1. Recruitment, randomisation and timelines. Mr Francis Dowling
Investigator Meeting 2018
Recruitment, randomisation and timelines. Mr Francis Dowling

2. PROFILE - Recruitment First participant recruited – December 2017
Overall Target – 400 participants over 2 years at approximately 50 sites
Site target recruitment is 5 per year i.e. one recruited participant every 2/3months

3. PROFILE - Sites Lead Site opened mid-Dec 2017
First external site opened Feb 2018 (well done QEHKL)
SIVs are rapidly filling my diary up! (please book if you haven’t already)

4. PROFILE - Predictions
All sites planned to be open before December 2018
Pace – 18 recruited per month

5. PROFILE - Randomisation

6. PROFILE - Randomisation

7. PROFILE - Randomisation

8. PROFILE - Randomisation

9. PROFILE - Randomisation

10. PROFILE - Randomisation

11. PROFILE - Randomisation

12. PROFILE - Randomisation

13. PROFILE - Randomisation

14. PROFILE - Randomisation

15. PROFILE – Timelines CRFs Screening CRF asap, within 7 days
Other CRFs within 14 days
scanned copies
Original copies to site file

16. PROFILE - CRF completion guidelines
The current & correct version of the CRF form must be completed.
Use Ticks
All dates are to be completed in the sequence day/month/year (DD/MMM/YYYY) with the month written using LETTERS not numbers
Enter a digit in each box provided, if three boxes are provided but only two are required please enter a preceding 0
Where data are not available please do not leave the answer blank as this will create unnecessary data queries
Please include one of the following abbreviations instead:
NK = Not known
NA = Not applicable
ND = Not done
Errors should be crossed out with a single line (i.e. mistake), the correction inserted and the change initialled and dated by the investigator or designee

17. PROFILE - Timelines
30 days from SIV to sponsor green light, otherwise SIV no. 2
CRN metric is 70 days from LIP submission to first patient recruited.

18. Questions? Thank for you time.
Please book you SIVs up asap.