DRUG HANDLING/INVESTIGATIONAL MEDICAL PRODUCT (IMP):
Q: Is temperature monitoring required during IMP transit from where the IMP has been received and to the ward? (This could be longer than 5 minutes as it will also involve awaiting handover of IMP to the Responsible ward staff)
A: This drug is rather stable, so it should not under normal conditions, be necessary to do temperature monitoring during short transits.
Q: Is temperature monitoring required whilst the IMP is being stored on the ward for 2 weeks?
A: Yes, there should be temperature monitoring during the weeks the drug is stored on the ward.
Q: Is it acceptable for sites to use their own temperature monitoring logs?
A: Yes, as long as it covers the information in NorCRIN template 2.13.2 (see Investigator Site File section 7.5)
Q: Electronic prescriptions: is it acceptable to print and sign these to use as source documents?
A: Yes, printed electronic prescriptions can be used as the source for the prescription, but we suggest printing the randomisation e-mail received from ENNOV / eCRF system as source for which kit the patient has been randomised to.
Q: What is the missed dose procedure?
A: A dose should only be replaced if it can be visually confirmed that the patient did not receive the dose, either due to vomiting with visible tablet remains or due to tablets getting stuck in the NG tube. No other missed/skipped doses should be replaced.
Q: The protocol states, “The dose of study intervention and study subject identification will be confirmed at the time of dosing by a member of the study site staff other than the person administering the study intervention.” What exactly is being asked for here – a two-nurse administration?
A: Yes. This is something from the Investigational Brochure (IB). Suggest that sites follow local procedures (double check simultaneously, delayed second check etc.)
Q: Drug reconciliation: Can you give us some guidance on when this is to occur?
A: Continuously, i.e. when IMPs are received, dispensed, returned or destroyed.
Q: Is the “Drug reconciliation log” completed by the monitor or the pharmacist?
A: The drug reconciliation log / accountability log at site level should be completed by the pharmacist or site staff responsible for the IMP and checked by the monitor.
Q: What will happen when the IMP arrives in the ward? Who can administer study drug?
A: It may be necessary for clinical staff (non-study staff) to be allowed to deliver the IMP. The PI should make the clinical staff in the ICU / ward aware of the study. The drug should be documented on the patients chart as per normal meds.
Q: If a patient does not have a nasogastric (NG) tube in and becomes NPO should a tube be put in just for IMP administration?
A: NG tube should only be placed on clinical indication and not for the trial per se.
Q: How will pharmacists receive information about kit numbers after randomisation?
A: If the IMP is stored at a pharmacy, the prescription will indicate which kit number to dispense to the patient.
Q: Can you give some clarification around what will happen on weekends if a patient’s results indicate the dosage needs to be changed?
A: It should be possible to contact study staff locally so that dose modifications can be performed even during weekends. These arrangements must be made locally at each site.
Q: Who can report AEs and SAEs in the eCRF?
A: AEs and SAEs can be reported by all investigators at a site, not only the PI.
Q: The assessments in section 8 of the protocol ‘Safety Assessments’: are these only required if an AE has occurred?
A: Please see the Bari-SolidAct protocol, schedule of assessments 1.3. Safety biochemistry samples should be taken regularly whether AE has occurred or not.
Q: Urine test at day 30: should sites provide a kit to patients?
A: The sites will receive a few pregnancy tests together with the delivery of study drugs for the first 10 patients from Theradis, and yes, the sites should provide a test to the patient when required.
Q: Baseline pregnancy test: is a urine test sufficient or will a blood test also be required?
A: A blood test is required.
Q: In cases where a lab member is not part of study staff, who should the lab contact person be?
A: If biobanking is planned, staff with experience in lab should be included locally.
Q: Is there any flexibility on day 3 for biobanking? If not it could limit days the site can recruit where there is no weekend cover.
A: The biobank assessment has a window of +/- 1 day (exept baseline which should be performed before first dose of IMP). If not possible to assess the patient during weekends, the Saturday assessment could be performed on Friday, and the Sunday assessment could be performed on Monday.
Q: Guidance is required around window for schedule of assessments. Is there a limit on the days a patient can be recruited if scheduled event falls on a weekend? For example patients will not be able to be recruited on a Thursday as the day 3 assessment will not be possible at our clinic.
A: Each of the assessments (including biobank and lab) has a window of +/- 1 day. If it is not possible to assess the patient during the weekend, the Saturday assessment could be performed on Friday, and the Sunday assessment could be performed on Monday.
Q: What days does renal function need to be documented? Does a renal function calculation need to be done and documented over the weekend?
A: Renal function is necessary for dose adjustment of IMP as noted in the protocol. It is possible to adjust time points for assessment with +/- 1 day, so that Saturday assessment could be done on a Friday, and the Sunday assessment could be performed on Monday.
Q: Corticosteroids: If a patient is started on oral corticosteroids after enrolment can they remain on the trial? Is this a PI decision?
A: The patient can remain in the trial, but start or dose increase in steroids should be noted under conmeds in the eCRF along with an assessment of potential disease progression.
* None noted yet.
Q: Will an approved GP letter be provided?
Q: Are financial disclosures required by the sponsor?
*None noted yet.