The DEEP project has received research funding from the European Union under the 7th Framework Programme
How long is the washout period?
Should treatment-naïve patients go through the wash-out period?
When will the clinical site receive the PK kit?
If my fax is not available or out of order, how should I notify a Serious Adverse Notification to the Pharmacovigilance Service?
What should I do if the icon of a battery appears on the display of the temperature data logger I use to monitor the storage temperature of the IMP?
What is the maximum and the minimum interval to perform Visits from 1 (screening) to 3 (randomization)?
When and how do I perform randomization?
When is cardiac MRI T2* required according to the protocol?
BLOOD SAMPLE HANDLING
What does the protocol statement: “serum creatinine must be assessed in duplicate (for the assessment of inclusion/exclusion criteria only)” mean?
What do I do if a blood sample for local determination is lost?
What do I do if a blood sample for central ferritin determination is lost?
What does the protocol statement: “all tests on hepatitis serology will be carried out on the same sample as collected for blood haematology/biochemistry” mean?
Is it possible to prefill the Exjade labels?
How many label logs for DFP and DFX should be used?
Can I dispense single blisters of Exjade to give to the patient the exact number of required tablets?
How do I dispense deferiprone between two consecutive visits?
What should I do if a patient vomits after the dose intake?
Are Exjade tablets divisible?
Can the Investigator re-dispense an already allocated bottle of deferiprone?
What if the patient didn’t return the IMPs?
Can I include patients under combined chelation therapy in the study?
Can a patient with high ALT values caused by muscular dystrophy be enrolled in the DEEP-2 study?
How do I define “contraindication” to DFO for a patient naïve to the chelation therapy, in order to include him/her in the study?
Can other medications be administered to the patient during the study?
ADVERSE EVENT MANAGEMENT AND IMP DOSE ADJUSTMENTS
If an adverse event occurs during the treatment period, what should I do regarding the study treatment?
How should any Serious Adverse Event (SAE) occurring during the trial be reported?
Instructions for management and rapid notification of Neutropenia events.
When a patient who experienced mild neutropenia can restart the IMP drug?
Which parameters should I evaluate in case of an early termination?
For those patients entering the trial with very high levels of ferritin, should I increase the dose of the drug if ferritin values remain stably high but do not increase further than the 20% margin as specified in the study protocol?
On which ferritin value can I perform dose adjustments?
If the patient by the time of inclusion in the study has scheduled surgery or any procedure requiring hospitalisation to be performed during the course of the trial, how can this be reported?
If a patient experiences an adverse event which requires temporary chelation interruption, is the Investigator allowed to prescribe a different iron chelator in order to let the patient continue chelation therapy?
Neutropenia is defined as any ANC < 1500/mm3 confirmed in two consecutive measurements and reported as SAE. What is the time-frame to repeat the neutrophil assessment for confirmation?
What is the management of neutropenia?
When will the V3 screenshot appear in the e-CRF?
When do I have to enter visit data in the e-CRF?
When do I have to fill in the renal function in e-CRF?
When do I have to fill in the Healthcare Resources form in the e-CRF?
What if the PI or his/her delegate wants to fill in the Drug Management section of the e-CRF,but one or more treatment numbers are missing on the dropdown menu?
What if does not appear the correct treatment number in the drop down menu of the field “returned drug” or “dispensed drug” of the drug management section on the e-CRF?