Trial management queries

Here are some answers to some of the most commonly asked questions by research staff at hospitals.

Registration

  • How can I check if an SMP2 patient is eligible for Matrix?
    SMP2 reports can be anonymised and emailed to lungmatrix@trials.bham.ac.uk if you would like to check whether the patient has any actionable mutations.
  • How do I reserve a slot for a patient nearly ready to go onto Matrix?
    Please perform the Screening Registration process, as per Section 7.3 of the Protocol. Please note this should only be done for patients in a ‘trial-ready’ position, to ensure that slots are only held by patients ready to start treatment shortly.
  • What do I do if the patient fails screening and no longer requires a slot?
    Please email lungmatrix@trials.bham.ac.uk quoting the Screening Number (SNO), reason for removal, and confirm that the held slot can be removed.
  • When can I give out the Arm-specific Patient Information Sheet (PIS)?
    No Arm-specific PIS’ may be given out until the Screening Registration Process has been performed and the Trials Office have returned a Cohort Allocation Form, confirming that a slot has been reserved.
  • How do I register the patient to the trial when I have confirmed they meet the eligibility criteria?
    Please follow the instructions found in Section 8 of the Protocol.

Biopsies

  • Which consent form do I use when a patient needs a repeat biopsy to send for repeat SMP2 testing?
    The Molecular Testing Biopsy Patient Information Sheet and Informed Consent Form should be used, as per Section 6.1.1 and 6.1.2 of the Laboratory Manual.
  • Can I perform other standard of care tests on the Matrix repeat biopsy?
    No. This biopsy is for Matrix research purposes only. It should be sent for repeat SMP2 testing as per section 6.1.1 of the Laboratory Manual and then stored in case of further tissue requirements
  • Why is a repeat biopsy needed?
    Repeat biopsies may be required for a number of reasons, as per Section 7.2.1 of the Protocol.

Data management

  • How do I create a Treatment Discontinuation visit timepoint/form?
    This is created as an ad hoc visit on the Patient’s Timeline. Please refer to Section 10.2.2 of the eRDC User Manual.
  • How do I enter the other assessments required at the Discontinuation visit?
    These will not appear until the Treatment Discontinuation form has been completed and reviewed by the Trials Office. Please refer to Section 10.3.4 of the eRDC User Manual.
  • Why are there still paper CRF updates?
    It is the CRCTU policy that as the trial opened and originally used paper CRFs, these will continue to be updated and distributed to sites in order to reflect the changes to be made to the eRDC.
  • Which paper CRFs are still in use?
    The latest version of the CRF Version Checklist, or the Paper CRF Completion Guidelines indicates the CRFs which are still in use in paper format, and those superseded by the eRDC.
  • How do I get eRDC access?
    Please email lungmatrix@trials.bham.ac.uk to request eRDC access. If you have not done so already, we will request that a Site Staff Registration Form is completed, and that you have been signed off on the Site Signature and Delegation Log by the Principal Investigator, before we are able to grant you access and email you your username.
  • How do I get Cenduit IWRS access?
    Please email lungmatrix@trials.bham.ac.uk to request Cenduit access. We will require the Cenduit User ID Request Form.

Clinical queries

  • Is the patient allowed palliative radiotherapy whilst on treatment?
    Please refer to the Arm-specific ‘Restrictions & Concomitant Medications’ section of the Protocol. Guidance will only be included here if we have received it for that particular drug. If it is not included, please email the Trials Office for further guidance.
  • Do you allow eligibility waivers?
    It is the CRCTU’s policy to never allow any eligibility waivers. No exceptions will be made. The patient should meet both the Core and Arm-specific eligibility criteria in the latest version of the Protocol with R&D Approval in place at your site.
  • Is there a maximum treatment interruption length allowed?
    Please refer to the Arm-specific ‘Dose Modifications and Toxicity Management - Treatment Delays and Discontinuation’ section of the Protocol.
  • Does the patient have to discontinue treatment if they meet RECIST 1.1 criteria for progressive disease?
    Not necessarily (see Section 9.3 of the protocol). If the patient has progressive disease but the Investigator believes that the treatment is tolerable and believed to be of clinical benefit, please email lungmatrix@trials.bham.ac.uk to discuss this. This MUST be discussed with the Trials Office before a decision is made to keep the patient on treatment.

Investigator Site File

  • Will you supply additional folders for the Site File?
    Yes. If you are running out of space please email lungmatrix@trials.bham.ac.uk for resupplies.
  • How do I get the login details to download documentation from the website?
    Please email lungmatrix@trials.bham.ac.uk to be sent the username and password. 

Translational

  • How do I arrange a shipment of ctDNA and whole blood germline DNA samples to the HBRC?
    Please follow the instructions within Section 7.4 of the Laboratory Manual and also contained within your Biocair starter pack. Samples should be stored in separately labelled freezer boxes, and a Sample Form should be completed for each distinct patient and timepoint. Please cc lungmatrix@trials.bham.ac.uk when booking shipments with Biocair.
  • What do I do once PBMC samples have been taken?
    If you have not done so already, please email lungmatrix@trials.bham.ac.uk and e.s.maneta@bham.ac.uk to advise that samples will shortly be posted using next day delivery. Samples should be labelled, stored and shipped as per Section 8 of the Laboratory Manual.

Finance

  • How are payments triggered?
    The Senior Trial Coordinator (STC) will contact the site every 2 months requesting priority completion of CRFs and instructing shipment of ctDNA/germline DNA samples. This will allow the STC to ascertain how much the site is owed. A few weeks later the STC will get in touch with the site with the details of payments due according to our records, and ask the site to raise an invoice to us.
    Payments are based on: ctDNA/germline and PBMC samples taken during the reporting period; biopsies during the reported period; and completion of CT Assessment Forms, Survival Follow Up Forms, Arm NA Cohort NA1 Lab Test Forms, Discontinuation Forms and Death Forms.

Matrix feeder site queries

  • What does a Matrix feeder site do?
    The Matrix feeder sites can consent patients to and perform repeat Matrix Molecular Testing Biopsies to be sent for repeat SMP2 testing if e.g. there was no sample available or the tissue failed the QC step at the Technology Hub. They may also identify potential patients with the Trials Office by performing the Screening Registration Process, before transferring to the main treating site for screening.
  • Do we receive accruals for the biopsies performed?
    No, accruals are not available as these patients are not yet registered to the trial.

Other

  • When does the trial close to recruitment?
    The current funding period runs until 30-Sep-2021, therefore this can be used as the recruitment end date. However due to the rolling nature of the trial, we highly expect this date to be extended once funding for the next period is confirmed.

Publicity

  • Can I tweet about Matrix?
    Of course! Please use the hashtag #lungmatrix for any relevant tweets about your experience of the trial. If you have your own department or hashtag that we can acknowledge in our tweets please let us know.
  • Are there any Matrix slides I can use?
    Within the For Professionals area of the website a slide deck is available for use. Please email lungmatrix@trials.bham.ac.uk for up to date recruitment slides if required.