ALEA eCRF

Link to ALEA

With the following link you can go to ALEA

All study specific questions about the use of ALEA can be asked to the responsible Global Clinical Project Manager (CPM) or central data manager of the study (see section participating parties at each trial – visible after log in).

For remarks with regards to the build of the eCRF in general, or suggestions for improvement, please send these to hdcict@erasmusmc.nl.

If HOVON is a collaborator within a trial set up by another sponsor, the ALEA eCRF is most probably not used. Please find the link to the eCRF of the collaborator in the Trials section (at Main info).

Account request

To get access to ALEA, please first fill out an account request form. The Global CPM of the study will notify you if the study is built in ALEA. If you did not receive any information with regards to the account creation from the Global CPM, please find a request form below.

ALEA e-CRF Account Request Form

You can send this to HOVON@erasmusmc.nl.

You can also use this form to update us with changes, for instance the adjustment of your email address or access to another hospital in your region

Once your account is activated the system will send out a message to your email address automatically.

Usermanuals

As you are accustomed from us, each study has their own study specific CRF instructions. We have also general instructions on the use of ALEA. You can find these below.

ALEA instructions for Local Data Managers
ALEA instructions for Pathology
ALEA instructions for Cytogeneticists
ALEA instructions for Central Laboratory
ALEA instructions for registration of patients
ALEA instructions for screening of patients

If there are questions or unclarities, please let us know: (hdcict@erasmusmc.nl)

eCRF design

The CRF breaks down into a number of separate events and below each event forms are shown that relate to that event. ALEA offers a range of possibilities in how to set up the design of a study. For example, are all events and/or CRFs predefined and bundled below one visit, or is the visit repeating so that the LDM can create a new visit for a new cycle. It depends on the study itself and the nature of the forms. We also like to learn from you what works best. If you have any suggestions, please send us an email (hdcict@erasmusmc.nl).

Independed on which visit an eCRF belongs to, generally speaking the following forms can be identified:

Registration form

This relates to the registration of the patient. It is important that the criteria for inclusion or exclusion are carefully checked.

On study form

This form records the status of the patient before treatment takes place. It is very important that these data are precise and complete. Comparison with the starting situation is essential in order to be able to answer the central question of the study – the effect of the treatment.

Treatment form

This form is used to record the treatment. This form must demonstrate that the treatment is in compliance with the condition of the patients and the protocol requirements. Alterations to the treatment or choice of a different variant are regularly necessary in connection with the progression of the disease or side effects. These alterations must be recorded on the treatment form.

Evaluation form

This relates to the effect of the treatment and the type of examination that demonstrates that effect: for example a biopsy (or aspiration), imaging results, general lab, physical examination.

Adverse event form

With this form, the CTC list must be used, to determine whether the adverse event relates to a described toxicity, and if yes, what level applies.

End of protocol form

This form is used to determine that the patient is no longer receiving any treatment according to the trial protocol. The reason may be: end of trial, treatment success, failure of the treatment, serious side effects.

Follow-up form

This form contains information about patients no longer receiving any (protocol-based) treatment. The following items are registered on the form: survival with no further illness, late toxicity and possible treatment outside the protocol.