Clinical Trial Roadmap overview

Phase 1
Preparation

Phase 2
Start up & initiation

Phase 3
Conduct

Phase 4
Analysis & publication

Phase 5
Wrap up

Phase 6
Implementation

Background

The Clinical Trial Roadmap is developed by DORP to optimally support investigator initiated clinical oncological research. It is not unique as most trial and science offices have their own guidelines. This roadmap is however the result of exchanging and combining experience and knowledge of experts from Erasmus MC, IKNL, LUMC, NKI-AvL, RadboudUMC, MUMC. It brings together useful tips, references and links to templates.

How to use

The Clinical Trial Roadmap guides investigators through 6 phases of a clinical trial. It gives an overview of responsibilities and of what needs to be organized. Importantly, at all times it should be used in conjunction with the investigator’s local institutional trial or science office. Services and contact information of clinical trial centers and datacenters can be found here.

Sponsor versus participating center

The activities differ for the initiating investigator (sponsor) and for participiating local investigators. Therefore two separate versions of the roadmap are available: one with to do’s for the sponsor and one with to do’s for participating centers. Each clinical trial phase is summarized by an infographic to illustrate the most important actions. By clicking on a phase in the general overview, the specified phase for the sponsor is entered. From there the corresponding phase for participating centers can be reached. Please note that an extensive full text version of the roadmap describing all actions more detailed is available on request via info@researchplatform-dorp.nl.

Status

Currently phases 1-2-3 of the Clinical Trial Roadmap are available. The subsequent phases are under construction and will be added in in due time.

Questions or feedback

DORP is happy to come by to talk investigators and colleagues through the roadmap to facilitate trial start up. If you are willing to provide us feedback on the roadmap, let us know and we will send you a questionnaire. We are also open for investigators to test the available and upcoming phases. Please contact DORP at info@researchplatform-dorp.nl.