications Concomitant Medication page of the CRF: ØGeneric name ØIngredients of combined medications should be listed separately ØAbbreviations should not be used ØOver-the-counter medications are not recorded. ØFrequency code: ØOD; BD; TID SIV V 1 09/08/2018 38
Visit 1: Medical History ØRelevant Medical History from medical notes / participant – tick Ø ‘Other’ include: currently active medical condition if con meds are taken or past medical condition that impacts ADL ØPlease NO abbreviations SIV V 1 09/08/2018 39
Visit 1: Blood Samples Local lab 10 ml venous blood: ØHb ØFerritin ØC-reactive protein, *creatinine, *e. GFR ØResults - numbers SIV V 1 09/08/2018 40
Visit 1: Physical Assessments ØRequirement: stopwatch, chair, 3 metre walking course, 30 metre flat walking area with 3 m interval markings, marker, measuring tape, emergency equipment / facilities ØShort Physical Performance Battery 3 Ø 6 minute Walk Test – min/secs SIV V 1 09/08/2018 41
Questionnaire Tools: up to 1 hour Participant refreshment Quiet space Table or Clipboard Pen SELF-REPORTED SIV V 1 09/08/2018 42
Visit 1: Questionnaire Tools SIV V 1 09/08/2018 43
Visit 1: Participant Information ØSchedule Visit 2 ØAdvise possible dates for Visit 3 ØSchedule Visit 4 ØProvide Study Participant Card ØParticipant Reported Anaemia Symptoms Questionnaires for completion at end of Month 1 and Month 2 ØProvide copy of PIS and signed Informed Consent Form. SIV V 1 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. ØCRF ØIron Treatment Data / Excel Spreadsheet SIV V 1 09/08/2018 45
Adverse Events AE definition: event requiring advice or treatment from a HCP Duration: Informed Consent – End Visit 4. ØCollect @ V 2 & after V 4 assessments (V 3 retrospective) ØRecording: AE Log & Medical Notes ØPI assess: severity, causality, expectedness and seriousness ØPI review and sign each AE ØFollow-up: till resolution or until V 4 + 30 days (whichever is first) SIV V 1 09/08/2018 46
Serious AEs ØDefinition – Related and Unexpected and not exempt ØReport to CI (cc TM) within 24 hours ØEmail form ØExceptions are recorded on AE log SIV V 1 09/08/2018 47
Visit 2: Randomisation PI final eligibility assessment & sign-off Unblinded RN TRu. ST: ØSite codes: ARI FIF NWC NUH ØHaemoglobin result after 8 weeks of oral iron ØFerritin prior to starting oral iron Ø 6 minute walk test distance Allocation: ØTreatment as usual ØStop oral iron treatment ØStop oral iron and give IV iron (as per local formulary). SIV V 1 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 Group 2: Stop oral iron 1. 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. Send recruited letter to GP informing Group 1 allocation Oral iron continuing for study duration Telephone participant and instruct to stop oral iron 1. Send recruited letter to GP informing Group 2 allocation Oral iron stopping for study duration 1. Telephone participant, instruct to stop oral iron. 2. Advise and confirm appointment to attend for 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 V 1 09/08/2018 49
Visit 2: Medical Notes & Data o Date and time of visit o Treatment allocation / Print TRu. ST notification o GP letter – Recruited o Name and Signature of RN completing the visit. ØCRF ØRecruitment Tracker SIV V 1 09/08/2018 50
Visit 3: IV Iron Administration Within 2 weeks of V 2 Approx 90 minutes Local Policy PI prescribe: dose, time & Hb Registered Nurse administer Unblinded RN attend Clinical Location & Emergency Facilities Record after V 4 assessments – Iron Treatment Log & Excel spreadsheet SIV V 1 09/08/2018 51
V 3: Medical Notes & Data o. Date and time of visit o IV iron prescription filed as per local policy o. Details of any notable events at the visit and any action taken. o. Name and Signature of RN completing the visit. ØNO CRF DATA ØNO RECRUITMENT TRACKER ØV 3 treatment retrospective Iron Treatment Data / excel spreadsheet ØAEs – retrospective @V 4 SIV V 1 09/08/2018 52
V 4: Assessments ØApprox 2 hours ØBlinded RN ØBlood samples: Hb & ferritin ØPhysical Assessments: SPPB. 6 minute walk ØQuestionnaire Tools (refreshment) ØAE / con meds after assessments ØIron specific dietary advice ØInform participant to contact GP ØTravel expenses ØOral iron pts – Unblinded RN call for Oral Iron Use Tool / Spreadsheet SIV V 1 09/08/2018 53
Visit 4: Concomitant Medications • Iron treatment name, dose, unit and frequency are captured following assessments: ØIron Treatment & Excel Spreadsheet. • Record all other prescribed medications on CRF Concomitant Medication page : ØGeneric name ØConcomitant medication taken after Visit 1 and before Visit 4 are not recorded, e. g. antibiotics. ØOver-the-counter medications are not recorded ØIngredients of combined medications should be listed separately ØAbbreviations should not be used. SIV V 1 09/08/2018 54
V 4: Medical Notes & Data o. Date and time of visit o. Details of any notable events at the visit and any action taken. o. Confirmation that the visit was carried out as per protocol. o. Name and Signature of RN completing the visit. ØCRF ØRecruitment Tracker ØQuarantined Data ØIron Treatment excel spreadsheet ØOral Iron Use excel spreadsheet ØParticipant experience questionnarie SIV V 1 09/08/2018 55
SYSTEMS
Monthly Logs & Essential Site Activities ØMonthly Email Logs: Ø Screening Ø Enrolment & Randomisation Ø Data Verification (Visual Verification) Ø Deviations Ø Delegation (if any team changes) ØRecruitment Tracker – live tool and event capture ØOpen. Clinica data entry – within 2 weeks of study visit ØLab Key Ø Completed CRF pages Ø Data queries / cleaning Ø Quarantined Data Uploads: Ø Oral Iron Use Ø Iron Treatment Data Ø Pt Experience Questionnaire ØISF filing – printed documents; correspondence. SIV V 1 09/08/2018 57
Monthly RN Meetings ØResearch Nurse Meeting SIV V 1 09/08/2018 58
Website Public information / Potential Participants Staff Portal ◦ ◦ ◦ ◦ Recruitment Tracker TRu. ST Open. Clinica Lab. Key Trial Documents – generic and site specific Recruitment / Accrual Numbers Trial Announcements Events Calendar SIV V 1 09/08/2018 59
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Recruitment Tracker • Password Protected Training Site • RAINDro. P Recruitment Tracker User Guide • Dummy Data • Password Protected Live Account o. HIC DATA LINKAGE SERVICE - NHS FIFE SIV V 1 09/08/2018 62
TRu. ST: Randomisation • Unblinded RN • RAINDRo. P TRu. ST User Guide • Password Protected Account Randomisation Notification ØUnblinded RN print and file in medical notes ØNo formal unblinding required Emergency Randomisation ØIf no web-access at site telephone TCTU 01382 383581 Treatment allocation notified by telephone & email (print and file when access resumes) SIV V 1 09/08/2018 63
Open. Clinica • Web-based Database • Web-based training to follow • RAINDro. P Open. Clinica User Guide • Dummy data • Training Certificate • Password Protected Account SIV V 1 09/08/2018 64
Quarantined Data Maintain statistician & health economist blinding Data held at site until post-database lock TCTU will request upload via Lab. Key ◦ 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 V 1 09/08/2018 65
Lab. Key Password Protected Account RAINDro. P 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 V 1 09/08/2018 66
Case Report Form: Review SIV V 1 09/08/2018 67
Investigator Site File: Review SIV V 1 09/08/2018 68
Next Steps RAINDro. P training GP invitations Recruitment Tracker Medical Notes Pre-screening / Clinician invitations FPFV SIV V 1 09/08/2018 69
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