Research Roadmap

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 available in Annex 1 Framework Quality documents research with human subjects. Researchers are allowed to modify the documents to personal standards, except for 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 - TMF/ISF/IPSF

• 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 combined TMF&ISF: nonWMO studies

• Index investigator site file (ISF): investigator medicinal product studies subject to the CTR*

  Index Investigator site file (ISF): medical device studies subject to MDR*

• Index investigator site file (ISF): WMO studies not subject to the CTR or MDR*
• Index investigator participant site file (IPSF)*
• Adverse Event tracking log

• Agreements with facilitating departments

• Attendance log
• Data management plan
• DSMB charter

• DSMB Member's Declaration of Independence

• DSMB report

• DSMB reporting table

  DSMB reporting table SAE (blinded)

• IMDD-guide
• IMDD example

• IMDD-light

• IMDD risk analysis

• 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
• Participant identification log
• Participant screening and enrolment log
• Principle Investigator statement CRF

• Protocol signature page

• SAE line listing

• SAE report form - clinical research involving medicinal products
• SAE report form - clinical investigations involving medical devices
• SAE report form - WMO studies not subject to the CTR or MDR
• Site assessment & feasibility questionnaire
• Site signature and delegation log

• Specimen tracking log

• Study Operations Manual (SOM)

• Study specific deviation log

• Study training log
• SUSAR reporting form

• 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 020-444 6123 (Monday to Thursday between 13:00 and 14:00).

Manuals

• Amsterdam UMC factsheet and roadmap for medical devices

• Epic research tipsheet

• Factsheet Human subject Research Program (HRP)

• Informed consent registration Epic (patients and healthy volunteers)

• Manual lateralization research Amsterdam UMC

• PB&IB guidance aid for using e-consent in research

• Manual for archiving study documentation

• Quick Win scientific research involving human subjects
• Studymanagement module (CTMS) Research Manager
• Submitting e-consent Mijn Dossier WMO

Research protocol

• CCMO templates: WMO, CTR, MDR, IVDR

• Biobank research protocols (Amsterdam UMC templates)

• non-WMO research protocol (Amsterdam UMC template)

Forms/tools

• Application form for archiving research data

• Application form for retrieval of research data

• Clinical Trial Registration for submission via CTIS

• Data protection impact assessment (DPIA)

• Declaration of intent for Site Suitability Declaration (VGO)

• Disclaimer confidential study documentation K2 iProva

• Flowchart: Important deviation / serious breach
• Qualification Questionnaire vendors research

• Risk Assessment and Classification Clinical Research

• Site Suitability Declaration (VGO)