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.
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.
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.
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:
- 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.
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.