205 Clinical Study Supplies

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies. 

This Standard Operating Procedure (SOP) describes the procedures for the receipt, distribution, accounting, and return of clinical study supplies for clinical studies on the CTRU.

• The Principal Investigator (PI) is responsible for accurate and complete accountability of the clinical supplies used in a clinical study and the proper storage of these supplies.
• The delegated personnel are responsible for assigning study subjects and study drug/device numbers and maintaining drug/device accountability records.
• The Sponsor is responsible for the manufacture and packaging of clinical supplies.

• The Investigator's Brochure (IB) and the protocol provide information about the study drug/device, its proper use and storage during the clinical study.
• The study drug/devices are packaged in a manner consistent with the protocol requirements and, if blinded, the blind should be maintained as instructed in the protocol. A note to file must be prepared to describe when, why, and how the blind is broken.
• The Sponsor should include a description of the packaging required for the supplies. The description should include but is not limited to:
  • The number of study subjects on each type of drug/device.
  • The dosing schedule.
  • Randomization code, if necessary.
  • A description of the size and type of study subject kits.

• Upon receipt, suppliers are checked to ensure all investigational drugs/devices are packaged and labeled with the following information (required by FDA are marked with an asterisk *):
  • Study name and number.*
  • Drug/device name.*
  • Drug dosage and formulation.*
  • Lot number.*
  • Sponsor name.*
  • Statement: “CAUTION: New Drug (or device) - Limited by US law to investigational use."*
  • Study subject numbers and/or visit numbers.
  • Special instructions regarding dosage or storage.
  • Expiration date.
  • Quantity in container.
• Delegated personnel perform an inventory upon receipt of investigational drugs/devices.
• List returned to the Sponsor with comments on any missing drugs/devices or other discrepancies.
• Inventory includes a check on lot numbers, study subject numbers, and the number of elements in each kit. Copy of this inventory kept in the documentation file.