British Association of Dermatologists’ Biologics Intervention Register Approval Process July 2007

What to do if you are interested in participating

Step 1 LREC application via NRES online form You need to register with NRES You can do this via the following web link

Register with NRES Go to Create account at top of web page

Step 2 Once you have registered Contact Kathy McElhone on Provide her with the address that you have registered She will then electronically transfer the online SSI Form to you for completion Kathy will confirm by that the form has been transferred to you Some information will already be completed please confirm its accuracy Once the SSI form is completed it needs to be locked, printed off and signed by the Principal Investigator (PI) Submit your SSI to your LREC along with the PI’s signed, dated CV and the locally adapted patient information sheet and consent form

Step 3 Once you have obtained LREC approval You now need Trust approval Contact your R & D Department for details of local procedures At a minimum you will need to send them A copy of the signed, locked SSI form A copy of the MREC approval form A copy of the currently approved study protocol A copy of the MREC and LREC approval letters A signed and dated copy of the PI’s CV Locally adapted patient information sheet and consent forms You should arrange Good Clinical Practice (GCP) training for all your researchers via your R & D department

Problems with the online form? We are happy to assist We can send you a questionnaire for you to complete and return to us We will then enter the information you provide on the questionnaire on the SSI on your behalf Return it to you so that you can sign, date and forward it onto your LREC along with the PI’s CV Further information and guidelines can also be found at

What next? When all these approvals are in place and have registered your details with us we can provide you with authentication log in and passwords You will then be able to access the website and enter patients You can see examples of our data collection forms, consent forms and patient literature on this website

Website

Summary Registration Instructions STEP 3: On receipt of Ethics approval submit SSI to R&D STEP 2: When SSI completed, lock and print. Submit both SSI and CV signed by (PI) with locally adapted Patient Information Sheet and Consent Form to LREC When both (Ethics and R & D) approvals are in place contact BADBIR for Log in passwords BADBIR will electronically transfer SSI form to you STEP 1: Create account with NRES Once registered contact BADBIR to provide address You are now ready to enter patients into the register

Contact BADBIR arc Epidemiology Unit The University of Manchester Oxford Road Manchester Contact Kathy McElhone BADBIR Study Co-ordinator Telephone: