managing or activities.
|
|
- Gervais West
- 6 years ago
- Views:
Transcription
1 STANDARD OPERATING PROCEDURE Clinical Research Monitoring TITLE: Site Initiation Visit TITLE: Site Initiation Visit 1. PURPOSE SOP Number: Version: 1.0 MICHR CRM MON 002 Effective Date: 19Dec This Standard Operating Procedure (SOP) describes the procedures, process, and responsibilities for conducting a Site Initiation Visit (SIV) for clinical trials monitored by MICHR, unless otherwise specified in the Monitoring Plan by the study team. The procedures outlined in this document are in place to ensure uniformity and consistency in monitoring procedures, regardless of the location or individual monitor, and to ensure the rights and welfare of human research participants engaged in studies monitored by MICHR are protected. 2. SCOPE 2.1 The procedures described in this document outline the process of f conducting SIVs, which are separate in scope from Interim Monitoring Visits andd Study Close Out visit are detailed throughout. 2.2 This SOP applies to all qualified colleagues or contractors of MICHR involved in managing or conducting SIV activities. Visits. The purpose, procedures, and documentation for this type of monitoring 3. POLICY This SOP supports the International Conference on Harmonization (ICH) and U.S. Food and Drug Administration (FDA) or other State, local, and institutional regulatory requirements for human subject research nvolving investigational agents and devices. 4. DEFINITIONS Blinding: A procedure in which one or more parties to the trial are kept unaware of subject treatment assignment(s). Monitoring Plan: A document that describess the study specific monitoring to be performed. It includes frequency of visits and data points to be monitored onsite and/or remotely. Clinical Trial/Study: Any investigation in human subjectss intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effectss of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/orr to study absorption, distribution, metabolism, and excretion of an investigational product( (s) with the object of ascertaining its safety and/or efficacy. Approver Name: Cathy Radovich, Dir. CRM Next Review Date: 19Dec2015 Last Reviewed Date: N/A Page 1 of 5
2 STANDARD OPERATING PROCEDURE Clinical Research Monitoring TITLE: Site Initiation Visit SOP Number: Version: 1.0 MICHR CRM MON 002 Effective Date: 19Dec2013 Good Clinical Practice (GCP): A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinicall trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. Institutional Review Board (IRB), Independent Ethics Committee (IEC), Human Subjects Review Committee (HSRC) or Ethical Review Board (ERB): a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects thatt are scientific, ethical, and regulatory. Monitoring: Monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, and the applicable regulatory requirements. Monitoring Report: A Monitoring Report is a written report from the monitor to the sponsor after each site visit and/ /or other trial related communication according to the sponsor ss SOPs. Protocol: A document that describes the objective(s), design, conduct, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the scientific background and rationale for the trial, but these could be provided inn other protocol referenced documents. Throughout ICH GCP Guidelines, the term protocol referss to protocol and protocol amendments. Sponsor: An individual (Investigator), company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. Sponsor Investigator: An individual who both initiates and conducts an investigation, and maintains the obligations of both a sponsor and an investigator. 5. RESPONSIBILITIES 5.1 Responsibilities of the The Research Monitor or qualified designeee is responsible for the arranging, conducting, and documentation of the SIV in accordance with the Monitoring Plan, this SOP (unless otherwise agreed) ), and regulatory requirements. Approver Name: Cathy Radovich, Dir. CRM Next Review Date: 19Dec2015 Last Reviewed Date: N/A Page 2 of 5
3 STANDARD OPERATING PROCEDURE Clinical Research Monitoring TITLE: Site Initiation Visit SOP Number: Version: 1.0 MICHR CRM MON 002 Effective Date: 19Dec Responsibilities of the Monitoring Manger: The Monitoring Manager or designee is responsible for the review and approval of the SIV report. The report review and approval will be designated to another qualified colleague if the Monitoring Manager was the person that conducted the visit. 6. PROCEDURE 6.1 Process Overview An SIV is arranged, conducted, and documented by the Research Monitor in order to verify regulatory compliance and readiness too begin study enrollment. The conduct of an SIV occurs in three stages: Preparing for the SIV Conducting the SIV Following up after the SIV 6.2 Preparing for the Interim Monitoring Visit The monitor, or designee, will ensure that visit arrangements are made with the investigational site. The monitor should attempt to schedule the visit at a time when key staff related to the investigation are available. Potential attendees may include the PI/Co I, research nurse, study coordinator, data manager,, pharmacist (if applicable) ), and Sponsor representative(s) (if applicable) The monitor, or designee, will book any needed travel in compliance with standing University of Michigan policies and procedures as well as any guidance issued by MICHR; and if needed, confirm travel plans prior to booking with the study manager, study sponsor, or other designated key personnel responsible for oversight of study budgetary expenditures The monitor, or designee, will send a confirmation communication, which may include the monitor s expected itinerary as well as a list of items necessary for the monitoring visit, to the site PI, study coordinator, study manager, and other designated study team members once a time and date for the monitoring visit has been established In some cases, the monitor, or designee, mayy create presentations or handouts to help facilitate the SIV. Possible topics for inclusionn in the presentations and/or handouts are: Good Clinical Practice overview, protocol review, study activities and schedule of events, safety reporting, and the study Monitoring Plan. 6.3 Conducting the IMV Sign the Site Initiationn Visit Log. Approver Name: Cathy Radovich, Dir. CRM Next Review Date: 19Dec2015 Last Reviewed Date: N/A Page 3 of 5
4 STANDARD OPERATING PROCEDURE Clinical Research Monitoring TITLE: Site Initiation Visit SOP Number: Version: 1.0 MICHR CRM MON 002 Effective Date: 19Dec Ensure that all required essential documents are present in the Investigator Regulatory file Review GCP standards and the Monitoring Plan Discuss study logisticss to ensure site preparedness for enrollment If applicable, check for the receipt, security, and proper storage of the investigational product, and review dispensing and accountability procedures Confirm that the site facilities and study personnel are adequate for the conduct of the study Document any concerns or action items. 6.4 Following up After the IMV A follow up communication will be sent to the Sponsor and site as soon as possible following the final day of the visit addressing any action items identified during the visit The Research Monitor will complete an SIV Report (Appendix A) and submit the draft to the Monitoring Manager or designee for review The Monitoring Manager will review the draft report and return the draft to the Research Monitor for finalization The SIV Report should be finalized with appropriate attachments (attachments may include the confirmation communication, Essential Document Checklist, Training Log, etc.) and distributed to appropriate study personnel, including pharmacist (if applicable) within 15 business days of the last day of the SIV A copy of the SIV report should be archived perr the Monitoring Plan. 7. REFERENCES FDA 45 CFR 46 and 21 CFR CFR CFR CFR 812 Protection of Human Subjects Institutional Review Boards Investigational New Drug (IND) Investigational Device Exemptions (IDE) ICH Consolidated Guideline E6 (R1) Approver Name: Cathy Radovich, Dir. CRM Next Review Date: 19Dec2015 Goodd Clinical Practice (GCP) Last Reviewed Date: N/A Page 4 of 5
5 STANDARD OPERATING PROCEDURE Clinical Research Monitoring TITLE: Site Initiation Visit SOP Number: Version: 1.0 MICHR CRM MON 002 Effective Date: 19Dec APPENDICES Appendix A: Site Initiation Visit Report Template REVISION HISTORY Date Author(s) Remarks Version 09 Sep 2013 Amanda Phelps Final version. 1.0 Approver Name: Cathy Radovich, Dir. CRM Next Review Date: 19Dec2015 Last Reviewed Date: N/A Page 5 of 5
6 Attendees: Trial Status (at this visit) Not Started In Progress Completed Discontinued Subject Enrollment Status (Cumulative) ICF Signed Screen Baseline Enrolled Ongoing Failed (if applicable) (Randomized) (Active) Withdrawn Completed Select the appropriate response(s) for the discussion/monitoring items listed below. Provide comments as necessary. Conduct 1. Conduct trial according to the approved Protocol, Investigator s Agreement, GCP, IRB policy and Federal regulations? YES NO N/A 2. Compliance with the protocol and handling of protocol deviations? 3. Recruitment and enrollment process? 4. Instructions on study-specific procedures, windows, and timelines? 5. Randomization procedures? 6. Informed Consent procedures? 7. Progress reports to EC/IRB?
7 Select the appropriate response(s) for the discussion/monitoring items listed below. Provide comments as necessary. YES NO N/A 8. Procedures for subject/study discontinuation? 9. Appropriate storage of study data and supplies Investigational Product 10. Current Investigator Brochure/Instructions For Use 11. Was the study drug and storage area inspected? 12. Were ordering and control procedures discussed? 13. Were dispensing, dose modification, accountability discussed? 14. Were storage conditions discussed? 15. Was return and destruction discussed? 16. Is the expiry date compatible with the study duration? 17. Are there sufficient study drug supplies available and stored appropriately? 18. Have unblinding procedures been discussed?
8 Select the appropriate response(s) for the discussion/monitoring items listed below. Provide comments as necessary. YES NO N/A Adverse Events and Serious Adverse Events 19. Description of Adverse Events and Serious Adverse Events? 20. Reporting requirements? 21. Documentation of Adverse and Serious Adverse Events? 22. Reporting regular safety updates, safety alerts and (S)AEs to EC/IRB in accordance to local requirements? Case Report Forms 23. Completion of the CRFs and database entry (if applicable)? 24. Data discrepancies and query resolution? 25. Monitoring frequency as per monitoring plan? Monitoring 26. Monitoring procedures and objectives as per monitoring plan? Audit 27. The investigational site s previous audit experience and outcomes?
9 Select the appropriate response(s) for the discussion/monitoring items listed below. Provide comments as necessary. 28. Procedure for contacting the Sponsor in the event of notification of audit by regulatory authority? YES NO N/A Facility/Laboratory 29. Were all required lab supplies present at the site? 30. Are the central laboratory ranges current? 31. Are the central laboratory certificates current? Biological Samples 32. Has the storage area been inspected? 33. Is site staff familiar with sample taking, labeling and storage procedures? 34. Is site staff familiar with the sampling handling and shipment procedure? 35. Is freezer log or other required temperature controls available and adequate? Study File 36. Was the investigator study file reviewed?
10 Select the appropriate response(s) for the discussion/monitoring items listed below. Provide comments as necessary. YES NO N/A 37. Are all required documents filed in the Investigator Study File? 38. Has document storage and archiving been discussed and agreed to? Activation 1. In the opinion of the monitor, is the study site ready to begin enrollment? Yes No Additional Narrative (as needed) Item No. Action Item By Whom Status Ongoing Resolved Ongoing Resolved Ongoing Resolved Ongoing Resolved Ongoing Resolved Prepared by: Signature: Printed Name: Date: Reviewed by: Signature: Printed Name: Date:
11
General Administration GA STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility
General Administration GA 102.01 STANDARD OPERATING PROCEDURE FOR Sponsor Responsibility and Delegation of Responsibility Approval: Nancy Paris, MS, FACHE President and CEO (17 July 2014) (Signature and
More informationGeneral Administration GA STANDARD OPERATING PROCEDURE FOR Document Development and Change Control
General Administration GA 104.00 STANDARD OPERATING PROCEDURE FOR Document Development and Change Control Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature and Date) Approval:
More informationStudy Start-Up SS STANDARD OPERATING PROCEDURE FOR PRE-STUDY SITE VISIT (PSSV)
Replaces previous version 203.01: 01 July 2014 Study Start-Up SS 203.01 STANDARD OPERATING PROCEDURE FOR PRE-STUDY SITE VISIT (PSSV) Approval: Nancy Paris, MS, FACHE President and CEO 24 May 2017 (Signature
More informationThe GCP Perspective on Study Monitoring
The GCP Perspective on Study Monitoring Heidi Judge, CCRP Sr. Clinical Trials Project Manager Clinical Trials Network and Institute Massachusetts General Hospital 1 Overview Monitoring Basics Who, What,
More informationStandard Operating Procedures
Clinical Monitoring and Site Verification Procedure Overview To define the standard procedures for preparation and documentation of site visits for clinical monitoring and spoke verification for any NETT
More informationNN SS 401 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR SITE SELECTION AND QUALIFICATION
NN SS 401 NEURONEXT NETWORK STANDARD OPERATING PROCEDURE FOR SITE SELECTION AND QUALIFICATION SOP: NN SS 401 Version No.: 2.0 Effective Date: 21Oct2016 SITE SELECTION AND QUALIFICATION Supercedes Document:
More informationGeneral Administration GA STANDARD OPERATING PROCEDURE ON SOPs: Preparing, Maintaining and Training
Replaces previous version 101.00: 01 April 2012 General Administration GA 101.01 STANDARD OPERATING PROCEDURE ON SOPs: Preparing, Maintaining and Training Approval: Nancy M. Paris, MS, FACHE President
More informationSTUDY INFORMATION POST-IRB APPROVAL FDA DEVICE (IDE) SPONSOR AND INVESTIGATOR RESPONSIBILITY (21 CFR 812)
POST-IRB APPROVAL FDA DEVICE (IDE) SPONSOR AND INVESTIGATOR RESPONSIBILITY (21 CFR 812) Purpose: Investigators who initiate and submit an IDE application to the FDA assume the responsibilities of both
More informationTrial Management: Trial Master Files and Investigator Site Files
Title: Outcome Statement: Written By: Trial Management: Trial Master Files and Investigator Site Files Staff working on research studies in NSFT will be informed about the requirements of setting up and
More informationDocument Title: Site Selection and Initiation for RFL Sponsored Studies Document Number: 026
Document Title: Site Selection and Initiation for RFL Sponsored Studies Document Number: 026 Version: 1.1 Ratified by: Committee Date ratified: 03/10/2017 Name of originator/author: Directorate: Department:
More informationResearch Governance Framework 2 nd Edition, Medicine for Human Use (Clinical Trial) Regulations 2004
Title: Outcome Statement: Research Auditing and Monitoring Procedures Researchers in the Trust and research partners will be informed about the requirements and procedures involved in research audit and
More informationGood Clinical Practice: A Ground Level View
Good Clinical Practice: A Ground Level View Jeanna Julo, BA, BA, CCRP Assistant Director, Clinical Data Management & Quality Controls, Auditing & Training Clinical Research Administration Research Institute,
More informationACTIONS/PSOP/001 Version 1.0 Page 2 of 6
1. The purpose of the Pharmacy Site File To enable the designated trust pharmacy to fulfil its role and exercise appropriate control over all aspects of study medication handling, an accurately maintained
More information4.2. Clinical Trial Monitor (or Monitor): The person responsible for monitoring the data on behalf of the sponsor or contract research organization.
SOP #: MON-101 Page: 1 of 6 1. POLICY STATEMENT: The DF/HCC understands that external sponsors are required to monitor the progress of clinical investigations and ensure appropriate research data collection
More informationStudy Monitoring Plan Template
Study Monitoring Plan Template Sponsor Reference Number: Study Title: Principal Investigator: Study Centre: The Sponsor risk assessment form and the trial risk based monitoring strategy appendices 2 &
More informationDocument Title: Research Database Application (ReDA) Document Number: 043
Document Title: Research Database Application (ReDA) Document Number: 043 Version: 1.1 Ratified by: Committee Date ratified: 23 February 2017 Name of originator/author: Rachel Fay Directorate: Medical
More informationInitially Submitted on 11/24/2009 Final Submission By Test6 CA on 11/24/2009 1:51 PM Approval By student13 student13 on 11/24/2009 1:52 PM Attendees
Location: Los Angeles Research Institute: Los Angeles, CA Investigation Product/Test Article: Laftr Visit Mechanism: On-site Initially Submitted on 11/24/2009 Final Submission By Test6 CA on 11/24/2009
More informationDocument Title: File Notes. Document Number: 024
Document Title: File Notes Document Number: 024 Version: 1.2 Ratified by: Committee Date ratified: 03/10/2017 Name of originator/author: Directorate: Department: Name of responsible individual: Rachel
More informationDocument Title: Research Database Application (ReDA) Document Number: 043
Document Title: Research Database Application (ReDA) Document Number: 043 Version: 1 Ratified by: Committee Date ratified: 30 September 2014 Name of originator/author: Directorate: Department: Name of
More informationSite Closedown Checklist for UoL Sponsored CTIMP Studies
Site Closedown Checklist for UoL Sponsored CTIMP Studies Site Information Site: Study Title: UoL study number: Centre name: Investigator: Date of Visit: Date of Report Date Responses due by: List of site
More informationSTANDARD OPERATING PROCEDURE FOR PHLEBOTOMY ROOM SOPs: Preparing, Maintaining and Training
STANDARD OPERATING PROCEDURE FOR PHLEBOTOMY ROOM SOPs: Preparing, Maintaining and Training SOP Number: Phleb 100.03 Version Number & Date: 3 rd version; 28 Feb 2011 Superseded Version Number & Date (if
More informationHertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust
Hertfordshire Hospitals R&D Consortium Incorporating West Herts Hospitals NHS Trust and East & North Herts NHS Trust STANDARD OPERATING PROCEDURE FOR RESEARCH Definition of Responsibilities for Externally
More informationDocument Number: 006. Version: 1. Date ratified: Name of originator/author: Heidi Saunders, Senior Portfolio Coordinator
including Roles and Responsibilities for the Conduct of Research Studies and Clinical Trials including CTIMPs (Clinical Trials of Investigational Medicinal Products) Document Number: 006 Version: 1 Ratified
More informationDr. R. Sathianathan. Role & Responsibilities of Principal Investigators in Clinical Trials. 18 August 2015
18 August 2015 Role & Responsibilities of Principal Dr. R. Sathianathan Professor of Psychiatry, SRMC, Porur & Former Director, Institute of Mental Health, Chennai Principal Investigators & GOOD CLINICAL
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Routine Project Audit SOP Number: 6 Version Number: 2.0 Supercedes: 1.0 Effective date: August 2013 Review date: August
More informationGCP: Investigator Responsibilities. Susan Tebbs Nicola Kaganson
GCP: Investigator Responsibilities Susan Tebbs Nicola Kaganson Investigator Responsibilities Qualifications & agreements Resources Responsibilities to the subject Ethics The protocol The IMP & randomisation
More informationSARASOTA MEMORIAL HOSPITAL CANCER RESEARCH PROGRAM POLICY
PS1006 SARASOTA MEMORIAL HOSPITAL CANCER RESEARCH PROGRAM POLICY TITLE: Satellite Site Management Plan Job Title of Reviewer: POLICY #: EFFECTIVE DATE: REVISED DATE: POLICY TYPE: Elizabeth Carr, R.N.,
More informationInvestigator-Initiated Studies: When you re the Sponsor. Cheri Robert & Tammy Mah-Fraser
Investigator-Initiated Studies: When you re the Sponsor Cheri Robert & Tammy Mah-Fraser ACRC Clinical Research Conference Edmonton, AB October 15, 2014 Session Objectives Define roles of the investigator,
More informationGCP INSPECTION CHECKLIST
(This list is not all inclusive; item may be added &/or deleted as per the Study/Site/Sponsor/Lab) I. General. Name and address of the clinical trial site Tel. No. & e- mail:. Date of Inspection. Inspection
More informationOffice of the Vice Chancellor for Research Supervisory Responsibilities of Clinical Investigators
Office of the Vice Chancellor for Research Supervisory Responsibilities of Clinical Investigators Patricia Fischer, RN, CCRP Investigator Responsibilities FDA Draft Guidance May 2007 Clarifies FDA s expectations,
More informationCLOSE OUT VISIT REPORT (NO CRF TO MONITOR)
Date: Page: 1 of 8 CLOSE OUT VISIT REPORT (NO CRF TO MONITOR) Protocol: PI Name: PI Address: Date of Visit: Monitor(s): Other Sponsor Personnel Present: Site Personnel Present at Visit (include names and
More informationEffective Date: April 2014 Revision: September 29, Executive Chair, Co-Chairs, NSHA REB Members, REB Office Personnel, Researchers.
TITLE: Standard Operating Procedure (SOP) External Inspections or Audits NUMBER: NSHA REB-SOP-9-002 Effective Date: April 2014 Revision: September 29, 2017 Applies To: Executive Chair, Co-Chairs, NSHA
More information12.0 Investigator Responsibilities
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, the investigational
More informationDocumenting the Story of a Clinical Trial: Concept to CAPA. Lori T. Gilmartin Gilmartin Consulting LLC
Documenting the Story of a Clinical Trial: Concept to CAPA Lori T. Gilmartin Gilmartin Consulting LLC The regulations represent the floor while ethical thinking is the sky. Dr. Thomas Moore Boston University
More informationStandard Operating Procedure. Essential Documents: Setting Up a Trial Master File. SOP effective: 19 February 2016 Review date: 19 February 2018
Standard Operating Procedure SOP number: SOP full title: SOP-JRO-06-003 Essential Documents: Setting Up a Trial Master File SOP effective: 19 February 2016 Review date: 19 February 2018 SOP author signature:
More informationSOP-QA-28 V2. Approver: Prof Maggie Cruickshank, R&D Director Approver: Prof Steve Heys, Head of School
Title: Effective Date: 1-4-17 Review Date: 1-4-20 Author: Richard Cowie, QA Manager QA Approval: Richard Cowie, QA Manager Approver: Prof Maggie Cruickshank, R&D Director Approver: Prof Steve Heys, Head
More informationUnofficial copy not valid
Page 2 (9) CONTENTS 1. PURPOSE... 3 2. DEFINITIONS... 3 3. RESPONSIBILITY... 3 4. INVESTIGATOR SELECTION... 3 4.1 Identification of Investigator s... 3 4.2 Initial Contacts... 4 4.3 Distribution of Pre-Study
More informationBIMO SITE AUDIT CHECKLIST
Item AUTHORITY AND ADMINISTRATION FOR STUDIES INVOLVING HUMAN DRUGS, BIOLOGICS AND DEVICES 1. Compare the Investigator Agreement with the information provided by the assigning Center. Auditor will check
More informationResearch Audits PGR. Effective: 12/04/2013 Reviewed: 12/04/2015. Name of Associated Policy: Palmetto Health Administrative Research Review
Effective: 12/04/2013 Reviewed: 12/04/2015 Name of Associated Policy: Palmetto Health Administrative Research Review Definitions Responsible Positions Equipment Needed Procedure Steps, Guidelines, Rules,
More informationDocument Title: Version Control of Study Documents. Document Number: 023
Document Title: Version Control of Study Documents Document Number: 023 Version: 1.1 Ratified by: Committee Date ratified: 03 OCT 2017 Name of originator/author: Directorate: Department: Name of responsible
More information16 STUDY OVERSIGHT Clinical Quality Management Plans
16 STUDY OVERSIGHT... 1 16.1 Clinical Quality Management Plans... 1 16.2 Site Visits by the LOC, SDMC and LC... 2 16.3 Protocol Team Oversight... 3 16.4 Oversight of Reportable Protocol Deviations... 3
More informationTrial set-up, conduct and Trial Master File for HEY-sponsored CTIMPs
R&D Department Trial set-up, conduct and Trial Master File for HEY-sponsored CTIMPs Hull And East Yorkshire Hospitals NHS Trust 2010 All Rights Reserved No part of this document may be reproduced, stored
More informationGood Documentation Practices. Human Subject Research. for
Good Documentation Practices for Human Subject Research Bridget M. Psicihulis, RHIA, CCRC Quality Improvement Unit Coordinator Human Research Protection Program Wheaton Franciscan Healthcare (last updated
More informationVCU Clinical Research Quality Assurance Assessment
VCU Clinical Research Quality Assurance Assessment Principal Investigator Protocol Title Protocol IRB Number Name of Person Completing Assessment Date Assessment was Completed The goal of this assessment
More informationStandard Operating Procedure (SOP) Research and Development Office
Standard Operating Procedure (SOP) Research and Development Office Title of SOP: Delegated Responsibilities in Research Projects SOP Number: 11 Version Number: 2.0 Supercedes: 1.0 Effective date: August
More informationAN OVERVIEW OF CLINICAL STUDY TASKS AND ACTIVITIES
1 AN OVERVIEW OF CLINICAL STUDY TASKS AND ACTIVITIES Key Clinical Study Tasks and Activities 2 Discussion of Key Tasks and Activities 3 Development of the Clinical Protocol and Study Materials 3 Qualification
More informationDocument Title: Document Number:
including Document Title: Document Number: Version: 2.0 Ratified by: Committee Date ratified: 25/01/2018 Name of originator/author: Directorate: Department: Name of responsible individual: Rachel Fay Corporate
More informationSOP: New Revised Reviewed Effective Date: 08 October Approved by : Supervisor/Manager Risk/Ethics Sr. Mgmt Committees Board/Councils
Title: Assessment of Study Feasibility Manual: RI MUHC Policies and Procedures Human Research SOPs Originating Dept/ Service: RI MUHC Division of Clinical Research SOP: New Revised Reviewed Effective Date:
More informationHIC Standard Operating Procedure. For-Cause Audits of Human Research Studies
HIC Standard Operating Procedure For-Cause Audits of Human Research Studies Background As part of the Wayne State University (WSU) Human Investigation Committee s (HIC) Human Research Protection Program,
More informationMHRA Findings Dissemination Joint Office Launch Jan Presented by: Carolyn Maloney UHL R&D Manager
MHRA Findings Dissemination Joint Office Launch Jan. 2012 Presented by: Carolyn Maloney UHL R&D Manager Purpose of presentation To feed back abridged findings from March 2011 MHRA Statutory Systems Inspection
More informationRegulatory Binder Checklist for FDA-Regulated Sponsor/Sponsor-Investigator Studies
Regulatory Binder Checklist for FDA-Regulated Sponsor/Sponsor-Investigator Studies DIRECTIONS: 1. The purpose of a regulatory binder is to assure that all essential elements are maintained in an organized
More information20 STEPS FROM STUDY IDEA INCEPTION TO PUBLISHING RESEARCH/ Evidence-Based Practice
20 STEPS FROM STUDY IDEA INCEPTION TO PUBLISHING RESEARCH/ Evidence-Based Practice Nursing Research/ Evidence-Based Practice Checklist (Version 31 January 2012) Specify the date in the left column when
More informationPROMPTLY REPORTABLE EVENTS
PROMPTLY REPORTABLE EVENTS PURPOSE AND SCOPE To define the structure and responsibility for reporting unanticipated problems that occurs during the conduct of research. APPLICABLE REGULATIONS Policy II.02
More informationSOP MONITORING & OVERSIGHT OF RESEARCH ACTIVITY. Contact Jess Bisset, Research Operations Manager x20227
SOP MONITORING & OVERSIGHT OF RESEARCH ACTIVITY SETTING FOR STAFF QUERIES Trust wide All staff involved in research Contact Jess Bisset, Research Operations Manager x20227 Guidance 1. Introduction In accordance
More informationPLATELET-ORIENTED INHIBITION ISCHEMIC STROKE (POINT) MONITORING PLAN IN NEW TIA AND MINOR. Version 2.0 Updated 11 May 2017
PLATELET-ORIENTED INHIBITION IN NEW TIA AND MINOR ISCHEMIC STROKE (POINT) MONITORING PLAN Version 2.0 Updated 11 May 2017 Monitoring Plan Table of Contents 1.0 Introduction... 4 2.0 Purpose... 4 3.0 Review
More informationStandard Operating Procedure CPFT/SOP006 GCP Training Procedure for Clinical Trial Staff
Standard Operating Procedure CPFT/SOP006 GCP Training Procedure for Clinical Trial Staff Author: Sponsor/Executive: Responsible committee: Ratified by: Consultation & Approval: (Committee/Groups which
More informationSTANDARD OPERATING PROCEDURE SOP 715. Principles of Clinical Research Laboratory Practice
STANDARD OPERATING PROCEDURE SOP 715 Principles of Clinical Research Laboratory Practice Version 1.2 Version date 13.11.2015 Effective date 24.04.2017 Number of pages 9 Review date June 2018 Author Role
More informationStandard Operating Procedure INVESTIGATOR OVERSIGHT OF RESEARCH. Chief and Principal Investigators of research sponsored and/or hosted by UHBristol
Standard Operating Procedure INVESTIGATOR OVERSIGHT OF RESEARCH SETTING FOR STAFF ISSUE Trustwide Chief and Principal Investigators of research sponsored and/or hosted by UHBristol Oversight of research
More informationTITLE: Reporting Adverse Events SOP #: RCO-204 Page: 1 of 5 Effective Date: 01/31/18
SOP #: RCO-204 Page: 1 of 5 1. POLICY STATEMENT: The research team is responsible for recognizing changes in subject health that may qualify as adverse events, classifying those results as defined in the
More informationLOUIS STOKES CLEVELAND VA MEDICAL CENTER RESEARCH SERVICE Human Subject Protection Standard Operating Procedure (SOP)
LOUIS STOKES CLEVELAND VA MEDICAL CENTER RESEARCH SERVICE Human Subject Protection Standard Operating Procedure (SOP) Effective Date: February 7, 2013 SOP Title: Study Monitoring Visits - Process for Access
More informationETHICS COMMITTEE: ROLE, RESPONSIBILITIES AND FUNCTIONS K.R.CHANDRAMOHANAN NAIR DEPARTMENT OF ANATOMY, MEDICAL COLLEGE, THIRUVANANTHAPURAM
ETHICS COMMITTEE: ROLE, RESPONSIBILITIES AND FUNCTIONS K.R.CHANDRAMOHANAN NAIR DEPARTMENT OF ANATOMY, MEDICAL COLLEGE, THIRUVANANTHAPURAM Outline Introduction Composition Responsibilities of IEC Responsibilities
More informationJoint R&D Support Office SOP S-2011 UHL
UNIVERSITY OF LEICESTER & UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST JOINT RESEARCH & DEVELOPMENT SUPPORT OFFICE STANDARD OPERATING PROCEDURES Joint R&D Support Office SOP S-2011 UHL Site Initiation for
More informationEffective Date: 11/09 Policy Chronicle:
Title: Investigational Drug Service Functions Policy Type: Clinical Operations Replaces (supersedes): Title: N/A Policy Chronicle: Date Original Version of Policy was Effective: 09/06 Reviewer Signature:
More informationVersion Number: 004 Controlled Document Sponsor: Controlled Document Lead:
Chief Investigators and Principal Investigators in Research Policy CONTROLLED DOCUMENT CATEGORY: CLASSIFICATION: PURPOSE Controlled Document Number: Policy Governance To set out the responsibilities of
More informationDocument Title: Study Data SOP (CRFs and Source Data)
Document Title: Study Data SOP (CRFs and Source Data) Document Number: SOP047 Staff involved in development: Job titles only Document author/owner: Directorate: Department: For use by: RM&G Manager, R&D
More informationFDA Medical Device Regulations vs. ISO 14155
Vol. 11, No. 9, September 2015 Happy Trials to You FDA Medical Device Regulations vs. ISO 14155 By Shawn Kennedy Medical device clinical trials must comply with 21 CFR Parts 11 (Electronic Records), 50
More informationEMA Inspection Site perspective
EMA Inspection Site perspective Hermien Gous Wits RHI Shandukani Research Centre 27.09.2016 Cape Town Why were we inspected times? Pharmaceutical company applied for registration of the study drug in a
More informationStandard Operating Procedure (SOP) for Reporting Serious Breaches in Clinical Research
Standard Operating Procedure (SOP) for Reporting Serious Breaches in Clinical Research For Completion by SOP Author Reference Number PHT/RDSOP/002 Version V2.0 07 Apr 2016 Document Author(s) Document Reviewer(s)
More informationSTANDARD OPERATING PROCEDURE
STANDARD OPERATING PROCEDURE Title Reference Number Sponsorship SOP-RES-001 Version Number 3 Issue Date 29 th Sep 2016 Effective Date 10 th Nov 2016 Review Date 10 th Nov 2018 Author(s) Reviewer(s) Teresa
More informationBuilding Quality into Clinical Trials. Amy C. Hoeper, MSN, RN, CCRC, Quality Manager Cincinnati Children s Gamble Program for Clinical Studies
Building Quality into Clinical Trials Amy C. Hoeper, MSN, RN, CCRC, Quality Manager Cincinnati Children s Gamble Program for Clinical Studies Objectives Identify strategies for developing a Quality Management
More informationInvestigator Site File Standard Operating Procedure (SOP)
Investigator Site File Standard Operating Procedure (SOP) DOCUMENT CONTROL: Version: 1 Ratified by: Quality and Safety Sub Committee Date ratified: 30 January 2017 Name of originator/author: Research Nurse
More informationConducting Monitoring Visits for Investigator-Initiated Trials (IITs)
Conducting Monitoring Visits for Investigator-Initiated Trials (IITs) Clinical Research Coordinator Society (CRCS) Forum 25 July 2014 Xia Yu Clinical Research Associate Singapore Clinical Research Institute
More informationMonitoring Clinical Trials
This is a controlled document. The master document is posted on the JRCO website and any print-off of this document will be classed as uncontrolled. Researchers and their teams may print off this document
More informationSelf-Monitoring Tool
This form is designed for research personnel to use to assess their compliance with TTUHSC El Paso IRB policies and procedures, and federal regulations and guidance governing research with human subjects,
More informationRecord or Document Type Retention Period Relevant Legal Citation(s) IRB Records: Training Records;
TEXAS HEALTH RESOUCES Table 17-III. Record Retention Schedule Human Subject Research Records and Documents Approved by THR System Performance Council (SPC): 19 January 2010 Effective Date: October 14,
More informationGood Clinical Practice. Lisa de Blieck MPA CCRC Clinical Trials Coordination Center
Good Clinical Practice Lisa de Blieck MPA CCRC Clinical Trials Coordination Center Good Clinical Practice (GCP) An international standard for the design, conduct, performance, monitoring, auditing, recording,
More informationDocument Title: Investigator Site File. Document Number: 019
Document Title: Investigator Site File Document Number: 019 Version: 1.1 Ratified by: R&D Committee Date ratified: 03/10/2017 Name of originator/author: Directorate: Department: Name of responsible individual:
More informationMARKEY CANCER CENTER CLINICAL RESEARCH ORGANIZATION STANDARD OPERATING PROCEDURES SOP No.: MCCCRO-D
Page 1 of 8 MARKEY CANCER CENTER CLINICAL RESEARCH ORGANIZATION STANDARD OPERATING PROCEDURES SOP No.: Title: Data Safety and Monitoring Committee Administrative and Revision: N/A Revision Date: N/A Functional
More informationEthics Committee Composition Roles & Responsibilities. Dr Girish Dayma Dr Sanjay Juvekar KEM Hospital Research Centre Pune
Ethics Committee Composition Roles & Responsibilities Dr Girish Dayma Dr Sanjay Juvekar KEM Hospital Research Centre Pune Outline Introduction Composition Roles & Responsibilities Overview of amendment
More informationDANA-FARBER / HARVARD CANCER CENTER POLICIES FOR HUMAN SUBJECT RESEARCH TITLE:
POLICY #: EDU-100 Page: 1 of 5 1. POLICY STATEMENT: Individuals who participate in research activities overseen by DF/HCC must satisfy specific training requirements in order to conduct human subject research.
More informationUNC Lineberger Comprehensive Cancer Center. Data and Safety Monitoring Plan
UNC Lineberger Comprehensive Cancer Center Data and Safety Monitoring Plan Norman E. Sharpless, MD, Director P30CA-16086 Approved: September 29, 2014 Table of Contents Monitoring Progress of Trials and
More information11/18/2016. UC Irvine s Clinical Research Coordinator Certification Preparation Series PI Roles and Responsibilities SESSION 4
UC Irvine s Clinical Research Coordinator Certification Preparation Series PI Roles and Responsibilities BEVERLY ALGER, CCRP, CHRC Research Compliance Officer Office of Research Compliance November 2016
More informationEssential Documents It s Not Just a Binder!
Essential Documents It s Not Just a Binder! Kelly Unsworth, MS, CCRC, CIP Director of Research Education & Training Office for Human Subject Protection SCORE June 5, 2014 But What percentage of 2014 (to
More information36 th Annual Meeting Preconference Workshop P4 Handout
36 th Annual Meeting Preconference Workshop P4 Handout Clinical Trial Management in Multicenter Trials: Collaborating for Success Meet Our Team Dixie Ecklund, RN, MSN, MBA Associate Director, University
More informationSTANDARD OPERATING PROCEDURE SOP 710. Good Clinical Practice AUDIT AND INSPECTION. NNUH UEA Joint Research Office. Acting Research Services Manager
STANDARD OPERATING PROCEDURE SOP 710 Good Clinical Practice AUDIT AND INSPECTION Version 1.3 Version date 27.02.2018 Effective date 3.03.2018 Number of pages 10 Review date February 2020 Author Role Approved
More informationAuditing of Clinical Trials
Version 1.2 Effective date: 3 September 2012 Author: Approved by: Claire Daffern, QA Manager Dr Sarah Duggan, CTU Manager Revision Chronology: Effective Date Version 1.2 3 Sept 2012 Version 1.1 12 May
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Site Selection and Initiation SOP number: TM 005 SOP category: Trial Management Version number: 03 Version date: 19 December
More informationClinical Trial Readiness Checklist October 2014
The clinical trial readiness checklist is a tool which can help new and experienced researchers prepare for upcoming clinical studies. It is designed to be a quick reference to ensure that you have the
More informationSTANDARD OPERATING PROCEDURE SOP 325
STANDARD OPERATING PROCEDURE SOP 325 STUDY START UP ACTIVITIES FOR CLINICAL RESEARCH TRIALS Version 1.4 Version date 28.03.2017 Effective date 28.03.2017 Number of pages 7 Review date April 2019 Author
More informationEMA & FDA Inspections: Site perspective. Shandukani Research Centre
EMA & FDA Inspections: Site perspective Shandukani Research Centre Why were we inspected? Pharmaceutical company applied for registration of the study drug (Phase I/II dosing studies in paediatrics) Large
More informationCOMPETENCY FRAMEWORK
COMPETENCY FRAMEWORK Theresa Ledger Lead Nurse Research and Development Clinical Research Facility Sheffield C:\Documents and Settings\Robertus\My Documents\Mariann\CRF\CRF Portfolio and Competency Template_DRAFT
More informationEuropean Medicines Agency Inspections ANNEX V TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: PHASE I UNITS
European Medicines Agency Inspections London, 23 July 2008 EMEA/INS/GCP/197215/2005 Procedure no.: INS/GCP/3/V ANNEX V TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE EMEA: PHASE I UNITS GCP
More informationSetting up a CITI account for users not enrolled at or employed by Georgia Tech. Georgia Institute of Technology December 2016
Setting up a CITI account for users not enrolled at or employed by Georgia Tech Georgia Institute of Technology December 2016 www.citiprogam.org Select REGISTER to establish an account. Affiliate with
More informationNEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES
NEWCASTLE CLINICAL TRIALS UNIT STANDARD OPERATING PROCEDURES SOP details SOP title: Site Selection and Initiation SOP number: TM-005 SOP category: Trial Management Version number: 04 Version date: 10 July
More informationRoles & Responsibilities of Investigator & IRB
Roles & Responsibilities of Investigator & IRB Jaranit Kaewkungwal Mahidol University Regulatory & Guidelines Regulatory & Guidelines GCP & Computer / Database Management Systems International Conference
More informationWIRBinar. How to Survive an FDA Inspection. Upcoming Trainings: Contact Us: (360)
WIRBinar How to Survive an FDA Inspection 10-26-2011 Brought to you by WIRB Education and Consulting Services. Improve your ability to maintain compliance and protect human subjects with guidance from
More informationStandard Operating Procedure Research Governance
Research and Enterprise Standard Operating Procedure Research Governance Title: Research Governance Audit SOP Reference Number: QUB-ADRE-08 Date prepared 7 August 008 Version Number: Final v -6.0 Revision
More informationGovernance %%.4- r2&% Queen s University Belfast. Standard Operating Procedure Research Governance. r2.aoc7. Research and Enterprise
Queen s University Belfast Research and Enterprise Standard Operating Procedure Research Governance Title: Delegation of Responsibilities SOP Reference QUB-ADRE-005 Date prepared 23 June 2008 Number: Version
More informationQUALITY ASSURANCE PROGRAM
QUALITY ASSURANCE PROGRAM Elaine Armstrong, MS Quality Assurance Manager PURPOSE Verify accuracy of submitted data Verify compliance with protocol and regulatory requirements Provide educational support
More informationResearch Adverse Event and Safety Reporting Procedures Outcome Statement: Title:
Title: Research Adverse Event and Safety Reporting Procedures Outcome Statement: Research Teams will be able to correctly identify and report Adverse Events and complete Annual Safety Reports for research
More information