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Data management info


Diagnostics in HOVON studies


Molecular Diagnostic (moldiag) information on patients in HOVON studies for which molecular diagnostics is relevant is collected through a special moldiag form. The moldiag form is not study-specific and the HOVON protocol number needs to be filled out on the form. 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.

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)

Conversion tool laboratory values
 

On most CRF’s the number of units to report laboratory values is limited to one option. For conversion of units used on local laboratory reports into the units on the CRF’s, the Conversion tool laboratory values can be used.

Conversion tool laboratory values

Common toxicity criteria used in HOVON studies

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

For all HOVON studies that relate to the usage of CTCAE criteria version 5.0 for the grading toxicity, please use the version 5.0 with publish date  November 27, 2017.

The version of the CTC criteria used by the HOVON can be found below

Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, 14jun10.
Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, 27nov17.

Transfer of patient document

 

For each patient included at a site and participating in a HOVON trial, there is one responsible Site Principal Investigator with one responsible local data manager. This is necessary for HOVON to perform the central data management of the trials. In principle this responsibility lies with the investigator of the 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 data manager 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 HOVON.
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 a HDC transfer of patient form 1 to HOVON.
  2. Upon receipt of HDC transfer of patient form 1, HOVON will perform expedited data cleaning.
  3. On the HOVON transfer form 2, which is sent by HOVON once data cleaning has been completed, the Site PI and LDM of the original (registration) hospital sign-off for the completeness and quality of the data.
  4. The original (registration) site sends HOVON the HOVON transfer form 2 to the new site AND sends a copy to HOVON.
  5. The Site PI and LDM of the new hospital sign-off HOVON transfer form 2 for taking over the patient and the associated responsibilities.
  6. The new site will sent the HOVON transfer form 2 to HOVON and a copy to the original site. They will keep a copy for themselves.
  7. Once all parties have signed-off, the central data manager will lock the data of the patient for further entry, and the patient dossier in ALEA will be transferred to the new hospital. Site staff of the original (registration) hospital will then no longer have access to the patient data in ALEA.

If the new investigator or LDM refuses to give confirmation, HOVON 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 HOVON 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 HOVON; any other issues like finances must be arranged separately by the investigators and data managers concerned

HDC Transfer of Patient form

Multiple Myeloma – HOVON response criteria


The HOVON myeloma trials all share the same response criteria.

Based on these criteria HOVON 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 HOVON.

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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