Site Activation: Keep Your Eyes on the Prize

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Site Activation: Keep Your Eyes on the Prize"

Transcription

1 Site Activation: Keep Your Eyes on the Prize Theresa Gamble, Ph.D. Senior Clinical Research Manager HPTN CORE, FHI October 2004 Slide 1

2 The Prize Site-Specific Protocol Activation Notice See Example Document 1 Slide 2

3 Components of the Notice The following site has met all Protocol Registration and Study Activation requirements and is hereby approved to begin screening and enrollment in the study entitled: WITHOUT THE NOTICE, YOU CANNOT BEGIN THE STUDY!!! Slide 3

4 Current Federal Wide Assurance (FWA) For Each Relevant IRB/EC TIP 1) We check the OHRP website ( TIP 2) So should you Slide 4

5 Completion of US FDA 30-day Review Period TIP 1) This only applies to IND studies TIP 2) If you are an HPTN site, there is nothing for you to do (this is usually handled by DAIDS) Slide 5

6 Local Regulatory Authority Approval of the Study Protocol (other than IRB approval) TIP 1) Only the site knows if this is required TIP 2) Keep the HPTN CORE informed of the status and timeline TIP 3) The HPTN CORE or DAIDS can often help provide necessary documents or information TIP 4) Provide the HPTN CORE with documentation of approval in English Slide 6

7 Examples Local Regulatory Authority Approval of the Study Protocol Drug Controller General of India (DCGI) Health Ministry s Screening Committee (HMSC) Thai FDA Slide 7

8 Completion of Human Subjects Research Training for All Key Staff TIP 1) Key staff is defined by NIH as anyone who designs or conducts the study TIP 2) At a minimum, train all staff who interact with study participants TIP 3) Have a plan to train new staff Slide 8

9 Examples Completion of Human Subjects Research Training for All Key Staff Annual HPTN Meeting At U.S. Institutions A copy of the attendance sheet or copies of the certificates are acceptable documentation Slide 9

10 Completion of Good Clinical Practice (GCP) Training by at Least One Study Staff Member with Responsibility for Oversight of Study Implementation TIP 1) Strongly recommend that as many staff as possible receive this training TIP 2) If only one or two staff can be trained, choose the Investigator of Record, the Investigator who signs the 1572, or the study coordinator TIP 3) Have a plan to train new staff Slide 10

11 Examples Completion of Good Clinical Practice (GCP) Training by at Least One Study Staff Member with Responsibility for Oversight of Study Implementation On Site PPD Training Annual HPTN Meeting Online Courses At U.S. Institutions or Companies A copy of the attendance sheet or copies of the certificates are acceptable documentation Slide 11

12 Protocol Registration Approval from the DAIDS RCC Protocol Registration Office based on: Approvals from all responsible IRBs/ECs IRB/EC-approved informed consent forms (local language and back-translation) Original Signed FDA Form 1572 or Investigator of Record Agreement CV of the Investigator of Record or 1572 Signee Slide 12

13 Slide 13 Protocol Registration Approval from the DAIDS RCC Protocol Registration Office TIP 1) Make sure your approval letters are in English and have the components required by the DAIDS Protocol Registration Manual TIP 2) Stay close to the ICF template, clearly label your consent forms, submit documentation of approval TIP 3) Check the 1572 or IoR for accuracy TIP 4) Have the IoR sign and date the CV

14 Examples IRB Approval Letter DAIDS-Required Elements Complete Protocol Title DAIDS Protocol Number DAIDS Protocol Version Number Date of IRB/EC Approval See Example Document 2 Slide 14

15 Examples IRB Approval Letter This is an excellent example of documenting that all consent forms have been approved. See Example Document 3 Slide 15

16 Examples IRB Approval Letter DAIDS-Required Elements IRB/EC Chairperson or Member Designee Signature IRB/EC Representative s Title Slide 16 See Example Document 4

17 Examples Protocol Registration Approval from DAIDS/RCC Protocol Registration Office Slide 17 See Example Document 5

18 DAIDS-Approved Pharmacy Establishment Plan (PEP) and Pharmacy SOP TIP 1) DAIDS PAB provides feedback and approval for these documents TIP 2) Provide HPTN CORE with documentation of approval TIP 3) Give yourself time there is usually some back and forth with DAIDS PAB Slide 18

19 All Applicable Import and Export Approvals for Study Products TIP 1) Only the site knows if these are required TIP 2) Keep the HPTN CORE informed of the status and timeline TIP 3) The HPTN CORE or DAIDS can often help provide necessary documents or information TIP 4) Provide the HPTN CORE with documentation of approval in English Slide 19

20 All Applicable Import and Export Approvals for Study Products TIP 5) Many parties are usually involved in this process - bureaucracy is the same all over - give yourself enough time!!! Slide 20

21 Study Staff Signature Sheet, Roster, and Delegation of Duties TIP 1) The easiest way to do this is a single log TIP 2) Your procedure should show when staff join and leave the project and if their duties change Slide 21

22 Examples Study Staff Signature Sheet, Roster, and Delegation of Duties NAME SIGNATURE INITIALS CREDENTIALS STUDY RESPONS- IBILITIES IoR DESIGNEE (Y/N) IF YES IoR INITIALS START DATE END DATE T. Gamble TRG Ph.D. B, C, G Y GD 01/01/04 01/30/04 M. McCauley MM MPH B, C, G Y GD 02/01/04 T. Gamble TRG Ph.D. D N 02/15/04 A, Investigator of Record B, Subinvestigator C, Verifies Eligibility D, Ships Specimens E, Study Coordinator F, Lab Technician G, Consents Participants H, Research Clinician I, Performs Study Assessments Slide 22

23 SCHARP Approval of Site Readiness for Data Management TIP 1) SCHARP Protocol Operations Coordinator (POC) guides preparedness activities and provides approval TIP 2) Stay in touch with your POC Slide 23

24 HPTN CL Approval of Local Laboratory Readiness TIP 1) HPTN Central Lab guides preparedness activities and provides approval TIP 2) The lab validation process takes time plan accordingly Slide 24

25 Required SOPs, Accrual and Retention Plans, and HIV Counseling Procedures TIP 1) Find out exactly what is required for your study TIP 2) Submit drafts early TIP 3) Agree on the process of review and approval TIP 4) Version 1.0 will change, don t agonize Slide 25

26 Examples SOP Review and Approval Process Set out expectations and timelines Designate point person for changes Use tracked changes appropriately Maintain version control SOPs can really help in the long run. Slide 26

27 PPD Study-Specific Initiation Visits TIP 1) Respond to the report in a timely fashion TIP 2) Proactively follow-up on issues Slide 27

28 Completion of Study-Specific Training and Resolution of Issues that are Identified during Training TIP 1) Use the training to walk-through your SOPs Slide 28 TIP 2) Clarify what issues are rate-limiting for site activation

29 Examples Resolution of issues that are identified during training REQUIRED FOR SITE ACTIVATION New IoR Agreement Site is missing CVs or financial disclosure forms Site has concerns about keeping drug within required temperature range The type of syphilis confirmatory test to be used for study was undetermined NOT REQUIRED FOR SITE ACTIVATION Approval of version 3.1 of ICFs when version 3.0 is available Finalize procedure to re-label medication that is nearing expiration Site will review ICFs and ICF process with CAB Site needs to hire an additional Medical Officer Slide 29

30 General Advice TIP 1) Determine a process of communication TIP 2) Track your progress TIP 3) Be organized TIP 4) Remember, we re all going to the same place, enjoy the ride Slide 30

31 Keep Your Eyes on the Prize Slide 31

Tool Summary Sheet. Tool: Extramural Essential Documents Binder/File Tabs

Tool Summary Sheet. Tool: Extramural Essential Documents Binder/File Tabs 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 information

The 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 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 information

Study 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) 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 information

No. 706. Page 1 of 5. Issue Date 4/21/2014

No. 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 information

The Study Site Master File and Essential Documents

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 information

CLINICAL DATA MONITORING PLAN (CDMoP) PROTOCOL # [0000] [TITLE]

CLINICAL 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 information

University of Oklahoma Office of Human Research Participant Protection SOP: 801 INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES

University of Oklahoma Office of Human Research Participant Protection SOP: 801 INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES 1. POLICY SOP: 801 INVESTIGATOR QUALIFICATIONS AND RESPONSIBILITIES The purpose of this policy is to outline the qualifications and responsibilities of the principal investigator and key personnel who

More information

Data Management DM STANDARD OPERATING PROCEDURE FOR Data Management

Data Management DM STANDARD OPERATING PROCEDURE FOR Data Management Data Management DM 401.00 STANDARD OPERATING PROCEDURE FOR Data Management Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature and Date) Approval: Frederick M. Schnell, MD, FACP

More information

CNE Disclosures. To change this title, go to Notes Master

CNE 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 information

Regulatory Binder Instructions 25 April 2016

Regulatory 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 information

Clinical Site Monitoring

Clinical Site Monitoring Clinical Site Monitoring Walt Jones RN, MPH Nurse Consultant Clinical Monitoring Coordinator OCRA, DMID, NIAID November 1, 2007 Clinical Monitoring Contractor Contracted to PPD from Wilmington, North Carolina

More information

Medical 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

Medical 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 information

FDA Audit Guidelines. University of Miami. Office of the Vice Provost for Research

FDA Audit Guidelines. University of Miami. Office of the Vice Provost for Research FDA Audit Guidelines University of Miami Office of the Vice Provost for Research FDA Audit Guidelines Contents INTRODUCTION 3 VICE PROVOST FOR RESEARCH ROLE IN FDA AUDITS 3 PRE-AUDIT REVIEW 3 INSPECTION

More information

Quality Monitoring Checklist

Quality 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 information

Data 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. 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 information

How 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 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 information

ROLES, RESPONSIBILITIES AND DELEGATION OF DUTIES IN CLINICAL TRIALS OF MEDICINAL PRODUCTS

ROLES, 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 information

Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs

Information 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 information

Reliance Agreement for Institutions Utilizing Stony Brook University s Institutional Review Board(s)

Reliance 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 information

Investigator Responsibilities in Clinical Research: Insights and helpful hints for researchers

Investigator Responsibilities in Clinical Research: Insights and helpful hints for researchers Investigator Responsibilities in Clinical Research: Insights and helpful hints for researchers ITHS Clinical Research Education Series September 7, 2010 Objectives Understanding the requirements of DHHS

More information

This unit will provide the structure needed to achieve successful supervision and oversight of the study. We will explain the importance of an

This 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 information

Essential 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 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 information

1 The Clinical Research Coordinator (CRC)... 1

1 The Clinical Research Coordinator (CRC)... 1 TABLE OF CONTENTS Acknowledgments... xi Introduction... xiii 1 The Clinical Research Coordinator (CRC)... 1 Background and Training of the CRC...1 Personality and Skills... 2 Where Do CRCs Work?... 2 CRC

More information

PI Name: PI Address: PI Phone No: Contracts Contacts: Contact Name: address: Phone Number:

PI Name: PI  Address: PI Phone No: Contracts Contacts: Contact Name:  address: Phone Number: A robust feasibility is an essential part of ensuring study delivery. Please pass this Study Feasibility Assessment and a copy of the Protocol to the individual(s) who are most appropriate to accurately

More information

Orientation Manual for Clinical Research Coordinators

Orientation 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 information

Roles & Responsibilities of the Sponsor

Roles & 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 information

Good Documentation Practices

Good 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 information

DHHS/NIH/OD/OIR/OHSRP 1/2/2015

DHHS/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 information

Clinical Investigator Inspections and FDA-483 Observations

Clinical 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 information

Vertex Investigator-Initiated Studies Program Overview

Vertex 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 information

Clinical Investigator Training Course

Clinical 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 information

ROLE OF THE RESEARCH COORDINATOR Study Start-up Best Practices

ROLE 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 information

Sharon H. Johnson, BS, MS 123 Main Street Capital City, VA 00000 Phone: 434-555-1234 Email: shjohnson@email.com

Sharon 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 information

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure

Subject: 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 information

SUBJECT: Principal Investigator Oversight POLICY: RA:HRPP:10.13

SUBJECT: Principal Investigator Oversight POLICY: RA:HRPP:10.13 SUBJECT: Principal Investigator Oversight POLICY: RA:HRPP:10.13 DATE EFFECTIVE: PAGE: 1 of 2 I. POLICY The Children s National Medical Center (CNMC) Human Research Protections Program (HRPP) recognizes

More information

DAIDS Bethesda, MD USA POLICY. Requirements for Clinical Quality Management Plans

DAIDS Bethesda, MD USA POLICY. Requirements for Clinical Quality Management Plans NOTE: This policy and associated appendices have been reviewed for accuracy and updated to meet 508 compliance guidelines. DAIDS has clearly stated the minimum requirements for the CQMP and provided examples

More information

Essential Documents for Clinical Trial Research. Centre for Health Evaluation and Outcome Sciences Manager, Clinical Research Development Office

Essential 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 information

SOURCE DOCUMENTATION REQUIREMENTS

SOURCE DOCUMENTATION REQUIREMENTS DAIDS Appendix 1 No.: DWD-POL-CL-04.00A1 SOURCE DOCUMENTATION REQUIREMENTS Addenda If source documentation is incorrect, incomplete, or otherwise deficient, it may be corrected/completed by making an additional

More information

Objectives. Monitoring & Auditing of Clinical Trials. Overview. Pre-study Qualification Visit. Industry-sponsored Trials

Objectives. 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 information

Site Study Start-Up Requirements for AFT Studies. Alicia Quirke, Site Manager

Site Study Start-Up Requirements for AFT Studies. Alicia Quirke, Site Manager Site Study Start-Up Requirements for AFT Studies Alicia Quirke, Site Manager Agenda Pre-Study Site Selection Site Start-up Documents Training Activation Pre-Study Prelim Site list created based on previous

More information

This policy applies to research administrators, investigators, research staff, Human Investigation Committee (HIC) members and HIC staff.

This 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 information

IRB Submissions and Human Subjects Research Compliance. Georgia Health Sciences University

IRB 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 information

INTERIM SITE MONITORING PROCEDURE

INTERIM 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 information

DAIDS LMS Content List

DAIDS LMS Content List The training modules listed are currently offered through the DAIDS Learning Management System (DAIDS LMS). Check back often for updates and new trainings! New to the DAIDS LMS? Request an account at:

More information

Hollie Goddard Sr. IRB Coordinator McKesson Specialty Health

Hollie 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 information

Pre-Questions. Mastering Clinical Research July 29, 2015

Pre-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 information

IMP management at site. Dmitry Semenyuta

IMP 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 information

Rashika Maharaj. Strategies for maintaining high standards for Good Clinical Laboratory Practices

Rashika Maharaj. Strategies for maintaining high standards for Good Clinical Laboratory Practices Strategies for maintaining high standards for Good Clinical Laboratory Practices Rashika Maharaj MRC HPRU Laboratory Manager MTN Regional Meeting 10 September 2008 What is GCLP? Is your lab GCLP compliant?

More information

12.0 Investigator Responsibilities

12.0 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 information

Comprehensive Study Documents List (Biomedical Studies)

Comprehensive 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 information

PREP Workshop #31: Preparing for Certification as a Clinical Research Coordinator

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 information

Principal Investigator Responsibilities for Education and Social/Behavioral Researchers

Principal 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 information

DAIDS Bethesda, MD USA. POLICY Requirements for Clinical Quality Management Plans

DAIDS Bethesda, MD USA. POLICY Requirements for Clinical Quality Management Plans CHANGE SUMMARY: This policy and associated appendices have been reviewed for accuracy and updated to meet 508 compliance guidelines. Key changes to the policy require all sites to submit a bi-annual Clinical

More information

TRIAL MASTER FILE- SPONSORED

TRIAL 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 information

2 Applicability: Effective Date: 1/15/2010 Revised: 8/13/2010, 9/10/10, 5/9/14

2 Applicability: Effective Date: 1/15/2010 Revised: 8/13/2010, 9/10/10, 5/9/14 2 Applicability: Effective Date: 1/15/2010 Revised: 8/13/2010, 9/10/10, 5/9/14 NDSU research may involve the collaboration or assistance of other research institutions, schools, hospitals, clinics, private

More information

OVERVIEW: ANCILLARY STUDY PROPOSALS, SECONDARY DATA ANALYSIS REQUESTS AND REQUESTS FOR DATASETS...

OVERVIEW: ANCILLARY STUDY PROPOSALS, SECONDARY DATA ANALYSIS REQUESTS AND REQUESTS FOR DATASETS... 19 OVERVIEW: ANCILLARY STUDY PROPOSALS, SECONDARY DATA ANALYSIS REQUESTS AND REQUESTS FOR DATASETS... 1 19.1 Ancillary Studies... 3 19.1.1 MTN Review and Approval of Ancillary Studies (Administrative)...

More information

Essential Standard Operating Procedures Sample Templates Table of Contents

Essential 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 information

Establishment of a Quality Systems approach to Clinical Site Management An Overview of Standard Operating Procedures (SOPs)

Establishment of a Quality Systems approach to Clinical Site Management An Overview of Standard Operating Procedures (SOPs) Establishment of a Quality Systems approach to Clinical Site Management An Overview of Standard Operating Procedures (SOPs) Cornelia Kamp, MBA Executive Director Strategic Initiatives Tim Hackett Director

More information

Data Management and Good Clinical Practice Patrick Murphy, Research Informatics, Family Health International

Data 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 information

Marie-Claire Rickard, GCP & Governance Manager Rachel Fay, GCP & Governance Manager Elizabeth Clough, R&D Operations Manager

Marie-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 information

DAIDS LMS Content List

DAIDS LMS Content List The training modules listed are currently offered through the DAIDS Learning Management System (DAIDS LMS). Check back often for updates and new trainings! New to the DAIDS LMS? Request an account at:

More information

STANDARD OPERATING PROCEDURE FOR RESEARCH. Management of Essential Documents and Trial Folders

STANDARD 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 information

Monitoring & 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 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 information

The 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 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 information

Clinical Research Professional Certification & Preparing for the CCRP Exam

Clinical 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 information

DAIDS Guidelines for Good Clinical Laboratory Practice Standards

DAIDS Guidelines for Good Clinical Laboratory Practice Standards DAIDS Guidelines for Public Health Services National Institutes of Health Bethesda, Maryland 20892 www.nih.gov Dear Site Principal Investigator and Laboratory Director: All National Institutes of Health,

More information

Site Initiation and Close Out (Sponsored Clinical Trials)

Site Initiation and Close Out (Sponsored Clinical Trials) Site Initiation and Close Out (Sponsored Clinical Trials) Standard Operating Procedure Office of Health and Medical Research Queensland Health SOP reference: 008 Version number: 1 Effective date: 01 June

More information

1/30/2013. Agenda. Electronic Signatures/ Informed Consent

1/30/2013. Agenda. Electronic Signatures/ Informed Consent 2013 UC Compliance & Audit Symposium Recordkeeping Matters: Part 11 Compliance Rachel Nosowsky ~ Acting Deputy General Counsel Rachel.Nosowsky@ucop.edu ~ (510) 987-9407 Agenda Electronic Signatures/Informed

More information

ICH CRA Certification Guide March 2009

ICH 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 information

Version Date: 03/17/2008 Page 1 of 8

Version 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 information

MANUAL OF PROCEDURES

MANUAL OF PROCEDURES Resource for Clinical Investigation in Blood and Marrow Transplant MANUAL OF PROCEDURES Version 1.0 dated September 27, 2007 CENTER FOR INTERNATIONAL BLOOD & MARROW TRANSPLANT RESEARCH National Marrow

More information

This policy applies to all clinical research conducted at Beaumont Health System.

This 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 information

Claim of Exemption Form Page 1 of 6

Claim of Exemption Form Page 1 of 6 Claim of Exemption Form Page 1 of 6 Principal Investigator: Phone: Project or Protocol Title: Contact Person: Address: Phone: Fax: E-mail: Copy of Principal Investigator s CV attached SPONSOR / FUNDING

More information

Objectives. The Paper Tells the Story

Objectives. 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 information

SUMMARY OF CHANGES INCLUDED IN THE FULL PROTOCOL AMENDMENT OF:

SUMMARY OF CHANGES INCLUDED IN THE FULL PROTOCOL AMENDMENT OF: SUMMARY OF CHANGES INCLUDED IN THE FULL PROTOCOL AMENDMENT OF: IMPAACT P1026s Pharmacokinetic Properties of Antiretroviral and Related Drugs During Pregnancy and Postpartum (DAIDS Document ID 10040) IND

More information

Attachment B HIPAA-P03 Instructions for Completing IU s Authorization for Research Purposes

Attachment B HIPAA-P03 Instructions for Completing IU s Authorization for Research Purposes Attachment B HIPAA-P03 Instructions for Completing IU s Authorization for Research Purposes The HIPAA Privacy Rule generally prohibits health care providers from using or releasing protected health information

More information

AAHRPP Standards. Investigator Responsibilities for Research Involving Human Subjects

AAHRPP Standards. Investigator Responsibilities for Research Involving Human Subjects AAHRPP Standards Investigator Responsibilities for Research Involving Human Subjects Regulatory Landscape 2 AAHRPP OHRP FDA Pennington Louisiana Laws The Association for the Accreditation of Human Research

More information

QUALITY CONTROL AND QUALITY ASSURANCE IN CLINICAL RESEARCH

QUALITY 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 information

HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA CONSENT TO PARTICIPATE IN A RESEARCH STUDY AND RESEARCH SUBJECT HIPAA AUTHORIZATION

HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA CONSENT TO PARTICIPATE IN A RESEARCH STUDY AND RESEARCH SUBJECT HIPAA AUTHORIZATION CONSENT TO PARTICIPATE IN A RESEARCH STUDY AND RESEARCH SUBJECT HIPAA AUTHORIZATION Protocol Title: A5322, Version 2.0, 01/28/15 Long-term Follow-up of Older HIV-infected Adults in the ACTG: Addressing

More information

Principal Investigator and Sub Investigator Responsibilities

Principal 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 information

Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues

Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues This guidance represents

More information

Data Management in Clinical Trials

Data 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 information

The Importance of Following the PROTOCOL in Clinical Trials

The 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 information

Where Are all the Patients? Recruitment and Advertising for Clinical Trials or How to Make Your Numbers Without Losing Your Mind

Where Are all the Patients? Recruitment and Advertising for Clinical Trials or How to Make Your Numbers Without Losing Your Mind Where Are all the Patients? Recruitment and Advertising for Clinical Trials or How to Make Your Numbers Without Losing Your Mind Carol Breland, MPH, RRT, RCP NC TraCS Research Recruitment Director Learning

More information

Signature Requirements for the etmf

Signature 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 information

Data Management Unit Research Institute for Health Sciences, Chiang Mai University

Data 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 information

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB)

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB) March 1, 2006 M E M O R A N D U M F O R R E C O R D TO: FROM: SUBJECT: Deans Department Chairs Principal Investigators Brian Herman, Ph.D. Vice President for Research Investigator responsibilities for

More information

CHAPTER 7 QUALITY ASSESSMENT

CHAPTER 7 QUALITY ASSESSMENT CHAPTER 7 QUALITY ASSESSMENT Chapter 7 QUALITY ASSESSMENT 7.1 OVERVIEW OF CBB-SPECIFIC QUALITY ASSURANCE/QUALITY CONTROL PROGRAM An extensive, site-specific Quality Assurance/Quality Control (QA/QC) program

More information

Audit Findings in Clinical Trials: Avoiding the Pitfalls. Kris West AVP A.V.P. & Director Office of Research Compliance

Audit Findings in Clinical Trials: Avoiding the Pitfalls. Kris West AVP A.V.P. & Director Office of Research Compliance Audit Findings in Clinical Trials: Avoiding the Pitfalls Kris West AVP A.V.P. & Director Office of Research Compliance Top Clinical Trial Audit Finding Areas Informed Consent Process & Documentation Accurate

More information

If you are signing for a minor child, you refers to your child throughout the consent document.

If you are signing for a minor child, you refers to your child throughout the consent document. CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY Adult Patient or Parent, for Minor Patient INSTITUTE: National Cancer Institute PRINCIPAL INVESTIGATOR: Raffit Hassan, M.D. STUDY TITLE: Tissue Procurement

More information

How to Run Clinical Trials in Private Practice

How 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 information

Guidance to Research Ethics Committees on Initial Facility Assessment

Guidance to Research Ethics Committees on Initial Facility Assessment Guidance to Research Ethics Committees on Initial Facility Assessment Introduction One of the roles of a Research Ethics Committee is to provide an opinion on a proposed study, based on the suitability

More information

STANDARD OPERATING PROCEDURE NO. CM.13-00 - 00

STANDARD OPERATING PROCEDURE NO. CM.13-00 - 00 STANDARD OPERATING PROCEDURE NO. CM.13-00 - 00 Version date: Effective Date: Replaces SOP No.: 1 5 January 20 13 15 February 20 13 Approved by: Date No: CM.13 00 00 Effective Date: 15 February 2013 Version

More information

The Elements of Success. Conducting Cancer Clinical Trials. A Guide. A guide to conducting Cancer Clinical Trials

The Elements of Success. Conducting Cancer Clinical Trials. A Guide. A guide to conducting Cancer Clinical Trials A guide to conducting Cancer Clinical Trials The Elements of Success Conducting Cancer Clinical Trials A Guide Preface In June 2005, The Lewin Group, in partnership with Lovett-Collins Associates, was

More information

GLP 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 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 information

Human Research Protection Program Good Clinical Practice Guidance for Investigators Investigator & Research Staff Responsibilities

Human 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 information

Policies, SOPs, MOPs, Protocols

Policies, SOPs, MOPs, Protocols PREP Course #6: Policies, SOPs, MOPs, Protocols OH MY! Presented by: Tina Chuck, MPH Manager, Research Policy and Training Research Administration North Shore-LIJ Health System E-mail: tchuck@nshs.edu

More information

John Keel, CPA State Auditor. An Audit Report on Inspections of Compounding Pharmacies at the Board of Pharmacy. August 2015 Report No.

John Keel, CPA State Auditor. An Audit Report on Inspections of Compounding Pharmacies at the Board of Pharmacy. August 2015 Report No. John Keel, CPA State Auditor An Audit Report on Inspections of Compounding Pharmacies at the Board of Pharmacy Report No. 15-039 An Audit Report on Inspections of Compounding Pharmacies at the Board of

More information

PREP Course #27: Medical Device Clinical Trial Management

PREP 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 information

CTSU Operational ET-CTN. April 21, 2013

CTSU Operational ET-CTN. April 21, 2013 CTSU Operational Support Services for the ET-CTN Early Drug Development tmeeting April 21, 2013 1 Presentation Agenda Describe the Objectives of Consolidating ET- CTN Support Services Provide an Overview

More information