Therapeutic Interventional Studies (FDA Regulated) at UCDHS – At-A-Glance
Page 1
Updated 09/15/2015
Chapter #1
Complete
Necessary
Training
Laws governing
Clinical Research
Read UC Davis
Clinical Research
Guidebook (current
edition)
Read Clinical Trials
SOPs housed by
CTSC
CITI training
UCDHS Mandatory
Annual Training
UCDHS Privacy
and Security
Training
Dangerous Goods
Shipping for
Infectious
Substances and
Dry Ice
Lab Safety training
IRB New Submitter
training
CTSC Clinical
Trials Education
and Training
Program
In service training:
Coverage Analysis
and Budgets
Chapter #2
Study Feasibility
and Start Up
CTSC Assistance
with study start-up.
Includes:
IRB preparation,
submission and
approval;
Coverage
Analysis;
Budget
preparation and
negotiation;
IT Approval;
Bridge
completion
IND and IDE
Assistance
CTSC Biostatistics
CTSC Clinical
Research Center
(CCRC)
CTSC Research
Ethics
CTSC Community
Engagement
CTSC Biomedical
Informatics
Chapter #3
IND and IDE Submissions
Chapter #4
Additional
reviews and
approvals
Contact CTSC for assistance
with IND/IDE
IT Technology
Evaluation for studies
with apps or software
Learn about
regulatory
requirements for
clinical studies
involving a drug,
biologic or dietary
supplement
Learn about
regulatory
requirements for
clinical studies
involving a device
Preclinical
Regulatory
requirements
Device
Classification and
SR vs NSR
Determine if your
study is exempt
from IND
requirements
Investigational
Device
Exemptions (IDE)
Investigational
New Drug
Application (IND)
Abbreviated IDE
and Exemptions
Expanded
Access to
Investigational
Drugs
Emergency,
Compassionate,
Treatment Use
New Drug
Application (NDA)
Dietary
Supplements as
Drugs
Clinical Engineering
Review
Radiation Use
Committee
Biological use
Authorization
Stem Cell research
oversight
Scientific Review
Committee (Cancer
Center Only)
Approvals
granted
Chapter #5
IRB review and
approval
Contact CTSC for
assistance with IRB
submissions
Chapter #6
Budgets and
Contracts
Contact CTSC and
Contracts for
assistance with
Coverage Analysis
and Budgets
Review IRB SOPs
and Investigator
manual
Review CTSC SOPs
4-8, and13
Prepare IRB packet
Submit the Initial
Submission to IRB
Respond to IRB
comments and
obtain IRB approval
File the approvals
in Regulatory
Binder
IRB
Approval
Learn about Sponsors, Investigators
and Sponsor-Investigators and their
responsibilities
COI Training and
Disclosure
Recruitment and
Retention Planning:
CTPQ
Recruitment
Funnel
Recruitment
Resource Plan
Recruitment
Action Plan
Best practices
Advertisement
Prepare internal
budget:
Unified Budget
template
Invoicable Fixed
Costs
Per Patient
Costs
Radiology Costs
Pathology Costs
IDS costs
Negotiate External
Budget with the
Sponsor
Budgets for grants /
Department funded
studies
Clinical Trials
Contracts:
Confidentiality
(non-disclosure)
Agreements
Clinical Trial
Agreements
(CTA)
Informed Consent
Patient Privacy and
Data Security:
HIPAA
Cohort
Discovery Tool
Access to PHI
Disclosure
Tracking
Database
FDA
Approval
Post information on
clinicaltrials.gov
Chapter #8
EMR: Scheduling,
Registration, Linking
and Billing
Chapter #9
Investigational
Drug Pharmacy
Contact CTSC for
assistance with the
Bridge and EMR
Contact IDS for
assistance and review
IDS website
Open DaFIS account
Overview of
Investigational Drug
Management process
Enter the information
into the Bridge
CTSC SOP#13
Research Study
Maintenance:
EMR Research
Study
Records
Necessary for
Billing
Associate patient
with the Research
Study
Associate encounters
with the study
Submit copy of
consent to HIM
Associate orders with
the study
Payments to subjects
and W9
Billing Review
Drawing blood for
research
CLIA waved
Diagnostic Testing
Create DSMB/Monitoring Plan
Contract
Executed
Epic EMR Clinical
Research Billing
Courtesy of Beth
Harper
Complete Coverage
Analysis
PMA vs 510(k)
Humanitarian use
Devices
Chapter #7
Subject
Recruitment
Subject Injury and
Complications
EMR Research
Functionality Training
Materials
Distribution and
maintenance of
Investigational
product
Prescribing,
dispensing and
transportation of
investigational drugs
IDS charges
Chapter #10
Clinical Research
Regulatory
Maintenance
Contact CTSC for
assistance with the
regulatory reporting and
preparation for audits
Reporting to the
IRB
Reporting to the
FDA and
Sponsors
Report New
Information
Report New
Information
Report Serious
Harms
Report Serious
Adverse Events
(IND/IDE Safety
Reports)
Report Protocol
Deviations and
Modifications
Report Protocol
Deviations
Submit
Continuing
Review Progress
Report
Submit Annual
Reports to CDER
and CDRH
Chapter #11
Sponsor Invoicing
(industry-sponsored
trials only)
Verify bulk
account
statements,
resolves issues w
Patient Financial
Services
Maintain log of
completed study
procedures for
billing/invoicing
references
Chapter #12
Study Closure
Financial analyst
closes DaFIS
account
IRB notified
about permanent
study closure
IDS notified and
study drug
disposed
Prepare invoice
to the Sponsor
HS Contracts
notified
PI minimum effort
recovery in
PRDRUG
subfund trials
Documents
Archived
Publications and
PMCID
Dietary supplements
Compounding
Investigational Drugs
Maintain Study Documentation:
Regulatory Binder
Source Document Binder
Case Report Forms
Financial Binder
IND/IDE Binder
Study Monitoring and Audits:
Monitoring, Auditing and
Inspecting
Monitoring by Industry
Sponsors
FDA Inspections
Audits by Office of
Research Compliance
CTSC Monitoring and QA
program
Study
Closed
Legend
Mandatory
Highly Advised