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
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)
Research protocol
Forms/tools
- Aanvraagformulier voor archivering onderzoeksgegevens
- Disclaimer vertrouwelijke studiedocumentatie K2 iProva
- Flowchart: Important deviation / serious breach
- Intakeformulier Legal Research Support
- Risicoclassificatie-instrument
- SOP template
- Intentieverklaring ten behoeve van VGO
- Qualification Questionnaire vendors research
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 *
- Individual Training Log
- Instruction template
- Investigational Medicinal Product accountability log: ward 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 signature page
- SOP template
- SAE report form medicinal products
- SAE report form medical devices
- Site assessment & feasibility questionnaire
- Site signature and delegation log
- study specific deviation log
- Study Operations Manual (SOM)
- Study training log
- Specimen Tracking log
- Telephone note