1. Lisa Hoebelheinrich, JD, CHRC Associate Vice Chancellor, Compliance
Good Clinical Practice and Clinical Research Standard Operating Procedures
Lisa Hoebelheinrich, JD, CHRC
Associate Vice Chancellor, Compliance
April 21, 2017

2. Good Clinical Practice (GCP)
GCP principals help assure the safety, integrity and quality of clinical trials.
They provide a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting.
They outline responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors. 
They address elements related to the design, conduct and reporting.

3. International Conference on Harmonisation (ICH) E6 (R2)
A worldwide standard for clinical research
Not adopted by FDA as regulation. However, compliance required for studies conducted under an IND or IDE.
Sponsors often insist that these requirements be met.

4. NIH Policy on GCP Training
Requires general GCP training (including ICH E6 R2) for “investigators” and “clinical trial staff” responsible for the conduct, management and oversight of NIH-funded “clinical trials”.
Effective January 1, 2017.
Requires renewal at least every 3 years.

5. NIH Policy on GCP Training
Investigators”: responsible for the conduct of the clinical trial at a trial site
“Clinical trial staff”:  responsible for study coordination, data collection and data management
“Clinical Trial”: consistent with NIH definition
See NIH Office of Science Policy FAQs on NIH GCP Policy

6. GCP Training at KUMC Required regardless of funding source
Additional information available on myKUMC (search “GCP Training”)
Options:
CITI: GCP Training (U.S. FDA Focus)
ACRP GCP Training (contact Mary Hindle)
TLC: NIH Course for Social and Behavioral Researchers

7. GCP Training at KUMC
NIH Course in TLC is tailored for social and behavioral researchers.
Social and behavioral researchers who have not yet completed training will have until June 30, 2017 to take it.
Those who have already completed the CITI Biomedical GCP training will not be required to repeat.

8. GCP at KUMC: The Bigger Picture
Effective implementation of GCP principles requires a “systems” approach:
Institutional (quality) oversight
Defined roles and responsibilities
Written standards
Training and education
Monitoring, auditing and process improvement
Responding to problems

9. GCP at KUMC: Institutional (Quality) Oversight
Institutional Official
Institutional Review Board
See IRB SOPs
KUMC Compliance Committee and working groups
Research Oversight Committee and Subcommittees
Various institutional provide high level quality oversight to determine needed process changes or educational needs.

10. GCP at KUMC: Defined Roles and Responsibilities
Clarity re: roles and responsibilities is necessary to effectively implement GCP principles.
KUMC Clinical Research SOPs provide additional guidance on the roles of Investigators, clinical trial staff, KUMC’s responsible research administration offices (RI and CTO), and others.

11. GCP at KUMC: Written Standards
Effective implementation of GCP principles requires:
Clear written standards at the institution and departmental level to assure standard practices and awareness of those standards.
Knowledge of protocol-specific procedures and regulatory requirements.

12. GCP at KUMC: Written Standards
KUMC Clinical Research SOPs
Apply to all personnel involved in implementation and coordination of clinical research
Not intended to replace unit-level SOPs needed to assure effective consistent functioning
First phase now posted on myKUMC Intranet
Department-Specific SOPs
Study-Specific SOPs

13. GCP at KUMC: Written Standards
KUMC Clinical Research SOPs address:
Start up and approval processes, Completing CRFs, managing source documents and other study documentation
Subject screening, tracking and informed consent processes
Specimen collection, handling and disposal

14. GCP at KUMC: Written Standards
KUMC Clinical Research SOPs address:
Investigational product storage, transportation and accountability
Training and maintaining related records
Self-monitoring
Preparing for sponsor visits and FDA inspections
Registering ClinicalTrials.gov

15. GCP at KUMC: Written Standards
The SOPs provide a “toolkit” of sample logs, checklists and study tools, for example:
Delegation of Duties and Training Logs
Investigational Product Accountability Log
Regulatory Binder Checklist
Subject Eligibility Checklist and Tracking Log
Temperature Log
Monitoring Visit Log

16. GCP at KUMC: Training and Education
Beyond CITI . . .
SOP addresses:
Reviewing and acknowledging KUMC SOPs
Department-specific training
Study-specific training
Clinical trial staff
Non-clinical trial staff

17. GCP at KUMC: Training and Education
Beyond CITI . . .
Study Coordinator Training
HRPP monthly classes
New RI Program coming
Cancer Center CTO orientation and training
HRPP, RI, CTO Consultations
Research & Discovery Grand Rounds
KUMC Research Guide coming soon

18. GCP at KUMC: Monitoring, Auditing & Process Improvement
Self-Monitoring
SOP 2.2 (Self-Monitoring Checklist and Log)
KUMC QA Programs
HRPP
Cancer Center CTO
Sponsors and CROs
SOP 19.4 (Sample Monitoring Visit Log)
FDA and OHRP
SOP 20.1 (Sample Audit Checklist)

19. GCP at KUMC: Monitoring, Auditing & Process Improvement
ACT
Take action to improve
PLAN
Set objectives and processes to deliver products that meet customer requirements DO
Implement processes
CHECK
Monitor/measure processes and products against objectives and requirements
Quality Systems Approach A “systems” approach that implements processes and structures to achieve and maintain compliance and to continuously improve the KUMC research enterprise.

20. GCP at KUMC: Monitoring, Auditing & Process Improvement
Our Goals:
Risk based approach
Emphasize continuous improvement
Break down silos
Involve stakeholders
Share information to avoid systemic issues

21. GCP at KUMC: Responding to Problems
Root Cause Analysis
Corrective Action
Preventative Action
We are here to help you!

22. Contacts Office of Compliance: Research Institute: Cancer Center:
Lisa Hoebelheinrich, Assoc. Vice Chancellor, Compliance (913)
Research Institute:
Kevin Smilor, Dir. of Data Management & Quality, CRA Division
(913)
Mary Hindle, Training and Education Manager
(913)
Cancer Center:
Hobs Apell, Sr. Director, Clinical Program Management (913)
Jennifer Kennedy-Eade, Dir. of Quality Assurance
(913)