Q. Who can correct or add data omitted from a Case Report Form (CRF)?

A. If the correction or addition relates to any data collected (i.e. a measurement value recorded or failed to be recorded in the body of the CRF, then the person who entered the value to be corrected should correct the form or add the value that was collected but not recorded. For example, if a blinded assessor called John Smith completed the form, only John Smith should correct or add to to the form, and not any blinded assessor.
However, if the correction relates to a error or omission in the header, then any local  (1) research therapist, (2) blinded assessor, (3) research administrator or (4) the Principal investigator with overview if the afore mentioned individuals can correct or complete the header as long as good data practice is followed (e.g. all individual changes made after the form was first completed initialed and dated, even if this is by the a same person who initially completed the form).

Q. Should the WITHDRAWAL/END OF STUDY FORM be used for a participant who has provided written informed consent to participate in the trial but is then identified as not eligible to take part in the Trial?


A .Yes, this form is designed to record the point in the trial, after written informed consent is provided, that a participant is no longer considered to be active 'on' the trial.  This is important as only participants 'on' the trial should be monitored for AEs and SAEs, participants who have been signed-off as End Of Trial (EOT) should not.  This form also provides a simple, single indicator of the completeness of the data we collect and/or the reason(s) why data could not be collected.  The form also let's anyone receiving or reading it know not to expect any further data for this participant which is important for quality control and audit.

Q. Who should complete the WITHDRAWAL/END OF STUDY FORM?


A. The Principal Investigator (PI) is responsible for completing this form.