SeluDex Case Report Forms

 

Screening CRFs - In use on paper

The following CRFs are in use on paper during screening and prior to trial entry registration.

Central RAS Mutation Testing at Northern Genetics Service in Newcastle 

Once a patient has consented to the Pre-trial Genetic Assessment (RAS mutation testing) and prior to sending the sample please complete a Screening Registration Form, obtaining the screening number from the Screening Registration Log in the Investigator Site File, and e-mail to the SeluDex Trial Office. We will then confirm receipt and that the patient has been registered for screening, you may then send the sample for analysis (please refer to the Laboratory Manual for further details). Results from Northern Genetics Service are returned to the SeluDex Trial Office in 5-7 working days, these will be forwarded immediately to site along with the Pre-Trial Genetic Assessment Result Form completed by the SeluDex Trial Office to confirm whether their result meets the eligibility criteria and confirmation on availability of slots. Should you reserve a slot this will be confirmed by the SeluDex Trial Office completing and sending a Treatment Slot Allocation Form. The patient may then consent to the main trial and undergo any remaining screening investigations. 

Locally Confirmed RAS Mutation Results at Site

Once a patient has a locally confirmed RAS Mutation result collected under local consent and analysed as part of standard care they may be allocated a screening number from the Screening Registration Log in the Investigator Site File. Please contact the SeluDex Trial Office to reserve a slot and we will confirm this by completing and returning a Treatment Slot Allocation Form. You may then obtain consent to the main trial in order to send us the completed Screening Registration Form and anonymised local RAS mutation result report via email  in addition to perform any remaining screening investigations. We will then confirm receipt and that the patient has been registered for screening in addition to completing and return a Pre-trial Genetic Assesssment Result Form with details of the patient's RAS mutation.

  • Screening Registration Form [702 KB .pdf]
  • Pre-Trial Genetic Assessment Result Form (Trial Office Staff Use Only) [261 KB .pdf]
  • Treatment Slot Allocation Form (Trial Office Staff Use Only) [249 KB .pdf]

Trial Entry Registration

If the patient meets the eligibility criteria and site staff wish to regsiter the patient for trial entry an Eligiblity Form should be completed, signed by a consultant level SeluDex clinician and emailed to the SeluDex Trial Office. Site Staff will then receive a call back from the SeluDex Trial Office who will complete the Trial Entry Registration Form (a copy can be found in the next section for reference - please have these details ready) electronically to register the patient over the phone.

  • Eligibility Form [321 KB .pdf]

Please also refer to the CRF Completion Guidelines for further information.

CRFs following Trial Entry - In use on Electronic Remote Data Capture (eRDC) system

The following CRFs are in use on the eRDC https://www.cancertrials.bham.ac.uk/SeluDexLive for site staff to enter directly and the PDFs below are for reference only. These CRFs are generated on the patients electronic record once the patient has been allocated a Trial Number (TNO) at registration. Should you require login details to the eRDC please ensure you complete a staff registration form and are listed on the delegation log with role 12 allocated and request a username from the SeluDex Trial Office.

  • Trial Entry Registration Form (Trial Office Staff Use Only) [ 510 KB .pdf]
  • Baseline Form [433 KB .pdf]
  • Screening Assessment Form [444 KB .pdf]
  • Laboratory Tests Form [470 KB .pdf]
  • Disease Assessment Form [406 KB .pdf]
  • Opthalmology Exam Form [444 KB .pdf]
  • Adverse Event Form [466 KB .pdf]
  • Concomitant Medication Form [451 KB .pdf]
  • Visit Assessment Form C1D1 Form [426 KB .pdf]
  • Visit Assessment Form C1D2 Form [387 KB .pdf]
  • Visit Assessment Form C1D4 Form [394 KB .pdf]
  • Visit Assessment Form C1D8, C1D15 and C1D22 Form [406 KB .pdf]
  • Visit Assessment Form C1D28 Form [389 KB .pdf]
  • Visit Assessment Form C2D1 Form [421 KB .pdf]
  • Visit Assessment Form C2D15 Form [382 KB .pdf]
  • Visit Assessment Form C3-6 D1 Form [411 KB .pdf]
  • Treatment Form Cycle 1 Form [467 KB .pdf]
  • Treatment Form Cycle 2 Form [485 KB .pdf]
  • Treatment Form Cycle 3-6 Form [519 KB .pdf]
  • Treatment Discontinuation Form [408 KB .pdf]
  • Visit Assessment Form End of Treatment Form [390 KB .pdf]
  • Visit Assessment Form 28 Day Follow Up Form [440 KB .pdf]
  • Withdrawal of Consent Form [385 KB .pdf]
  • Deviation Form [392 KB .pdf]
  • Pregnancy Notification Form [448 KB .pdf]
  • Relapse Form [398 KB .pdf]
  • Death Form [478 KB .pdf]
  • MRD Result Form [386 KB .pdf]
  • PK Results Form (Trial Office Use Only) [387 KB .pdf]
  • Combined eRDC CRFs [2,930 KB .pdf]

Please also refer to the CRF Completion Guidelines for further information.