Key elements for success
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 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
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
Concept --- protocol development 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
Key questions you need to ask before deciding to take part: 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 Once you decide to participate in a
study, the following processes should be activated: 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 Health Canada submission for a Clinical
Trials Application (CTA): 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
Protocol submission: IRB/REB/EC
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
Collecting documents prior to trial activation: PI and investigator CVs, GCP
certificates Lab licenses/certificates, normal ranges Financial disclosure agreements
Regulatory binder index1. Protocol Study Protocol
Study Protocol Amendments Protocol or Amendment Signature Pages Non-Disclosure Agreement Investigator Drug Brochure
2. 1572/Regulatory Forms/CV Form FDA 1572 (If applicable) Curricula Vitae Medical Licenses (US only, if applicable) Financial Disclosure Agreement
3. Approved Consent Form(s) Informed Consent(s)
4. IRB Approvals and Correspondence 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 Lab Certifications (CAP & CLIA) CV pathologist, if applicable
6. Study Logs 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 Study related correspondence between the site, sponsor, CRO,etc.
8. Serious Adverse Events (SAE) Master SAE Reporting Form and Instructions Blank SAE Forms Safety Letters Completed SAE Reports (or note where they are located)
9. Drug Accountability Study Drug Receipt/packing invoices Study Drug Accountability Form Study Drug Supply Forms
10. Miscellaneous Miscellaneous (CRF transmittal logs), etc.
Step-by-step guide to activating a clinical trial - 6 Site initiation visit (SIV)
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