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.

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!!