CRF Version Log CRFs Current

advertisement
CRF Version Log
CRFs
Current
Version &
Date
Superseded
Version and
Date
CRF 1 Eligibility Form
V2.1
09.09.14
V2.0
29.04.12
CRF 2A Randomisation
Form
V2.1
23.05.14
V2.0
29.04.14
CRF 2B Registration Form
V2.1
23.05.14
V2.0
29.04.14
CRF 3 Baseline Form
V2.3
09.09.14
V2.2
09.06.14
CRF 4A Mammography
Form
CRF 5A Annual Follow-up
Form Main Study
CRF 5B Annual Follow-up
Form Cohort Study
V2.2
09.09.14
V2.2
10.12.14
V1.1
10.12.14
V2.1
01.08.14
V2.1
23.05.14
V1.0
23.05.14
CRF and Questionnaire Booklet Version Log V3.2; 17 Dec 2014
Summary of Changes
 To modify option 7 · No bilateral disease (Including DCIS)
 And expand free text box in section 1.2
 Amended question 2.4.2.
 Amended answer options for question 2.5.5.
 Added question 2.5.6.
Approved by TMG 22/05/2014
 Amended question 2.4.2.
 Amended answer options for question 2.5.5
 Added question 2.5.6.
Approved by TMG 22/05/2014
Changed:
 Question 6 in section 3.1
 Added ‘Not Done’ ‘Not Known’ tick boxes in section 3.6 ‘Pathology details’
 Added note in question 4 section 3.8
Changes made as requested by the programming team
The wording ‘Years from trial entry’ has been changed to ‘Years from surgery’
The wording ‘Years from trial entry’ has been changed to ‘Years from surgery’
CRF Version Log
CRFs
CRF 6A Withdrawal Form
CRF 6B Sub-Study
Withdrawal Form
CRF 7 Event Form
CRF 8 Notification of Death
Form
CRF 9 Transfer Form
Current
Version &
Date
Superseded
Version and
Date
V2.1
16.09.14
V1.0
16.09.14
V2.0
29.04.14
V2.0
29.04.14
V2.0
29.04.14
V2.0
29.04.14
CRF and Questionnaire Booklet Version Log V3.2; 17 Dec 2014
Summary of Changes
Wording changed to state: ‘ This form must be completed if a patient decides to withdraw
their consent from all aspects of the trial’
NEW FORM
CRF Version Log
Questionnaire Booklets
CRF 4b Main Study
Questionnaire Booklet
Cohort Questionnaire
Booklet
Quality of Life
Questionnaire Booklet
New Version
& Date
Superseded
Version and
Date
V1.0
01.10.13
V1.0
01.10.13
V1.0
01.10.13
CRF and Questionnaire Booklet Version Log V3.2; 17 Dec 2014
Summary of Changes
Download