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 and is also a useful reference work for the staff in carrying out the trial. We expect you to store all necessary documents in a binder, preferably 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 you must complete for every trial, such as a 'signature and delegation of responsibilities log' and a 'subject screening, enrolment and identification log'. Templates for these forms can also be downloaded below.

Investigator File – Signature and delegation log
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 then far easier of course 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

The HOVON Data Center 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 setting up details for (research) nurses on executing HOVON trials. To support this, we have set up a template version that might be used for creating instructions for nurses. Please find the template below.

HOVON nursing guideline template (in Dutch only)

HOVON handout

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

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