Trial documents

Investigator File

The Investigator File (IF) is a file in which the Site Principal Investigator stores all important documents about a trial. This is compulsory according to GCP but also serves as a useful reference. Each site participating in a HOVON trial should store all necessary documents in a binder according to the HOVON format.

A table of contents, labels for tab pages and the spine and further explanation on which document belongs to which section can be found below.

A trial specific version is available at the download section of the trial itself.

Investigator File – Table of contents
Investigator File – Labels
Investigator File – Spine label
Investigator File - explanation (in Dutch only)

In the table of contents for the IF a number of forms are listed that must be completed for every trial, such as a 'signature and delegation of responsibilities log (or authorization log)' and a 'subject screening, enrolment and identification log'. Templates for these forms can also be downloaded below.

Investigator File – Signature and delegation log (deprecated)
Investigator File - Authorization log (request through your Global CPM)
Investigator File – Subject screening enrolment and identification log

Central File

A proportion of the documents in the IF are identical for a number of different trials. Think for example of CVs or lab certificates. It is useful to store and keep those documents up to date at a single location. This is possible in the Central File (CF). In the IF, you then only need to insert a note to file referring to the CF for those documents. The use of a CF is strongly recommended if your department is participating in more than two HOVON trials.
A table of contents for a HOVON format CF can be downloaded below.

Central File – Table of contents

General documents

HOVON address form for contact information

HOVON has a large database for all its site contact information. When you are collaborating in one of the HOVON trials you will be asked to fill out a HOVON address form. Please notify us when there is a change in address or function, so we can keep our address database up to date.

HOVON address form

Additional local participants form

For each study we provide a trial specific Local Contact Form to a participating site. This document lists all functions that will have some involvement in this study. It might be that there are more people involved for a certain study and that notification of registration or study information is desired. In that case you can use an additional local participants form.

HDC Additional local participants form

HOVON templates

HOVON has its own template for powerpoint presentations

HOVON powerpoint presentation

Templates for sites

Each site has its own way of disseminating knowledge about HOVON studies within the hospital study. The protocol in particular contains a great deal of information about the study, which is translated into practical guidelines and examinations to be conducted by (research) nurses. To support this, we have prepared a template version for nursing guidelines that can be used as an instruction to nurses.

HOVON nursing guideline template (in Dutch only)

HOVON handout

Once a year HOVON organizes a HOVON meeting also called protocol day where all trials are discussed. For this day also a hand out is created, that provides an overview of the current status of each trial. You are able to download this document after loging in below. 

This content is restricted. Please log in.