Managing Clinical Supplies and Laboratories

1. Managing Clinical Supplies andLaboratories

2. Managing Supplies • The type of supplies that need to be managed can vary from study to study. • Examples of study supplies • Forms • Case Report Forms (CRFs) • Informed Consent forms • Worksheets/log sheets • Serious Adverse Event Forms • Order forms for above supplies • Other study specific forms • Investigational Product • Lab Supplies • Subject instructional materials • Other - specific to study

3. Managing Clinical SuppliesWhat is the CRC’s role? (Will vary from study to study and vendor to vendor) • Determining amount of supply needed • Initiating supply order in a timely manner to ensure availability when needed • Completing necessary paperwork • Making shipping arrangements • Ensuring supply arrival at site • Establish a tracking system • Clarify with sponsor the site’s scope of responsibilities for managing supplies

4. LaboratoriesLocal , Central and Core Laboratories • Local • Located near the point of care for the site’s subject population (e.g. Hematology lab at Duke for Duke sites) • Central Laboratories • Provider of clinical trial laboratory services • Dedicated to testing specimens and reporting data to site and sponsor • Sponsor hires a central lab to process all lab samples for a specific study • Provide visit-specific collection kits for clinical studies • Site draws sample using kit supplies and ships samples to central lab in packaging supplied by lab

5. LaboratoriesLocal , Central and Core Laboratories • Core laboratories are designed to support more sophisticated clinical research. Similar to Central labs in that they provide a centralized service to the sponsor (e.g. blood assays, ECG readings)

6. LaboratoriesLocal , Central and Core Laboratories • A study may use a local lab, a central lab or both during one study • Both local and central labs are held to the same regulatory standards

7. Laboratory CertificationsClinical Laboratory Improvement Amendments (CLIA) • Bill Passed in 1988; Final regulations published in 1992 • Established quality standards for all laboratory testing • All labs (#176,000) are under the authority of CLIA and must be certified/accredited by CLIA or a CLIA certified accreditation program. • The CLIA program is administered under Centers for Medicare & Medicaid services (formally HCFA)

8. Laboratory CertificationsClinical Laboratory Improvement Amendments (CLIA) • Approved Accrediting Organizations under CLIA • American Association of Blood Banks • College of American Pathologists (CAP) • American Osteopath Association • American Society of Histocompatibility and Immunogenetics • COLA (Commission on Office Laboratory Accreditation) • JCAHO (Joint Commission on Accreditation of Healthcare Organizations) 

9. FAA Requirement for Sites Shipping Biological Samples • 49 CFR Parts 100-185 • “ It is the duty of each person who offers hazardous materials for transportation to instruct each of his…employees having any responsibility for preparing hazardous materials for shipment as to applicable regulations in this subchapter.” • FAA is inspecting sites for compliance

10. FAA Requirement • Site must have documentation of training that meets FAA requirements. • Duke sites are trained through OESO (Occupational and Environmental Safety Office) which meets FAA standards