Monitoring PaCCSC studies

1. Monitoring PaCCSC studies Improving quality

2. Acknowledgements • Each and every site • Investigators • Site coordinators • Study staff • Caroline Litster, Natalie Cutri, Linda Devilee

3. Brief overview • PaCCSC has a comprehensive monitoring programme • Unusual for investigator initiated studies • Usual for pharmaceutical sponsored studies • Programme is based on best practice and ICH GCP guidelines • All sites • All participants • Incorporates an element of pragmatism and realistic opportunity

4. Monitoring • GCP requirement of sponsors • Verifies • rights and well being of participants • protocol has been followed • trial conduct is in compliance with GCP • Also a means to verify participant data • Data used in the study analysis is correct and can be verified from other sources • The study results are based on the data from participants • ensures that participant data counts

5. Monitoring • Is a detailed review of study documents, protocol implementation and procedures • After study is complete this is the only way to verify compliance • Enables assessment of each site and the opportunity to provide support for specific problems • Enables training at each site to bring about internal quality improvement

6. Monitoring • Assess all site files • Review all participant files against source documents • Targeted review of critical data elements • Eligibility • Consent • Administration of study medication • Review of safety assessments • Review of primary outcome assessments • Reasons for cessation

7. What worked well • Early monitoring included a variety of strategies • Aimed at simply getting through the numbers of files required • Also to increase learning amongst sites and to increase the capacity of all in a period of learning and expansion • Fostered mentoring between recruitment sites and with PaCCSC

8. Ketamine study • Monitoring included taking a site coordinator to monitor another site along side the PaCCSC monitor • Rotated at least once • On site training

9. Ketamine study • Enabled each site coordinator to see how another site organised their files, how they prepared for monitoring, and what problems arose • Site coordinators could discuss recruitment, filing, organisation and staffing issues • Good feedback, and some sites implemented some of the tips seen at the other site

10. Ketamine study • Did this process bring about improvements in basic monitoring outcomes for this or future studies • The main problems for this study • First study and everyone was learning • Changes in HREC organisation occurred

11. Octreotide study • Impending study closure initiated a different monitoring strategy • All study nurses joined a teleconference to review and discuss the specific monitoring needs for this study • Details of monitoring process, paperwork and assessment was discussed • Each study nurse then monitored another site alongside a PaCCSC monitor

12. Octreotide study • Study nurses could see for themselves what was monitored, how files at other sites looked, and what problems were found • Provided an opportunity to prepare their own files for subsequent monitoring.

13. Octreotide study • Did this process bring about improvements in basic monitoring outcomes for this or future studies • The main problems for this study • Study was nearing completion and findings could not be implemented at sites for subsequent participants

14. Risperidone study • Specific issues related to consent and medication dosing • Monitoring has been later than other studies so lessons learned from earlier should be seen here

15. What didn’t work well • Organisational factors • Very difficult to arrange dates and sites availability • PaCCSC monitors • Site to be monitored • Site providing support monitor • Personnel factors • Much time taken up with training on site, slows down the process • In some cases, networking, discussion and learning resulted in slow file review.

16. Results • Did any of these activities result in improvement in monitoring outcomes at sites? • Three studies were examined • Ketamine, inpatient study, complete • Octreotide, inpatient study, complete • Risperidone, inpatient study, almost complete

17. General methods • Reviewed all the corrective action sheets • Listed the number of actions for each participant at each visit, along with date of randomisation • Listed the number of actions related to general site investigator files • Noted the dates of any training (during ketamine, octreotide, or due to previous monitoring) • Determined the average number of errors for before training and after training.

18. Results Only 1 participant prior to training Only 1 participant after training

19. Results Only 1 participant prior to training Did not have training

20. Results No errors in early monitoring Only 1 participant after training

21. Next time • Reinforce that monitoring is a QA activity • Results from one visit should be corrected: • For the reviewed file • For next files and future files • For monitored study and other studies • Recognise that sites value visits to other sites • to compare notes and see what they are doing • How can we continue to learn and share experiences

22. Next time • There are common errors across all studies, and errors specific to a particular study • We need to identify the common errors and determine ways to improve • Consent • Signing, filing, documentation • Documentation • Completion of the CRFs • Answer every question • Ensuring that source documents are clear and available

23. Next time • Each site needs to discuss the monitoring outcomes between themselves • Look at the corrective actions • How could this have been avoided • What can be improved for next time and not repeat the same errors • What can PaCCSC do to assist?