Nieuwsbrieven EC Onderzoek

Nieuwsbrief EC mei 2024

Nieuwsbrief EC mei 2024
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  • New members
  • Statistical Analysis Plan
  • Secondary use of patient data
  • Deviation from an approved protocol is only possible after a prior approval of an amendment by EC/competent authority (CA)
  • Intranet UZ Leuven for study announcements and participant recruitment
  • Retrospective study
  • Fee commercial retrospective studies
  • Patient Referrals
  • How to make proper audio recordings?
  • Necessity of respectful interaction among colleagues and good communication within research projects
  • Use of medical devices in the study

Nieuwsbrief EC april 2024

Nieuwsbrief EC april 2024
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  • Transition of clinical trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR)
  • Clinical study application
  • International studies
  • UZ Leuven: correct name
  • Opt-out
  • Recruitment via intranet
  • Patient facing documents

Nieuwsbrief EC februari 2024

  • Transfer of artificialized and extracted material from a researcher at KU Leuven to a third party
  • eConsent in REDCap
  • KU Leuven: correct name for the university in publications
  • EC can contact PI's for more information about their study with IMP
  • Umbrella protocol for human bodily material (HBM) collection
  • New members EC
  • Trial at a glance
  • Annual progress report EudraCT studies
  • Compensation of contraception
  • Sponsor change

Nieuwsbrief EC December 2023

  • Data Access Committee (DAC) 
  • Including prison inmates as participants in clinical trials 
  • Requests for secondary use of (personal) data and/or samples
  • m-Path
  • Lay summary master's theses
  • Decision tree SMEC - EC
  • Complaints about clinical studies received by ombudsman
  • Maintaining Ethical Standards beyond approval
  • Procedure for medicinal products in compassionate use and medical need programs, urgent situations, off label use, samples and import
  • BAREC Compensation guidance
  • UZ Leuven policy regarding source data/medical record sharing
  • ICF template interventional study without investigational medicinal product (IMP) 
  • Race and ethnicity in clinical trials with investigational medicinal products
  • Qualtrics
  • Winter clock stop 

Nieuwsbrief EC Juli 2023

Nieuwsbrief EC Juli 2023
PDF - 1.46 Mb
  • Global Code of Conduct for Research in Resource-poor Settings
  • Optimize the study submission and approval flow
  • Annual report EC Research 2022
  • Standard Operating Procedures (SOP) in Muzlidoc
  • Ethics and Privacy in Child and Youth Research
  • Procedure for medicinal products in compassionate use and medical need programs, urgent
    situations, off label use, samples and import
  • Clinical studies with questionnaires
  • Planning study-related investigations

Nieuwsbrief EC April 2023

Nieuwsbrief EC April 2023
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  1. Informing parents about a pregnant child
  2. English website EC
  3. Helpdesk data reporting
  4. Clinical Trial Regulation (CTR)
  5. Suitability of Principal Investigator for clinical trials (CTR)
  6. Informed consent interview
  7. Scientific Integrity Seminar
  8. Medical Device Regulation (MDR) (software)
  9. Clinical trials within scope: submission Biobank

Nieuwsbrief EC December 2022

  1. Research with food products
  2. Winter clock stop
  3. Clinical trials: Development Safety Update Report replaces the Annual Safety Report
  4. Early Access Programs
  5. Off label use
  6. Good Clinical Practice (GCP)
  7. Recommendation paper on decentralized elements in clinical trials

Nieuwsbrief EC Oktober 2022

  1. EC member call
  2. Annual progress reports
  3. CTC Office
  4. Training (Tuskegee syphilis study) - teaching by history
  5. ACT EU initiative of the European Commission
  6. Clinical Trial Regulation (CTR) 
  7. Decentralised Clinical Trials 
  8. Change of procedure for research with artificialised and extracted material when they are not used for genetic research
  9. Flagging patients in (retrospective) studies
  10. Serious breach in clinical trials

Nieuwsbrief EC April 2022

  1. Guidance on the use of electronic informed consent
  2. Training General Data Protection Regulation (GDPR) and Medical Device Regulation (MDR)
  3. GCP training by e-learning
  4. Initial submission
  5. Safety related events reporting to EC
  6. Answers to EC-remarks
  7. Case reports
  8. Change of procedure for research with artificialised and extracted material when they are not used for genetic research

Nieuwsbrief EC December 2021

  1. Lottery as compensation
  2. Storage essential documents
  3. Correct use e-mail addresses EC Research
  4. CHMP Guideline on registry-based studies
  5. Remote source data verification
  6. Contraception and pregnancy testing in clinical trials
  7. "Weak health studies can do more harm than good"
  8. Compliance with reporting to the EU trial registry
  9. Cell lines
  10. Information about vaccinations disappear from KWS when a patient dies
  11. Winter clock stop EC

Nieuwsbrief EC Oktober 2021

Nieuwsbrief EC oktober 2021
PDF - 984.21 Kb
  1. Template retrospective studies
  2. Training information
  3. Signed cover letter Principal Investigator
  4. Invitation
  5. Monocentric – multicentric???
  6. Statistical Analysis Plan
  7. Master's student access in KWS

Nieuwsbrief EC Juli 2021

Nieuwsbrief EC juli 2021
PDF - 926.18 Kb
  1. Procedures for the use of bodies and body material in research (via a will)
  2. Communication to co-investigators
  3. Acceptability of PI and facilities
  4. Conflict of interest (COI)
  5. (Non-)substantial modifications
  6. Studies in which employees are involved
  7. Phase I/II
  8. Research quality
  9. Proper pdf files
  10. Interactions, contraception…

Nieuwsbrief EC April 2021

  1. ICF templates for studies with UZ Leuven sponsor
  2. Annual progress report
  3. Protocol written in the present tense
  4. Qualification Principal Investigator (PI)
  5. Medical Device Regulation (MDR)
  6. Retrospective studies
  7. Rewarding study participants
  8. Data management
  9. And sorry for the many do’s and don’ts

Nieuwsbrief EC December 2020

  1. Modify the GDPR questionnaire
  2. Requests for secondary use of (personal) data and/or samples
  3. Compensation for subjects participating in a clinical study
  4. What are the requirements to be PI within UZ Leuven?
  5. Study access to medical files
  6. Template protocol IMP
  7. Guidelines for preparing interventional studies and observational studies
  8. Studies in which UZ Leuven acts as sponsor and VIB is involved as partner

Nieuwsbrief EC November 2020

  1. Guidance on the use of electronic informed consent
  2. Flow from conceptualization until study start
  3. Case reports
  4. Flow study evaluation when EC Research acts as local EC
  5. Recruitment and inclusion employees UZ Leuven in a clinical study
  6. Statistical Analysis Plan
  7. Submission of a project to the UZ/KU Leuven Biobank
  8. General Data Protection Regulation: implications on the ICF
  9. Studies using human body material: EC Research from deceased persons
  10. Clinical Trial Regulation and pilot projects
  11. Contact

Nieuwsbrief EC Juli 2020

Nieuwsbrief EC juli 2020
PDF - 933.7 Kb
  1. COVID-19
  2. The use of Mynexuzhealth to inform patients/study participants in accordance with GDPR
  3. Cover letter
  4. Electronic application of new clinical studies to CTC
  5. Informed Consent Form templates
  6. All previous newsletters can be found on the EC website

Nieuwsbrief EC April 2020

  1. COVID-19
  2. Conflict of interest by EC-members
  3. Communication pilot studies CTR
  4. ICF diagnostic radiopharmaceuticals
  5. Online submission EC Research
  6. Contact persons

Nieuwsbrief EC December 2019

  1. Protocol synopsis
  2. New website in January 2020
  3. GDPR Questionnaire
  4. Quality of academic studies (= statistiek)
  5. FDA 1572 form
  6. Source documents

Nieuwsbrief EC November 2019

  1. Quality of academic studies
  2. Patient representatives as EC members
  3. Adverse events and “Patient-related incident reporting and management system” (PiMS)
  4. Ethical approval required when using “historical” cell lines
  5. Good Clinical Practices (GCP)
  6. Informed Consent Form (ICF)
  7. Harms from Uninformative Clinical Trials
  8. Retrospective studies
  9. Response to comments of EC
  10. Submit separate documents
  11. Online registration CTC
  12. Confidential handling of patient data in communication to EC
  13. Approval letter EC
  14. Submitting amendments simultaneously to all participating sites
  15. Annual progress report
  16. Reduced fee concept for National Scientific and Technical-Regulatory advice (STA) (communication from the Innovation office of FAMHP)
  17. Contact EC Research UZ/KU Leuven

Nieuwsbrief EC Juni 2019

  1. Adverse events and “Patient-related incident reporting and management system” (PiMS)
  2. Summary in the ICF
  3. Contact point for students
  4. Ethical approval when using historical cell lines
  5. Publishing the results of clinical trials
  6. ICF addendum versus adapted ICF in amendments
  7. Database clinical trials Federal Agency for Medicines and Health Products (FAMHP)
  8. Patient brochure "Deelnemen aan een klinische studie”
  9. Contact EC Research UZ/KU Leuven

Nieuwsbrief EC April 2019

  1. Recognition of EC according to the national Law dated 7th of May 2017
  2. Change PI
  3. GCP
  4. Master’s thesis
  5. Social media
  6. Conflict of interest
  7. Radiation exposure
  8. GDPR
  9. Cover letter
  10. Approval EC valid for 1 year
  11. ICF addendum versus adapted ICF in amendments
  12. Name of KU Leuven (cf. Newsletter Research)
  13. Contact EC Research UZ/KU Leuven

Nieuwsbrief EC December 2018

  1. Members of EC Research
  2. File submission
  3. Suitability of researchers and facilities
  4. Recruitment for clinical studies
  5. Retrospective study
  6. Phases of clinical studies
  7. Contact EC Research UZ/KU Leuven

Nieuwsbrief EC Oktober 2018

Nieuwsbrief EC oktober 2018
PDF - 660.44 Kb
  1. CTR
  2. Composition EC Research in response to CTR
  3. GDPR
  4. Annual progress report
  5. End of trial
  6. Principal investigator emirate
  7. Information for patients in “foreign” languages
  8. Responses to comment letter
  9. Contact with EC Research UZ/KU Leuven

Nieuwsbrief EC Maart 2018

  1. GDPR
  2. OBC
  3. Social media
  4. Approval Dutch documents 
  5. Reporting of a death during an experiment
  6. CV of the principal investigator
  7. Annual progress report and Clinical Study Report
  8. Submitting files and documents to EC Research UZ/KU Leuven
  9. Change principal investigator
  10. Submission of a new study with EC Research as local EC
  11. Contact with EC Onderzoek UZ/KU Leuven
  12. Interesting publications

Nieuwsbrief EC December 2017

  1. Name EC Research
  2. Meetings EC Research
  3. Contact with EC Research
  4. Comment letters
  5. Annual progress report
  6. Validation amendements
  7. Change principal investigator 
  8. CTR
  9. OBC
  10. Retrospective studies
  11. Data protection
  12. Frequently asked questions
  13. GCP
  14. UMN
  15. Off-label
  16. Abbreviations 
Laatste aanpassing: 24 mei 2024