Newsletter EC April 2025
- New version Good Clinical Practice (GCP) guidelines
- Reconsent
- ICF templates
- External research requests
- Ensuring continuity in sample collections
- Master's theses that are related to another study that has been evaluated by EC Research
- Use of track changes for amendments
- Policy research data management
- Blind carbon copy
- Principal investigator (PI) and responsibilites
- Delegation log
Newsletter EC December 2024
- Contacting study participants by phone
- Registration form: "other submission" of projects to the EC
- Annual progress report
- Submission of a case report
- Inviting the principal investigator to Ethics Committee meetings for CTR studies
- Save the date: DAC Seminar
- Winter clock stop
- Costs for foreign patients in clinical studies at UZ Leuven
Newsletter EC November 2024
- Clinical Research Office
- CTIS Helpdesk for non-commercial sponsors
- Which studies does EC Research evaluate?
- Change of contact information during the study
- Clarification on Master's Thesis integration with approved projects
- CV of the principal investigator
- Declaration of Helsinki version October 9, 2024
- Highlighting changes in amended documents
Newsletter EC August 2024
- New ICF templates
- Statistics seminar
- Are you planning to conduct a clinical trial? Make sure to check whether or not you need biobank approval
- Use of ICF and Protocol Templates for specific studies
- Flagging UZ Leuven patients in studies
- Difference between Anonymous and Pseudonymous data
- EFGCP eConsent Initiative
- Global Ethics Charter for the Protection of Healthy Volunteers in Clinical Trials
- Fee commercial retrospective studies – initial submission and amendments
- Submission guidelines for study documents: important notice
Newsletter EC May 2024
- 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
Newsletter EC April 2024
- 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
Newsletter EC February 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
Newsletter 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
Newsletter EC July 2023
- 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
Newsletter EC April 2023
- Informing parents about a pregnant child
- English website EC
- Helpdesk data reporting
- Clinical Trial Regulation (CTR)
- Suitability of Principal Investigator for clinical trials (CTR)
- Informed consent interview
- Scientific Integrity Seminar
- Medical Device Regulation (MDR) (software)
- Clinical trials within scope: submission Biobank
Newsletter EC December 2022
- Research with food products
- Winter clock stop
- Clinical trials: Development Safety Update Report replaces the Annual Safety Report
- Early Access Programs
- Off label use
- Good Clinical Practice (GCP)
- Recommendation paper on decentralized elements in clinical trials
Newsletter EC October 2022
- EC member call
- Annual progress reports
- CTC Office
- Training (Tuskegee syphilis study) - teaching by history
- ACT EU initiative of the European Commission
- Clinical Trial Regulation (CTR)
- Decentralised Clinical Trials
- Change of procedure for research with artificialised and extracted material when they are not used for genetic research
- Flagging patients in (retrospective) studies
- Serious breach in clinical trials
Newsletter EC April 2022
- Guidance on the use of electronic informed consent
- Training General Data Protection Regulation (GDPR) and Medical Device Regulation (MDR)
- GCP training by e-learning
- Initial submission
- Safety related events reporting to EC
- Answers to EC-remarks
- Case reports
- Change of procedure for research with artificialised and extracted material when they are not used for genetic research
Newsletter EC December 2021
- Lottery as compensation
- Storage essential documents
- Correct use e-mail addresses EC Research
- CHMP Guideline on registry-based studies
- Remote source data verification
- Contraception and pregnancy testing in clinical trials
- "Weak health studies can do more harm than good"
- Compliance with reporting to the EU trial registry
- Cell lines
- Information about vaccinations disappear from KWS when a patient dies
- Winter clock stop EC
Newsletter EC October 2021
- Template retrospective studies
- Training information
- Signed cover letter Principal Investigator
- Invitation
- Monocentric – multicentric???
- Statistical Analysis Plan
- Master's student access in KWS
Newsletter EC july 2021
- Procedures for the use of bodies and body material in research (via a will)
- Communication to co-investigators
- Acceptability of PI and facilities
- Conflict of interest (COI)
- (Non-)substantial modifications
- Studies in which employees are involved
- Phase I/II
- Research quality
- Proper pdf files
- Interactions, contraception…
Newsletter EC April 2021
- ICF templates for studies with UZ Leuven sponsor
- Annual progress report
- Protocol written in the present tense
- Qualification Principal Investigator (PI)
- Medical Device Regulation (MDR)
- Retrospective studies
- Rewarding study participants
- Data management
- And sorry for the many do’s and don’ts
Newsletter EC December 2020
- Modify the GDPR questionnaire
- Requests for secondary use of (personal) data and/or samples
- Compensation for subjects participating in a clinical study
- What are the requirements to be PI within UZ Leuven?
- Study access to medical files
- Template protocol IMP
- Guidelines for preparing interventional studies and observational studies
- Studies in which UZ Leuven acts as sponsor and VIB is involved as partner
Newsletter EC November 2020
- Guidance on the use of electronic informed consent
- Flow from conceptualization until study start
- Case reports
- Flow study evaluation when EC Research acts as local EC
- Recruitment and inclusion employees UZ Leuven in a clinical study
- Statistical Analysis Plan
- Submission of a project to the UZ/KU Leuven Biobank
- General Data Protection Regulation: implications on the ICF
- Studies using human body material: EC Research from deceased persons
- Clinical Trial Regulation and pilot projects
- Contact
Newsletter EC July 2020
- COVID-19
- The use of Mynexuzhealth to inform patients/study participants in accordance with GDPR
- Cover letter
- Electronic application of new clinical studies to CTC
- Informed Consent Form templates
- All previous newsletters can be found on the EC website
Newsletter EC April 2020
- COVID-19
- Conflict of interest by EC-members
- Communication pilot studies CTR
- ICF diagnostic radiopharmaceuticals
- Online submission EC Research
- Contact persons
Newsletter EC December 2019
- Protocol synopsis
- New website in January 2020
- GDPR Questionnaire
- Quality of academic studies (= statistiek)
- FDA 1572 form
- Source documents
Newsletter EC November 2019
- Quality of academic studies
- Patient representatives as EC members
- Adverse events and “Patient-related incident reporting and management system” (PiMS)
- Ethical approval required when using “historical” cell lines
- Good Clinical Practices (GCP)
- Informed Consent Form (ICF)
- Harms from Uninformative Clinical Trials
- Retrospective studies
- Response to comments of EC
- Submit separate documents
- Online registration CTC
- Confidential handling of patient data in communication to EC
- Approval letter EC
- Submitting amendments simultaneously to all participating sites
- Annual progress report
- Reduced fee concept for National Scientific and Technical-Regulatory advice (STA) (communication from the Innovation office of FAMHP)
- Contact EC Research UZ/KU Leuven
Newsletter EC June 2019
- Adverse events and “Patient-related incident reporting and management system” (PiMS)
- Summary in the ICF
- Contact point for students
- Ethical approval when using historical cell lines
- Publishing the results of clinical trials
- ICF addendum versus adapted ICF in amendments
- Database clinical trials Federal Agency for Medicines and Health Products (FAMHP)
- Patient brochure "Deelnemen aan een klinische studie”
- Contact EC Research UZ/KU Leuven
Newsletter EC April 2019
- Recognition of EC according to the national Law dated 7th of May 2017
- Change PI
- GCP
- Master’s thesis
- Social media
- Conflict of interest
- Radiation exposure
- GDPR
- Cover letter
- Approval EC valid for 1 year
- ICF addendum versus adapted ICF in amendments
- Name of KU Leuven (cf. Newsletter Research)
- Contact EC Research UZ/KU Leuven
Newsletter EC December 2018
- Members of EC Research
- File submission
- Suitability of researchers and facilities
- Recruitment for clinical studies
- Retrospective study
- Phases of clinical studies
- Contact EC Research UZ/KU Leuven
Newsletter EC October 2018
- CTR
- Composition EC Research in response to CTR
- GDPR
- Annual progress report
- End of trial
- Principal investigator emirate
- Information for patients in “foreign” languages
- Responses to comment letter
- Contact with EC Research UZ/KU Leuven
Newsletter EC March 2018
- GDPR
- OBC
- Social media
- Approval Dutch documents
- Reporting of a death during an experiment
- CV of the principal investigator
- Annual progress report and Clinical Study Report
- Submitting files and documents to EC Research UZ/KU Leuven
- Change principal investigator
- Submission of a new study with EC Research as local EC
- Contact with EC Onderzoek UZ/KU Leuven
- Interesting publications
Newsletter EC December 2017
- Name EC Research
- Meetings EC Research
- Contact with EC Research
- Comment letters
- Annual progress report
- Validation amendements
- Change principal investigator
- CTR
- OBC
- Retrospective studies
- Data protection
- Frequently asked questions
- GCP
- UMN
- Off-label
- Abbreviations