Qualité
About Qualité
Qualité (Quality in French) is a quarterly to bi-monthly newsletter published by NHG Research Education Unit of Research & Development Office with a focus in educating researchers and clinical research professionals on reseaarch policies, best practices and Responsible Conduct of Research (RCR) concepts to facilitate high standards of research conduct.
The newsletter also regularly features common cases of non-compliances detected by the NHG Research Quality management Unit through Study Reviews conducted, meant to educate the research community on the proper conduct of research and with tips and recommendations for the prevention of similar occurrence.
You may download a full copy of the latest or past Qualité newsletter from below:
Latest Issue:
Issue (35)
QLT2020-78: Obtaining Remote Consent for your Research
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ARTICLE CATEGORIES
Click on the categories below to see the related articles.
(1) Data Collection & Source Documentation
(2) DSRB Approval & Documentation
(3) Informed Consent
(4) Investigator File and Overall Study Documentation
(5) Monitoring, Audit & Inspection
(6) Research Policies, Ethical Guidelines & SOP Updates
(7) Responsible Conduct of Research (RCR)
(8) Safety / UPIRTSO Reporting
(9) Study Team & Responsibilities
(10) Subject Recruitment
(11) Updates from Office of Human Research Protection Programme (OHRPP)
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(1) Data Collection & Source Documentation
QLT2016-56: Data collected prior to subject withdrawal - To keep or to discard?
QLT2014-42: GCP Frequently Asked Questions - Guidelines on Source Documentation of Subject's Study Progress
QLT2012-23: Protocol Non-Compliance - Compromising the Privacy and Confidentiality of Subjects Information
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(2) DSRB Approval & Documentation
QLT2018-77: Monitoring Observations On Essential Document
QLT2018-73: Serious Non-Compliance: Collection & Use of Data Without IRB’s Approval
QLT2015-52: Screening Subjects Prior to Study Enrollment. Does This Require DSRB Approval
QLT2014-40: Improving your DSRB Ethics Application Process
QLT2013-32: Non-Compliance Report - Major Deviations in Study Conduct from the DSRB-Approved Protocol
QLT2012-22: Frequently Asked Question on Trial Conduct
QLT2012-20: Protocol Non-Compliance - DSRB and Subjects Not Updated of Study Changes
QLT2010-07: Non Compliance Issues Conducting Human Subjects Research without Ethics Approval
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(3) Informed Consent
QLT2020-78: Obtaining Remote Consent for your Research
QLT2018-76: Human Biomedical Research Case Study: Who Can Recruit Subjects?
QLT2015-53: Informed Consent Fundamentals - Handling Subjects’ Personal Information
QLT2015-50: Waiver of Documentation of Consent vs Waiver of Consent: The difference and what should be documented?
QLT2014-39: Non-Compliance Report: Informed Consent Process for Non-English Speaking Subjects
QLT2012-26: GCP Topic – Informed Consent
QLT2012-24: Informed Consent Documentation – The Use of Short Form Consent Forms
QLT2011-14: Participant Information Sheet Readability: Developing a Readable Participant Information Sheet
QLT2010-09: Non-Compliance Report: Manpower constraint leading to compromise and omission of informed consent taking
QLT2010-05: Alterations To Informed Consent Requirements: Waiver for Informed Consent and Waiver of Documentation of Informed Consent
QLT2009-04: Frequently Asked Questions (FAQs) on Informed Consent Process and Documentation
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(4) Investigator File and Overall Study Documentation
QLT2009-02: Essential Documents and Documentation. What are they?
QLT2009-01: Important Tips to survive the study documentation audit
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(5) Monitoring, Audit & Inspection
QLT2018-75: Common Observations from Monitoring visits: Documentation of Informed Consent
QLT2017-63: Monitoring for HBR (Exempt & Expedited) Studies
QLT2012-21: Understanding the Differences and Preparing for Monitoring, Audit and Inspection
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(6) Research Policies, Ethical Guidelines & SOP Updates
QLT2018-72: Non-Compliance Report: Transferring Personal Data Overseas
QLT2018-71: Non-Compliance Report: Accidental Leakage of Personal Information
QLT2018-70: Good Practices for Maintaining Essential Documents
QLT2018-69: [Update 2] Is My Study Human Biomedical Research or Restricted Human Biomedical Research?
QLT2017-68: [Update] Is My Study Human Biomedical Research?
QLT2017-Is26-A: The Human Biomedical Research Act: Prohibition Against Commercial Trading of Human Tissue
QLT2017-Is26-B: Revision of the DSRB Policy to Allow Dentists Registered under Temporary or Conditional Registration to be Principal Investigators
QLT2017-Is26-C: DSRB Update: Financial Conflict of Interest (FCOI) Annual Declaration Cycle for 2017
QLT2016-60: Updates To The Regulatory Framework For Clinical Trials
QLT2016-59: DSRB SOP Updates in Alignment to Human Biomedical Research Act (HBRA)
QLT2016-57: Updates on the Principal Investigator Self-Assessment Program
QLT2015-51: DSRB Update: Revised Declaration Process for Financial Conflict of Interest
QLT2015-47: DSRB Update: NHG’s Revised Conflict of Interest Policy
QLT2014-44: Qualifications and Requirements for Principal Investigators of Clinical Trials
QLT2014-43: DSRB Announcement: Changes to the Informed Consent Form Requirements for Studies Involving Prospective Collection of Biological Sample(s) and Re-Consenting Subjects for Ongoing Studies
QLT2013-34: Proper Conduct of Research (PCR) Standard Operating Procedure (SOP) Updates and New Study Templates
QLT2013-33: GCP Frequently Asked Questions – How to Write a CAPA (Corrective Action & Preventive Action Plan)
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(7) Responsible Conduct of Research (RCR)
QLT2017-65: Responsible Conduct of Research (RCR) – Peer Review
QLT2016-58: Responsible Conduct of Research (RCR) – Authorship & Publication
QLT2015-54: Responsible Conduct of Research (RCR) – Collaborative Research
QLT2015-48: Responsible Conduct of Research (RCR) – Data Management Practices
QLT2015-45: Responsible Conduct of Research (RCR) – Conflicts of Interest and Commitment
QLT2014-41: Responsible Conduct of Research (RCR) – Protection of Human Subject
QLT2014-38: Responsible Conduct of Research (RCR) - RCR Case Study
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(8) Safety / UPIRTSO Reporting
QLT2017-67: [Update] Human Biomedical Research Act: Reporting of Expected Serious Adverse Events (SAE)
QLT2017-62: HBRA Update: Reporting of Expected Serious Adverse Events (SAE)
QLT2016-55: Alteration of Local Death Reporting Requirements (Exempt & Expedited Studies)
QLT2010-06: Safety Reporting: Unanticipated Problems Involving Risk to Subjects or Others (UPIRTSO) and Serious Adverse Events (SAE)
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(9) Study Team & Responsibilities
QLT2017-66: Outsourcing Study-Related Functions to External Service Providers - Tips for Study Conduct
QLT2017-64: Non-Compliance Report: Lapses in Subject Recruitment Procedures
QLT2014-35: Non-Compliance Report: Importance of the Study Responsibility Log and Training Log
QLT2013-30: Non-Compliance Report: Placing Subjects' Interests Before Research Pursuits
QLT2013-29: GCP Frequently Asked Questions – What are the Principal Investigator’s responsibilities with regard to the management of a study team?
QLT2012-28: Taking the Extra Mile – Best Practices in Ensuring Quality & Regulatory Compliance
QLT2012-25: NHG RDO OHRPP Updates: New Minimum Training Requirement For Principal Investigators
QLT2011-18: The Principal Investigator’s Roles & Responsibilities (Part 5/5 series): No.10: Ensure Documentation of Study Related Procedures and Events
QLT2011-19: The Principal Investigator’s Roles & Responsibilities (Part 5/5 series): No. 9: Protect the Rights and Welfare of Research Participants
QLT2011-17: Continuation of Participation in Clinical Trials at Step-Down Care Facilities
QLT2011-15: The Principal Investigator’s Roles & Responsibilities (Part 4/5 series): No. 8 Direct all Relevant Site Operations
QLT2011-16: The Principal Investigator’s Roles & Responsibilities (Part 4/5 series): No. 7 Ensure that the Investigational Product is Properly Administered and Stored
QLT2011-12: The Principal Investigator’s Roles & Responsibilities (Part 3/5 series): No. 6 Assure protocol compliance throughout study
QLT2011-13: The Principal Investigator’s Roles & Responsibilities (Part 3/5 series): No. 5 Communicate with regulatory agencies and obtain approval to conduct study
QLT2010-10: The Principal Investigator’s Roles & Responsibilities (Part 2/5 series): No. 4 : Managing the Medical Care of Subject
QLT2010-11: The Principal Investigator’s Roles & Responsibilities (Part 2/5 series): No. 3 : Determining that Adequate Resources are Available to Conduct the Study
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(10) Subject Recruitment
QLT2018-74: Assessment of Eligibility of Research Subjects Prior to Recruitment
QLT2015-49: Newspaper Advertisements, News Stories and Subject Recruitment: Is DSRB Review Required?
QLT2015-46: Non-Compliance Report: Subject Screening and Recruitment
QLT2012-27: Protocol Non-Compliance: Continuous Over Recruitment of Research Subjects
QLT2010-08: Non-Compliance Report: Patient Enrolled into Trial before Screening Procedures and Registration were Complete (Protocol Non-Compliance)
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(11) Updates from Office of Human Research Protection Programme (OHRPP)
QLT2014-37: The Research Education Unit (NHG)
QLT2014-36: Clinical Research Coordinator Society (CRCS) Forum
QLT2013-31: Overview of NHG Research Quality Management (RQM)
QLT2009-03: Association for the Accreditation of Human Research Protection Programs (AAHRPP)
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WRITE TO US!
If you have any research conduct /quality-related topic suggestions, stories, best practices or question you are unsure about which you would like featured in Qualité newsletter, you are invited to write in to us at researchcoord@nhg.com.sg. In your email, please include your name, job designation, institution and contact information, together with your suggestion, contribution or question.
Your inputs or questions together with our recommendations may be selected for feature in subsequent issues of Qualité. Remember, other readers facing similar issues may benefit from your experience sharing or questions you ask. We look forward to hearing from you!
Disclaimer: To ensure that you are complying to the latest regulation, DSRB policies and NHG Proper Conduct of Research SOPs, please check the respective webpages (e.g. HSA’s website) for the latest regulation, (NHG Research website: Resources > Research Online Guidebooks: Investigator Manual (IM) and the IM Addendum) for the latest DSRB policies/requirement, and (Research SOPs tab) for the latest NHG PCR SOP.
