4.1. Accurate: The information is a true reflection of the original observation.
|
|
- Erik Phelps
- 6 years ago
- Views:
Transcription
1 SOP #: DOC-101 Page: 1 of 7 Effective Date: 1. POLICY STATEMENT: The Principal Investigator and research team members are required to prepare and maintain adequate and accurate case histories designed to record all observations and other data pertinent to the investigation on each subject. Source documents include all original records from which case report forms (CRFs) and data collection forms are completed and all medical records and research charts used to document source data. 2. BACKGROUND: None 3. RESPONSIBLE PERSONNEL: 3.1. Overall Principal Investigator (PI) 3.2. Site Responsible Investigator 3.3. Subinvestigator 3.4. Research Nurse 3.5. Study Coordinator 4. DEFINITIONS: 4.1. Accurate: The information is a true reflection of the original observation Case History: A record of all observations and other data pertinent to the research on each individual enrolled in a research Case Report Form (CRF): A document designed to record all of the protocolrequired information to be reported to the sponsor on each subject. Case report form information is transcribed from source data recorded on source documents Legible: All source data must be clear, readable, and interpretable Original: The first recording of the observation. Effective Date: 0
2 SOP #: DOC-101 Page: 2 of 7 Effective Date: 4.6. Source Data: All information in original records and certified copies of original records of clinical findings, observations, or other activities in a study necessary for the reconstruction and evaluation of the study. Source data are contained in source documents Source Document: Original documents, data, and records Subject: Under the FDA regulations, an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. For non-fda regulated research, a subject is a living individual about whom an investigator obtains: 1) data through intervention or interaction with the individual; or 2) identifiable private information. 5. POLICY: 5.1. The Overall PI and research team are responsible for ensuring source documentation is sufficient to support subject participation in the research. Source documentation must enable CRF entries to be verifiable. The Overall PI may delegate the task of source documentation to qualified research team members after ensuring their experience and training. Final determination of subject eligibility must be signed off by a physician investigator before a subject is registered on a trial Rules for Source Entry: Recorded observations that are used as source documents must be signed or initialed and dated Unless otherwise stipulated by the Institutional Review Board (IRB), source documents will have clear subject identifiers (i.e., screen number, randomization number, initials) to track the document to the participating subject All source documents are dated by the research team member making the source entry The Case Report Form (CRF/eCRF) must only be a collection of transcribed source data (unless otherwise defined in the protocol). The source documents must capture all information required in the CRFs, (e.g., physical exam requirements, all adverse event parameters, etc.). Effective Date: 0
3 SOP #: DOC-101 Page: 3 of 7 Effective Date: The CASE REPORT FORM cannot be used as a source document unless the sponsor specifically identifies the forms in the protocol for direct entry prior to study start-up Any change or correction to a source document or paper CRF must be dated, initialed, explained (as necessary), and must not obscure the original entry. Amended versions of notes in the Medical Record System are acceptable If an Overall PI uses Satellite sites or the Dana-Farber/Partners Cancer Care (DF/PCC) Network Affiliates, the satellite and affiliate facilities must follow the same source document and record-keeping practices as the main location Specific Requirements for Medical Records and Research Charts: The medical records and research charts are the only chronological subject records to remain long after the research is completed. These records and the information captured are potentially important to the subject s future well-being, care, and treatment. The following is a list of requirements for entries in the medical record and/or the research chart: When the research relates to clinical activity, a record of the subject s participation in the research; abbreviated description of the purpose and nature of the trial, including active control and/or placebo if known, and dates of participation are recorded in the medical record A record of the subject consenting to research participation. For research related to clinical activity, the consenting process is recorded in the medical record. Otherwise the consenting process is recorded in the research chart. A description of the consenting process includes the date(s) of consent and states that the subject (or legally authorized representative) has received an explanation of the content of the consent. If witnesses or others were present this is noted. If any new safety information is presented to the subject (or legally authorized representative) that may affect participation and is not documented in the informed consent document, the verbal consent must be documented. Effective Date: 0
4 SOP #: DOC-101 Page: 4 of 7 Effective Date: When applicable, note that the subject (or legally authorized representative) had an opportunity to ask questions about the research and received a signed and dated copy of the informed consent document. The signed informed consent document is retained in the research chart All adverse event parameters must be captured in the source notes. It is the responsibility of the designated research team member to determine the severity and duration of the event, and assess the relationship of the event to the investigational drug(s)/device(s) or research intervention(s) A record of each visit and synopsis of progress in addition to all the information required at that visit is required to support all data in the CRFs (including Quality of Life Questionnaires, Diaries, etc) The records including per visit progress notes, concomitant medications, vitals, etc. will be completed in a timely manner The records need to clearly identify who made the observations or made decisions regarding the subject s care All deviations, exemptions, or waivers (e.g., from inclusion/exclusion criteria) must be recorded in the subject s records and have written prospective approval from the sponsor and the IRB prior to the subject s participation (or continued participation) in the protocol Original records such as laboratory, radiology, or cardiology reports (i.e. EKGs) must be reviewed and the review must be documented. For laboratory reports and EKGs, abnormal or out of range values must be assessed for clinical significance Provide a summary statement when the subject has completed the research stating the condition and disposition of the subject at that point. Effective Date: 0
5 SOP #: DOC-101 Page: 5 of 7 Effective Date: 5.4. Case Report Forms Used as Source Documents: The CRF/eCRF can only be used as a source when specifically identified by the sponsor in the IRB approved protocol. When the CRF/eCRF is used as a source document, the following requirements must be followed: The CRF pages are treated in the same fashion as all other source documents, maintaining all the data quality attributes CRF pages routinely used as source documents are medical evaluations, patient quality of life questionnaires (QOL), or subject self-evaluations such as diaries, rating scales, and visual analogue scales. The person completing the CRF (research team members, rater, or subject) signs or initials and dates the actual CRF page. Assessments, such as QOLs, that are required to be confidential must not be signed and dated by the subject If the sponsor does not provide a signature line, the diary must still be signed or initialed and dated by the person completing the diary, preferably the study subject The person making the observation (whether it is a subject or a research team member) signs (or initials if stated on the form) and dates the entry. If no place is designated for date and signature or initials on the CRF, it still needs to be signed or initialed and dated at the appropriate time point If the CRF is a three-part document, extra care should go into writing down observations to ensure that a legible and readable copy remains at the site. Adequate pressure must be placed on the document to produce a clear, legible pink (sponsors may have a different color that remains with the investigator) third copy. The pink copy is to be retained at the site Source Preparation: The Overall PI with the assistance of appropriate research team members will develop study-specific source document templates to ensure thorough, prospective data collection if not covered in a routine charted source Effective Date: 0
6 SOP #: DOC-101 Page: 6 of 7 Effective Date: document. Sponsor generated data collection tools may be used for source documentation, if specified in the protocol and not in conflict with local policies and procedures. Progress notes will cover all subject interactions and observations, the subject s progress on the research, and the subject s exposure to and experience with the investigational drug(s)/device(s) or intervention(s) The Overall PI and a designated research team member will review protocol requirements and data collection procedures with the other research team members. The designated research team member will work closely with the other members of the research team to ensure protocol compliance and appropriate documentation of protocol-required data points by training and review of documentation The research team will ensure that all study-related source documents are labeled with appropriate subject identification. All documentation pertaining to clinical assessments and medical evaluations must be signed and dated by an appropriate member of the research team The Overall PI and research team members are permitted to make late entries or addendums to medical records when new information is provided or clarifications are necessary. This information may best be explained in a progress note filed with the corrected or updated information. Entries are corrected by the person that made that entry and the date the correction was made needs to be entered. To correct information written on paper, a single line is made through the incorrect entry. No prior entry is ever obscured. No correction fluid or tape is used. Personnel not listed on the Delegation of Authority log can not write on CRFs or source documents The research team will ensure that personal identifying information on copies of source documents to be submitted to the sponsor or IRB in support of CRF entries is blackened out or obliterated except for the subject's initials and research identification number in order to protect subject confidentiality If the sponsor is using a CRF remote data capture system, the research team will keep source documentation in support of electronic entries in a research chart for the subject. Effective Date: 0
7 SOP #: DOC-101 Page: 7 of 7 Effective Date: 6. APPLICABLE REGULATIONS & GUIDELINES: 21 CFR 50 Protection of Human Research Subjects 21 CFR 54 Financial Disclosure by Clinical Investigators 21 CFR 56 Institutional Review Boards 21 CFR Investigational New Drugs Drugs for Human Use 21 CFR 812 Investigational Device Exemptions 45 CFR 46 Protection of Human Subjects FDA Industry Guidelines and Information Sheets FDA Compliance Policy Guidance Programs: , , and RELATED REFERENCES: International Conference on Harmonisation E6 8. RELATED FORMS & TOOLS: DF/HCC Guidance on Source Documents DF/HCC Guidance on Good Study Documentation Practices Effective Date: 0
When Must a Non-UH Investigator Seek Review by the UH IRB? the Issue of Engagement
University of Hawai i HRPP Standard Operating Procedures When Must a Non-UH Investigator Seek Review by the UH IRB? the Issue of Engagement Purpose and Scope SOP 103 Date: December 18, 2015 The question
More informationCASE REPORT FORM DESIGN AND IMPLEMENTATION
CASE REPORT FORM DESIGN AND IMPLEMENTATION DOCUMENT NO.: CR013 v1.0 AUTHOR: Elizabeth Craig ISSUE DATE: 25 October 2016 EFFECTIVE DATE: 08 November 2016 1 INTRODUCTION 1.1 The Academic & Clinical Central
More informationQuality and GLP for Histology and Pathology of Drug Safety Studies
Quality and GLP for Histology and Pathology of Drug Safety Studies Roger Alison BVSc MRCVS DiplECVP Consultant Toxicological Pathologist What is Quality Histology? It depends upon the purpose - Answer
More informationAgency Information Collection Activities; Proposed Collection; Comment Request; Good
This document is scheduled to be published in the Federal Register on 06/12/2014 and available online at http://federalregister.gov/a/2014-13787, and on FDsys.gov DEPARTMENT OF HEALTH AND HUMAN SERVICES
More informationIRBNet: https://training.irbnet.org/training/study/wizard.do 1 of 1 01/10/2014 11:17 AM IRBNet ID: 52832-1 My Reminders (26) UC Davis - Project Information Worksheet - [52832-1] Smart Form Screen Shots
More informationIRB APPLICATION PROCESS. Claire V. Murphy, PharmD, BCPS
IRB APPLICATION PROCESS Claire V. Murphy, PharmD, BCPS What is the IRB? Institutional Review Board responsible for the risks to research participants Mission is to protect the rights, dignity, welfare
More informationPrivacy Policy SOP-031
SOP-031 Version: 2.0 Effective Date: 18-Nov-2013 Table of Contents 1. DOCUMENT HISTORY...3 2. APPROVAL STATEMENT...3 3. PURPOSE...4 4. SCOPE...4 5. ABBREVIATIONS...5 6. PROCEDURES...5 6.1 COLLECTION OF
More informationMISSISSIPPI STATE UNIVERSITY Office of Planning Design and Construction Administration
SECTION 01 340 - SHOP DRAWINGS, PRODUCT DATA AND SAMPLES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other
More informationAcademic Medical Center Security and Privacy Conference (AMCSP)
Academic Medical Center Security and Privacy Conference (AMCSP) econsent Guidance and Use Cases JUNE 27, 2016 Colleen Lawrence, PhD, CCRP, Research Services Consultant, Vanderbilt University Medical Center
More informationAnswer: Qualification statement should be provided with the bid.
Little Diversified Architectural Consulting, Inc. 5815 Westpark Drive Charlotte, North Carolina 28217 Phone: 704-525-6350 Fax: 704-561-8700 Lincoln County Probation Renovation 208 N. Government Street
More informationAppendix 6.1 Data Source Described in Detail Vital Records
Appendix 6.1 Data Source Described in Detail Vital Records Appendix 6.1 Data Source Described in Detail Vital Records Source or Site Birth certificates Fetal death certificates Elective termination reports
More informationLurie Children s Panel #2
Lurie Children s Panel #2 Tricia E ifler, CIP Assistant Director Office of Research Integrity & Compliance teifler@luriechildrens.org 773-755- 7482 Michelle Brown, CIP Biomedical IRB Manager Northwestern
More informationNIHR / Wellcome Trust King s Clinical Research Facility. Guidance for Investigators
NIHR / Wellcome Trust King s Clinical Research Facility Guidance for Investigators Introduction The NIHR Clinical Research Facilities provide dedicated facilities to support the delivery of externally-funded
More informationCENTER FOR DEVICES AND RADIOLOGICAL HEALTH. Notice to Industry Letters
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Standard Operating Procedure for Notice to Industry Letters PURPOSE This document describes the Center for Devices and Radiological Health s (CDRH s, or Center
More informationNORTHWESTERN UNIVERSITY PROJECT NAME JOB # ISSUED: 03/29/2017
SECTION 01 3300 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 01 Specification
More informationPatient-Assisted Compression Impact on Image Quality and Workflow
Patient-Assisted Compression Impact on Image Quality and Workflow Senographe Pristina In 2017, GE Healthcare s Senographe Pristina ( Pristina ) was approved by the FDA using the standard technologist-controlled
More informationclarification to bring legal certainty to these issues have been voiced in various position papers and statements.
ESR Statement on the European Commission s proposal for a Regulation on the protection of individuals with regard to the processing of personal data on the free movement of such data (General Data Protection
More informationA. Action Submittals: Written and graphic information that requires Architect's responsive action.
SECTION 01330 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 1 Specification
More informationTCC/SHORE TRANSIT BUS MAINTENANCE FACILITY - PHASE II
SECTION 013300 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 01 Specification
More informationSECTION SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS
SECTION 01 33 00 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 01 Specification
More informationBELGIAN GLP COMPLIANCE MONITORING PROGRAMME MANUAL
PAGES : 1/70 ANNEXES: 14 BELGIAN GLP COMPLIANCE MONITORING PROGRAMME MANUAL SCIENTIFIC INSTITUTE OF PUBLIC HEALTH BUREAU OF QUALITY ASSURANCE Juliette Wytsmanstreet 14 1050 Brussels Phone IPH: 0032-2-642.51.11
More informationUCCS University Hall Fire Sprinkler System Upgrade March 1, 2011 RTA SECTION SUBMITTAL PROCEDURES PART 1 - GENERAL
SECTION 013300 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 01 Specification
More informationGuideline for Creating Disconnection Points and Establishing a Not Electrically Connected Area
Guideline for Creating Disconnection Points and Establishing a Not Document Number: Authorised by: Issue Date: 29 June 2012 Previous Document: 12 February 2010 Principal Authors: J Dohmen Powerlink D Brown
More informationTGA Discussion Paper 3D Printing Technology in the Medical Device Field Australian Regulatory Considerations
TGA Discussion Paper 3D Printing Technology in the Medical Device Field Australian Regulatory Considerations MTAA Response - October 2017 October 2017 Australian Regulatory Considerations Page 1 of 7 Level
More informationA. Action Submittals: Written and graphic information that requires Engineer's responsive action.
SECTION 01330 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 1 Specification
More informationRevisions and Clarifications to the Franchise Review Process. February 21, Franchise Updates
Revisions and Clarifications to the Franchise Review Process February 21, 2017 Franchise Updates Steve Olear Chief Franchise Counsel U.S. Small Business Administration 2 Alternative Documentation: Certification
More informationNOTICE TO THE INDIVIDUAL SIGNING THE POWER OF ATTORNEY FOR HEALTH CARE
NOTICE TO THE INDIVIDUAL SIGNING THE POWER OF ATTORNEY FOR HEALTH CARE No one can predict when a serious illness or accident might occur. When it does, you may need someone else to speak or make health
More informationSECTION SUBMITTAL PROCEDURES
SECTION 01330 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 1 Specification
More informationHuman Biological Material Collection, Storage and Use
Avenue E. Mounier 83/11 1200 Brussels Belgium Tel: +32 2 774 1611 Email: eortc@eortc.be www.eortc.org Human Biological Material Collection, Storage and Use POL020 Version 2.1 ALWAYS REFER TO THE INTERNET
More informationTITLE V. Excerpt from the July 19, 1995 "White Paper for Streamlined Development of Part 70 Permit Applications" that was issued by U.S. EPA.
TITLE V Research and Development (R&D) Facility Applicability Under Title V Permitting The purpose of this notification is to explain the current U.S. EPA policy to establish the Title V permit exemption
More informationAn individual LEAP Response is required for this event and must be submitted at event check-in (see LEAP Program).
DIGITAL PHOTOGRAPHY OVERVIEW Participants produce a digital album consisting of color or black and white digital photographs that represent or relate to a chosen theme (posted on the TSA website under
More informationGuidance for Industry and FDA Staff Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
Guidance for Industry and FDA Staff Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use Document issued on: November 30, 2004 The draft of this document
More informationSECTION SUBMITTAL PROCEDURES
SECTION 013300 PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 01 Specification Sections, apply
More informationE5 Implementation Working Group Questions & Answers (R1) Current version dated June 2, 2006
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE E5 Implementation Working Group & (R1) Current version dated June 2, 2006 ICH Secretariat,
More informationPREP Course 10: Electronic External Interests Review & The HRPP Review Process Presented by: Hallie Kassan Scott Beardsley Gerry Kassoff
PREP Course 10: Electronic External Interests Review & The HRPP Review Process Presented by: Hallie Kassan Scott Beardsley Gerry Kassoff January 18, 2018 1 CME Disclosure Statement The Northwell Health
More informationEast Central College
SECTION 013300 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 01 Specification
More informationUNION COUNTY VOCATIONAL-TECHNICAL SCHOOLS West Hall Addition Project Raritan Road, Scotch Plains, NJ
SECTION 013300 - SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 RELATED DOCUMENTS A. Drawings and general provisions of the Contract, including General and Supplementary Conditions and other Division 1 General
More informationMinistry of Justice: Call for Evidence on EU Data Protection Proposals
Ministry of Justice: Call for Evidence on EU Data Protection Proposals Response by the Wellcome Trust KEY POINTS It is essential that Article 83 and associated derogations are maintained as the Regulation
More informationINDUSTRIAL HYGIENE NOISE DOSIMETRY SURVEY FORM
INDUSTRIAL HYGIENE NOISE DOSIMETRY SURVEY FORM Sample Date: IH UIC: Activity: UIC: Field Office: Bldg./Hull #: Shop Location: Shop Code/Name: Shift: 1. Day Frequency 1. Daily 2. 2-3/wk 3. Weekly 4. 2-3/mo
More informationAPPENDIX K UNF RADIATION GENERATING DEVICE SAFETY PROCEDURES
APPENDIX K UNF RADIATION GENERATING DEVICE SAFETY PROCEDURES Policy and Purpose This policy provides administrative control over the use of radiation generating devices and is designed to ensure that such
More informationHuman Factors Points to Consider for IDE Devices
U.S. FOOD AND DRUG ADMINISTRATION CENTER FOR DEVICES AND RADIOLOGICAL HEALTH Office of Health and Industry Programs Division of Device User Programs and Systems Analysis 1350 Piccard Drive, HFZ-230 Rockville,
More informationWANT TO PARTICIPATE IN RESEARCH? THERE S AN APP FOR THAT!
WANT TO PARTICIPATE IN RESEARCH? THERE S AN APP FOR THAT! SECURITY AND PRIVACY ISSUES WITH THE INCREASED USE OF CONNECTED DEVICES, APPS, AND SOCIAL MEDIA IN RESEARCH. PRESENTED BY: DAVID MATA, SENIOR ASSOCIATE,
More informationJEFFERSON LAB TECHNICAL ENGINEERING & DEVELOPMENT FACILITY (TEDF ONE) Newport News, Virginia
BULLETIN NO. 6 TO THE PLANS AND SPECIFICATIONS FOR JEFFERSON LAB TECHNICAL ENGINEERING & DEVELOPMENT FACILITY (TEDF ONE) Newport News, Virginia EwingCole Architects.Engineers.Interior Designers.Planners
More informationSECTION SHOP DRAWINGS, PRODUCT DATA, AND SAMPLES
SECTION 01 33 23 - SHOP DRAWINGS, PRODUCT DATA, AND PART 1 - GENERAL 1.1 SUMMARY A. Products include, but are not limited to, the following construction submittals: 1. Shop Drawings. 2. Product Data. 3.
More informationSECTION SUBMITTAL PROCEDURES
SECTION 01330 SUBMITTAL PROCEDURES PART 1 - GENERAL 1.1 DESCRIPTION A. Scope: 1. CONTRACTOR shall provide submittals in accordance with the General Conditions as modified by the Supplementary Conditions,
More informationParticipants are limited to one (1) individual per chapter; one (1) entry per individual.
PHOTOGRAPHIC TECHNOLOGY OVERVIEW Participants have the opportunity to demonstrate understanding of and expertise in using photographic and imaging technology processes to convey a message. Semifinalists
More informationDiana Gordick, Ph.D. 150 E Ponce de Leon, Suite 350 Decatur, GA Health Insurance Portability and Accountability Act (HIPAA)
Diana Gordick, Ph.D. 150 E Ponce de Leon, Suite 350 Decatur, GA 30030 Health Insurance Portability and Accountability Act (HIPAA) NOTICE OF PRIVACY PRACTICES I. COMMITMENT TO YOUR PRIVACY: DIANA GORDICK,
More informationA Proper Research Record: The Basic Mechanics. Russ Lea, VPR Fall 2010
A Proper Research Record: The Basic Mechanics Russ Lea, VPR Fall 2010 Acknowledgements Columbia University. (2003 2004). Responsible conduct of research: Courses portal. Course 6: Data acquisition and
More informationConsiderations in Conforming Data from Multiple Implantable Medical Devices to CDISC Standards Using SAS Julia Yang, Medtronic plc.
Considerations in Conforming Data from Multiple Implantable Medical Devices to CDISC Standards Using SAS Julia Yang, Medtronic plc. Mounds View, MN ABSTRACT Both pharmaceutical and medical device trial
More informationSHTG primary submission process
Meeting date: 24 April 2014 Agenda item: 8 Paper number: SHTG 14-16 Title: Purpose: SHTG primary submission process FOR INFORMATION Background The purpose of this paper is to update SHTG members on developments
More informationEnvironmental Protection Agency
Good Laboratory Management: Means compliance with the correct regulations for each individual study.. Environmental Protection Agency Established 1970 To enforce environmental protection standards Clean
More informationGlobal Alliance for Genomics & Health Data Sharing Lexicon
Version 1.0, 15 March 2016 Global Alliance for Genomics & Health Data Sharing Lexicon Preamble The Global Alliance for Genomics and Health ( GA4GH ) is an international, non-profit coalition of individuals
More informationPREP Course #11: Interactions with Industry What Most Docs Ask About
PREP Course #11: Interactions with Industry What Most Docs Ask About Presented by: Lou DiGiovanni, Corporate Compliance & Emmelyn Kim, Research Compliance January 23, 2018 1 CME Disclosure Statement The
More informationNotice of Privacy Practices
Notice of Privacy Practices THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY. Privacy is a very
More informationStaffordshire Police
Staffordshire Police ANPR ANPR Project Document Reference: Author: D PLATT Date: 16 TH NOV 2012 Change Control Record Date Document Reference Change By 16/11/12 Initial version, for review D PLATT Contents
More informationAir Monitoring Directive Chapter 9: Reporting
Air Monitoring Directive Chapter 9: Reporting Version Dec 16, 2016 Amends the original Air Monitoring Directive published June, 1989 Title: Air Monitoring Directive Chapter 9: Reporting Number: Program
More informationMedical Devices cyber risks and threats
Medical Devices cyber risks and threats David Grainger Senior Medical Device Specialist MHRA The challenges of software medical device regulation. david.grainger@mhra.gov.uk Current framework 1998 In Vitro
More informationThe General Data Protection Regulation and use of health data: challenges for pharmaceutical regulation
The General Data Protection Regulation and use of health data: challenges for pharmaceutical regulation ENCePP Plenary Meeting- London, 22/11/2016 Alessandro Spina Data Protection Officer, EMA An agency
More informationRecast de la législation européenne et impact sur l organisation hospitalière
Recast de la législation européenne et impact sur l organisation hospitalière MEDICAL DEVICES IN BELGIUM. What s up? Brussels44Center 24.10.2017 Valérie Nys Need for changes? Regulatory system is highly
More informationNEMA XR X-ray Equipment for Interventional Procedures User Quality Control Mode
NEMA XR 27-2012 X-ray Equipment for Interventional Procedures User Quality Control Mode Published by: National Electrical Manufacturers Association 1300 North 17th Street, Suite 1752 Rosslyn, Virginia
More informationVice President, Regulatory Affairs, Clinical Research, and Quality Assurance AREAS OF EXPERTISE
Vice President, Regulatory Affairs, Clinical Research, and Quality Assurance AREAS OF EXPERTISE Medical Device Expert (21 years with FDA, 18 years in the device industry) Planning, implementing, and managing
More informationJune 29, / C2. Mr. David E. Hilliard, Esq. Wiley, Rein & Fielding 1776 K Street, N.W. Washington, DC Dear Mr.
Mr. David E. Hilliard, Esq. Wiley, Rein & Fielding 1776 K Street, N.W. Washington, DC 20006 Dear Mr. Hilliard: June 29, 1999 31030/4-3-4 1300C2 This is in response to the petition for waiver of Part 15
More informationCENSUS INFORMED CONSENT
CENSUS INFORMED CONSENT 1. PURPOSE This document describes the process by which DeWorm3 study staff obtain informed consent from eligible participants after they have been provided all necessary information
More informationDNVGL-CP-0338 Edition October 2015
CLASS PROGRAMME DNVGL-CP-0338 Edition October 2015 The electronic pdf version of this document, available free of charge from http://www.dnvgl.com, is the officially binding version. FOREWORD DNV GL class
More informationModify Section , Major Impact Services and Utilities, of Chapter (Civic Use Types):
ORDINANCE NO. AN ORDINANCE CHANGING THE ZONING CODE FOR MENDOCINO COUNTY The Board of Supervisors of the County of Mendocino, State of California, ordains as follows: Pursuant to Division I of Title 20,
More informationLoyola University Maryland Provisional Policies and Procedures for Intellectual Property, Copyrights, and Patents
Loyola University Maryland Provisional Policies and Procedures for Intellectual Property, Copyrights, and Patents Approved by Loyola Conference on May 2, 2006 Introduction In the course of fulfilling the
More informationAdvance Health Care Directive Form Instructions
Advance Health Care Directive Form Instructions You have the right to give instructions about your own health care. You also have the right to name someone else to make health care decisions for you. The
More informationJustice Select Committee: Inquiry on EU Data Protection Framework Proposals
Justice Select Committee: Inquiry on EU Data Protection Framework Proposals Response by the Wellcome Trust KEY POINTS The Government must make the protection of research one of their priorities in negotiations
More informationCOCIR SELF-REGULATORY INITIATIVE FOR MEDICAL IMAGING EQUIPMENT COMPUTED TOMOGRAPHY MEASUREMENT OF ENERGY CONSUMPTION
COCIR SELF-REGULATORY INITIATIVE FOR MEDICAL IMAGING EQUIPMENT COMPUTED TOMOGRAPHY MEASUREMENT OF ENERGY CONSUMPTION Revision: 1 Date: June 2015 Approved: June 2015 TABLE OF CONTENT 1. INTRODUCTION...
More informationNotice to The Individual Signing The Power of Attorney for Health Care
Notice to The Individual Signing The Power of Attorney for Health Care No one can predict when a serious illness or accident might occur. When it does, you may need someone else to speak or make health
More informationAbout Advance Directives for Mental Health
About Advance Directives for Mental Health An advance directive explains both your perceptions of what is helpful in a treatment sense as well as covering larger life issues that may arise if you are unwell.
More informationPORT MOODY POLICE DEPARTMENT
Revised. 2008-08-27 APPLICATION DATE YEAR MONTH DAY PORT MOODY POLICE DEPARTMENT EMPLOYMENT APPLICATION (EXEMPT CANDIDATE) Carefully read the following instructions before commencing the task of completing
More informationYou may provide the following information either as a running paragraph or under headings as shown below. [Informed Consent Form for ]
[Informed Consent Form for ] Name the group of individuals for whom this consent is written. Because research for a single project is often carried out with a number of different groups of individuals
More informationCity of Saratoga Springs Vital Records
City of Saratoga Springs Vital Records Handbook Title: Vital Records Program Date of Origin: TBD Responsible Party: Registrar of Vital Records/Statistics Date of Review: Annual DRAFT Title: City of Saratoga
More informationChristina Narensky, Psy.D.
Christina Narensky, Psy.D. License # PSY 25930 2515 Santa Clara Ave., Ste. 207 Alameda, CA 94501 Phone: Fax: 510.229.4018 E-Mail: Dr.ChristinaNarensky@gmail.com Web: www.drchristinanarensky.com Notice
More informationChapter 19 Section 4
Health Insurance Portability and Accountability Act (HIPAA) of 1996 Chapter 19 Section 4 Health Insurance Portability And Accountability Act (HIPAA) Standard Unique Health Identifier For Health Care Providers
More informationTotal Test Questions: 34 Levels: Units of Credit: 0.50
DESCRIPTION The first in a sequence of courses that prepares individuals with a lab-based hands-on curriculum combining electrical, mechanical and engineering principals. Students will learn to design,
More informationPlanning for the Future: The Role of Advance Directives
Planning for the Future: The Role of Advance Directives Robert H. Lurie Comprehensive Cancer Center of Northwestern University Cancer Connections November 3, 2018 Jane Light and Cindy Bordelon Advance
More informationResearch with Digital Health Methods 2.0 version date: 03/06/18
Research with Digital Health Methods 2.0 version date: 03/06/18 Important Caveat: This is intended to be general guidance to assist investigators in navigating a complex area; it is a points to consider
More informationPrimary IVF Conditions for Registration For Assisted Reproductive Treatment Providers under the Assisted Reproductive Treatment Act 2008
Primary IVF Conditions for Registration For Assisted Reproductive Treatment Providers under the Assisted Reproductive Treatment Act 2008 Effective: 1 June 2018 Contents SECTION 1: Background... 3 SECTION
More information(R) Aerospace First Article Inspection Requirement FOREWORD
AEROSPACE STANDARD AS9102 Technically equivalent to AECMA pren 9102 Issued 2000-08 Revised 2004-01 REV. A Supersedes AS9012 (R) Aerospace First Article Inspection Requirement FOREWORD In December 1998,
More informationMaintaining a Lab Notebook. Purpose of lab notebook. Why does your PI care? Your notebook is the proof of what you did AND what you/we were thinking.
Maintaining a Lab Notebook Your notebook is the proof of what you did AND what you/we were thinking. Purpose of lab notebook Maintain records of your methods and results of experiment to pass on to others
More informationGuidance for Industry
Guidance for Industry Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP U.S. Department of Health and Human Services Food and Drug Administration Center for Drug
More informationChapter 19 Section 4
Health Insurance Portability and Accountability Act (HIPAA) of 1996 Chapter 19 Section 4 Health Insurance Portability And Accountability Act (HIPAA) Standard Unique Health Identifier For Health Care Providers
More informationINVENTION DISCLOSURE. University of Denver Denver, CO 80208
University Disclosure Log No. (Assigned by Patent Administrator) INVENTION DISCLOSURE University of Denver Denver, CO 80208 Instructions.- Fill out as completely as possible. Answer all questions; if none,
More informationW5 Application of Gamification in Healthcare and Outcomes measurement : Improving treatment compliance and research engagement
W5 Application of Gamification in Healthcare and Outcomes measurement : Improving treatment compliance and research engagement MICHAEL ACQUADRO, JOHN HARRISON, JURRIAAN VAN RIJSWIJK Discussion leaders
More informationSTEP Code for Will Preparation in England & Wales
STEP Code for Will Preparation in England & Wales Introduction The STEP Code for Will Preparation in England & Wales is a set of ethical principles that operate for the benefit of clients and demonstrate
More informationNortheast Alabama Community College
Student Attainment of General Education and Program Learning Outcomes Learning Outcomes Summary Report: 2015-2016 Academic Year Written Communication Students will demonstrate adequate writing skills by
More informationThe European Securitisation Regulation: The Countdown Continues... Draft Regulatory Technical Standards on Content and Format of the STS Notification
WHITE PAPER March 2018 The European Securitisation Regulation: The Countdown Continues... Draft Regulatory Technical Standards on Content and Format of the STS Notification Regulation (EU) 2017/2402, which
More informationMATERIALS DIVISION MEMORANDUM
MATERIALS DIVISION MEMORANDUM GENERAL SUBJECT: Precast Concrete and Concrete Pipe Quality Control/Quality Assurance Programs SPECIFIC SUBJECT: Sections 204.22(c), 204.26(d) and Minimum Acceptance Sampling
More informationStage 2: eligibility screening. Stage 3: prioritisation. Stage 4: selection
Digital therapy technology endorsement for IAPT project eligibility and prioritisation criteria NICE has been commissioned by NHS England to assess selected, digitally enabled therapies for depression
More informationSECTION A. RFI: Request from Contractor seeking interpretation, information, or clarification of the Contract Documents.
SECTION 01 3000 PART 1 GENERAL 1.1 SECTION INCLUDES A. Electronic document submittal service. B. Preconstruction meeting. C. Submittals for review, information, and project closeout. D. Submittal procedures.
More informationGood Laboratory Notebook Practices
Good Laboratory Notebook Practices Background You have discovered a new lead compound and have tested it in animal models to prove it has therapeutic effect in treating prostate cancer. After many months
More informationImportance of ICH Guidance in Fulfilling Process Validation Requirements
Importance of ICH Guidance in Fulfilling Process Validation Requirements Presented by: Gamal Amer All rights reserved. Do not copy without permission. Principal 1 Premier Compliance Services, Inc. Process
More informationCARRA PUBLICATION AND PRESENTATION GUIDELINES Version April 20, 2017
CARRA PUBLICATION AND PRESENTATION GUIDELINES Version April 20, 2017 1. Introduction The goals of the CARRA Publication and Presentation Guidelines are to: a) Promote timely and high-quality presentation
More informationGuide to completing the Tier 4 online application from overseas
1 Guide to completing the Tier 4 online application from overseas This document will assist you in completing the Tier 4 online form for applications made overseas. This guide will not go through every
More informationJ. Lawrence Stevens, RAC 833 E. Rosedale Dr. East Alton, IL (office) (mobile)
J. Lawrence Stevens, RAC 833 E. Rosedale Dr. East Alton, IL 62024 314-499-5148 (office) 714-473-0863 (mobile) Larry@fdadeviceexpert.com INTRODUCTION: Over 20 years of FDA experience encompassing virtually
More informationInstructions for development of an assent script
Human Research Protection Program Institutional Review Board Assent Script Template: Ages 7-11 Instructions for development of an assent script ASSENT OF MINOR (AGES 7-11) Children should be approached
More informationPrivacy Procedure SOP-031. Version: 04.01
SOP-031 Version: 04.01 Effective Date: 01-Mar-2017 Table of Contents 1. DOCUMENT HISTORY... 3 2. APPROVAL STATEMENT... 3 3. PURPOSE... 4 4. SCOPE... 4 5. ABBREVIATIONS... 4 6. PROCEDURES... 5 6.1 COLLECTION
More informationRulemaking Hearing Rules of the Tennessee Department of Health Bureau of Health Licensure and Regulation Division of Emergency Medical Services
Rulemaking Hearing Rules of the Tennessee Department of Health Bureau of Health Licensure and Regulation Division of Emergency Medical Services Chapter 1200-12-01 General Rules Amendments of Rules Subparagraph
More information