The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial
|
|
- Collin Lawrence
- 8 years ago
- Views:
Transcription
1 The Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial Clinical Research Operations & Regulatory Support (CRORS) Ann Glasse, RN, BSN, MBA Director-CRORS
2 Objectives To understand: The definition and purpose of the Regulatory Binder/Trial Master File (TMF) The required essential documents Maintenance of the Regulatory Binder/Trial Master File 2
3 Definition International Conference On Harmonization- Good Clinical Practice (E-6) (ICH-GCP 8.1) Defines Essential Documents as: Documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. ICH-GCP E-6 website: 3
4 Purpose These documents serve to demonstrate: Compliance of the investigator, sponsor and monitor with the standards of GCP and with all applicable regulatory requirements. Management of a trial when documents are filed in timely manner. Documents are available for review by study monitors, auditors and regulatory authorities to demonstrate validity of study conduct and data integrity. **The regulatory binder/trial master file should be established at the beginning of the trial and maintained throughout. 4
5 IRB Essential Documents IRB initial submissions & approvals IRB submission form IRB approval letter IRB approved documents Study Protocol Version # and date Signed & dated IRB communications Amendments submissions & approvals Modification submission form Protocol Revisions Revision date and/or version number Signed & dated IRB approval letter Other IRB approved documents IRB communications 5
6 IRB Essential Documents Reportable New Information (RNI) [SAEs, Deviation/Violation, Exception, Unanticipated Problems, etc.] RNI submission form IRB approved documents, if applicable IRB acknowledgement letter IRB communications Continuing Report submissions & approvals IRB continuing review report AE logs and deviation logs IRB approval letter IRB approved documents IRB communications Final study report Final study report submission (all applicable logs/reports) IRB acknowledgment of study closure 6
7 IRB Essential Documents Informed Consent Forms (ICFs) UM-ICFs, JHS-ICFs, any translated versions and certificate of translation Initial approved version and all applicable revisions HIPAA Research Authorization Form B Translated versions Initial approved version and all applicable revisions Information provided to or seen by (potential) subjects Advertisement for subject recruitment, web postings Letters, telephone scripts Diaries, Assessments, Questionnaires Instructions for subjects (study-specific instructions not individual instructions such as appt. reminders, etc.) 7
8 IRB Essential Documents Investigator s Brochure To document that relevant & current scientific info about the investigational product has been provided to the investigator Maintain all revisions Deviation Reports Assessment of the cause of the deviation Ensure it does not happen again: training, change process, Corrective Action & Preventative Action (CAPA) Plans, etc. Ensure correct assignment of major/minor classification Serious Adverse Events submitted to the IRB and sponsor Initial submission, follow up submission, IRB acknowledgment letters IRB Committee Composition List (spanning duration of review of study) 8
9 FDA Essential Documents For drugs or biologics studies: Copy of Form FDA 1571 Cover sheet for all initial FDA submission and amendments to the IND Signed and dated by Sponsor-Investigator Start with serial number 0000 and then sequentially thereafter Copies of Form FDA 1572 Signed and dated by PI Updated as needed: PI & Sub-Investigator names, IRB, clinical sites, clinical labs Keep all revisions For device studies: Copies of Investigator s Agreement (every 6 months) Signed and dated by PI Updated as needed (as above) Keep all revisions 9
10 FDA Documents For drugs, biologics and device studies: Copies of Financial Disclosures provided to Sponsor Disclosures for PI and all Sub-Investigators Form FDA 3454 (Certification): To attest to the absence of financial interests and arrangements Form FDA 3455 (Disclosure): Disclosure of financial arrangements between investigator and sponsor, or investigator interest in tested product, etc. 10
11 JHS and UMH Essential Documents JHS Clinical Research Review Committee (CRRC) at the JHS Clinical Trial Office (CTO) approval documents: Studies testing a drug, device or biologic at JHS Procedures, lab tests (including blood draws) at JHS Review of JHS patient records Recruitment or referral of JHS patients Use of JHS research pharmacy or other JHS facilities University of Miami Hospital (UMH) Quality Department : Same as above but at UMH 11
12 Additional Essential Documents Qualification documents for PI and all key research personnel CITI Certifications (UM requirement is every 2 years) Medical licenses for physicians and nurses Current CVs for all study team members Certifications such as ACRP, SOCRA, Phlebotomy, etc. Study-specific training: Documentation of protocol review with study team, in-service Research-related training documentation Spanning duration of study or assignment to study Maybe maintained in a separate credential binder(s) with a documentation of where to locate these. 12
13 More Essential Documents Laboratory Credentials For all labs listed in protocol and on the 1572 (if applicable) Current and updated laboratory certifications (e.g. CLIA or CAP) Current and updated lab Director s CV & medical license(s) Normal values/ranges for all tests included in protocol Delegation of Authority Typically a table listing all study personnel and their assigned responsibilities as delegated by the PI: Required by ICH-GCP, strongly recommended by FDA (mentioned in guidance and audits) Lists all key personnel and Sub-Investigators Duties & responsibilities assigned by PI Informed Consent, physical exams, data entry, etc. Start date & end date for all personnel Include creation date Signed by PI: at start date and at end date for all study personnel Note: This is an active document that should be continuously updated to reflect personnel being added and removed from study. 13
14 More Essential Documents Subject screening & enrollment log: Required by ICH-GCP Randomization list Monitoring Decoding procedure for blinded trials» In case of emergency, identity of blinded investigational product can be revealed without breaking blind of remaining subjects Trial initiation monitoring report Monitor follow up letters - documents monitor site visits, deviations, action items Monitoring visit log(s) Corrective Actions Preventive Actions (CAPA), if any Correspondence ( s, etc.) with monitors 14
15 More Essential Documents DSMB plan (if applicable): including committee members DSMB reports: Determination of subject safety and continuation of trial Notification of SAEs From investigator to sponsor Include Documentation of submission within required timeframe From sponsor to investigator (External SAEs/IND Safety Reports) Findings that could adversely affect subject safety Findings that could impact the conduct of the trial or impact the IRB s favorable opinion to continue the trial See 21 CFR and for safety reporting 15
16 More Essential Documents Adverse Event Log (s) (recommended) Running log of SAEs, AEs and unanticipated problems Helps monitor the safety of subjects Helps to compile Continuing Reports Sponsor correspondences and/or communications: amendments, requests, queries Correspondences: with IRB, medical monitor, relevant s Research team meeting minutes (including agendas and sign in sheets) Case Report Forms (blank template) 16
17 More Essential Documents Investigational Product IP includes drugs, devices and biologics Instructions for handling investigational product (if not included in protocol or Investigator s Brochure) Includes instructions for storage, packaging, dispensing and disposition If the study team dispenses IP: Suggest to create a SOP on dispensing IP Must meet pharmacy requirements; includes: Procedures on handling, storage, dispensing and disposition of IP Record keeping of accountability logs Storage requirements: locked, limited access Temperature controlled environment Destruction of IP» Calibrated thermometers» Temp logs or charts» Emergency back-up power 17
18 More Essential Documents Investigational Product Shipping Records Shipment dates Lot/Batch numbers Method of shipment Shipping conditions Investigational Product Accountability Logs Amount dispensed Date dispensed Lot/batch number Name of personnel dispensing Name of recipient & date received Amount returned & date returned Disposition Investigational Product Temperature logs 18
19 Agreements/Contracts To document financial agreements: Grant proposal & award letter May list conditions for clinical trial Investigator/institution agreement with trial sponsor Recommendation to maintain in a separate binder 19
20 Maintaining the Regulatory Binder Organize binder with: Labeled cover: study # and title, PI name, volume #, etc. Sections: with labeled tabs Chronological order within sections Maintain a schedule for: Continuing Reports CITI re-certification due dates Update on a regular basis: Delegation of Authority Log Qualification documentation: CITI, medical licenses, CVs Subject Enrollment/Disenrollment Log *Keep all documents throughout the life of the study 20
21 Investigator held IND/IDE Studies: Sponsor-Investigator Responsibilities Investigators holding an IND/IDE have sponsor responsibilities in addition to investigator responsibilities Separate sponsor binder(s) containing IND/IDE submissions, annual reports, amendments, FDA correspondence, etc. 21
22 Recommended SOPs For research teams: Maintaining the Regulatory Binder Storage, handling and dispensing IP (if applicable) 22
23 Final Words Organize the regulatory/tmf binders: Chronological order Tell the story of your study such that an outside reviewer or new study team member can read it and understand what happened Maintain documentation of all approvals and re-approvals Update documents as needed: Form FDA1572, DOA log, training records, etc. The regulatory/tmf binders are continuously evolving throughout the study 23
24 Questions? 24
25 How to Contact us Office of Clinical Research Operations & Regulatory Support Telephone: (305) To report a problem or concern: 25
The Study Site Master File and Essential Documents
The Study Site Master File and Essential Documents Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 002 Version number: 1 Effective date: 01 June 2010
More informationComprehensive Study Documents List (Biomedical Studies)
Comprehensive Study Documents List (Biomedical Studies) Investigators conducting human subjects research must maintain study documents in adherence to federal and state regulations, USC policies, and good
More informationEssential Documents for the Conduct of a Clinical Trial. Debra Dykhuis Associate Director RSO
Essential Documents for the Conduct of a Clinical Trial Debra Dykhuis Associate Director RSO Introduction Rationale for choosing this topic AHC movement toward setting GCP (Good Clinical Practice) guidelines
More informationHow To Write A Binder Tab
Tool Summary Sheet Tool: Extramural Essential Documents Binder/File Tabs Purpose: To provide an organizational framework and guidance for filing paper versions of essential study documents (or referencing
More informationGood Documentation Practices
Good Documentation Practices Clinical Research Operations & Regulatory Support Ann Glasse, RN, BSN, MBA Director, Regulatory Support Author: Johanna Stamates, RN, MA, CCRC, CHRC Objectives Recognize the
More informationRegulatory Binder Instructions 25 April 2016
Regulatory Binder Instructions 25 April 2016 Instructions This Regulatory Binder is available to help study sites achieve and maintain regulatory compliance and adhere to high standards of practice in
More informationPre-Questions. Mastering Clinical Research July 29, 2015
Pre-Questions Mastering Clinical Research July 29, 2015 1. To be compliant with SOP 2.1 Obtaining Informed Consent for greater than minimal risk interventional clinical trial, which Licensed Professional
More informationQuality Monitoring Checklist
Quality Monitoring Checklist Instructions: For each task below, the Quality Monitor indicates in the appropriate column if the Monitor accomplished the task by using the following codes Yes No N/A = Monitor
More informationCONTROLLED DOCUMENT- DO NOT COPY STANDARD OPERATING PROCEDURE. STH Investigator
Research Department STANDARD OPERATING PROCEDURE STH Investigator Archiving of Essential Documentation Generated During Clinical Research SOP Number A127 Version Number V1.3 Effective Date Author Zoe Whiteley
More informationTRIAL MASTER FILE- SPONSORED
gsop-06-04 - Management of TMF for ENHT/ WHHT Sponsored CTIMPs Page 1 of 16 Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust TRIAL MASTER
More informationThe Monitoring Visit. Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis
The Monitoring Visit Denise Owensby, CCRP Sr. Clinical Research Coordinator Clinical & Translational Science Center University of California, Davis Disclosure The information herein is not intended to
More informationROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices
Clinical and Translational Science Institute / CTSI at the University of California, San Francisco Welcome to Online Training for Clinical Research Coordinators ROLE OF THE RESEARCH COORDINATOR Study Start-up
More informationCNE Disclosures. To change this title, go to Notes Master
CNE Disclosures Successful Completion: Participants must complete an evaluation form to receive a certificate of completion Contact Hours: 1 contact hour is available to those who meet the successful completion
More informationStudy Start-Up SS-204.01. STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV)
Study Start-Up SS-204.01 STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature and Date) Approval: Frederick M. Schnell,
More informationSharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com
SAMPLE CRA CV Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com Education: Masters of Science, Healthcare Administration, Capital City University,
More informationClinical Investigator Inspections and FDA-483 Observations
Clinical Investigator Inspections and FDA-483 Observations Nancy A. Bellamy, Investigator Bioresearch Specialist/ BIMO Coordinator FDA Detroit District Office October 2, 2013 Objectives Background on FDA
More informationEssential Documents for Clinical Trial Research. Centre for Health Evaluation and Outcome Sciences Manager, Clinical Research Development Office
Essential Documents for Clinical Trial Research Erin Cherban, MSc., CCRP Centre for Health Evaluation and Outcome Sciences Manager, Clinical Research Development Office Document Examples See the following
More informationRECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING
RECOMMENDATION ON THE CONTENT OF THE TRIAL MASTER FILE AND ARCHIVING July 2006 TABLE OF CONTENTS Page 1. Introduction 2 2. Scope 2 3. Documents to be archived 2 4. Quality of essential documents 10 5.
More informationROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS
ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS STANDARD OPERATING PROCEDURE NO SOP 09 DATE RATIFIED 4/7/13 NEXT REVIEW DATE 4/7/14 POLICY STATEMENT/KEY OBJECTIVES:
More informationHow to Run Clinical Trials in Private Practice
How to Run Clinical Trials in Private Practice Thomas M. Siler, MD Midwest Chest Consultants, PC Saint Charles, MO DISCLOSURE Dr. Siler has received research grants from GlaxoSmithKline, Forest, Boehringer
More informationSTANDARD OPERATING PROCEDURE FOR RESEARCH. Management of Essential Documents and Trial Folders
STANDARD OPERATING PROCEDURE FOR RESEARCH Management of Essential Documents and Trial Folders Author Linda Ward Author s Job Title QA Coordinator Division Department Version number 2 Ref SOP/CLN/001/2
More informationData Management & Case Report Form Development in Clinical Trials. Introduction to the Principles and Practice of Clinical Research.
Data Management & Case Report Form Development in Clinical Trials Introduction to the Principles and Practice of Clinical Research February 3, 2015 Marge Good, RN, MPH, OCN Nurse Consultant Division of
More informationDHHS/NIH/OD/OIR/OHSRP 1/2/2015
DHHS/NIH/OD/OIR/OHSRP 1/2/2015 The audience for this course is Principal Investigators (PIs), investigators and Research Coordinators (RCs) serving on the study team of human clinical studies and trials.
More informationMedical College of Georgia SOP NUMBER: 03 INVESTIGATIONAL DRUG HANDLING Version Number: 1.0, 1.1 Effective Date: 09/12/06, 08/02/10, 3/2/11
Effective Date: 09/12/06, 08/02/10, 3/2/11 Title: 1.0 OBJECTIVE: 1.1 This SOP describes the methods and policies for: Handling investigational drug Dispensing investigational drug 1.2. This procedure applies
More informationSubject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure
703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a
More informationTo Certify or Not to Certify
To Certify or Not to Certify Sandra Halvorson, BA, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus Sue Logan, BS, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus November
More informationTo Certify or Not to Certify Sandra Halvorson, BA, CCRP
To Certify or Not to Certify Sandra Halvorson, BA, CCRP Clinical Research Coordinator II CIBMTR Minneapolis Campus Sue Logan, BS, CCRP Clinical Research Coordinator II We have no financial relationships
More informationObjectives. Monitoring & Auditing of Clinical Trials. Overview. Pre-study Qualification Visit. Industry-sponsored Trials
Objectives Monitoring & Auditing of Clinical Trials Sponsored by Center for Cancer Research National Cancer Institute Guidelines suggest that following the good clinical research practice of monitoring/auditing
More information12.0 Investigator Responsibilities
v. 5.13.13 12.0 Investigator Responsibilities 12.1 Policy Investigators are ultimately responsible for the conduct of research. Research must be conducted according to the signed Investigator statement,
More informationNo. 706. Page 1 of 5. Issue Date 4/21/2014
Subject: ROUTINE MONITORING VISITS Standard Operating Procedure Prepared By: Beaumont Research Coordinating Center, Research Institute PURPOSE Prior Issue Date 8/15/2011 No. 706 Issue Date 4/21/2014 Page
More informationMonitoring & Auditing of Clinical Trials. Sponsored by Center for Cancer Research National Cancer Institute
Monitoring & Auditing of Clinical Trials Sponsored by Center for Cancer Research National Cancer Institute Objectives Guidelines suggest that following the good clinical research practice of monitoring/auditing
More informationElectronic Medical Records and Source Data for Research: What s the Difference?
Electronic Medical Records and Source Data for Research: What s the Difference? Tammy Anderson, CCRC, CCRA, CRCP Director, Clinical Trials Office Virginia Commonwealth University Research Coordinator 4
More informationIMP management at site. Dmitry Semenyuta
IMP management at site Dmitry Semenyuta TOP 5 FDA inspections finding 1999-2009 Center of Drug Evaluation and Research (CDER) Failure to follow the protocol Failure to keep adequate and accurate records
More informationRoles & Responsibilities of the Sponsor
Roles & Responsibilities of the Sponsor Developed by Center for Cancer Research, National Cancer Institute, NIH Endorsed by the CTN SIG Leadership Group Objectives Funding for clinical research comes from
More informationInformation Sheet Guidance for Sponsors, Clinical Investigators, and IRBs
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) U.S. Department of Health and Human Services Food and Drug
More informationHollie Goddard Sr. IRB Coordinator McKesson Specialty Health
Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health We are responsible for acquiring, analyzing, and protecting medical information vital to providing quality patient care HIM professionals ensure
More informationObjectives. The Paper Tells the Story
Notes to File: An Auditor s Perspective Lorrie D. Divers, CCRP, RQAP-GCP Executive Director, Global Quality Assurance & Compliance ACM Medical Laboratory / ACM Global Central Laboratory Clinical Translation
More informationOrientation Manual for Clinical Research Coordinators
Orientation Manual for Clinical Research Coordinators Maine Medical Center Research Institute Page 1 of 19 Version 1 (2009) MAINE MEDICAL CENTER RESEARCH INSTITUTE Statement of Mission, Vision, Goals and
More informationThe role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations
The role, duties and responsibilities of clinical trials personnel Monitoring: rules and recommendations Maria Luisa Paoloni OPBG Clinical & Research Services Monitoring and Responsible of monitoring:
More informationHuman Research Protection Program Good Clinical Practice Guidance for Investigators Investigator & Research Staff Responsibilities
This Guidance Document is to ensure that investigators and research personnel recognize their responsibilities associated with the conduct of human subject research by outlining their responsibilities,
More informationA Principal Investigator s Guide to Responsibilities, Qualifications, Records and Documentation of Human Research University of Kentucky
A Principal Investigator s Guide to Responsibilities, Qualifications, Records and Documentation of Human Research University of Kentucky I. Compliance with IRB and Applicable Federal Requirements A. Investigators
More informationData Management in Clinical Trials
Data Management in Clinical Trials Introduction to the Principles and Practice of Clinical Research February 19, 2013 Diane St. Germain, RN, MS Nurse Consultant Division of Cancer Prevention National Cancer
More informationInvestigational Drugs: Investigational Drugs and Biologics
: I. PURPOSE The purpose of this policy is to establish procedures for the proper control, storage, use and handling of investigational drugs and biologics to ensure that adequate safeguards are in place
More informationNew Investigator Collaborations and Interactions: Regulatory
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité New Investigator Collaborations and Interactions: Regulatory NCIC Clinical Trials Group New Investigator Clinical Trials
More informationRole of IRB/IEC in GCP. Benjamin Kuo, MD, Dr.PH, CIP.
Role of IRB/IEC in GCP Benjamin Kuo, MD, Dr.PH, CIP. Institutional Review Board (IRB) An independent body constituted of medical, scientific and non scientific members Responsible for ensuring protection
More informationSOP TD 01: Research Documentation and File Management
Gloucestershire Research and Development Consortium Standard Operating Procedure R&DSOP TD 01 Research Documentation and File Management SOP TD 01: Research Documentation and File Management IT IS THE
More informationEssential Documentation and the Creation and Maintenance of Trial Master Files
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 informationUniversity of Hawai i Human Studies Program. Guidelines for Developing a Clinical Research Protocol
University of Hawai i Human Studies Program Guidelines for Developing a Clinical Research Protocol Following are guidelines for writing a clinical research protocol for submission to the University of
More informationThis policy applies to all clinical research conducted at Beaumont Health System.
CLINICAL RESEARCH QUALITY AND PROCESS IMPROVEMENT PROGRAM 113 1 of 6 PURPOSE Prior The purpose of this policy is to provide an overview of the Clinical Research Quality and Process Improvement Program
More informationGOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE
ICH E6 GCP: Consolidated Guideline: Investigator 1/7 Institutional Review Board Services ICH HARMONIZED TRIPARTITE GUIDELINE E6: GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE 4. INVESTIGATOR 4.1 Investigator's
More informationVersion Date: 03/17/2008 Page 1 of 8
The Jackson Health System Clinical Trials Office requires a complete submission of all required documents for the study to be accepted and reviewed by the JHS Clinical Research Review Committee (CRRC):
More informationSite Activation: Keep Your Eyes on the Prize
Site Activation: Keep Your Eyes on the Prize Theresa Gamble, Ph.D. Senior Clinical Research Manager HPTN CORE, FHI October 2004 Slide 1 The Prize Site-Specific Protocol Activation Notice See Example Document
More informationArchiving of Research Documentation
Suspension, Termination & Completion Standard Operating Procedure VERSION / REVISION: 2.0 EFFECTIVE DATE: 28 05 12 REVIEW DATE: 28 05 14 AUTHOR(S): CONTROLLER: APPROVED BY: Clinical Trials Manager; Recruitment
More informationDocumentation of the Informed Consent Process. USC Office for the Protection of Research Subjects (OPRS)
Documentation of the Informed Consent Process USC Office for the Protection of Research Subjects (OPRS) Session Overview Highlights: Purpose of Informed Consent (IC) IC Process and Documentation Witness
More informationICH CRA Certification Guide March 2009
ICH CRA Certification Guide March 2009 ICH CRA CERTIFICATION GUIDE... 1 GENERAL INFORMATION... 2 BENEFITS OF CERTIFICATION... 2 INDUSTRY RECOGNITION... 2 ABOUT THE EXAM... 2 CRA DEFINITION... 2 REQUIREMENTS
More informationSTANDARD OPERATING PROCEDURES FOR GOOD CLINICAL PRACTICE
STANDARD OPERATING PROCEDURES FOR GOOD CLINICAL PRACTICE UNC OB/GYN (V.1) 9.1.2014 Page i TABLE OF CONTENTS INTRODUCTION. iii ABBREVIATIONS iv GLOSSARY v LISTING OF ATTACHMENTS.... xi I. 1.0 GENERAL ADMINISTRATION
More informationVersion history Version number Version date Effective date 01 dd-mon-yyyy dd-mon-yyyy 02 dd-mon-yyyy dd-mon-yyyy 03 (current) dd-mon-yyyy dd-mon-yyyy
Trial name: HOVON xxx yyy Sponsor: HOVON Version history Version number Version date Effective date 01 dd-mon-yyyy dd-mon-yyyy 02 dd-mon-yyyy dd-mon-yyyy 03 (current) dd-mon-yyyy dd-mon-yyyy QRMP authors
More informationCatherine Jahrsdorfer, RN, BSN Director of Clinical Services USF Health Office of Clinical Research
A Practical Guide on Applying USF HRPP P&Ps in the Clinical Setting Catherine Jahrsdorfer, RN, BSN Director of Clinical Services USF Health Office of Clinical Research Learning Objectives Recognize the
More informationGuide for Research Sites Seeking Accreditation
Guide for Research Sites Seeking Accreditation (For research sites that only conduct research and do not have their own IRBs) November 16, 2010 Purpose of the Guide The accreditation process for most research
More informationCLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE]
CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE] CONTRACT RESEARCH ORGANIZATION SPONSOR [NAME] [ADDRESS] 1 TABLE OF CONTENTS 1. Purpose 3 2. References 3 3. Study Roles and Responsibilities
More informationResearch Coordinator - PI s who have research coordinators or secretarial support can designate individuals to manage their IRB protocols in Mentor.
Mentor Online IRB System IRB s require lots of documentation and managing this process can get to be a burden for both investigators and the IRB committee and administrator. The Mentor IRB system is designed
More informationEssential Standard Operating Procedures Sample Templates Table of Contents
Essential Standard Operating Procedures Sample Templates Table of Contents Introduction Study Conduct and Good Clinical Practice 1: JHM Training/Certification Documentation 2: Delegation of Responsibility
More informationClinical Research Professional Certification & Preparing for the CCRP Exam
Clinical Research Professional Certification & Preparing for the CCRP Exam Signe Denmark, MS, CCRP Toni Mauney, CCRP SoCRA: Society of Clinical Research Associates SoCRA established the Certification Program
More informationGood Clinical Practice 101: An Introduction
Good Clinical Practice 101: An Introduction Presented by: Lester Jao Lacorte, MD Medical Officer Commissioner s Fellow Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological
More informationPrincipal Investigator and Sub Investigator Responsibilities
Principal Investigator and Sub Investigator Responsibilities I. Purpose To define the roles and responsibilities of Principal Investigators conducting research at GRU. II. Definition The term Principal
More informationNEGOTIATING CLINICAL TRIAL BUDGETS. Debbie Williams R.N., C.C.R.C., C.R.A., A.B.N.
NEGOTIATING CLINICAL TRIAL BUDGETS Debbie Williams R.N., C.C.R.C., C.R.A., A.B.N. A.B.N. Amateur Budget Negotiator OVERVIEW Budget Types Analyzing the Protocol Negotiating the Contract Discussion / Tips
More informationSignature Requirements for the etmf
Wingspan Technology Signature Requirements for the etmf A Regulatory and Technological Assessment Kathie Clark Director, Product Management Wingspan Technology 1 November 2012 Signature Requirements for
More informationPREP Course #27: Medical Device Clinical Trial Management
PREP Course #27: Medical Device Clinical Trial Management Presented by: Evelyn Huang Jeffrey Revello Office of Research Compliance North Shore-LIJ Health System CME Disclosure Statement The North Shore
More informationJoint Research Office
Office Location: 1 st Floor Maple House 149 Tottenham Court Road London W1T 7DN Joint Research Office Postal Address: UCL, Gower Street London WC1E 6BT Email: hameedah.bogle-dawoud@nhs.net Tel No. 020
More informationVertex Investigator-Initiated Studies Program Overview
Vertex Investigator-Initiated Studies Program Overview Our Goal To support independent, investigator-initiated research designed to advance scientific knowledge of disease states, patient populations,
More informationSAMPLE POLICY/PROCEDURE TEMPLATE INVESTIGATIONAL DEVICE ACCOUNTABILITY
APPROVAL SIGNATURE (DEPARTMENT DIRECTOR OR PRINCIPAL INVESTIGATOR) DATE 1. INTRODUCTION This document describes (PI name or department) s policies/procedures for the receipt, storage, dispensing, reconciliation,
More informationPREP Workshop #31: Preparing for Certification as a Clinical Research Coordinator
PREP Workshop #31: Preparing for Certification as a Clinical Research Coordinator Presented by: Susan Ray, MS, CCRC Supervisor Research Coordination Clinical Research Service CME Disclosure Statement The
More informationThe Importance of Following the PROTOCOL in Clinical Trials
The Importance of Following the PROTOCOL in Clinical Trials Presentation Objectives: Upon completion of this presentation, participants will be able to: Describe the following terms: Protocol, Protocol
More informationClinical Investigator Training Course
Clinical Investigator Training Course Investigator Responsibilities in Biomedical Research Covered by FDA Regulations Lisa Zimmerman Objectives Discuss Clinical Investigator Obligations according to FDA
More informationCLINICAL RESEARCH PROTOCOL CHECKLIST
CLINICAL RESEARCH PROTOCOL CHECKLIST [taken from ICH GCP : Guidance for Industry, Good Clinical Practice: Consolidated Guidance, Revision 1 (R1) June 1996] ICH GCP, Section 6. CLINICAL TRIAL PROTOCOL AND
More informationINTERIM SITE MONITORING PROCEDURE
INTERIM SITE MONITORING PROCEDURE 1. PURPOSE The purpose of this SOP is to describe the interim monitoring procedures conducted at Institution, according to GCP and other applicable local regulations.
More informationClinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity
Clinical Trial Oversight: Ensuring GCP Compliance, Patient Safety and Data Integrity Michelle Quaye Regulatory Manager, Advanced Therapy Trials University College London Overview The Principles of Good
More informationHow Industry Can Partner with FDA in Defining a Risk- Based Monitoring Program
How Industry Can Partner with FDA in Defining a Risk- Based Monitoring Program Presenter: Jan Holladay Pierre, MPH Quality Principal Leader DynPort Vaccine Company LLC, A CSC Company This presentation
More informationThe Beginner Research Assistant/Coordinator (CRC) Track Basic Level
The Beginner Research Assistant/Coordinator (CRC) Track Basic Level Who: Clinical Research Assistant (CRA) CRC I This track was designed for the CRA/CRC I with less than 2 years of clinical research experience.
More informationResearch Study Close-down and Archiving Procedures
Title: Outcome Statement: Research Study Close-down and Archiving Procedures To inform researchers of the process for closing down research studies, retaining and storing research materials in the Trust.
More informationYale Cancer Center Data and Safety Monitoring Committee Charter
Yale Cancer Center Data and Safety Monitoring Committee Charter Purpose/Mission The purpose of the Yale Cancer Center (YCC) Data and Safety Monitoring Committee (DSMC) is to provide ongoing data and safety
More informationStandard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL
Page 1 of 10 Standard Operating Procedure on Training Requirements for staff participating in CTIMPs Sponsored by UCL SOP ID Number: Effective Date:01/08/2012 Version Number & Date of Authorisation: V02,
More informationDecember 13, 2011 Maureen Coyne
December 13, 2011 Maureen Coyne No industry relationships No financial conflicts of interests Recent experience weighted toward industrysponsored clinical trials Information based on my experiences IRB
More informationNova Southeastern University Institutional Review Board Policies and Procedures
Nova Southeastern University Institutional Review Board Policies and Procedures Monitoring of Approved Research, Approval Duration, and Continuing Review Effective 03/08/2007; Revised 10/14/2010; 8/29/2011;
More informationData Management Unit Research Institute for Health Sciences, Chiang Mai University
Data Management Unit Research Institute for Health Sciences, Chiang Mai University Clinical Data Management is the process of handling data from clinical trials. The inherent goal of any clinical data
More informationThis unit will provide the structure needed to achieve successful supervision and oversight of the study. We will explain the importance of an
Music No audio Please review information shown to understand the general course navigation and available resources. Resources, such as the audio script, example forms, and website links, can be accessed
More informationIRB Submissions and Human Subjects Research Compliance. Georgia Health Sciences University
IRB Submissions and Human Subjects Research Compliance Offi f H R hp t ti Office of Human Research Protection Georgia Health Sciences University Objectives Identify the steps required to submit a protocol
More informationQUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH
QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH Martin Valania, Executive Director, Corporate QA and Compliance Introduction Pharmaceutical companies recognize the benefits of carefully managing
More informationCore Training Outline
Core Training Outline Modules: 1) Study Design 2) PI Oversight 3) Financial Management 4) Study Operations 5) Recruitment & Retention 6) Informed Consent 7) Investigational Products 8) Subject Safety 9)
More informationRoadmap for study startup
How-To Guide Roadmap for study startup Deploying Adobe technology to automate clinical study startup procedures Section 1: Introduction and overview 2 1.1 Introduction 2 1.2 Overview of the clinical study
More informationOverview of Study Start Up Activities for a Clinical Trial at an Investigative Site
University of North Texas Health Science Center UNTHSC Scholarly Repository Theses and Dissertations 11-2012 Overview of Study Start Up Activities for a Clinical Trial at an Investigative Site Prianka
More informationTEMPLATE DATA MANAGEMENT PLAN
TEMPLATE DATA MANAGEMENT PLAN ICRIN (QM sub group) Version: XX Date: XXXXXXX Page 1 of 6 1.0 Document Ownership The Data Management Plan (DMP) will be initiated and subsequently owned by the Data Manager
More informationIRBNet Instructions for SBU and BNL Investigators
IRBNet Instructions for SBU and BNL Investigators October 2014 Stony Brook University uses IRBNet for the electronic administration and management of its IRB s, the Committees on Research Involving Human
More informationCLINICAL RESEARCH ROLES CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES
CLINICAL RESEARCH ROLESCLINICAL RESEARCH ROLES 1. Clinical Study Team Principal Investigator Co Principal Investigator (Co PI) Research Coordinator Study Monitor Data manage Sponsor Post Doctoral Scholar
More informationMarie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager
Standard Operating Procedures (SOP) for: Monitoring SOP 28 Version 7.0 Number: Number: Effective Date: 29 th November 2015 Review Date: 6 th January 2017 Author: Reviewer: Reviewer: Authorisation: Name
More informationHealth Care Job Information Sheet #20. Clinical Research
Health Care Job Information Sheet #20 Clinical Research A. Background B. Occupations 1) Clinical Research Associate (Study Monitor) 2) Clinical Research Coordinator 3) Other positions in the field C. Labour
More informationApplication for Research
Application for Research All research conducted within the Brooks Rehabilitation system or any entity or facility bearing the Brooks name, including the Brooks Rehabilitation Clinical Research Center,
More informationThe Ontario Cancer Research Ethics Board Overview
The Ontario Cancer Research Ethics Board Overview Research Ethics Research ethics review is vital to the advancement of ethically sound research. Before individuals can be enrolled in a research study,
More informationDocument Title: Supply of Clinical Trials Investigational Material: Dispensing, Returns and Accountability
Document Title: Supply of Clinical Trials Investigational Material: Document Number: SOP072 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G
More informationGuidance for Industry Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects
Guidance for Industry Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects U.S. Department of Health and Human Services Food and Drug Administration Center for Drug
More information