This page contains an overview of all local templates and documents Amsterdam UMC offers. The templates are developed to assist in obtaining the minimum required information to safeguard subjects' safety and data integrity. The investigator is allowed to modify the documents to personal standards except the documents marked *. These documents are mandatory in the current format when Amsterdam UMC is the sponsor of the study.
Agreements
- Afspraken faciliterende afdelingen
- Clinical Trial Agreements (CCMO templates): WMO, CTR, MDR, IVDR*
Manuals
- Handleiding lateralisatie onderzoek Amsterdam UMC
- Amsterdam UMC factsheet and Roadmap for medical devices
- Factsheet Human subject Research Program (HRP)
- Quick Win mensgebonden wetenschappelijk onderzoek
- Informed consent registration Epic (patients and healthy volunteers)
- Epic research tipsheet
- Onderzoeksproject aanmelden via Research Manager (Biobank)
- Handleiding voor onderzoeker Studymanagement module (CTMS) Research Manager
Research protocol
Forms/tools
- Aanvraagformulier voor archivering onderzoeksgegevens
- Disclaimer vertrouwelijke studiedocumentatie K2 iProva
- Flowchart: Important deviation / serious breach
- Intakeformulier Legal Research Support
- Risicoclassificatie-instrument
- Intentieverklaring ten behoeve van VGO
- Qualification Questionnaire vendors research
- Data protection impact assessment (DPIA)
Trial Master File/ Investigator Site File
- Adverse Events Tracking log
- Attendance log
- Data management plan
- DSMB charter
- DSMB rapportage
- DSMB rapportagetabel SAE (geblindeerd)
- DSMB rapportagetabel
- IMDD-guide
- IMDD example
- IMDD risk analysis
- IMDD-light
- Important deviation / serious breach form
- Important deviation form - PARTICIPATING SITE
- Index ISF medical devices *
- Index ISF medicinal product *
- Index ISF other WMO studies*
- Index combined TMF/ISF medicinal product *
- Index combined TMF/ISF for studies with medical devices *
- Index combined TMF/ISF for other WMO studies *
- Index combined TMF/ISF for non-WMO studies *
- Index investigator subject site file (ISSF)*
- Individual Training Log
- Instruction template
- Investigational Product accountability log: subject level
- Note to file form
- Onafhankelijkheidsverklaring DSMB leden
- Principle Investigator statement CRF
- Protocol template medicinal product (CCMO)
- Protocol (CIP) template medical device (CCMO)
- Protocol signature page
- SAE report form medicinal products
- SAE report form medical devices
- SAE report form for other WMO-studies
- Site assessment & feasibility questionnaire
- Site signature and delegation log
- study specific deviation log
- Study Operations Manual (SOM)
- Study training log
- Specimen Tracking log
- Subject Identification log
- Subject screening and enrolment log
- Telephone note