Remember that agents are provided and accounted for on a protocol-by-protocol basis. oEach agent should be accounted for separately by protocol. If an agent is used for more than one protocol, there should be a separate Investigational Agent Accountability Record Form (DARF) for each protocol, http://ctep.cancer.gov/forms/index.html. There should be a separate DARF for each agent in a multi-agent protocol. oSeparate accountability forms should be maintained for each different strength or dosage form of a particular agent (e.g., an agent with a 1-mg vial and a 5-mg vial would require a different DARF for the 1-mg vial than for the 5-mg vial). oThe DARF has been designed for use at each location where agents are stored, e.g., main pharmacy, satellite pharmacy, physician's office, or other dispensing areas. oThe DARF is also designed to accommodate both dispensing records and other agent transaction documentation (e.g., receipt of agent, returns, broken vials, etc.). A copy of the DARF may be found at http://ctep.cancer.gov/forms/index.html. oUnauthorized inter-institutional transfer of BTTC investigational agents from one participating institution to another is not permitted. For some protocols the lead institution may enter into contractual agreements to forward agents to participating institutions (Refer to the BTTC Operations Manual). oBTTC Supplied agents must not be repackaged and forwarded to patients on a routine basis. Refer to the BTTC Operations Manual for BTTC polices on forwarding BTTC supplied agents under certain limited circumstances. 105 Abbreviated Title: GBM Pembro HSPPC Version Date: 03/26/2024 14.5.6 Verification of Compliance Investigators are reminded that compliance with procedures to ensure proper agent usage will be reviewed during site visits conducted under the monitoring program. Specifically, site visitors will check that the agent accountability system is being maintained, and will spot-check the agent accountability records by comparing them with the patients' medical records to verify that the agents were administered to a patient entered in the recorded protocol. 14.6 RETURNING OR DESTROYING UNUSED AND/OR DEFECTIVE AGENT: 14.6.1 Pembrolizumab Return Procedure All unused and returned pembrolizumab may be destroyed on site. The site must follow their local drug destruction policy and procedure. A copy of the drug destruction record must be submitted to BTTC to send to Merck.. Contact: Eleonora Veglia, PhD Scientific Leadership & Research Manager (EU SLRM) Merck Investigator Initiated Studies Program/ Scientific Engagements MSD, MRL Innovation Hub Two Pancras Square, Kings Cross London N1C 4AG Tel: +44 (0) 7824524450 Email: eleonora.veglia@msd.com The investigator is responsible for keeping accurate records of the clinical supplies received from Merck or designee, the amount dispensed to and returned by the subjects and the amount remaining at the conclusion of the trial. Upon completion or termination of the study, all used and/or partially used investigational product will be destroyed at the site per institutional policy. It is the Investigator’s responsibility to arrange for disposal of all empty containers, provided that procedures for proper disposal have been established according to applicable federal, state, local and institutional guidelines and procedures, and provided that appropriate records of disposal are kept. 14.6.2 HSPPC-96 or Placebo Return Procedure If a subject is randomized to receive placebo or if there is any remaining vaccine after the subject has finished treatment, it will be coded and linked and used by Agenus or other approved investigators for development and research purposes. Refer to section 16.6 for HSPPC-96 or Placebo return instructions. 106 Abbreviated Title: GBM Pembro HSPPC Version Date: 03/26/2024 15 REFERENCES 1. Gilbert, M.R., et al., Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol, 2013.