Clinical Research Professional Certification & Preparing for the CCRP Exam
|
|
- Laurence Briggs
- 8 years ago
- Views:
Transcription
1 Clinical Research Professional Certification & Preparing for the CCRP Exam Signe Denmark, MS, CCRP Toni Mauney, CCRP
2 SoCRA: Society of Clinical Research Associates SoCRA established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the health care research community. Individuals approved may use the title of Certified Clinical Research Professional or C.C.R.P
3 Upcoming SoCRA Certification Exam Date: Saturday, September 20, 2014 Place: MUSC, ART Auditorium Time: 9AM 1PM Cost: $195 Registration deadline for the MUSC exam is: August 8, 2014
4 Who is eligible for SoCRA Certification? The applicant must meet one of the following criteria: 2 years of experience as a full time Clinical Research Professional (or have 3,500 hours part time) during the last five years OR Associate s or Bachelor s Degree in Clinical Research AND have 1 year of full time experience (or 1750 part time hours) during the last two years in an area of clinical research OR Certificate of Completion from an Undergraduate or Graduate Clinical Research curriculum of no less than 12 semester (credit) hours at an academically accredited institution of higher learning (community college, college or university) AND hold an Associate s or Bachelor s Degree in science, health science, pharmacy or related field PLUS have 1 year of full time experience (or 1750 hours part time) during the past 2 years in an area of clinical research.
5 Why Should I Obtain Certification? Acknowledgement of your expertise Competitive edge in vying for innovative clinical trials Professional networking and development
6 About the Certification Exam The certification examination is made up of five major subject areas There are 135 questions Each major area will be included in each examination, but specific questions will vary from one examination date to another The percentage of questions from each area will change slightly from one examination to another, with each question equivalent in weight
7 Five Subject Areas of the Exam Percent of Scored Test Items in Each Area Ethical Principles / Informed Consent / Safety = 20% 25% Institutional Review Board / Institutional Ethics Committee (IRB/IEC) Roles and Responsibilities = 7% 11% Clinical Trial Protocol and Protocol Amendments = 4% 8% Investigator Roles and Responsibilities = 28% 32% Sponsor Roles and Responsibilities = 31% 35%
8 Five Subject Areas of the Exam Ethical Principles/ Informed Consent/Safety (20% 25%) Nuremberg Code Belmont Report Declaration of Helsinki Informed consent including development, content, review, approval, discussion, documentation and ongoing updates Maintenance of informed consent documents (paper/electronic) Abstracting/verification of information from medical records related to informed consent and safety reporting Vulnerable subjects Safety Reporting (adverse events, serious adverse drug experiences, unanticipated adverse device effects) Financial disclosure
9 Five Subject Areas of the Exam Institutional Review Board/ Institutional Ethics Committee (IRB/IEC) Roles and Responsibilities (7% 11%) Roles and Responsibilities roles, etc. of IRB/IEC Determination that the rights, welfare and safety of study subjects including vulnerable populations are protected Development and implementation of Standard Operating Procedures (SOPs) Membership Significant Risk/Non Significant Medical Device study determination Documentation Record retention IRB/IEC
10 Five Subject Areas of the Exam Clinical Trial Protocol and Protocol Amendments (4% 8%) Protocol development (including study design with considerations methods to reduce bias, objectives, endpoints, data safety monitoring) Protocol Amendments
11 Five Subject Areas of the Exam Investigator s Roles and Responsibilities (28% 32%) Roles, responsibilities and obligations of the investigator Study conduct in accordance with investigational plan, investigator agreement and applicable regulations Protocol(s) and protocol related document(s) (i.e., informed consent documents, recruitment materials, safety reports, continuing reviews) development, review, and submission for reviewing authorities Recruitment, screening, enrollment, and retention of subjects Investigational site source documentation Documentation/Reporting discontinuation study subjects Investigational site study related reports (i.e. progress reports, protocol changes, protocol deviations, final reports) Source Documentation/Case Report Forms Maintenance of essential study related documents (paper/electronic) Abstracting/verification of Information from Medical Records Record retention requirements for clinical sites
12 Five Subject Areas of the Exam Sponsor s Roles and Responsibilities (31% 35%) Investigator/site qualification Investigational site training, management, oversight and investigator compliance (including GCP, investigational product, study and reporting requirements) Protocol and protocol related documents Sponsor investigational product accountability Standard operating procedures Regulatory documents (FDA Forms 1571, 1572, 3454, 3455, IND, IDE, Medwatch (3500 and 3500A)) Study plan Development, verification, maintenance of electronic records and electronic record systems Maintenance of essential study related documents (paper/electronic)
13 Exam Structure 135 multiple choice and true/false questions Case Studies: The examination will contain case studies that relate to clinical research practice. The case studies are intended to evaluate a candidate s ability to abstract data and do not require clinical experience. Case studies may involve questions regarding scheduling, dose modifications and reading medical and clinical reports.
14 SoCRA Exam Preparation Utilize the materials provided and review your study guide. The Certification Program Reference Manual includes: The Nuremberg Code The Belmont Report The Declaration of Helsinki 21 U.S. Code of Federal Regulations Parts 11, 50, 56, 312, U.S. Code of Federal Regulations Part 46 ICH GCP Guideline for Good Clinical Practice (E6), and ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) Please note: The Health Canada Sections are printed as reference material. You will NOT be tested on content related to this section on the certification examination.
15 SoCRA Exam Preparation Tips Don t get overwhelmed by the amount of text in the regulations. Pull out the key points and organize your thoughts. Be confident. Over your time in research, you know a lot more than you think. Test smart. Don t get stuck on questions. Don t overanalyze. Put a place holder on your answer sheet, move on and come back to a difficult question later. Patient safety first. When in doubt, go for the answer that offers the best protection to the subject s rights and welfare.
16 SoCRA Study Sessions Thursday, 8/14, 11:30AM 12:30PM Ethical Principles, Informed Consent, Research Nexus Conference Room CSB 214A Safety Wednesday, 8/20, 12:00PM 1:00PM IRB/IEC Roles and Responsibilities Research Nexus Conference Room CSB 214A Thursday, 8/28, 11:30AM 12:30PM Clinical Trial Protocol and Protocol Research Nexus Conference Room CSB 214A Amendments Wednesday, 9/3, 12:00PM 1:00PM Investigator s Roles and Research Nexus Conference Room CSB 214A Responsibilities Thursday, 9/11, 11:30PM 12:30PM Sponsor s Roles and Research Nexus Conference Room CSB 214A Responsibilities
PREP 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 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 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 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 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 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 informationHistory and Principles of Good Clinical Practice
History and Principles of Good Clinical Practice Cristina E. Torres, Ph.D. Social Science Professor, UPM-NIH FERCAP Coordinator ICH: International Conference on Harmonization GCP: Good Clinical Practices
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 informationDifferential Training by Job Function ACRP Job Analysis Results
Differential Training by Job Function ACRP Job Analysis Results Morgean Hirt, ACA, Director of Certification Association of Clinical Research Professionals Disclaimer The views and opinions expressed in
More informationHealth Canada s GCP Compliance Program. GCP Information Sessions November 2010
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada s GCP Compliance Program GCP Information Sessions November 2010 Objective To describe the role that Health
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 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 informationThe Regulatory Binder/Trial Master File: Essential Records for the Conduct of a Clinical Trial
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 Objectives
More informationCERTIFICATE IN CLINICAL TRIAL MANAGEMENT
Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034-2713 Phone: 267.468.8560 Fax: 267.468.8565 CERTIFICATE IN CLINICAL TRIAL MANAGEMENT Designed for Pharmaceutical
More informationThe 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 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 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 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 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 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 informationSchool of Pharmacy TEMPLE UNIVERSITY
School of Pharmacy TEMPLE UNIVERSITY Regulatory Affairs and Quality Assurance Graduate Program Te mple Unive rsity School of Pharmacy Re gulatory Affairs and Quality Assurance Graduate Program 4 25 Comme
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 informationCLINICAL RESEARCH GENERIC TASK DESCRIPTIONS
Purpose Purpose Purpose Primary responsibility for implementation, coordination, evaluation, communication and/or management of research studies. May involve more than one study or multiple sites within
More informationU.S. Food and Drug Administration
U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA s website for reference purposes only. It was current when produced, but is no longer maintained
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 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 information2015 Core Clinical Research Training (CCRT)
2015 Core Clinical Research Training (CCRT) Core Topics Overview Introduction to Clinical Trials Laura Fields Research Coordinator SCTR NEXUS Research Coordination and Management This introductory course
More informationAdventist HealthCare, Inc.
IRB POLICY ON HUMAN RESEARCH PROTECTION (HRP) AND GOOD CLINICAL PRACTICE (GCP) TRAINING Collaborative Institutional Training Initiative (CITI) Requirements at Adventist Healthcare, Inc. I. Required Human
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 informationLIBRARY GUIDE: Clinical Medical Device
LIBRARY GUIDE: Clinical Medical Device Table of Contents Overview... 3 Clinical Curriculum Core Program Course Descriptions: A Tour of Health Canada (PHDV89)...5 A Tour of Health Europe (PHDV90)...5 A
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 informationPrincipal Investigator Responsibilities for Education and Social/Behavioral Researchers
Principal Investigator Responsibilities for Education and Social/Behavioral Researchers Introduction The purpose of this module is to provide a basic understanding of the responsibilities of the principal
More informationGuide 2013 to CERTIFICATION PROGRAMS
Guide 2013 to CERTIFICATION PROGRAMS 2015 WMDO SA Route de Denges 28C 1027 Lonay Switzerland Tel. +41 21 349 96 36 Fax +41 21 349 96 37 WMDO US 80 South 8th Street 3565 S Center Minneapolis, MN 55402 USA
More informationCHARTERED FINANCIAL ANALYST (USA)
CHARTERED FINANCIAL ANALYST (USA) CFA (USA) The CFA qualification is the gold standard in the fields of Investment Banking and Finance. Endorsed by over130 Countries in the world, it has an annual registration
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 informationEthics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong. Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015
Ethics and Scientific Oversight for Phase 1 Clinical Trials in Hong Kong Sydney TANG Chairman, HKU/HA HKW IRB November 21, 2015 Clinical Trials at HKU Phase 1 Phase II Phase III Phase IV Conducted on patient
More informationRegulator s Role in GCP
Regulator s Role in GCP David A. Lepay, M.D., Ph.D. APEC GCP Inspection Workshop May 27, 2008 Objectives of this Talk Review the roles and responsibilities of the regulatory authority under GCP Identify
More informationThis policy applies to research administrators, investigators, research staff, Human Investigation Committee (HIC) members and HIC staff.
REVIEW BY AN EXTERNAL INSTITUTIONAL REVIEW BOARD 233 1 of 5 PURPOSE The purpose of this policy is to establish a procedure for requesting authorization for an approved, external (non-beaumont) institutional
More informationStaff Member Signature Date Direct Supervisor Related Mater Health Services Position Description attached. Theme Leader Signature Date.
POSITION DESCRIPTION Mothers and Babies Theme Position Title Division Position Purpose Position Scope Occupational Category and Level Reporting Relationship Review Date Next Review Due, Mothers and Babies
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 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 informationEthical Principles in Clinical Research. Christine Grady Department of Bioethics NIH Clinical Center
Ethical Principles in Clinical Research Christine Grady Department of Bioethics NIH Clinical Center 1 Ethical principles Are these studies ethical? How do we know? Ethics of clinical research The goal
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 informationAnnex A. Levels 1 5 of the Clinical Research Coordinator Track in the Clinical Research WSQ Framework
Annex A Levels 1 5 of the Clinical Research Coordinator Track in the Clinical Research WSQ Framework WSQ Higher Certificate in Clinical Research (Clinical Research Coordinators) Apply Drug Development
More informationClinical Research Associate (CRA) - A Growing Career Path in Biotechnology / Pharmaceutical Industry
Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / Pharmaceutical Industry By http://www.clinicalresearchassociate cra.com/studyguide/ A clinical research associate (CRA) is a
More informationDisclaimer. Objectives 5/30/2016
Good Clinical Practice Informed Consent Training Presented by Jacqueline Everett Clinical Trial Governance Manager, Research Integrity Disclaimer The material in this presentation has been prepared by
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 information1.2 - Overview of Regulation of Clinical Trials in Canada
1.2 - Overview of Regulation of Clinical Trials in Canada Presentation to APEC Preliminary Workshop on Review of Drug Development in Clinical Trials Celia Lourenco, PhD, Manager, Clinical Group I Office
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 informationData Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International
Data Management and Good Clinical Practice Patrick Murphy,, Family Health International 1 What is GCP? Good Clinical Practice is an international ethical and scientific quality standard for designing,
More informationIndustry Experience in Clinical Trials Management. Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels
Industry Experience in Clinical Trials Management Catherine Lee Area Head Clinical Operations Asia Pfizer Inc 20 May 2011 Brussels Stakeholders in clinical research Critical activities to ensure patient
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 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 informationClinical Trials Ontario
Clinical Trials Ontario Streamlined Research Ethics Review System Erin Bell, Program Coordinator June 6-7, 2016 CLINICAL TRIALS ONTARIO Independent non-profit, established in June 2012 and funded by the
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 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 informationA responsible approach to clinical trials. Bioethics in action
A responsible approach to clinical trials Bioethics in action What is bioethics? At Novo Nordisk bioethics is the expression used for all ethical issues related to the use of life science technologies
More information2014 Metrics on Human Research Protection Program Performance
2014 Metrics on Human Research Protection Program Performance Updated May 15, 2015 About the Metrics Improving the quality of human research protection programs (HRPP) is a top priority of AAHRPP. Effective
More informationDepartment of Health and Human Services. Final Guidance Document
Department of Health and Human Services Final Guidance Document Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection This document replaces
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 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 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 informationINVESTIGATOR HANDBOOK
INVESTIGATOR HANDBOOK Liberty IRB, Inc. 1450 S. Woodland Blvd., Suite 300A Deland, Florida 32720 Phone (386) 279-4318 Fax: (386)868-4563 Website: www.libertyirb.com Business hours: Monday Friday, 8:00am
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 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 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 informationA Clinical Research Coordinator for an International Study THE GYMNAST
A Clinical Research Coordinator for an International Study THE GYMNAST Anita Ng Research Coordinator The Scarborough Hospital May 12, 2007. 1. What is Research? 2. Characteristics of a Clinical Research
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 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 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 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 informationPHARMACY TECHNICIAN STRUCTURED PRACTICAL EXPERIENCE PROGRAM
PHARMACY TECHNICIAN STRUCTURED PRACTICAL EXPERIENCE PROGRAM WELCOME Welcome to the Eastern College Pharmacy Technician Structured Practical Experience (SPE) program. For those graduating from a CCAPP-accredited
More informationGLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com
GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process
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 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 informationREGULATIONS FOR THE POSTGRADUATE DIPLOMA IN CLINICAL RESEARCH METHODOLOGY (PDipClinResMethodology)
452 REGULATIONS FOR THE POSTGRADUATE DIPLOMA IN CLINICAL RESEARCH METHODOLOGY (PDipClinResMethodology) (See also General Regulations) M.57 Admission requirements To be eligible for admission to the courses
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 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 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 informationCHANGE OF MONITOR AT STUDY SITE No: CM.8 01 02 Effective Date: 15 April 2013 Version Date: 15 March 2013
CONTENTS: 1. DEFINITIONS/REFERENCES 2. 2. PURPOSE 2. 3. SCOPE.2. 4. RESPONSABILITIES 2. 5. PROCEDURES...3. 5.1 Assessment of Need and Approval of Change of CRA... 3. 5.2 Project training......3. 5.3 Documentation
More informationCERTIFICATE IN BASIC PHARMACEUTICAL DEVELOPMENT Focusing on the Business of Pharmaceuticals
Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034 Phone: 267.468.8560 Fax: 267.468.8565 CERTIFICATE IN BASIC PHARMACEUTICAL DEVELOPMENT Focusing on the Business
More informationOECD Recommendation on the Governance of Clinical Trials
OECD Recommendation on the Governance of Clinical Trials Marketing authorisation status of the medicinal products Non-authorised medicine Authorised medicine, treatment regimen outside
More informationHealth Canada: Clinical Trial Inspection Planning. GCP Information Sessions November 2010
Your Health and Safety... Our priority Votre santé et votre Securité notre priorité Health Canada: Clinical Trial Inspection Planning GCP Information Sessions November 2010 Overview GCP Inspection Target
More informationTemple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034. Phone: 267.468.8560 Fax: 267.468.
Temple University - School of Pharmacy 425 Commerce Drive, Suite 175 Fort Washington, PA 19034 Phone: 267.468.8560 Fax: 267.468.8565 POST-MASTER S CERTIFICATE in CLINICAL TRIAL MANAGMENT Designed for Pharmaceutical
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 informationAlternate Route to Interim Teaching Certification Program Application
Office of Professional Preparation Services Alternate Route to Interim Teaching Certification Program Application For Educator Preparation Providers seeking approval to offer an alternate route to interim
More informationEMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART
EMA Clinical Laboratory Guidance - Key points and Clarifications PAUL STEWART Framework Labs generate data that are used to make decisions on the safety and efficacy of medicinal products; consequently,
More informationClinical evaluation Latest development in expectations EU and USA
Clinical evaluation Latest development in expectations EU and USA Medical Devices: staying ahead of regulatory developments Gert Bos BSI Israel 22 April - Herzliya Copyright 2012 BSI. All rights reserved.
More informationGuidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions
Guidance for Industry and FDA Staff FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions U.S. Department of Health and Human Services Food and Drug Administration
More informationReliance Agreement for Institutions Utilizing Stony Brook University s Institutional Review Board(s)
Name of Organization Providing IRB Review: Stony Brook University ( SBU IRB ) Name of Institution Relying on the SBU IRB ( Institution ): Latest AAHRPP Accreditation Date (if applicable) OHRP Federal Wide
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 informationCFA. Chartered Financial Analyst
CFA Chartered Financial Analyst About Institute for Financial Analysts IFA CFA Program at IFA IFA s live preparation courses are the best choice for you. We move step by step with every candidate through
More informationSingapore Clinical Trials Register. Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY
Singapore Clinical Trials Register Foo Yang Tong Director Clinical Trials Branch Health Products Regulation Group HEALTH SCIENCES AUTHORITY Clinical Trial Register Global Trend EMA: EU Clinical Trials
More informationPolicy on Human Subject Protection Training, Certification and Recertification at AUB
Policy on Human Subject Protection Training, Certification and Recertification at AUB Policy Number: 005 Draft Version Number: 1 Dated: Prepared and Edited by: Mona Nabulsi and Mary Ellen Sheridan (Consultant)
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 informationWhat is necessary to provide good clinical data for a clinical trial?
What is necessary to provide good clinical data for a clinical trial? Alain Barrois, Assistant Clinical Trials Operations Manager #EBMT2015 www.ebmt.org Is this a (typical) clinical trial? 2 Agenda Introduction
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 informationHealth Products and Food Branch. www.hc-sc.gc.ca
Health Products and Food Branch 1 HEALTH CANADA PART C DIVISION 5 - DRUGS FOR CLINICAL TRIALS INVOLVING HUMAN SUBJECTS Part C - Division 5 2 Part A: Part B: Part C: Part D: Part E: Part G: Part J: Administration
More informationConduct of clinical Trials Communication of
PrinciPles on Conduct of clinical Trials Communication of clinical Trial results Table of Contents Preamble...1 Commitment to Protecting Research Participants...5 Conduct of Clinical Trials...7 Ensuring
More information