This page provides an overview of the local templates and documents Amsterdam UMC offers. The templates are developed to help obtain the minimum required information to safeguard participant safety and data integrity. A complete list is to be found in Annex 1 Framework Quality documents research with human subjects. The researcher is allowed to modify the documents to personal standards except the TMF/ISF/IPSF indexes marked *. These documents are mandatory in the current format when Amsterdam UMC is the sponsor of the study.
Study File templates- Trial Master File/Investigator Site File/ ISPF
- Index combined TMF&ISF: investigational medicinal product studies subject to the CTR*
- Index combined TMF&ISF: medical device studies subject to the MDR*
- Index combined TMF&ISF: WMO studies not subject to the CTR or MDR*
- Index Investigator site file (ISF): medical device studies subject to MDR*
- Index investigator site file (ISF): investigator medicinal product studies subject to the CTR*
- Index investigator site file (ISF): WMO studies not subject to the CTR or MDR*
- Index investigator participant site file (IPSF)*
- Adverse Events Tracking log
- Attendance log
- Data management plan
- DSMB charter
- DSMB report
- DSMB reporting table SAE (blinded)
- DSMB reporting table
- IMDD-guide
- IMDD example
- IMDD risk analysis
- IMDD-light
- Important deviation / serious breach form
- Important deviation form - participating site
- Individual Training Log
- Instruction template
- Investigational Product accountability log: participant level
- Note to file form
- DSMB Member's Declaration of Independence
- Principle Investigator statement CRF
- SAE report form - clinical trials involving medicinal products
- SAE report form - clinical investigations involving medical devices
- SAE report form - 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
- Participant Identification log
- Participant screening and enrolment log
- Telephone note
Agreements
- Clinical Trial Agreements (CCMO templates): WMO, CTR, MDR, IVDR
For the review and drafting of CTAs and other (medical) research related agreements such as MTA, DSA etc contact our Legal Research Support department via
lrs@amsterdamumc.nl or bt telephone 020-444 6123 (Monday to Thursday between 13:00 and 14:00)
Manuals
- Manual lateralization research Amsterdam UMC
- Amsterdam UMC factsheet and roadmap for medical devices
- Factsheet Human subject Research Program (HRP)
- Quick Win scientific research involving human subjects
- Informed consent registration Epic (patients and healthy volunteers)
- Epic research tipsheet
- Studymanagement module (CTMS) Research Manager
- PB&IB guidance aid for using e-consent in research
Research protocol
- CCMO templates: WMO, CTR, MDR, IVDR
- non-WMO research protocol (Amsterdam UMC template)
- Biobank research protocols (Amsterdam UMC templates)
Forms/tools
- Disclaimer confidential study documentation K2 iProva
- Flowchart: Important deviation / serious breach
- Qualification Questionnaire vendors research
- Data protection impact assessment (DPIA)
- Site Suitability Declaration (VGO)