"Conducting Clinical Trials A-Z"
 Contacts for Clinical Trials
 Faculty Resources
 

Contents

Acknowledgements

Purpose Statement

Belinda Smith, M.S., R.D., C.C.R.C.
Sr. Research Administrative Coordinator/Education

Part I - Clinical Trials - The Who, What, and Whys

     A.  Why consider being a clinical trial investigator?
           1.  What do you need to conduct trials?
     B.  What exactly are clinical trials and the clinical trial process?
           1.  Glossary of Clinical Trials Terms
           2.  CenterWatch Clinical Research Glossary
           3.  Clinical Trials & Drug Development Process
           4.  OHRP Human Subject Research Decision Charts
     C.  Who are the players and what are their roles and responsibilities?
           1.  The Research Sponsor Lineup
           2.  The Safety Squad
           3.  Investigational Site Team      
     D.  What regulations and guidelines must be followed?
           1.  Code of Federal Regulation (CFR)
           2.  State Law & Institutional Policy
           3.  The International Conference of Harmonization (ICH)
                Good Clinical Practice (GCP) Guidelines
           4.  Title 21, Code of Federal Regulations (CFR)
                Statement of Investigator - FDA Form 1572
     E.  What institutional resources and support services are available at UK?
           1.  UK Clinical Research Organization
           2.  General Clinical Research Center (GCRC)
           3.  Office of Sponsored Projects Administration (OSPA)
           4.  Office of Research Integrity (ORI)
           5.  Investigational Drug Service (IDS)
           6.  Faculty Support Services
     F.  How do you garner industry trials?
           1.  UKCRO Marketing - Providing a Link Between Industry and Academics
           2.  Profile of UKCMC - also located on CenterWatch
     G.  What Trainings Are Required and Available?
           1.  UK Mandatory Trainings and education opportunities for Clinical Trial Staff
           2.  National Training & Certification Programs

Part II - How to Conduct a Clinical Trial

     A.  Pre-Award
           1.  Feasibility Assessment
           2.  Feasibility Checklist (PDF)
           3.  Site Selection - What The Sponsor Is Looking For 
           4.  Site Selection Checklist (PDF)
           5.  Investigator Start Up Meeting
     B.  Study Initiation:  4 Admission Tickets to Initiate a Clinical Trial at UK
           1.  Federal/Regulatory Documents/Form 1572
           2.  Financial/Budget Development
           3.  Clinical Trials Agreement (CTA)
           4.  IRB Submission
           5.  Additional Tickets (Applications) if applicable
     C.  Recruitment & Retention
           1.  Recruit and Retain Study Volunteers - The Ultimate Challenge
           2.  Recruitment Planning
           3.  Internal Recruitment
           4.  External Recruitment
                a.  Advertising Clinical Trials
           5.  Funnel Concept
           6.  Monitoring Your Progress
           7.  Subject Retention: Treating Study Volunteers as Customers
     D.  Study Coordination & Operations
           1.  Study Supplies
           2.  Informed Consent Process
           3.  Initial and Ongoing Communications with the IRB
           4.  TIPS to Maintain Complete IRB Records
           5.  Typical Clinical Trial Visit Procedures
           6.  Paying Research Subject Stipends
           7.  Subject Documentation and Data
           8.  Case Histories = Case Report (CRF) + Source Data
           9.  Adverse Event Management and Reporting
           10.  ORI Guidance in Reporting Unanticipated Problems and
                  Adverse Events in Human Research
           11.  Continuation Review Relative to Adverse Events
           12.  IRB Adverse Event Report Forms
           13.  Protocol Violations
           14.  Drug Dispensing & Accountability
     E.  Special Consideration for Device Studies
           1.  FDA Center for Devices and Radiological Health
           2.  Medicare Reimbursements - Devices
           3.  UK Technology Assessment Committee
     F.  Ongoing Review, Monitoring, and Quality Assurance
           1.  IRB Continuation Review Slide Presentation (PDF)
           2.  Sponsor Monitoring
           3.  Data Safety Monitoring (DSM)
           4.  Quality Assurance (QA)
           5.  ORI Investigator Self-Assessment Tool
     G.  Study Closure & Preparation for Potential Audits
                a.  Study Close-Out or Termination
                b.  Document Retention and Long-Term Storage
      H.  Sponsor or Regulatory Audits
        I.  Investigator Initiated Trials