Initialisation

MISTIR Flowchart During the initialisation of a project, a protocol is set up conform the ones used in real clinical trials[1]. It states the hypotheses to investigate and the ways to test them. Common items in the protocol are:

  • primary and secundary study endpoints
  • sample size calculation
  • project management: goals, milestones

An example of a protocol will be made available.

A Material Transfer Agreement (MTA) is used to formalise the participants' roles, rights and liabilities. After signing the MTA, the participant is granted access to the central database.

A template of the MTA can be downloaded here (pdf|odt|doc).

 

Click on the blocks in the image to get more information about their contents.

 


[1] Bolla M, Bartelink H, Garavaglia G, et al. EORTC guidelines for writing protocols for clinical trials in radiotherapy. Radiother Oncol 1995;36:1-8.

 


Preparation
Initialisation
Treatment Planning
Quality Assurance
Data Exchange
Analysis
Reporting