Study Product Accountability Clause Samples
Study Product Accountability. Upon receipt of the study products, the investigator or designee will conduct an inventory. In accordance with federal regulations, the investigator must agree to keep all test article in a secure location with restricted access. Designated study personnel will provide the test article to the subjects in accordance with the protocol. During the study, the investigator must maintain records of study treatment dispensation and collection for each subject. This record must be made available to the study monitor for the purposes of verifying the accounting of clinical supplies. Any discrepancies and/or deficiencies between the observed disposition and the written account must be recorded along with an explanation. At the conclusion of the study, the investigator will be responsible for returning all unused study product (i.e., Restylane® Contour) unless otherwise instructed by the Sponsor. Shipping label and cost will be provided to the investigator by the Sponsor.
Study Product Accountability. The A5208/OCTANE site pharmacist is required to maintain complete records of all study products received from the NIAID Clinical Research Products Management Center and subsequently dispensed. Further instruction will be provided by the DAIDS Pharmaceutical Affairs Branch regarding final disposition of unused study products. The procedures to be followed are provided in the manual, Pharmacy Guidelines and Instructions for DAIDS Clinical Trials Networks, in the section Study Product Management Responsibilities.
5.4 Concomitant Medications (Steps 1 and 2) Sites must refer to the most recent study medication’s package insert or investigator’s brochure to access additional current information on prohibited and precautionary medications. To avoid drug interaction and adverse events, the manufacturer’s package inserts of the antiretroviral and concomitant agent should be referred to whenever a concomitant medication is initiated or dose changed. Concomitant use of ingested traditional medicines is strongly discouraged while participants are taking ART. Information on drugs without trade names, with many marketed forms, or those not available in the U.S. may be found at:
5.4.1 Required Medications No concomitant medications are required.
5.4.2 Prohibited Medications Prohibited Medications with NVP Antihistamines Astemizole (Hismanal®) Terfenadine (Seldane®) Anti-infectives Systemic Ketoconazole Alternative/Complementary St. John’s wort (Hypericum perforatum) GI Motility Cisapride (Propulsid®) Psychiatric Medication Pimozide Sedatives/Hypnotics Midazolam (Versed®)2 Triazolam (Halcion®) Other Dihydroergotamine Ergonovine Ergotamine Methylergonovine 1 Rifampin decreases NVP serum levels. Concomitant use of Rifampin with NVP-containing regimens is not recommended, although sometimes its use with Rifampin is difficult to avoid. 2 Midazolam can be used with caution as a single dose, when given in a monitored situation for procedural sedation. Prohibited Medications with LPV/RTV Antiarrhythmics Amiodarone Quinadine Antihistamines Astemizole (Hismanal®) Terfenadine (Seldane®) Anti-infectives Systemic Itraconazole (Sporonox®) Rifampin, Rifapentine, Rifampicin Alternative/Complementary St. John’s wort (Hypericum perforatum) HMG CoA Reductase Inhibitors Lovastatin (Mevacor®) Simvastatin (Zocor®) GI Motility Cisapride (Propulsid®) Psychiatric Medication Pimozide Sedatives/Hypnotics Midazolam (Versed®)1 Triazolam (Halcion®) Other Dihydroergotamine Ergonovine Ergotamine Flutic...