Getting started with a Clinical Trial

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, Senior Network 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
- NIH Training Tutorial (every 4 years)
  **Send copy of your Certificate to the Clinical Trials Office**
- Disclosure Form (yearly or if change in financial COI)
  **Send copy of your Certificate to the Clinical Trials Office**
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**

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!!

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!!