Trial execution

Trial documents

There are quite a lot of documents adhered to each trial. At the HOVON Data Center we keep the Trial Master File. Based upon the approval per country we set up an Investigator File (IF). This can also be downloaded per trial with trial specific documentation inside at the Download section of a trial.

For general documentation, that is not trial specific (like HOVON address form or transfer of patient form, please find them at our Trial document section.

Site responsibilities in case of site personnel updates

If there is an update in the site-PI or other site personnel, please note that HOVON (and your national coordinator if you have this function in place) need to be made aware of this update as well.

Always send HOVON (hdc@erasmusmc.nl) the latest version of the Site signature & delegation log / Site authorization log (including correct stop and start dates of the personnel that is added / no longer responsible).

If it is beforehand known that the site-PI will be changed, inform HDC as quickly as possible so that a trial amendment can be sent to the authorities.

Also make sure that you provide us the correct updates of other trial documents, it does depend on the specific trial, which documents these are (the list below is not exhaustive). You can think of:

Signed protocol signature page (in case of site-PI update)
Updated ICF (in case personnel at ‘contact details’ section was changed)
Updated / new ALEA account request form (please also notify us if a person no longer needs access to ALEA)
Updated / new Financial Disclosure Forms (in case of site-PI or sub investigators)
Updated Clinical Trial Agreement (if update had impact on those who signed the CTA)

In case there is a temporarily replacement of the site-PI (more then 4 weeks), HOVON must be made aware as well. We will assess which documents are necessary in that case.

Local Data Management

We would like to request the following tasks from the local data managers:

registering and randomizing patients (if applicable – sometimes done by the trial coordinator at a site or the (treating) physician)
collecting patient data from medical files
completing Case Report Forms
informing and consulting with physicians and nurses with regards to requested trial data
answering queries
being present at monitor visits, making sure that requested files are available and ready for review and answers all questions raised during the visit by the monitor

For most of our HOVON trials we use the eCRF ALEA to capture all trial data. Please find all information and also documents like ALEA account request forms and ALEA manuals at the ALEA eCRF section.

There is quite a body of information necessary for performing data management. This is not only restricted to understanding the disease which can be quite complex in regards to Hematology, but also understanding the diagnostics, scoring adverse events, converting lab values in the correct format and evaluating the data according to the correct response assessment guidelines.

Please find more information on these topics at the Data management info section.

Monitoring

Depending on the risk of the trial, it is decided if the trial is performed using a set-up of site specific monitoring (by performing so called Site Evaluation Visits (SEV)) or study specific monitoring.

During a SEV the HOVON monitor will evaluate the overall quality of executing HOVON trials by reviewing procedures and study documents from a randomly chosen trial).

Study specific monitoring will be done according to a monitoring plan. This might be executed by a HOVON monitor or a CRO.

We will inform the participating sites during the start-up, which kind of monitoring is chosen.

Further information can be found at the Monitoring section.

Safety

Patient safety is of course key in all HOVON trials. To be able to closely monitor the safety we request to send in an Serious Adverse Event (SAE) form in the following cases:

Death
A life-threatening condition
(extension of) Hospitalization
Major/permanent injury
A congenital disorder or birth defect
Another medical circumstance threatening the patient or requiring intervention to prevent the developments referred to above.

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.

Based upon the SAE information received, the safety desk evaluates if the SAE translates into a Suspected Unexpected Serious Adverse Reaction (SUSAR).

Every type of SAE must be reported to the HOVON Data Center within 24 hours by the treating physician/researcher. For all new and open studies this is done via an SAE form. All trials use a trial-specific SAE form (please find these at the download section of the Trial itself). Please follow the instructions in the header of the SAE form to determine how the SAE should be send in. If you have any questions about SAE (reports), you can always contact the HOVON Data Center:

Telephone +31(0)10 704 1560

More information on reporting SAEs and tools can be found at the Safety section.

Reimbursement

Participating in a HOVON trial will yield the possibility to participate in the front lines of hematological research. But participation also requires resources from you, like the performance of trial related activities, receiving monitors and setting up trial treatment protocols. HOVON attempts as far as possible to compensate your site for these efforts. What is or is not reimbursed will vary from trial to trial. On the trial specific declaration of expenses form you can request reimbursement. This is allocated in 2 different tiers:

Reimbursement on site level
Patient fee

You can complete the declaration of expenses form on a periodic basis and send it to the HOVON office, so they can reimburse your site.

More information on reimbursement can be found at the Reimbursement section.