Study Drug Handling and Disposal Sample Clauses

Study Drug Handling and Disposal. During the treatment period of the study, CRV431or placebo will be supplied by a pharmacist or investigator designee responsible for study drug administration and accountability. On study visit days, treatment may only be administered under the supervision of the investigator or site designee(s). Any used, expired, or non-usable study drug can be destroyed on-site as per the sites standard operating procedures with approval of the sponsor. If study drug cannot be destroyed on-site, it must be returned to the sponsor or designee. 01 March 2021 Confidential Page 42 of 64 Protocol HEPA-CRV431-201 Hepion Pharmaceuticals, Inc. Version 5.0 Table 6: Pharmacokinetic Sampling Schedule Day Day 1 Day 14 Day 28 Time (h) Pre-dose 2.0 4.0 8.0 312 (Pre-dose) Pre-dose 2.0 4.0 8.0 Whole blood (PK) X X X X X X X X X Plasma (fu) X X X X Abbreviations: fu, fraction unbound; h, hour; PK, pharmacokinetic(s).
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Study Drug Handling and Disposal. At the conclusion of the study or in an instance of planned study drug replacement, the Sponsor or its designee will direct the site regarding the final disposition of study drug.
Study Drug Handling and Disposal. At the end of the study, all used and unused study drug will be reconciled and returned to Sage Therapeutics for destruction or destroyed locally; disposition of study drug will be documented. A copy of the inventory record of any clinical supplies that have been received, dispensed or destroyed must be documented by the site as directed. This documentation must include at least the information below: • The number of dispensed units; • The number of administered units; • The number of unused units; • The number of units destroyed at the end of the study; • The date, method, and location of destruction.
Study Drug Handling and Disposal. Study treatment handling and disposal are described in the master protocol.
Study Drug Handling and Disposal. All material containing LJPC-501 will be treated and disposed of in accordance with governing regulations.
Study Drug Handling and Disposal. All investigational products including unused vials of RBM-007 supplied by RIBOMIC/Representative will be fully accounted for by the monitor with the help of the person responsible for dispensing the RBM-007 and will be returned to RIBOMIC/Representative or designee. Accountability will be documented by use of drug accountability forms. The used vials of RBM-007 will be stored at the investigational site upon completion of accountability procedures and returned to RIBOMIC or designee after the trial is completed.
Study Drug Handling and Disposal. ‌ Nitrile or vinyl examination gloves must be worn during the application process. Latex gloves are prohibited.
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Related to Study Drug Handling and Disposal

  • Prescription Drugs and Diabetic Equipment or Supplies Biological products for allergen immunotherapy and vaccinations. • Blood fractions. • Compound prescription drugs that are not made up of at least one legend drug. • Bulk powders and chemicals used in compound prescriptions that are not FDA approved, are not covered unless listed on our formulary. • Prescription drugs prescribed or dispensed outside of our dispensing guidelines. • Prescription drugs ordered or prescribed based solely on online questionnaires, telephonic interviews, surveys, emails, or any other marketing solicitation methods, whether alone or in combination. • Prescription drugs that have not proven effective according to the FDA. • Prescription drugs used for cosmetic purposes. • Prescription drugs purchased from a non-designated pharmacy, if a pharmacy has been designated for you through the Pharmacy Home Assignment program. • Experimental prescription drugs including those placed on notice of opportunity hearing status by the Federal Drug Efficacy Study Implementation (DESI). • Prescription drugs provided to you that are not dispensed by a network pharmacy or covered under your medical plan. • Prescription drugs and diabetic equipment and supplies purchased at a non-network pharmacy unless indicated as covered in the Summary of Pharmacy Benefits. • Prescription drug related medical supplies except for diabetic, regardless of the reason prescribed, the intended use, or medical necessity. Examples include, but are not limited to, alcohol pads, bandages, wraps or pill holders. • Off-label use of prescription drugs except as described in Experimental or Investigational Services in Section 3; • Prescribed weight-loss drugs. • Replacement of prescription drugs resulting from a lost, stolen, broken or destroyed prescription order or refill. • Therapeutic devices and appliances, including hypodermic needles and syringes except when used to administer insulin. • Prescription drugs, therapeutic equivalents, or any other pharmaceuticals used to treat sexual dysfunctions. • Vitamins, unless specifically listed as a covered healthcare service. • A prescription drug refill greater than the refill number authorized by your physician, more than a year from the date of the original prescription, or limited by law. • Long acting opioids and other controlled substances, nicotine replacement therapy, and specialty prescription drugs when purchased from a mail order pharmacy. • Prescription drugs and specialty prescription drugs when the required prescription drug preauthorization is not obtained. • Certain prescription drugs that have an over-the-counter (OTC) equivalent. • Prescriptions filled through an internet pharmacy that is not a verified internet pharmacy practice site certified by the National Association of Boards of Pharmacy. • Illegal drugs, including medical marijuana, which are dispensed in violation of state and/or federal law. Private Duty Nursing Services • Services of a nurse's aide. • Services of a private duty nurse: o when the primary duties are limited to bathing, feeding, exercising, homemaking, giving oral medications or acting as companion or sitter; o after the caregiver or patient have demonstrated the ability to carry out the plan of care; o provided outside the home. Examples include at school, or in a nursing or assisted living facility; o that are duplication or overlap of services. Examples include when a person is receiving hospice care services or for the same hours of a skilled nursing home care visit; o that are for observation only; and o provided as part-time/intermittent and not continuous care. • Maintenance care when the condition has stabilized including routine ostomy care or tube feeding administration or if the anticipated need is indefinite. • Twenty-four (24) hour private duty nursing care for a person without an available caregiver in the home. • Respite care (e.g., care during a caregiver vacation) or private duty nursing so that the caregiver may attend work or school. Surgery Services • Abdominoplasty. • Brow ptosis surgery. • Cervicoplasty. • Chemical exfoliations, peels, abrasions, dermabrasions, or planing for acne, scarring, wrinkling, sun damage or other benign conditions. • Correction of variations in normal anatomy including augmentation mammoplasty, mastopexy, and correction of congenital breast asymmetry. • Dermabrasion. • Ear piercing or repair of a torn earlobe. • Excision of excess skin or subcutaneous tissue except for panniculectomy. • Genioplasty. • Hair transplants. • Hair removal including electrolysis epilation, unless in relation to gender reassignment services or skin grafting. • Inverted nipple surgery. • Laser treatment for acne and acne scars. • Osteoplasty - facial bone reduction. • Otoplasty. • Procedures to correct visual acuity including but not limited to cornea surgery or lens implants. • Removal of asymptomatic benign skin lesions. • Repeated cauterizations or electrofulguration methods used to remove growths on the skin. • Rhinoplasty.

  • Incident Reporting and Client Risk Prevention An incident report shall be created and maintained at the AGENCY for the following: in the event the AGENCY’S staff or subcontractor becomes aware of an occurrence of any incident of injury to a client receiving program services through the COUNTY, requiring medical treatment by a licensed physician; any lawsuit entered into or against the AGENCY, all allegations of any kind of abuse, neglect, or exploitation of the AGENCY’S clients with the exception of those AGENCIES whose primary function is working with those that have been abused, neglected or exploited unless the allegation is against an AGENCY staff member; media coverage relating to the media expressing an interest in a case or issue concerning a client of the AGENCY or an employee on the AGENCY premises, a fire, hostage situation, bomb threat, epidemic or any circumstance which may impact the service provision. All occurrences shall be verbally communicated directly to COUNTY staff no later than 10:00 a.m. the following business day via telephone to the COUNTY. All incident reports shall be made available to the COUNTY upon request and maintained at the AGENCY. These reporting requirements shall in no way supersede the requirements for notification of allegations of abuse/neglect/exploitations to the State of Florida Abuse Hotline, as mandated in Chapter(s) 39 and 415, Florida Statutes.

  • Archival Back-Up and Disaster Recovery Licensee may use and copy the Product and related Documentation in connection with: i) reproducing a reasonable number of copies of the Product for archival backup and disaster recovery procedures in the event of destruction or corruption of the Product or disasters or emergencies which require Licensee to restore backup(s) or to initiate disaster recovery procedures for its platform or operating systems; ii) reproducing a reasonable number of copies of the Product and related Documentation for cold site storage. “Cold Site” storage shall be defined as a restorable back-up copy of the Product not to be installed until and after the declaration by the Licensee of a disaster; iii) reproducing a back-up copy of the Product to run for a reasonable period of time in conjunction with a documented consolidation or transfer otherwise allowed herein. “Disaster Recovery” shall be defined as the installation and storage of Product in ready-to-execute, back-up computer systems prior to disaster or breakdown which is not used for active production or development.

  • Pharmacy Benefits - Prescription Drugs and Diabetic Equipment or Supplies from a Pharmacy This plan covers prescription drugs listed on our formulary and diabetic equipment or supplies bought from a pharmacy as a pharmacy benefit. These benefits are administered by our Pharmacy Benefit Manager (PBM). Our formulary includes a tiered copayment structure and indicates that certain prescription drugs require preauthorization. If a prescription drug is not on our formulary, it is not covered. For specific coverage information or a copy of the most current formulary, please visit our website or call our Customer Service Department. Prescription drugs and diabetic equipment or supplies are covered when dispensed using the following guidelines: • the prescription must be medically necessary, consistent with the physician’s diagnosis, ordered by a physician whose license allows him or her to order it, filled at a pharmacy whose license allows such a prescription to be filled, and filled according to state and federal laws; • the prescription must consist of legend drugs that require a physician’s prescription under law, or compound medications made up of at least one legend drug requiring a physician’s prescription under law; • the prescription must be dispensed at the proper place of service as determined by our Pharmacy and Therapeutics Committee. For example, certain prescription drugs may only be covered when obtained from a specialty pharmacy; and • the prescription is limited to the quantities authorized by your physician not to exceed the quantity listed in the Summary of Pharmacy Benefits. Prescription drugs are subject to the benefit limits and the amount you pay shown in the Summary of Pharmacy Benefits.

  • GARBAGE DISPOSAL, RECYCLING, AND BIODEGRADABLE MATERIALS A. Concessionaire shall be responsible for maintaining the cleanliness of the Concession Premises. Concessionaire shall ensure placement of all garbage and trash generated by the Concession Operation in designated containers and that said containers are emptied daily, or as more frequently required by Department, at a location within the Area designated by Department. Disposal costs from this latter location shall be borne by Department. Concessionaire shall provide such additional trash containers as may be required to keep the immediate Concession Premises clean at all times. The type of trash containers provided by Concessionaire shall be approved by Department prior to use.

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

  • DELIVERY, STORAGE, AND HANDLING The Contractor shall be responsible to inspect all components on delivery to ensure that no damage occurred during shipping or handling for furnish and installation projects. For equipment only purchases, the ordering entity shall be responsible to inspect all components on delivery. Materials must be stored in original undamaged packaging in such a manner to ensure proper ventilation and drainage, and to protect against damage, weather, vandalism, and theft until ready for installation.

  • DATA HANDLING AND SECURITY It will always be the responsibility of the selected Contractor to manage data transfer and to secure all data appropriately during the project to prevent unauthorized access to all data, products, and deliverables.

  • Required Procurement Procedures for Obtaining Goods and Services The Grantee shall provide maximum open competition when procuring goods and services related to the grant-assisted project in accordance with Section 287.057, Florida Statutes.

  • Transportation of Students Employees will not be required to transport students.

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