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