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. 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 NewGene 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. 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 faxed to the SeluDex Trial Office. Site Staff should then telephone the Trial Office to regiser the patient over the phone.

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 site staff register a patient for trial entry by telephoning the SeluDex Trial Office who will complete the Trial Entry Registration Form on the eRDC. 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.

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