Clinical Trial Infrastructure in
Centres
Lillian L. Siu
Princess Margaret Hospital
Key elements for success
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Building a research team
Engaging others in your research
Be engaged in the work of others
who collaborate with your research
Know some basic accounting
Learn how to navigate the system
Publish your work
Make sure your staff are well
trained
Personnel
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Your research program’s success depend on
the “buy-in” from your team:
 Other investigators:
 Oncologists, laboratory scientists,
pathologists, radiologists, etc.
 Trial nurses, clinical research associates
 Pharmacists
 Biostatisticians
Meet with them regularly and tell them
what’s happening!
Resources - institutional
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Grants and contracts services
Research financial services
Technology development and
commercialization
Institutional review board/research
ethics board/ethics committee
(IRB/REB/EC)
Protocol review committee
Step-by-step guide to activating a
clinical trial - 1
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Concept --- protocol development
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Pharmaceutical-sponsored
Investigator-initiated research (IIR)
Academic agency-sponsored (e.g.
NCIC, NCI, RTOG, etc)
Once confidential non-disclosure is
established, review the protocol in
detail, and asks key individuals in
your research team for input
Protocol review committee (if any)
Step-by-step guide to activating a
clinical trial - 2
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Key questions you need to ask
before deciding to take part:
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Do you have enough patients to put on
the trial?
Do you have any competing trials?
Do you have the personnel to run the
trial?
Do you have the resources and
infrastructure to run the trial (e.g.
electronic data capture; IV pumps;
treatment space, etc)?
Step-by-step guide to activating a
clinical trial - 3
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Once you decide to participate in a
study, the following processes
should be activated:
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Grants and contracts office – existent
templates would expedite contract
review
Budget – you (or someone familiar with
the costs of procedures and tests in
your institution) need to review this
carefully
IRB/REB/EC submission
Example of budget items – don’t forget the
overhead (indirect costs)!
Procedure
Administrative Cost per Patient Visit (Includings Nursing)
Adverse Event / Toxicity Assessment (Average)
BIOCHEM-HCG (PREGNANCY) QUANT - S
Biomarkers
Biopsy - Procurement
Biopsy - Processing
Blood Sample Collection - Pharmacokinetic (PK)
Blood Sample Processing - Pharmacokinetic (PK)
Blood Sample Processing / Shipping
Blood test-Other
Concomitant Medication Assessment
Coordinator Activity - Pt Visit (Unit 0.25 Hour)
CT scans
Documentation (Source) - Follow-Up
Documentation (Source)-Eligibility/Entry (Average)
Documentation (Source)-Treatment Visit (Average)
Drug Administration (Oral)
eCase Report Form Completion Treatment, (Average)
eCase Report Form Completion, Baseline (Simple)
ECG / EKG / Electrocardiogram
Eligibility or Inclusion/Exclusion Assessment
History (Medical)
Informed Consent (ICF) - Other (See Note)
NUCLEAR-MUGA SCAN NUC MED
Patient Teaching / Patient Education (Average)
Performance Status (ECOG)
Pharmacy Activity
Physical, Weight & BSA
Routine Study Screening
Telephone Contact
Archival Tissue Sample Collection Coordination
Tumour Response Assessment (RECIST)
TOTAL
Total Plus 30% Overhead
Cumulative visit totals
Total cost per patient over study (all sites):
One Time Financial Events (All Sites)
OCREB (Ontario REB) Initial Local Submission and Annual Renewal
Document Archiving
Pharmacy Fees (Start-Up)
Pharmacy Fees (Annual) x 5
Study Start-Up (Average)
Study Close-Out
Step-by-step guide to activating a
clinical trial - 3
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Health Canada submission for a
Clinical Trials Application (CTA):
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Pharmaceutical-sponsored – done by
company or by a Clinical/Contract
Research Organization (CRO)
Investigator-initiated research (IIR) –
you may have to do this yourself!
Academic agency-sponsored (e.g.
NCIC, NCI, RTOG, etc) – done by the
sponsor ususally the academic agency
itself. Typically done prior to IRB
submission
Step-by-step guide to activating a
clinical trial - 4
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Protocol submission:
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IRB/REB/EC
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Format consent forms to meet your
institutional format and IRB preferred
language
Other institutional committees that
need to approve of protocol before
activation
Step-by-step guide to activating a
clinical trial - 5
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Collecting documents prior to trial
activation:
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PI and investigator CVs, GCP
certificates
Lab licenses/certificates, normal ranges
Financial disclosure agreements
Regulatory binder index
1. Protocol
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Study Protocol
Study Protocol Amendments
Protocol or Amendment Signature Pages
Non-Disclosure Agreement
Investigator Drug Brochure
2. 1572/Regulatory Forms/CV
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Form FDA 1572 (If applicable)
Curricula Vitae
Medical Licenses (US only, if applicable)
Financial Disclosure Agreement
3. Approved Consent Form(s)
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Informed Consent(s)
4. IRB Approvals and Correspondence
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IRB/IBC/RAC Approvals for Protocol
Amendments, Advertisements, Renewals
IRB Correspondence (Progress reports, letters of submission for
approval, IRB notification, responses to SAE reports, and Safety
Reports, Etc.
5. Laboratory
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Lab Certifications (CAP & CLIA)
CV pathologist, if applicable
6. Study Logs
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Investigator Personnel Team Signature Page
Site Visit Logs
Site Signature Logs
Master Subject Logs
Screening Logs
Training Logs (Site initiation Visit attendance log & training
certificates)
7. Correspondence
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Study related correspondence between the site, sponsor, CRO,etc.
8. Serious Adverse Events (SAE)
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Master SAE Reporting Form and Instructions
Blank SAE Forms
Safety Letters
Completed SAE Reports (or note where they are located)
9. Drug Accountability
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Study Drug Receipt/packing invoices
Study Drug Accountability Form
Study Drug Supply Forms
10. Miscellaneous
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Miscellaneous (CRF transmittal logs), etc.
Step-by-step guide to activating a
clinical trial - 6
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Site initiation visit (SIV)
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Personnel/signature log
Drug and protocol review
Investigator responsibilties
Patient enrollment procedures
Serious adverse event reporting
Handling and shipment of biological
samples
Drug shipment, storage, dispense
CRF completion
Future state value stream map for the protocol development process
McJoynt, T. A. et al. J Clin Oncol; 27:3855-3860 2009
Copyright © American Society of Clinical Oncology