Study Drug Accountability and Reconciliation Sample Clauses

Study Drug Accountability and Reconciliation. All patients will be expected to bring their bottles of study medication with them to all study visits. At each study visit, the site staff will inspect the medication bottles, and perform a count of the tablets remaining in the bottles and document this in the patient’s record. An assessment of medication adherence should be done by the study staff to ensure that the patient understands all dosing instructions and is taking the medication as prescribed. Patients will be asked for an explanation if the count of returned study drug tablets indicates a discrepancy between the expected number of tablets dosed and the number returned in the bottles. If it is found that the patient is not taking the study medication as expected, the patient will be re-counseled with instructions, and this should be noted in the patients’ records. A deviation should be recorded on any patient who is less than 70% compliant with dosing between visits. If the patient fails to return any of the unused study drug as expected, the patient should be questioned regarding the reason for the lower than expected tablet number and about potential misuse, abuse or diversion. If more than 8 tablets cannot be accounted for at any of the visits where drug is returned (week 4, 8 or 12), the investigator will be asked to evaluate the situation, and a written summary of this evaluation should be added to the source and entered onto the case report form (CRF). Situations where replacement drug is requested, or when more than 8 tablets cannot be accounted for, should be recorded as deviations. All study medication, including partial and empty bottles, must be maintained at the study site until Tonix or its designee verifies drug accountability and provides instruction for destruction or the return of the investigational product to the Sponsor’s drug distribution depot. Tonix or their designee will perform drug accountability which entails reconciliation between the amount of drug shipped to the study site, study drug assigned and dispensed to the patient (including returned unused assigned study drug), and study supplies that were never dispensed and/or assigned to patients.
Sample 1
AutoNDA by SimpleDocs

Related to Study Drug Accountability and Reconciliation

  • Health Insurance Portability and Accountability Act Grantee certifies that it is in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law Xx. 000-000, 00 XXX Parts 160, 162 and 164, and the Social Security Act, 42 USC 1320d-2 through 1320d-7, in that it may not use or disclose protected health information other than as permitted or required by law and agrees to use appropriate safeguards to prevent use or disclosure of the protected health information. Grantee shall maintain, for a minimum of six (6) years, all protected health information.

  • Health Care Accountability Ordinance If Administrative Code Chapter 12Q applies to this contract, Contractor shall comply with the requirements of Chapter 12Q. For each Covered Employee, Contractor shall provide the appropriate health benefit set forth in Section 12Q.3 of the HCAO. If Contractor chooses to offer the health plan option, such health plan shall meet the minimum standards set forth by the San Francisco Health Commission. Information about and the text of the Chapter 12Q, as well as the Health Commission’s minimum standards, is available on the web at xxxx://xxxxx.xxx/olse/hcao. Contractor is subject to the enforcement and penalty provisions in Chapter 12Q. Any Subcontract entered into by Contractor shall require any Subcontractor with 20 or more employees to comply with the requirements of the HCAO and shall contain contractual obligations substantially the same as those set forth in this Section.

  • Wall Street Transparency and Accountability Act In connection with Section 739 of the Wall Street Transparency and Accountability Act of 2010 (“WSTAA”), the parties hereby agree that neither the enactment of WSTAA or any regulation under the WSTAA, nor any requirement under WSTAA or an amendment made by WSTAA, shall limit or otherwise impair either party’s otherwise applicable rights to terminate, renegotiate, modify, amend or supplement this Confirmation or the Agreement, as applicable, arising from a termination event, force majeure, illegality, increased costs, regulatory change or similar event under this Confirmation, the Equity Definitions incorporated herein, or the Agreement (including, but not limited to, rights arising from Change in Law, Hedging Disruption, Increased Cost of Hedging, an Excess Ownership Position, or Illegality (as defined in the Agreement)).

  • Federal Funding Accountability and Transparency Act (FFATA Subrecipient shall comply with the requirements of 2 CFR part 25 Universal Identifier and System for Award Management (XXX). Subrecipient must have an active registration in XXX, xxxxx://xxx.xxx.gov/XXX/ in accordance with 2 CFR part 25, appendix A, and must have a Data Universal Numbering System (DUNS) number xxxxx://xxxxxx.xxx.xxx/webform/ Subrecipient must also comply with provisions of the Federal Funding Accountability and Transparency Act, which includes requirements on executive compensation, 2 CFR part 170 Reporting Subaward and Executive Compensation Information.

  • Wall Street Transparency and Accountability Act of 2010 The parties hereby agree that none of (i) Section 739 of the WSTAA, (ii) any similar legal certainty provision included in any legislation enacted, or rule or regulation promulgated, on or after the Trade Date, (iii) the enactment of the WSTAA or any regulation under the WSTAA, (iv) any requirement under the WSTAA or (v) any amendment made by the WSTAA shall limit or otherwise impair either party’s right to terminate, renegotiate, modify, amend or supplement this Confirmation or the Agreement, as applicable, arising from a termination event, force majeure, illegality, increased cost, regulatory change or similar event under this Confirmation, the Equity Definitions or the Agreement (including, but not limited to, any right arising from any Acceleration Event).

  • A Service Accountability Agreement This Agreement is a service accountability agreement for the purposes of the Enabling Legislation.

  • Service Accountability Agreements The HSP acknowledges that if the LHIN and the HSP enter into negotiations for a subsequent service accountability agreement, subsequent funding may be interrupted if the next service accountability agreement is not executed on or before the expiration date of this Agreement.

  • Health Insurance Portability and Accountability Act of 1996 This paragraph was intentionally left blank.

  • Money Market Fund Compliance Testing and Reporting Services Subject to the authorization and direction of the Trust and, in each case where appropriate, the review and comment by the Trust’s independent accountants and legal counsel, and in accordance with procedures that may be established from time to time between the Trust and the Administrator, the Administrator will:

  • Accountability Actuaries and external auditors will be appointed by the Trust. Audited financial statements, and an actuarial evaluation report will be obtained for the Trust on an annual basis. The actuarial report will include projections for the Trust for a period of not less than 3 years into the future.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!