Jeffery Wong, Clinical Research Coordinator, Nucleus Network Ltd

1. T16 Phase I studies – Phase I units and you, a Phase I unit’s expectation – A Day in the Life of a Phase I Study Coordinator Jeffery Wong, Clinical Research Coordinator, Nucleus Network Ltd

2. A Day in The Life of A Study Coordinator • Main objectives: • To create awareness and a better understanding of a Phase I clinical research co-ordinator’s (CRC) role • To provide an understanding of the intensity of Phase I clinical trials • To highlight some of the differences between Phase I trials and later phase trials

3. A Day in The Life of A Study Coordinator Clinical Research Co-ordinator Principal Investigator Commercial Sponsor Ethics Committee Subjects/ Participants Technical/ Study Logistics Recruitment/ Screening Data Management Clinical Trials Pharmacy

4. A Day in The Life of A Study Coordinator Principal Investigator • Report and discuss any adverse events as well as any subject safety concerns. - Daily updates if conducting MAD study • Provide PI with periodic update on study progress. Ethics Committee • Prepare ethics submission package in conjunction with Project Manager • Provide safety updates, submit amendments and obtain approvals. i.e. fortnightly safety reports. • Provide annual progress reports.

5. A Day in The Life of A Study Coordinator Commercial Sponsor • Provide updates to Sponsor/CRA pertaining to recruitment and progress of study. • Clarify specific protocol requirements i.e. inclusion/exclusion criteria, study procedures. • Confirm timeline for DSMB and the data required for evaluation. DSMB meetings could be fortnightly. • Provide daily AE and safety lab updates via email. • SAE reporting.

6. A Day in The Life of A Study Coordinator Recruitment/Screening • Ensure adequate subjects are recruited for each study including availability of alternate subjects. • Up to 4 – 6 volunteers being screened daily • Average screening window is 28 days • Ensure exclusion/inclusion criteria are clear to minimise ratio of screen failures. Patient/Subject • Ensure subjects’ compliance and their understanding of each study’s requirements. • Ensure subjects’ safety and comfort whilst participating in a study i.e. laundry, catering, entertainment etc.

7. A Day in The Life of A Study Coordinator Technical/Study Logistics • Ensure study related samples i.e. PK, PD and PGx are appropriately processed and shipped to specified destination as indicated in study protocol. • Shipment could occur on the same day after last sample is collected. • Liaise with technical lead to ensure study laboratory requirements are adequate. • Liaise with other contracted laboratories i.e. Melbourne Path, Alfred Path etc. • Short turnaround time for results.

8. A Day in The Life of A Study Coordinator Clinical Trials Pharmacy • Provide prescriptions to Clinical Trials Pharmacy for dispensing of IP • Dispensing of IP could take place on the morning of dosing. • Ensure proper destruction/return of IP post dosing – IP accountability. Data Management • Ensure completeness of source documentation. • Ensure CRF transcription is performed in a timely manner in accordance with pre-defined timelines. • Ensure open queries are resolved.

9. A Day in The Life of A Study Coordinator Scenario Study 1: Dosing Day • Very intense with all activities running by the clock. • Triplicate ECGs, Supine/Seated/Standing vitals, multiple blood sampling time points • Every team member needs to know their role and be on stand by to provide assistance. • Every change in circumstances result in a chain reaction i.e. delay in dosing. • Food effect trials have additional concerns i.e. meal times & type of food. • Sponsors may witness dosing or require verbal updates on day of dosing.

10. A Day in The Life of A Study Coordinator Fig 1. Study Task Pad

11. A Day in The Life of A Study Coordinator Fig 1. Study Task Pad

12. A Day in The Life of A Study Coordinator Scenario Study 2: Source notes documentation • Multiple data points due to assessment intensity. • 100 – 200 data points from predose to 1st hr post dose. • Documentation involves entry from multiple study personnel (entire study team). • Medical history and concomitant medication records are usually brief compared to later phase trials i.e. several volumes.

13. A Day in The Life of A Study Coordinator Fig 2. Source Notes

14. A Day in The Life of A Study Coordinator Fig 2. Source Notes

15. A Day in The Life of A Study Coordinator Scenario Study 3: Data Management • QC performed on source documentation prior to being monitored. • More and more sponsors are requesting real time data entry. • CRA may need to come in and perform SDV whilst data is being entered into the CRFs. • Lab results are transferred electronically – dose escalation evaluation. • Tight timeline for query resolution before data base lock.

16. A Day in The Life of A Study Coordinator Conclusion • Men can multitask too! Old myth is busted. • The success/smooth running of an early phase trial relies heavily on team effort hence clear communication line is imperative. • Early phase trials are intense hence study protocol clarity is essential to ensure expectations could be met. • Main differences between Phase I trials and later phase trials are the intensity and study timelines.