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Research & Innovation

Getting started with a Clinical Trial
Clinical Trials

Here you can find an overview of the process to get started with a clinical trial, as well as some helpful links, forms, and policies related to clinical trials and the process here at St. Luke’s.

If you are interested in being involved in a clinical trial, whether as a PI or Sub-I, please contact Tracy Butryn, Director of Clinical Trials and Research, at 484-526-5190 or Tracy.Butryn@sluhn.org for assistance as all clinical trials are required to be facilitated through the centralized Clinical Trials Office.

LINKS AND FORMS

Requirements to be an Investigator on a Clinical Trial
  • GCP CITI Training
    **Send copy of your Certificate to the Clinical Trials Office**
  • NCI Registration (Oncology ONLY)
    **Work with the Clinical Trials Office to complete this registration**
  • Conflicts of Interest
  • Current CV and Medical License
    • Signed and Dated CV (every 2 years)
      **Send copy of your Certificate to the Clinical Trials Office**
    • Signed Medical License every year
      **Send signed and dated copy to Clinical Trials Office**

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Industry-Sponsored Research
  • Contact Clinical Trials Office
    • Provide basic trial information
    • Provide sponsor contact info. (if sponsored study)
    • Who will serve as PI?
  • Confidentiality Disclosure Agreement (CDA)
    • Clinical Trials Office to facilitate process with sponsor and SLUHN Legal
    • PI and Institutional Signatory to sign CDA
  • Protocol Received
    • PI to thoroughly review protocol for feasibility (e.g. patient population, ability to enroll, competing trials, operational issues, etc.)
    • Clinical Trial Office to thoroughly review protocol for operational feasibility and special requirements
    • Decision to move forward – yes or no?
    • Complete Internal Feasibility Questionnaire
  • Complete Sponsor Feasibility Questionnaire(s)
  • Clinical Trials Office to schedule Pre-site Visit (PSV) – if required
  • Selected as a site!!!
    • Receipt of Regulatory Start-up Packet
    • Receipt of Budget and Contract
  • IRB Submission and Completion of Essential Reg Docs
    • Completed by Clinical Trials Office
    • PI required to sign all paperwork in a timely manner
  • Budget and Contract Negotiation
    • Billing Coverage Analysis (SOC vs. non-SOC)
      • Completed by Clinical Trials Office
      • Reviewed and approved by PI
    • Cost Analysis completed by Clinical Trials Office
    • Budget Negotiated by Clinical Trials Office
    • Contract Negotiated and Executed by Clinical Trials Office and Legal
    • PI required to sign necessary paperwork in timely manner
  • Site Initiation Visit (SIV) and Activation
    • SIV scheduled by Clinical Trials Office
    • SIV/Activation Checklist completed by Clinical Trials Office
    • SIV completed and Training documents signed by PI and other investigators
    • Activation Email blast sent by Clinical Trials Office
  • READY TO ENROLL!!

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Investigator-Initiated Research (funded)
  • Contact Clinical Trials Office
    • Provide basic trial information and protocol
    • Provide funding sponsor contact info.
    • St. Luke’s only or Multi-Institutional?
  • Protocol Review
    • Clinical Trial Office to thoroughly review protocol for operational feasibility and special requirements
    • Complete Internal Feasibility Questionnaire
  • Registration on ClinicalTrials.gov
    • Clinical Trial Office to register the trial and obtain NCT number
    • To be updated at least every 6 months and when there are changes
  • Consent, IRB Submission and Completion of Essential Reg Docs
    • Completed by Clinical Trials Office
    • PI required to sign all paperwork in a timely manner
  • Budget and Contract Negotiation
    • Billing Coverage Analysis (SOC vs. non-SOC)
      • Completed by Clinical Trials Office
      • Reviewed and approved by PI
    • Cost Analysis completed by Clinical Trials Office
    • Budget Negotiated by Clinical Trials Office
    • Contract Negotiated and Executed by Clinical Trials Office and Legal
    • PI required to sign necessary paperwork in timely manner
  • Internal Site Initiation Visit (SIV) and Activation
    • SIV scheduled by Clinical Trials Office
    • SIV/Activation Checklist completed by Clinical Trials Office
    • SIV completed and Training documents signed by PI and other investigators
    • Activation Email blast sent by Clinical Trials Office
  • READY TO ENROLL AT SLUHN!!
  • If Multi-Institutional:
    • Clinical Trials Office to facilitate Confidentiality Disclosure Agreement (CDA) process with participating site(s) and SLUHN Legal
    • Clinical Trials Office will send Protocol, Multi-Site Procedures Manual, and Start-up Packet to participating site(s)
    • Clinical Trials Office will review and approve Informed Consent Form (ICF) from participating site(s) prior to their submission to their IRB
    • Clinical Trials Office will collect all required documents from participating site(s)
    • Clinical Trials Office will facilitate Sub-Site Agreement process with participating site(s) and SLUHN Legal
    • Site Initiation Visit (SIV) and Activation
      • SIV scheduled by Clinical Trials Office
      • SIV completed and Training documents signed by sub-site PI and other investigators/key personnel
      • Activation Email to participating site(s) sent by Clinical Trials Office
    • PARTICIPATING SITE READY TO ENROLL!!

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