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HOVON richtlijnen & documenten

 

Priorities for sending in CRFs HOVON studies 

1. Non Hodgkin's Lymphomas - HOVON staging and response criteria
2. Multiple Myeloma - HOVON response criteria
3. Common Toxicity Criteria used in HOVON studies
4. Serious Adverse Event reporting in HOVON studies
5. Diagnostics in HOVON studies

6. Transfer of patients in HOVON studies
7. Duration of Follow Up in HOVON studies
8. TOP information and documents
9. HOVON studies and METC approval
10. HOVON address form for contact information
11. HDC Additional local participants form
12. Central Site File - Table of contents
13. Investigator Trial File - Signature and delegation log
14. Investigator Trial File - Subject screening enrolment and identification log

Priorities for sending in CRFs HOVON studies

 

Because a lot of studies are conducted by HOVON, it might be hard to prioritize which study must come first when filling out the CRFs. Therefore we provide a list of studies with high priority, for which we are very keen to receive the filled out CRFs first.
Invariable of the priority, we always appreciate it to receive an estimation when the filled out CRFs will be sent to us.

 

Priority HOVON studies

 

 


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1. Non Hodgkin's Lymphomas - HOVON staging and response criteria

 
The HOVON Staging and response criteria for Non Hodgkin's Lymphomas are guidelines that describe the minimally required staging and evaluation procedures and response criteria to be applied in all HOVON NHL studies. The guidelines are based on international working group recommendations (JCO, Vol 17, 1999, pp 1244-1253). The Ann-Arbor staging criteria are included.

NHL Staging and response criteria, version 11apr03.



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2. Multiple Myeloma - HOVON response criteria


The HOVON myeloma trials all share the same response criteria.
Based on these criteria the HOVON Data Center has developed automated tests to check responses on the CRF's for these trials.
If there are any questions with regards to the HOVON response criteria, please contact the HOVON data center, and we will provide you with information how to fill this out.



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3. Common Toxicity Criteria used in HOVON studies

 
From HOVON study number 40 all HOVON studies apply CTC criteria for the grading of toxicity, version 2.0 with publish date April 30, 1999.

From HOVON study number 58 all HOVON studies apply to CTCAE criteria for the grading of toxicity, version 3.0 with publish date December 12, 2003.

For all HOVON studies that relate to the usage of CTCAE criteria version 4.0 for the grading toxicity, please use the version 4.03 with publish date  June 14, 2010.

The criteria, a manual and the most recent updates may be downloaded from http://ctep.cancer.gov/reporting/ctc.html. The version of the CTC criteria used by the HOVON may be downloaded in Acrobat Reader format by clicking one of the options below.

Common Toxicity Criteria, version 2.0, 30apr99.
Common Toxicity Criteria - Notice of Modifications, version 2.0.

Common Toxicity Criteria - Manual, version 2.0, 01jun99.

Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, 10jun03.

Common Terminology Criteria for Adverse Events (CTCAE) - Notice of Modifications, version 3.0. 

Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, 12dec03.

Common Terminology Criteria for Adverse Evenst (CTCAE), version 4.02, 15sep09.

Common Terminology Criteria for Adverse Evenst (CTCAE) - Notice of Modifications, version 4.02.

Common Terminology Criteria for Adverse Evenst (CTCAE), version 4.03, 14jun10.




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4. Serious Adverse Event reporting in HOVON studies


Serious Adverse Events (SAEs) have to be reported as specified in the trial protocol.
SAE's will be reported from the first study-related procedure until 30 days following the last dose of any drug from the protocol treatment schedule or until the start of subsequent systemic therapy for the disease under study, if earlier. Serious Adverse events occurring after 30 days should also be reported if considered at least possibly related to the investigational medicinal product by the investigator.
SAEs must be reported to the HOVON Data Center by fax within 24 hours after the event was known to the investigator, using the trial specific SAE report form provided. The SAE report form and detailed instructions for completing the form can be downloaded for each trial at the section "Download documentation / forms".

Reported SAE's will be handled by HOVON as specified in the trial protocol. For the majority of HOVON trials SAE data management, SAE evaluation and SAE & SUSAR reporting is handled by the HOVON Data Center Safety Desk.

 


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5. Diagnostics in HOVON studies


Molecular Diagnostic (MD) information on patients in HOVON studies for which molecular diagnostics is relevant is collected through a special MD-form. The MD-form is not study-specific and the HOVON protocol number needs to be filled out on the form (42 for HOVON42 AML, etc.). The data are collected via the responsible local data manager. Since the molecular data require special knowledge for interpretation it is important that the forms are filled out by or in close collaboration with the Molecular Diagnostics coordinator who is responsible for molecular diagnostics in the hospital, or – if such a function does not exist – by the local investigator.

 

Cytogenetic evaluation for patients in HOVON studies can be reported on a Cytogenetic form. If additional FISH has been done, this information should be supplied too. The CRFs are made study specific.

From the HO92 onwards, the Cytogenetic form is combined with the FISH form. On a separate form the target codes are mentioned that belong to the FISH form. This HOVON FISH Target Code Form is a general form and will be similar for all HOVON studies. You can find this form below.

 

  HOVON Fish Target Code Form, version 18dec08

 

For multiple myeloma, there are different forms of diagnostics. You find more details in the articles provided below.

  Molecular diagnostics, imaging and flow cytometry in MM (Dutch)

  M-protein diagnostics (Dutch)



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6. Transfer of patients in HOVON studies


For each patient included in a HOVON trial, there is one responsible local investigator with one responsible local data manager. This is necessary for the HOVON Data Center to perform the data management of the trials. In principle this responsibility lies with the investigator of the registration hospital and the associated local data manager. It is possible to transfer responsibility for a patient in a trial. This should only be done if the transfer is permanent. To transfer a patient in a HOVON trial, the investigator fills out the 'HDC transfer of patient form'.

How do I use this form?

If the patient is transferred permanently to another hospital, but the local datamanager does not change: fill out the data regarding the patient, fill out the data regarding yourself and the new responsible investigator, sign the form and send it to the HDC.
If the patient is transferred permanently to another hospital and the local data manager changes as well: also fill out the data regarding your data manager and the new local data manager.

What happens next?

1. The original investigator sends form to new hospital and investigator AND sends a copy to the HDC.

2. The new hospital and investigator sign this form ( in order to confirm the transfer) and send this form back to the original investigator & LDM.

3. The completely filled out ‘ transfer of patient form’ will be send from the original investigator & LDM to the HDC. They will keep a copy for themselves.
4. Finally, upon receipt of the signed form, the HDC will complete the transfer of patient.

 

If the new investigator or LDM refuses to give confirmation, HDC does not complete transfer and continues to address communications to the original investigator / LDM.

What are the consequences of a transfer?

1. after the transfer the HDC holds the new investigator and new data manager (if applicable) completely responsible for all trial data regarding the patient. From then on, they will receive all queries and data requests for this patient, even if this concerns data from before the time of transfer.
2. the transfer only applies to data management at the HDC; any other issues like finances must be arranged separately by the investigators and data managers concerned

HDC Transfer of Patient form

 


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7. Duration of Follow Up in HOVON studies


The follow up duration of patients in all HOVON studies has - till now - never been explicitly stated in the protocol and implicitly it has always been indefinitely till death. Thus follow up continues and requires efforts from investigators and data managers for studies long after the publication of the results, while there may be no prospects of any further publications. And even for studies that have failed to recruit enough patients the follow up may never have been formally stopped. The HOVON board has decided to improve the situation with the following rules: 

1. For each new HOVON study the planned duration of follow up will be stated explicitly in the protocol. 
2.The following guidelines for duration of follow up apply:
- Phase I studies: duration of follow up from end of treatment 6 months
- Phase II studies: duration of follow up from inclusion 5 years or shorter in line with the expected response duration
- Phase III studies: duration of follow up from inclusion 10 years
3. However, in studies with a maintenance treatment arm the follow up continues as long as a patient is on maintenance treatment according to protocol, even if that is longer than the planned follow up duration.
4. One may specify a follow up duration different from these guidelines in a study, if motivated.
5. If a study fails because of insufficient recruitment or because of too much toxicity, the treatment data of all included patients will be collected in order to round of the study with a report of the treatment and toxicity outcomes. No further follow up will be required.

These rules been applied now to the old already closed studies. Moreover for some studies the principal investigators have indicated that further follow up is already no longer relevant and can be stopped.
For the following studies the follow up will be stopped for all patients still alive: HOVON 4(A) 5 8 10 18 24 25 27pilot 36 38 57 58 and 72. For other studies the data management of some of the patients with long follow up can now be closed: HOVON 26 29 39 32 40 41 and 45. The total number of patients for which the follow up will be stopped now is 876. This is a considerable number and implies a considerable reduction in workload for all involved.

Each year the HOVON Data Center will send out new listings of the patients who have reached their end of follow up.


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8. TOP information and documents


TOP (Trial Online Process) is an application for registration and randomisation of patients in studies via Internet. The URL for the HOVON TOP website is https://www.hdc.hovon.nl/top/. You can also reach this site by clicking on the button 'Go to TOP', at the top of this website.

The webserver has been configured to support Secure Socket Layer (SSL).
SSL is a protocol used for secure Internet communications with encryption of data sent between client and server. SSL also ensures that the information is sent, unchanged, only to the server you intended to send it to. The protocol is identified by the use of HTTPS in the URL instead of HTTP.

SSL works with a certificate.
To download this certificate right click on the certificate link below and choose 'save' and save the file 'furoreca.cer' on your PC.

Installation of the certificate on your PC will ease the access to TOP. More information can be found in the installation instructions.

Furore certificate for SSL

Instructions for installation of Furore SSL certificate
TOP logon request form (please note that request for TOP and/or HOVON website can also be placed electronically on the HOVON website, see help for further instructions)
TOP patient registration manual


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9. HOVON studies and METC approval


Before a HOVON trial starts, all legally required approvals from Ethics Committees, Competent Authorities and local approvals are obtained. Participating sites are informed by the Trial Manager on the status of national approvals and will receive documents and instructions necessary to obtain local approval.


 


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10. HOVON address form for contact information


The HOVON data center has a large database for all its contact information. When you are participating in one of our studies you will be asked to fill out a 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

  


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11. HDC Additional local participants form


For each study we provide a hospital registration 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 a additional local participants form.
Please note that the investigator's signature is required. If this signature is missing we cannot process your application.

HDC Additional local participants form

 


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12. Central Site File - Table of contents


We have created a template Table of Contents that can be used in your Central Site File. By setting up a Central Site File (next to the Investigator Trial File, which is study specific) it will compensate the amount of (administrative) work that needs to be done on each site before the site can be opened to participate in a HOVON study. It is also a usefull list that summarises the documents needed to be present on each site.

Central Site File - Table of contents

 


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13. Investigator Trial File - Signature and delegation log


We have created a signature and delegation log that can be used in a HOVON study. This document is study specific and lists all local participants that are involved in a trial. Please note that the column on the right (signature for authorisation by investigator) needs to be signed by the local investigator for each participant that is listed. When a participant is no longer involved in the study please fill out the 'date responsibility end', and if applicable fill out the name of the participant that will be his/here replacement. If any mutations are executed, please send in this form to the HOVON data center.

Investigator Trial File - Signature and delegation log

 


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14. Investigator Trial File - Subject screening enrolment and identification log


This document is created to track which patients were screened for enrolment in one of our HOVON studies. Please record these screening meticulous. Especially when a study fails to deliver its desired accrual these records can be used to analyse the reasons.

Subject screening enrolment and identification log 


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