british association of dermatologists’ biologics intervention register approval process july 2007
TRANSCRIPT
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
https://www.nresform.org.uk
Go to Create account at top of web page
Step 2 Once you have registered
• Contact Kathy McElhone on 0161 603 7731 • Provide her with the email address that you have registered
• She will then electronically transfer the online SSI Form to you for completion
• Kathy will confirm by email 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 www.nres.org.uk
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
Summary Registration Instructions
STEP 3: On receipt of Ethics approval submit SSI to R&DSTEP 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
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 youBADBIR will electronically transfer SSI form to you
STEP 1: Create account with NRESSTEP 1: Create account with NRES
Once registered contact BADBIR to provide email addressOnce registered contact BADBIR to provide email address
You are now ready to enter patients into the registerYou are now ready to enter patients into the register
Contact BADBIR
arc Epidemiology UnitThe University of Manchester
Oxford RoadManchester
Contact Kathy McElhoneBADBIR Study Co-ordinator
Telephone: 0161 603 7731Email: [email protected]