Study Drug Accountability. The investigator will maintain accurate records of receipt of all study drugs, including dates of receipt. Accurate records will be kept regarding when and how much study drug is dispensed and used by each subject in the study. Reasons for departure from the expected dispensing regimen must also be recorded. At the completion of the study, and to satisfy regulatory requirements regarding drug accountability, all study drugs will be reconciled and retained or destroyed according to applicable regulations.
Study Drug Accountability. The investigator, or designee, will maintain a record of all study drug received, dispensed, and returned to the Sponsors’ designee. No study drug shall be destroyed by the clinical site unless directed in writing to do so by the Sponsor’s quality assurance department. Study drug bottles and any unused capsules should be returned to the study staff for eventual disposition by the Sponsor. The number of capsules returned at each visit will be recorded for each bottle in the kit.
Study Drug Accountability. All used (empty and partially empty) and unused LJPC-501 vials must be saved for reconciliation by the Study Monitor or Clinical Research Associate (CRA). Following final reconciliation, all used and unused vials of LJPC-501 are to be returned to La Jolla or its designee for destruction, or destroyed (if approved by La Jolla) at the site.
Study Drug Accountability. Each study drug shipment will include a packing slip, explaining the contents of the shipment, and drug return instructions and forms. The investigator is responsible for ensuring that deliveries of study drug and other study materials from the sponsor are correctly received and recorded, handled and stored safely and properly in accordance with the CFR or local regulations, and used in accordance with this protocol. A record of study drug accountability (ie, study drug and other materials received, used, returned, or destroyed) must be prepared and signed by the principal investigator or designee, with an account given for any discrepancies. Empty, partially used, and unused vials of study drug will be destroyed at the study center or returned to ImmuPharma or its designee.
Study Drug Accountability. The Principal Investigator is responsible for ensuring that an inventory is conducted upon receipt of the clinical supplies. The temperature recorder from the shipment will be deactivated and authorized study staff will verify that the temperature was maintained at - 20°C during transit. The clinical supplies shipment form should be completed, signed, and returned as directed. A copy must be maintained at the site for the Principal Investigator's records. The Principal Investigator will keep a current record of the inventory, storage conditions and dispensing of all study drugs. This record will be made available to RIBOMIC (or designee) for accounting for all clinical supplies. Any significant discrepancy and/or deficiency must be recorded with an explanation. All supplies sent to the Principal Investigator must be accounted for and in no case will study drugs be used in any unauthorized situation. It is the responsibility of the Principal Investigator to ensure that any used and unused supplies are available to RIBOMIC (or designee) throughout the study.
Study Drug Accountability. The accurate record of the medical ID number of the study drug administered will be maintained including the exact volume and the date and time of dispensing. This study drug accountability record will be available for inspection at any time by an unblinded study monitor. At the completion of the study, the original drug accountability record will be available for review by the Sponsor upon request. Used vials and containers will be destroyed upon satisfactory completion of the treatment compliance and study drug accountability procedures. Any unused unit doses will be retained until completion of the study or until permission to destroy has been received by the Sponsor. At the completion of the study, unused study drug remaining at the sites (if applicable) will be returned to the Sponsor or designee or disposed of by study sites with drug destruction standard operating procedures and written Sponsor approval. For further details refer to the Pharmacy Manual.
Study Drug Accountability. The study drug will be stored in accordance with Decree No. 4.6 Evidence Hodnoceného přípravku. Hodnocené léčivo bude v souladu s vyhláškou č. 226/2008 Coll., as amended, in the Institution’s Pharmacy, which undertakes to comply with the conditions of the good pharmacy practice and the associated instructions of SÚKL and guarantees handling of the drug by authorized persons only. 226/2008 Sb., v platném znění, uskladněno v Lékárně zdravotnického zařízení, která se zavazuje dodržovat podmínky správné lékárenské praxe, související pokyny SÚKL a zaručuje manipulaci s léčivem pouze oprávněnými osobami. The shipment of the study drug will be delivered to the address: "Lékárna FNO" (Hospital Pharmacy)17. listopadu 000000 000 Xxxxxxx - Xxxxxx Xxxxx Xxxxxxxx and identified with the protocol number„APL2-GA-305“The FNO Pharmacy will be responsible for receiving the shipment of the study drug and for dispensing the study drugto the Investigator or his/her designee. Institution and Investigator or their authorized designee will: (a) verify receipt of the Study Drug by signing the appropriate documentation provided by Sponsor or its designee; (b) store all Study Drug securely as designated in the Protocol; (c) document the administration of the Study Drug to Study Subjects; (d) only dispense the Study Drug to Study Subjects in accordance with the Protocol; and (e) upon completion or early termination of the Study, destroy or return to Sponsor or its designee, at Sponsor’s expense, all unused Study Drug, as well as any containers (whether containing unused Study Drug or not) in accordance with Sponsor’s instructions or as set forth in the Protocol. These arrangements shall also apply to all study drugs provided by the Sponsor under the Study that have passed their expiration date. Zásilka Hodnoceného přípravku bude dodána na adresu:„Lékárna FNO“17. listopadu 179070 852 Ostrava – PorubaČeská republikaoznačena číslem protokolu „APL2-GA-305“ Lékárna Zdravotnického zařízení bude zodpovídat za příjem zásilky Hodnoceného přípravku a výdej Hodnoceného přípravku Zkoušejícímu lékaři nebo xxx xxxxxxxx osobě. Zdravotnické zařízení a Zkoušející lékař nebo xxx xxxxxxxx zástupce: (a) ověří přijetí Hodnoceného přípravku podpisem příslušné dokumentace poskytnuté Zadavatelem nebo jeho zástupcem; (b) bezpečně uloží veškerý Hodnocený přípravek způsobem stanoveným v Protokolu; (c) dokumentuje podávání Hodnoceného přípravku Subjektům hodnocení; d) vydá Hodnocený přípravek pouze Subjektům ho...
Study Drug Accountability. Upon receipt of study drug, the Investigator or designee will inspect the materials and follow the instructions regarding receipt in the Pharmacy Manual. A copy of the shipping documentation will be kept in the study files. The study drug provided is for use only as directed in this protocol. The Investigator or designee must maintain a record of all study drug received, used, and discarded. It must be clear from the records which subject received which kit of active or placebo treatment. If a dose adjustment is deemed necessary by the Investigator at any time during the treatment period (see Section 9.3 for dose adjustment criteria), the subject will be instructed to return to the site to return any remaining current dose and for the adjusted dose to be dispensed. Sage or designee will be permitted access to the study supplies at any time within usual business hours and with appropriate notice during or after completion of the study to perform drug accountability reconciliation.
Study Drug Accountability. An accurate and current accounting of the dispensing and return of study drug for each subject will be maintained on an ongoing basis by a member of the study site staff. The number of bags dispensed and returned by the subject and the volume remaining will be recorded on the Investigational Drug Accountability Record.
Study Drug Accountability. The investigator or designee will maintain an accurate record of the receipt of the study medications as shipped by Aclaris Therapeutics, Inc. (or designee), including the date received and the condition of the study medications. One copy of this receipt will be returned to Aclaris Therapeutics, Inc. (or designee) when the contents of the study medication shipment have been verified and one copy maintained in the study file. In addition, an accurate study medication disposition record will be kept, specifying the amount dispensed for each subject and the date of dispensing. This inventory record will be available for inspection at any time. At the completion of the study, the original inventory record will be available for review by Aclaris Therapeutics, Inc. upon request. Final drug accountability will be completed by the study monitor at the completion of the study and all unused study medication will be returned to Aclaris Therapeutics, Inc. drug depot for disposal per Aclaris Therapeutics, Inc. (or designee’s) written instructions.
