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Clinical Trials: How do I get started?. OSP Brown Bag Session March 16, 2012 Ann J. Melvin MD, MPH Co-Director ITHS Regulatory Support and Bioethics Core. Objectives. Provide an overview of: How to assess study feasibility Clinical research approval process- UW Where you can go for help.

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Clinical trials how do i get started

Clinical Trials: How do I get started?

OSP Brown Bag Session

March 16, 2012

Ann J. Melvin MD, MPH

Co-Director ITHS Regulatory Support and Bioethics Core


  • Provide an overview of:

    • How to assess study feasibility

    • Clinical research approval process- UW

    • Where you can go for help

Study feasibility
Study feasibility

  • Population

  • Procedures

  • Collaborations

  • Staff

  • Budget

  • Space

  • etc.


  • Do you have access to the right patient population?

  • Are the enrollment goals realistic?

  • Will you need to recruit outside of your system?

  • Will enrollment compete with other studies?

  • Are there special consent issues?

  • Have you reviewed the inclusion/exclusion criteria and are they too restrictive?


  • Are procedures approvable?

  • Are procedures frequent/painful/inconvenient?

  • Do procedures require special equipment/expertise?


  • Do you need additional specialists?

  • Do you need access to outside clinics/schools/etc?


  • Do you have qualified staff?

  • Any special training required?

  • Do you need an RN?

  • Do you have time to devote to the protocol?

  • Does your staff have time to devote to the protocol?

Budget considerations
Budget considerations

  • Your time

  • Staff time

  • Sub-investigator time

  • Consultant time

  • Cost of procedures

  • Cost of labs

  • Cost of space (CRC)

  • Cost of shipping

  • Records Storage

  • Cost of storing specimens

  • Pharmacy costs

  • Cost of data collection system

  • Cost of monitoring (study and site)

  • Cost of statistician

  • Manuscript preparation and presentation


  • If budget is determined by sponsor do they allow time for

    • Study start-up activities (non-refundable)

    • Training

    • Unanticipated activities – protocol amendments, unanticipated monitoring visits, audits, etc

    • Keep in mind industry budgets are negotiable

  • If you are writing the budget, is the RFA amount sufficient for all the study activities?

    • If not – what will need to be cut from the protocol.


  • Do you have room for:

    • Research personnel

    • Study binders

    • Any equipment needed

    • Lab supplies OR

  • Will you have to look for more space?

Start up activities contracts
Start up activities - contracts

  • Read the protocol

    • Make sure everyone on the research team reads the protocol

  • Decide if the study is feasible

    • Will study change clinical practice?

  • Let your Division/Departmental administrator know you are thinking of pursuing/accepting the contract

Considerations if you didn t write the protocol
Considerations if you didn’t write the protocol

  • Is it well designed?

  • Any ethical issues?

  • Is there potential benefit to participants?

  • Will the sponsor allow modifications if you don’t think it is feasible as written?

  • Are the visits/procedures onerous for participants?

  • Drug available at the end of the study?

Study start up activities develop all study materials
Study start-up activities - Develop all study materials

  • Regulatory Binder

  • Study visit records

  • Case report forms

  • Eligibility checklist

  • Adverse event report forms

  • Protocol deviation report forms

  • Screening logs

  • Training logs

  • PI Delegation log

    ITHS forms -

Study start up activities training
Study start up activities – training

  • Investigator training

  • Staff training

Training requirements
Training requirements

  • Human Subjects Protection Training

    • Required by all IRBs

    • Provided periodically by SCH IRB and FHCRC IRB

    • Or on-line at CITI – Collaborative Institutional Training Initiative


  • CRBB:

    • UW Medicine Clinical Trial Policy

    • Clinical Research Staff

Training requirements1
Training requirements

  • Good Clinical Practice

    • Required by some NIH consortia

    • Required by FHCRC

    • On-line at CITI




Additional educational options
Additional educational options

  • ITHS CRES – Clinical Research Education Series – monthly seminars on topics relevant to clinical and translational research

  • Fundamentals of Clinical Research – hands-on course for new research staff

  • Periodic seminars through OSP

Abbreviations 101
Abbreviations 101

  • CRBB – Clinical Research Budget and Billing

  • ITHS – Institute for Translational Health Sciences

  • OSP – Office of Sponsored Projects

  • DBT – Detailed Budgeting Tool

  • HSD – Human Subjects Division

  • CTP analysis – Clinical Trials Policy analysis

  • WIRB – Western Institutional Review Board

Abbreviations 101 cont
Abbreviations 101 - cont

  • HSRAC – Human SubjectsRadiation Approval Committee

  • GIM – Grants Information Memoranda

  • CTA – Clinical Trials Agreement

  • OR – Office of Research

  • GCA – Grants and Contracts Accounting

  • EFA – Electronic Funding Action

  • RTS – Research Testing Service

  • SAGE – System to Administer Grants Electronically

  • CRBB Detailed Budget Tool


  • For help contact CRBB

    • [email protected]

    • 206-543-7774

Who to go to for help
Who to go to for help

  • Grant and contracts questions – your Division/Departmental administrator

  • General questions about clinical research at the UW – Ella Mae Kurashige, Director Clinical Research Services - [email protected]

  • Office of Sponsored Programs -

  • ITHS Research Navigator -

Who to go to for help1
Who to go to for help

  • How to get assistance from a research coordinator – Michelle Doyle – ITHS Research Coordinator Core [email protected]

  • Study design and biostatistical help – ITHS Center for Biomedical Statistics

  • Investigational Drug Service – Sheree Miller – [email protected]

  • Research Bioethics – Ben Wilfond - ITHS RSB core [email protected]

Who to go to for help2
Who to go to for help

  • Research labs - Research Testing Service – [email protected]

  • Regulatory questions – Ann Melvin, Jason Malone ITHS RSB core [email protected]

  • Working with the UW CRC – Paul Hughes – [email protected]

  • ITHS Bionutrition Core – Holly Callahan - [email protected]

  • ITHS Body Composition and Exercise Laboratory– Holly Callahan - [email protected]

Additional resources
Additional Resources

  • Institute for Translational Health Sciences (ITHS)

  • Additional education

  • UW Clinical trials handbook submission checklists, repository for how to do clinical research at the UW Medicine

  • Translational Research Toolkit – UW Healthlinks: search for Translational Research Toolkit

  • PRIMER toolkit -