Hur du effektivt genomför dina studier med hjälp av elektroniska CRF
|
|
- Harry Burns
- 5 years ago
- Views:
Transcription
1 Hur du effektivt genomför dina studier med hjälp av elektroniska CRF Maria Öhlander, Director Clinical Operations, Karo Bio Sverre Bengtsson, VP Business Development, PCG
2 Current problems in clinical trials Recruitment and performance metrics* 70 % of clinical trials don t reach recruitment goal Up to 30 % of the sites do not recruit any patients Up to 95 % of all delays are caused by slow recruitment Only 8 % of all physicians participate in more than one trial 87 % of all physicians are not involved in clinical trials 38 % of investigators only conduct one trial More metrics**, between Protocol length increased with 18 pages Number of eligibility criteria rose 23 % Number of protocol procedures (lab/heart/imaging/questionnaires/ ) rose by 48 % (especially in oncology/pain) Median enterable fields in the CRFs rose by 103 % *Eglmeir, W, Head Clinical Operations at Grünenthal, presented at DIA Clinical Forum 2010 ** Joseph, D, Pfizer US, presented at DIA Clinical Forum 2010
3 Immediate and clean data Data Management Drug logistics Project Management Site Management Randomisation Metric Analysis Data input Study Management Informed decisions Adaption from Rosenberg, M, President & CEO Health Decisions, presented at DIA Clinical Forum 2010
4 Hur man effektivt genomför sin studie med hjälp av elektroniska CRF Seminarium Lyckad läkemedelsutveckling 9 Juni 2011 Maria Öhlander Director Clinical Operations
5 Background information 5 Phase II study Dose-finding study Patients: 1000 screened 200 randomized 15 clinics in Sweden and Finland To be fully outsourced 25 ug/d 50 ug/d 100 ug/day KB statin Statin trt 25 ug/d 50 ug/d 50 ug/day KB statin 25 ug/d 25 ug/d 25 ug/day KB statin Pl. Pl. Placebo + statin Enrolment Randomization Follow-up 14-Jun-11 Confidential Information
6 Timelines 2007 KBT004 June July Aug Sept Oct Nov Dec Site/feasibility etc Study drug CSP Authoring Feasibility Production Site identification Contracting Stab tests Packaging - release Labeling Distribution CTA CTA ECG set up IVRS set-up Central lab set-up DM set-up Agree on scope Agree on scope Agree on scope Contract Agree on scope Contract Contract System build and translations System build Ship to sites Ship to sites Validation Validation Go live Go live Inv Mtg FSI/FPD 6 IM FSI FPD
7 Problems! 7 No delivery by CRO despite repeatedly discussions September No ecrf available Project team at CRO not communicating October New team in place at CRO Still no ecrf Site complaints no binders, no information given at Site Initiation Visits Decision: Change CRO! 14-Jun-11 Confidential Information
8 Study organisation Karo Bio PM Viedoc utilized as ecrf 2 CROs for monitoring (PCG and Crown) I3 safety for pharmacovigilance ert as ECG vendor Karolinska as Central lab vendor Quintiles as bioanalytical vendor NMCT as recruitment agency SMF in-house KB PM PCG KS Quintiles ert I3 safety NMCT Crown Viedoc
9 What to be in control of 9 Start-up Study conduct Reporting Recruitment Patient retention Monitoring Site payments Safety Reconsiliation Extra visits Data cleaning Database lock Vendor management Report 14-Jun-11 Confidential Information
10 What happened? 10 ecrf up and running in 2 weeks Training of sites through web and telephone conferences Repeat of site initiation visits First Patient In according to plan! How is this possible? Recruitment agency (NMCT) in charge from beginning of site contracts and recruitment Flexibility and a sense of urgency from all vendors selected Experienced PM at KB 14-Jun-11 Confidential Information
11 Recruitment and retention 11 When is information accessible ecrf Site contract enter in ecrf within 48h of visit NMCT database Lab transfers every day Run report to see Screened Enrolled Randomized Completed Early terminations 14-Jun-11 Confidential Information
12 Site contracting and payments 12 Managed by NMCT and they go bancrupt! How to handle payments from now on? KB to manage Payments based on visits entered in Viedoc New contracts by KB with sites 14-Jun-11 Confidential Information
13 Monitoring 13 Very quick recruitment 1000 pts screened in 4 weeks 200 randomized 4 weeks later A couple of very high recruiting sites Monitoring reports available in Viedoc Crown PCG Challenge Monitoring in time First visit after 2 patients entered at a site Some sites in need of more support Timely entry of reports Completed x days after a visit Managment review After that entered in Viedoc 14-Jun-11 Confidential Information
14 During study conduct Swedish hospital strike includes hospital labs! KS closed during some periods Lab samples analysed at Danderyd Any problem? Slightly different LDL cholesterol normal range (x.xx instead of x.x mmol/l) = site problem! From KS: 3.1 then >3 = inclusion From Danderyd: 3.01 then >3 = inlcusion = data problem! 3.01 = 3.0 if one decimal >3 = not correctly included!
15 Safety 15 Viedoc gave possibility to remote access to individual CRF data by Medical Monitor Vitals AEs Lab ECG DSMB same access to individual data Reports available to run including Lab listings per patient or per analysis Premature discontinuations AE listings ECG data from ert not daily Only available through ert web portal 14-Jun-11 Confidential Information
16 Collaboration partners NMCT Screening numbers and dates from NMCT into Viedoc KS Lab Daily transfers of lab data ECG - ert Regular transfers to Viedoc Direct access ert web I3 safety Reconsiliation SAE/AE Quintiles Bioanalytical data transfer at end of study PCG/Crown Monitoring reports NMCT ert Crown Quintiles Viedoc KS I3 safety
17 Lessons learnt Everything can happen be prepared What to think of: Be clear on which SOPs which processes to use Define roles and responsibilities clearly between parties Fast recruitment requires resources! Make sure the different systems are compatible and able to talk Karo Bio learnings: Keep Project Management in-house Recruit senior personnel to oversee study conduct Keep study master file in-house
18 Eprotirome, when added to statin, reduces key markers of CV risk at safe and tolerable doses 18 LDL-C, Non-HDL-C & ApoB 25% TG * -30% to -40% Lp(a)* -30% to -40% Eprotirome could be an attractive add-on to current lipid lowering therapy *Denotes subjects with pre-treatment levels above treatment goals 6/14/2011 Confidential Information
Clinical Trial Readiness Checklist October 2014
The clinical trial readiness checklist is a tool which can help new and experienced researchers prepare for upcoming clinical studies. It is designed to be a quick reference to ensure that you have the
More informationComprehensive Protocol Feasibility Questionnaire
Protocol Title: Potential Principal Investigator: Regulatory Coordinators: Department Chair: PROJECT FEASIBILITY PI and Study Team: YOUR RESPONSES TO THIS SURVEY CONSTITUTE A BEST ESTIMATE OF RESOURCES
More informationUnofficial copy not valid
Page 2 (9) CONTENTS 1. PURPOSE... 3 2. DEFINITIONS... 3 3. RESPONSIBILITY... 3 4. INVESTIGATOR SELECTION... 3 4.1 Identification of Investigator s... 3 4.2 Initial Contacts... 4 4.3 Distribution of Pre-Study
More informationExperiences of using routinely collected medical data in a cardiovascular safety trial?
Experiences of using routinely collected medical data in a cardiovascular safety trial? Ian Ford Robertson Centre for Biostatistics and Glasgow Clinical Trials Unit Issues in clinical trials Study feasibility
More informationNN SS 401 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR SITE SELECTION AND QUALIFICATION
NN SS 401 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR SITE SELECTION AND QUALIFICATION SOP: NN SS 401 Version No.: 2.0 Effective Date: 21Oct2016 SITE SELECTION AND QUALIFICATION Supercedes Document:
More informationPresented by NC TraCS Institute UNC Office of Clinical Trials UNC Network for Research Professionals
ORIENTATION FOR NEW CLINICAL RESEARCH COORDINATORS Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network for Research Professionals Overall Agenda for Orientation Module 1: Introduction
More informationTargeted technology and data management solutions for observational studies
Targeted technology and data management solutions for observational studies August 18th 2016 Zia Haque Arshad Mohammed Copyright 2016 Quintiles Your Presenters Zia Haque Senior Director of Data Management,
More informationPresented by NC TraCS Institute UNC Office of Clinical Trials UNC Network of Clinical Research Professionals
ORIENTATION FOR NEW CLINICAL RESEARCH COORDINATORS Presented by NC TraCS Institute UNC Office of Clinical Trials UNC Network of Clinical Research Professionals Overall Agenda for Orientation Module 1:
More informationConducting Monitoring Visits for Investigator-Initiated Trials (IITs)
Conducting Monitoring Visits for Investigator-Initiated Trials (IITs) Clinical Research Coordinator Society (CRCS) Forum 25 July 2014 Xia Yu Clinical Research Associate Singapore Clinical Research Institute
More information36 th Annual Meeting Preconference Workshop P4 Handout
36 th Annual Meeting Preconference Workshop P4 Handout Clinical Trial Management in Multicenter Trials: Collaborating for Success Meet Our Team Dixie Ecklund, RN, MSN, MBA Associate Director, University
More information4.2. Clinical Trial Monitor (or Monitor): The person responsible for monitoring the data on behalf of the sponsor or contract research organization.
SOP #: MON-101 Page: 1 of 6 1. POLICY STATEMENT: The DF/HCC understands that external sponsors are required to monitor the progress of clinical investigations and ensure appropriate research data collection
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Routine Project Audit SOP Number: 6 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August
More informationGood Clinical Practice: A Ground Level View
Good Clinical Practice: A Ground Level View Jeanna Julo, BA, BA, CCRP Assistant Director, Clinical Data Management & Quality Controls, Auditing & Training Clinical Research Administration Research Institute,
More informationPLATELET-ORIENTED INHIBITION ISCHEMIC STROKE (POINT) MONITORING PLAN IN NEW TIA AND MINOR. Version 2.0 Updated 11 May 2017
PLATELET-ORIENTED INHIBITION IN NEW TIA AND MINOR ISCHEMIC STROKE (POINT) MONITORING PLAN Version 2.0 Updated 11 May 2017 Monitoring Plan Table of Contents 1.0 Introduction... 4 2.0 Purpose... 4 3.0 Review
More informationBIMO SITE AUDIT CHECKLIST
Item AUTHORITY AND ADMINISTRATION FOR STUDIES INVOLVING HUMAN DRUGS, BIOLOGICS AND DEVICES 1. Compare the Investigator Agreement with the information provided by the assigning Center. Auditor will check
More informationResearch & Development. Case Report Form SOP. J H Pacynko and J Illingworth. Research, pharmacy and R&D staff
Department Title of SOP Research & Development Case Report Form SOP SOP reference no: R&D GCP SOP 03 Authors: Current version number and date: J H Pacynko and J Illingworth Version 2, 01.02.18 Next review
More informationEMSCO. The European MDS studies coordination office. Supporting Clinical Research, Education and Consulting in the field of MDS across Europe
EMSCO The European MDS studies coordination office Supporting Clinical Research, Education and Consulting in the field of MDS across Europe FISM Torino, 1. Apr. 2014 MDS Clinical Trials in Europe 2014
More informationLearning from Patient Deaths: Update on Implementation and Reporting of Data: 5 th January 2018
Learning from Patient Deaths: Update on Implementation and Reporting of Data: 5 th January 218 Purpose The purpose of this paper is to update the Trust Board on progress with implementing the mandatory
More informationThe GCP Perspective on Study Monitoring
The GCP Perspective on Study Monitoring Heidi Judge, CCRP Sr. Clinical Trials Project Manager Clinical Trials Network and Institute Massachusetts General Hospital 1 Overview Monitoring Basics Who, What,
More informationConducting Academic Trials Under EU Law The EBMT Experience. Zoë Doran Director, Clinical Trials Operations EBMT
Conducting Academic Trials Under EU Law The EBMT Experience Zoë Doran Director, Clinical Trials Operations EBMT Sponsorship Major Challenges The Approval Process Monitoring/Quality Assurance Support Infrastructure
More informationRequest for Proposal
Request for Proposal Electronic Data capture and Data Management activities to support the conduction of a phase 2 trial in Chagas Disease Dated: 29 June 2015 Page 1 TABLE OF CONTENTS 1. PURPOSE... 3 2.
More informationACCREDITATION OF PHASE I UNITS AND PROTECTION OF THE SUBJECTS PARTICIPATING IN CLINICAL TRIALS IN FRANCE
ACCREDITATION OF PHASE I UNITS AND PROTECTION OF THE SUBJECTS PARTICIPATING IN CLINICAL TRIALS IN FRANCE Alain Patat, M.D. VP Medical, Chief Medical & Officer & Regulatory Affairs BIOTRIAL Rennes & Paris,
More informationMedication Adherence Texting Pilot Program
Medication Adherence Texting Pilot Program 1 1 Introductions CareMessage is a San Francisco based nonprofit that empowers healthcare organizations to improve health outcomes and reduce cost of care. 2
More informationGuideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol
1 2 31 January 2017 EMA/430909/2016 3 4 5 Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or Draft Adopted by GCP Inspectors Working Group (GCP IWG) 30 January 2017 Adopted
More informationSOP16: Standard Operating Procedure for Establishing Sites and Centres - Site Setup
SOP16: Standard Operating Procedure for Establishing Sites and Centres - Site Setup Authorship Team: Leanne Quinn for Joint SOP Group on Trial Processes (viz Ian Russell, Anne Seagrove, Jemma Hughes, Yvette
More informationSite-Less CRO Model and esource: Framework for Action
Site-Less CRO Model and esource: Framework for Action Joe Martinez, RPh, PDE, PPC Princeton, NJ In-home and site-less clinical trials: changing the landscape How to test drugs, devices and procedures better
More informationProtocol Feasibility and Operationalization Framework. Beth Harper, BS, MBA. President, Clinical Performance Partners, Inc.
Protocol Feasibility and Beth Harper, BS, MBA President, Clinical Performance Partners, Inc. Overview This will be a highly interactive session We will introduce you to new ways of thinking about the study
More informationGeneral Administration GA STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility
General Administration GA 102.01 STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility Approval: Nancy Paris, MS, FACHE President and CEO (17 July 2014) (Signature and
More informationWIRBinar. How to Survive an FDA Inspection. Upcoming Trainings: Contact Us: (360)
WIRBinar How to Survive an FDA Inspection 10-26-2011 Brought to you by WIRB Education and Consulting Services. Improve your ability to maintain compliance and protect human subjects with guidance from
More informationMonitoring Clinical Trials
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
More informationmanaging or activities.
STANDARD OPERATING PROCEDURE Clinical Research Monitoring TITLE: Site Initiation Visit TITLE: Site Initiation Visit 1. PURPOSE SOP Number: Version: 1.0 MICHR CRM MON 002 Effective Date: 19Dec2013 1.1 This
More informationdiabetes care and quality improvement in our practice
The Multidisciplinary Team: The key to successful planned diabetes care and quality improvement in our practice Robb Malone, PharmD UNC General Internal Medicine January 20, 2009 Objectives Review the
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Sponsorship SOP-RES-001 Version Number 3 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s) Reviewer(s) Teresa
More informationEMA Inspection Site perspective
EMA Inspection Site perspective Hermien Gous Wits RHI Shandukani Research Centre 27.09.2016 Cape Town Why were we inspected times? Pharmaceutical company applied for registration of the study drug in a
More informationKeele Clinical Trials Unit
Keele Clinical Trials Unit Standard Operating Procedure (SOP) Summary Box Title Safety Reporting and Pharmacovigilance SOP Index Number SOP 20 Version 4.0 Approval Date 31-Jan-2017 Effective Date 14-Feb-2017
More informationTrial Management: Trial Master Files and Investigator Site Files
Title: Outcome Statement: Written By: Trial Management: Trial Master Files and Investigator Site Files Staff working on research studies in NSFT will be informed about the requirements of setting up and
More informationInvestigator-Initiated Studies: When you re the Sponsor. Cheri Robert & Tammy Mah-Fraser
Investigator-Initiated Studies: When you re the Sponsor Cheri Robert & Tammy Mah-Fraser ACRC Clinical Research Conference Edmonton, AB October 15, 2014 Session Objectives Define roles of the investigator,
More informationSOP MONITORING & OVERSIGHT OF RESEARCH ACTIVITY. Contact Jess Bisset, Research Operations Manager x20227
SOP MONITORING & OVERSIGHT OF RESEARCH ACTIVITY SETTING FOR STAFF QUERIES Trust wide All staff involved in research Contact Jess Bisset, Research Operations Manager x20227 Guidance 1. Introduction In accordance
More informationACTIONS/PSOP/001 Version 1.0 Page 2 of 6
1. The purpose of the Pharmacy Site File To enable the designated trust pharmacy to fulfil its role and exercise appropriate control over all aspects of study medication handling, an accurately maintained
More informationSite Closedown Checklist for UoL Sponsored CTIMP Studies
Site Closedown Checklist for UoL Sponsored CTIMP Studies Site Information Site: Study Title: UoL study number: Centre name: Investigator: Date of Visit: Date of Report Date Responses due by: List of site
More informationCLIC Clinical Investigator (And Site Staff) Certification
CLIC Clinical Investigator (And Site Staff) Certification CLIC Level 1: 23-24 March 2015 CLIC Level 2: 25-27 March 2015 Cape Town (Venue to be confirmed) C PD points L e v e l 1 : 1 4 G e n e r a l, 2
More informationChange Management at Orbost Regional Health
Change Management at Orbost Regional Health Our change management journey 1 Medication Change System Meds at Beds 2 The slightly exaggerated before process 3 Project Goals The purpose of the Meds at Beds
More informationFDA Inspection Readiness
FDA Inspection Readiness Richard Angelo, Ph.D. Director, Managing Consultant October 17, 2014 Agenda Reasons for Inspections Preparing for Inspections Inspection Day Inspection Outcomes 2013 Inspection
More informationAN OVERVIEW OF CLINICAL STUDY TASKS AND ACTIVITIES
1 AN OVERVIEW OF CLINICAL STUDY TASKS AND ACTIVITIES Key Clinical Study Tasks and Activities 2 Discussion of Key Tasks and Activities 3 Development of the Clinical Protocol and Study Materials 3 Qualification
More informationfor Critical Result Notification
Development of a Push Alert System for Critical Result Notification Challenges, Successes, and Lessons Learned Dr. Michael Feldman Assistant Director, Clinical Informatics Medical Director, Sunnybrook
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Risk Assessment SOP-RES-002 Version Number 2 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s) Reviewer(s)
More informationStandard Operating Procedure INVESTIGATOR OVERSIGHT OF RESEARCH. Chief and Principal Investigators of research sponsored and/or hosted by UHBristol
Standard Operating Procedure INVESTIGATOR OVERSIGHT OF RESEARCH SETTING FOR STAFF ISSUE Trustwide Chief and Principal Investigators of research sponsored and/or hosted by UHBristol Oversight of research
More informationDocument Title: Investigator Site File. Document Number: 019
Document Title: Investigator Site File Document Number: 019 Version: 1.1 Ratified by: R&D Committee Date ratified: 03/10/2017 Name of originator/author: Directorate: Department: Name of responsible individual:
More informationOntario Shores Journey to EMRAM Stage 7. October 21, 2015
Ontario Shores Journey to EMRAM Stage 7 October 21, 2015 ICE BREAKER Agenda System overview & pervasiveness of use Review Clinical Practice Guideline implementation Discuss Patient Portal implementation
More informationVersion Number: 004 Controlled Document Sponsor: Controlled Document Lead:
Chief Investigators and Principal Investigators in Research Policy CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Policy Governance To set out the responsibilities of
More informationEssential Documents It s Not Just a Binder!
Essential Documents It s Not Just a Binder! Kelly Unsworth, MS, CCRC, CIP Director of Research Education & Training Office for Human Subject Protection SCORE June 5, 2014 But What percentage of 2014 (to
More informationGCP INSPECTION CHECKLIST
(This list is not all inclusive; item may be added &/or deleted as per the Study/Site/Sponsor/Lab) I. General. Name and address of the clinical trial site Tel. No. & e- mail:. Date of Inspection. Inspection
More informationVascular Surgery Academic Coordinating Center (VSACC) & Peripheral Vascular Core Lab (PVCL)
Vascular Surgery Academic Coordinating Center (VSACC) & Peripheral Vascular Core Lab (PVCL) What are the VSACC and the PVCL? The Vascular Surgery Academic Coordinating Center (VSACC) is an academic research
More informationThis Agreement dated DD/MM/YYYY (the Effective Date ) is between
Clinical Trial Delegation of Sponsorship Responsibilities to Chief This Agreement dated DD/MM/YYYY (the Effective Date ) is between Nottingham University Hospitals NHS Trust, Derby Road, Nottingham, NG7
More informationMeaningful Use: A Practical Approach. CSO HIMSS Spring Conference 2013
CSOHIMSS 2013 Slide 0 May 17 th, 2013 Meaningful Use: A Practical Approach Jay Brown Sr. VP & CIO, UC Health Rick Haucke Manager, IS&T, PMO, UC Health Ajay Sharma FHIMSS, Sr. Manager, Sogeti USA, LLC CSO
More information20, avenue Appia CH-1211 Geneva 27 Switzerland Tel central Fax central
SOP 408.4 Annex C 20, avenue Appia CH-1211 Geneva 27 Switzerland Tel central +41 22 791 2111 Fax central +41 22 791 3111 www.who.int WHO PUBLIC INSPECTION REPORT (WHOPIR) Contract Research Organization
More informationStudy Management SM STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting
Study Management SM 306.00 STANDARD OPERATING PROCEDURE FOR Adverse Event Reporting Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature and Date) Approval: Frederick M. Schnell, MD,
More informationSTUDY INFORMATION POST-IRB APPROVAL FDA DEVICE (IDE) SPONSOR AND INVESTIGATOR RESPONSIBILITY (21 CFR 812)
POST-IRB APPROVAL FDA DEVICE (IDE) SPONSOR AND INVESTIGATOR RESPONSIBILITY (21 CFR 812) Purpose: Investigators who initiate and submit an IDE application to the FDA assume the responsibilities of both
More informationImplementing Changes in Pharmacovigilance Regulations. Presented by Dr Ennis H Lee, Senior Partner, TranScrip 14 June 2016
s Presented by Dr Ennis H Lee, Senior Partner, TranScrip 14 June 2016 Monitor for changes in regulations Regulatory Authority websites Pharmaceutical industry bodies Pharmaceutical press Use global subsidiaries
More informationPrepared by the American College of Radiology Imaging Network Protocol Development and Regulatory Compliance Department
AUDIT MANUAL Prepared by the American College of Radiology Imaging Network Protocol Development and Regulatory Compliance Department Original: October 2001 Revised: June 2010 American College of Radiology
More informationStudy Start-Up SS STANDARD OPERATING PROCEDURE FOR PRE-STUDY SITE VISIT (PSSV)
Replaces previous version 203.01: 01 July 2014 Study Start-Up SS 203.01 STANDARD OPERATING PROCEDURE FOR PRE-STUDY SITE VISIT (PSSV) Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature
More informationDocument Title: Site Selection and Initiation for RFL Sponsored Studies Document Number: 026
Document Title: Site Selection and Initiation for RFL Sponsored Studies Document Number: 026 Version: 1.1 Ratified by: Committee Date ratified: 03/10/2017 Name of originator/author: Directorate: Department:
More informationClinical Research Professionals
Training & Resources for Clinical Research Professionals Course & Publications Catalog January July 2016 In-Person and Web-Based Training Courses, Customized Training, elearning and Publications for Clinical
More informationClinical Research Service Provider Information Form
Clinical Research Service Provider Information Form General information Name of Organisation Vitalograph Ireland Ltd Contact information Head of Organisation Main contact Name: Frank Keane Address: Gort
More informationClinical Trials Where World Class Care Begins
Office of Clinical Trials Clinical Trials Where World Class Care Begins We seek to attract novel, innovative and transformational research and devices to our medical center and its stakeholders, and serve
More informationCPRD Clinical Practice Research Datalink
CPRD Clinical Practice Research Datalink john.parkinson@cprd.com NCIN June 2012 Simon Davies CEO of Teenage Cancer Trust spoke to us recently about changing the current clinical trial system to auto-enrol
More informationCOLLABORATIVE PRACTICE SUCCESSES IN PRIMARY CARE
COLLABORATIVE PRACTICE SUCCESSES IN PRIMARY CARE KPhA Annual Meeting September 7, 2014 Tiffany R. Shin, PharmD, BCACP Lyndsey N. Hogg, PharmD, BCACP Objectives Describe basic concepts of collaborative
More informationClinical Trials at PMH
Clinical Trials at PMH What You Need To Know UHN Patient Education Improving Health Through Education A Guide for Patients, Their Families and Friends in the PMH Cancer Program This information is to be
More informationStandardising Acute and Specialised Care Theme 3 Governance and Approach to Hospital Based Services Strategy Overview 28 th July 2017
Standardising Acute and Specialised Care Theme 3 Governance and Approach to Hospital Based Services Strategy Overview 28 th July 2017 Background Theme 3 builds upon previous key strategic commissioning
More informationTHE BRIDGE MODEL. Walter Rosenberg, MSW, LCSW Manager of Transitional Care Rush University Medical Center Health and Aging
THE BRIDGE MODEL Walter Rosenberg, MSW, LCSW Manager of Transitional Care Rush University Medical Center Health and Aging "If patient engagement were a drug, it would be the blockbuster drug of the century,
More informationGood Documentation Practices. Human Subject Research. for
Good Documentation Practices for Human Subject Research Bridget M. Psicihulis, RHIA, CCRC Quality Improvement Unit Coordinator Human Research Protection Program Wheaton Franciscan Healthcare (last updated
More informationFDA Medical Device Regulations vs. ISO 14155
Vol. 11, No. 9, September 2015 Happy Trials to You FDA Medical Device Regulations vs. ISO 14155 By Shawn Kennedy Medical device clinical trials must comply with 21 CFR Parts 11 (Electronic Records), 50
More informationSARASOTA MEMORIAL HOSPITAL CANCER RESEARCH PROGRAM POLICY
PS1006 SARASOTA MEMORIAL HOSPITAL CANCER RESEARCH PROGRAM POLICY TITLE: Satellite Site Management Plan Job Title of Reviewer: POLICY #: EFFECTIVE DATE: REVISED DATE: POLICY TYPE: Elizabeth Carr, R.N.,
More informationRegulatory Binder Checklist for FDA-Regulated Sponsor/Sponsor-Investigator Studies
Regulatory Binder Checklist for FDA-Regulated Sponsor/Sponsor-Investigator Studies DIRECTIONS: 1. The purpose of a regulatory binder is to assure that all essential elements are maintained in an organized
More informationPlease place your phone line on mute.
We will begin the MaRISS Coordinator Call shortly Please place your phone line on mute. 8/26/2016 2 Overview Missing data Correct dates on Baseline NIHSS Form 24 hour window for consent CRF Forms What
More informationCVD Prevention Takes a Team. Ed Havranek, MD Denver Health University of Colorado
CVD Prevention Takes a Team Ed Havranek, MD Denver Health University of Colorado CVD Prevention Potential Impact Modality # RCTs Outcome RR Aspirin 1 10 CV events 0.94 (0.88 0.99) BP control 2 68 All-cause
More informationAmbulatory Patient Safety
We Harm Patients Too: Ambulatory Patient Safety James Park, MD Associate Medical Director Primary & Urgent Care Jeri Craine, RN, MN Health Promotions Program Manager UW Medicine Valley Medical Center Clinic
More informationCOMPETENCY FRAMEWORK
COMPETENCY FRAMEWORK Theresa Ledger Lead Nurse Research and Development Clinical Research Facility Sheffield C:\Documents and Settings\Robertus\My Documents\Mariann\CRF\CRF Portfolio and Competency Template_DRAFT
More informationNHS Research Scotland Permissions Coordinating Centre (NRS Permissions CC)
permissions NHS RESEARCH SCOTLAND nrs c c NHS Research Scotland Permissions Coordinating Centre (NRS Permissions CC) Coordinating faster permissions for Scotland A guide to who we are and what we do Foreword
More informationUNC Lineberger Comprehensive Cancer Center. Data and Safety Monitoring Plan
UNC Lineberger Comprehensive Cancer Center Data and Safety Monitoring Plan Norman E. Sharpless, MD, Director P30CA-16086 Approved: September 29, 2014 Table of Contents Monitoring Progress of Trials and
More informationKentucky Sepsis Summit. August 2016
1 Kentucky Sepsis Summit August 2016 St. Elizabeth Healthcare About Us: - 7 facilities & over 1200 licensed beds - Serving the NKY/Cincinnati Region in: - Orthopedic Care - Heart and Vascular Institute
More informationIN ACCORDANCE WITH THIS INTERNATIONAL DEVICE STANDARD
COMPLIANCE WITH ISO 14155:2011 GUIDANCE FOR ENSURING YOUR CLINICAL STUDY IS BEING DESIGNED, EXECUTED, AND MONITORED IN ACCORDANCE WITH THIS INTERNATIONAL DEVICE STANDARD Introduction: An increasing trend
More informationManaging Patients with Multiple Chronic Conditions
Managing Patients with Multiple Chronic Conditions Sponsored by AMGA and Merck & Co., Inc. 1 Group Pre-work Affinity Medical Group Heart, Lung & Vascular Center COURAGE Clinic 2 Medical Group Profile Affinity
More informationR. Fay, Research Governance & GCP Manager K. Mahiouz, Clinical Trials Facilitator E. Clough, R&D Governance Operations Manager
Standard Operating Procedures (SOP) for: BH/QMUL Sponsorship of CTIMPs, ATMPs and Clinical Trials of non- CE marked Medicinal Devices Process for Researchers SOP Number: 11a Version Number: V1.0 Effective
More informationRISK ASSESSMENT AND MONITORING - EXPERIENCE FROM PHILEMON
RSK ASSESSMENT AND MONTORNG - EXPERENCE FROM PHEMON AU UNVERSTET HEATH BRGTTE ORK SCHEMMER GCP-KOORDNATOR 22. OKTOBER 2015 Mantle Cell ymphoma Working Group: Designs and runs clinical trials NG-MC6 - PHEMON
More informationHandling Organisational Complaints
Council meeting 12 January 2012 Public business Handling Organisational Complaints Purpose To report to the Council on the handling of organisational complaints for the period 27 September 2010 to 30 September
More informationIntegrating Community and Primary Care: the eyes and ears of general practice
re Integrating Community and Primary Care: the eyes and ears of general practice Context and Evidence Increasing numbers of people over 65 with chronic conditions being managed in primary care. Acute exacerbations
More informationTranslating Evidence to Safer Care
Translating Evidence to Safer Care Patient Safety Research Introductory Course Session 7 Albert W Wu, MD, MPH Former Senior Adviser, WHO Professor of Health Policy & Management, Johns Hopkins Bloomberg
More informationIntroduction To Medpace & Clinical Research Overview
Introduction To Medpace & Clinical Research Overview Medpace Overview o o o o o We are a Contract Research Organization (CRO) Work closely with biotech, pharma, and device companies Full Service Model
More informationRoyal Children s Hospital- Melbourne Information Session
Royal Children s Hospital- Melbourne Information Session The Role of the Lead Site: a CRO Perspective Rebecca Nuhiu PPD Australia Pty Ltd, Associate Country Manager, SIA-ANZ THE ROLE OF THE CRO IN NMA
More informationCarers Strategy
Carers Strategy 2015 2017 UHSM Vision, Mission, Values and Strategic Intent Vision to become a top 10 NHS provider in the country Mission to improve the health and quality of life for all our patients
More informationOverview of a new study to assess the impact of hospice led interventions on acute use. Jonathan Ellis, Director of Policy & Advocacy
Overview of a new study to assess the impact of hospice led interventions on acute use Jonathan Ellis, Director of Policy & Advocacy The problem Almost 600,000 people die each year Half will die in a hospital
More informationUNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEM HOSPITAL DASHBOARD
UNIVERSITY OF ILLINOIS HOSPITAL & HEALTH SCIENCES SYSTEM HOSPITAL DASHBOARD January 19, 2017 UI Health Metrics FY17 Q1 Actual FY17 Q1 Target FY Q1 Actual Ist Quarter % change FY17 vs FY Discharges 4,836
More informationSOP-QA-28 V2. Approver: Prof Maggie Cruickshank, R&D Director Approver: Prof Steve Heys, Head of School
Title: Effective Date: 1-4-17 Review Date: 1-4-20 Author: Richard Cowie, QA Manager QA Approval: Richard Cowie, QA Manager Approver: Prof Maggie Cruickshank, R&D Director Approver: Prof Steve Heys, Head
More informationPresentation Outline
Chronic Disease Toolkits: Spreading Quality Outcomes Simply Gerald H. Angoff, MD, FACC, MBA Steve Sarette, BA Presentation Outline It Introduction ti Setting the scene Quality Improvement Project Details
More informationIntroduction to the United States Food and Drug Administration (FDA) and FDA Inspection Process VOICE
Introduction to the United States Food and Drug Administration (FDA) and FDA Inspection Process VOICE 2011 MTN Annual Meeting March 27, 2011 Lisa Noguchi, MSN Donna Germuga, DAIDS, OCSO, RN, BSN Objectives
More informationThe recruitment challenge
The recruitment challenge Five patient-centric steps to boost clinical trial recuitment Photography by Isy & Leigh Anderson Introduction Recruiting patients for clinical trials is notoriously difficult.
More informationWARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUESTED. Ref: 06-HFD
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 WARNING LETTER CERTIFIED MAIL RETURN RECEIPT REQUESTED Evangeline G. Gonzalez, M.D. Gonzalez
More informationImplementation of Student Pharmacist-Led Anticoagulation Counseling
Implementation of Student Pharmacist-Led Anticoagulation Counseling Jamie Sebaaly, PharmD Candidate Class of 2013 UNC Eshelman School of Pharmacy Co-Investigator: Jenna M. Huggins, PharmD, BCPS Clinical
More informationEuropean Patients Academy (EUPATI) Update
European Patients Academy (EUPATI) Update EMA meeting with patient/consumer organisations 11 Dec 2013 Maria Mavris EURORDIS // EUPATI WP4 Co-Lead For patient-centric medicines R&D and to contribute to
More information