Documents & Templates
- WMO
Hereby an overview of all local templates and documents Amsterdam UMC offers. The templates are developed to assist in obtaining the minimum required information to safegard subjects' safety and data integrity. The investigator is allowed to modify the documents to personal standards except the documents marked * these documents are mandatory.
Agreements
Manuals
- Handleiding lateralisatie onderzoek Amsterdam UMC
- Handleiding voor onderzoekers Studymanagement module Research Manager
- Onderzoeksproject aanmelden via Research Manager (Biobank)
- 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
Research protocol
Forms/tools
- Aanvraagformulier voor archivering onderzoeksgegevens
- Intakeformulier Legal Research Support
- Risicoclassificatie-instrument
- SOP template
- Voorblad ten behoeve van VGO deel B
- Qualification Questionnaire vendors research
Trial Master File/ Investigator Site File
- Aansprakelijkheidsverzekeringscertificaat AMC
- Aansprakelijkheidsverzekeringscertificaat VUmc
- Adverse Events Tracking log (link under maintenance)
- Data management plan
- DSMB charter
- Index ISF medical devices *
- Index ISF medicinal product *
- 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 *
- Individual Training Log
- Instruction template
- Investigational Medicinal Product accountability log: subject level
- 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 deviation log on subject level
- Protocol deviation log on study level
- Protocol signature page
- SOP template
- SAE meldformulier geneesmiddelenonderzoek
- SAE meldformulier medische hulpmiddelen (link under maintenance)
- Site signature and delegation log
- Study Operations Manual (SOM) (link under maintenance)
- Study training log
- Specimen Tracking log
- Telephone note
- Trainingslog