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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. A Day in The Life of A Study Coordinator. Main objectives:

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Jeffery wong clinical research coordinator nucleus network ltd

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


A day in the life of a study coordinator

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


A day in the life of a study coordinator1

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


A day in the life of a study coordinator2

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.


A day in the life of a study coordinator3

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.


A day in the life of a study coordinator4

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.


A day in the life of a study coordinator5

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.


A day in the life of a study coordinator6

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.


A day in the life of a study coordinator7

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.


A day in the life of a study coordinator8

A Day in The Life of A Study Coordinator

Fig 1. Study Task Pad


A day in the life of a study coordinator9

A Day in The Life of A Study Coordinator

Fig 1. Study Task Pad


A day in the life of a study coordinator10

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.


A day in the life of a study coordinator11

A Day in The Life of A Study Coordinator

Fig 2. Source Notes


A day in the life of a study coordinator12

A Day in The Life of A Study Coordinator

Fig 2. Source Notes


A day in the life of a study coordinator13

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.


A day in the life of a study coordinator14

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.


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