3.10 Data

Patient entry form (or enrolment form or initiation form) should be submitted to the coordinating centre without delay, within 24 hours of randomisation. This is the requirement for the trial indemnity policy to cover the patients taking part in the trial. Other CRFs should be completed and returned in a timely manner as indicated in the trial protocol.

All forms should be completed clearly and legibly and all fields must be completed. The principal investigator or delegate responsible person will need to certify the accuracy of data submitted. Should you need to correct any entries it should be done in the following manner:

• cross over the incorrect entry but do not obscure it
• write the correct entry next to it
• date and initial the correction
• DO NOT DELETE ANY ENTRIES ON THE FORM

CRF CORRECTIONS