Participantsresponsibilities Sample Clauses
Participantsresponsibilities
Participant Responsibilities You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, which may put your safety at risk or could have an effect on the study results • You may be eligible to participate if you have well controlled hypertension or hyperlipidemia (high cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between 30 – 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 14 days plus 5 half-lives before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary or herbal supplements that are sensitive CYP3A, BCRP, P-gp/MDRI, OATP1B, or UGT1A1 and UGT1A4 substrates after Day -1 of the study. o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study • You will need to stay in the CRU for 24 days starting with check-in o You may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples • You may drink water freely while in the CRU • You must not eat anything for at least 10 hours before eating breakfast • If dosing when an OGTT will be done you must not eat anything for at least 10 hours before dosing and/or OGTT • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. This study is for research purposes only. Your alternative is to not take part in the study.
Employer Responsibilities Recognizing the inherent risk(s) in a correctional setting, the Employer is obligated to provide a safe workplace and to educate employees on proper safety procedures and use of protective and safety equipment. The Employer is committed to responding to legitimate safety concerns raised by the Union and employees. The Employer will comply with federal and state safety standards, including requirements relating to first aid training, first aid equipment and the use of protective devices and equipment.
IRO Responsibilities The IRO shall: 1. perform each Claims Review in accordance with the specific requirements of the CIA;
Allocation of Responsibilities The persons responsible for the Plan and the duties and responsibilities allocated to each are as follows:
Fund Responsibilities 3.1. The management and control of the Fund are vested exclusively in the Fund’s governing body (e.g., the board of directors or trustees for a Fund that is a mutual fund or the Trustee for a Fund that is a collective trust, as applicable) and such officers and agents as may be appointed by the board from time to time, subject to the terms and provisions of the Fund’s Governing Documents. The Fund’s governing body and the duly appointed officers and agents appointed by the governing body on behalf of the Fund will make all decisions, perform all management functions relating to the operation of the Fund and shall authorize all Transactions. Without limiting the foregoing, the Fund shall: (a) Designate properly qualified individuals to oversee the Services and establish and maintain internal controls, including monitoring the ongoing activities of the Fund. (b) Evaluate the accuracy, and accept responsibility for the results, of the Services, review and approve all reports, analyses and records resulting from the Services and inform DST of any errors that it is in a position to identify. (c) Provide DST with timely and accurate information required by DST in order to perform the Services and its duties and obligations hereunder. 3.2. Without limiting DST’s obligations to comply with applicable Law and the Fund’s Governing Documents, the Fund is responsible for ensuring that it complies with Law and its respective Governing Documents. It is the Fund’s responsibility to provide all final Fund Governing Documents as of the Effective Date. The Fund will notify DST in writing of any changes to the Fund Governing Documents, with the exception of minutes of meetings of the board of directors, that may materially impact the Services prior to such changes taking effect. DST is not responsible for monitoring compliance by the Fund with (i) Law, or (ii) its respective Governing Documents. 3.3. In the event that Market Data is supplied to or through DST Associates in connection with the Services, the Market Data is proprietary to Data Suppliers and is provided on a limited internal-use license basis. Market Data may: (i) only be used by the Fund in connection with the Services and (ii) not be disseminated by the Fund or used to populate internal systems in lieu of obtaining a data license. Access to and delivery of Market Data is dependent on the Data Suppliers and may be interrupted or discontinued with or without notice. Notwithstanding anything in this Agreement to the contrary, neither DST nor any Data Supplier shall be liable to the Fund or any other Person for any Losses with respect to Market Data, reliance by DST Associates or the Fund on Market Data or the provision of Market Data in connection with this Agreement. 3.4. The Fund shall deliver, and procure that its agents, counsel, advisors, auditors, and any other Persons promptly deliver to DST all Fund Data. The Fund shall arrange with each such Person to deliver such information and materials on a timely basis, and DST will not be required to enter any agreements with that Person in order for DST to provide the Services. 3.5. Notwithstanding anything in this Agreement to the contrary, so long as they act in good faith and without negligence, willful misconduct or fraud, DST Associates shall be entitled to rely on the authenticity, completeness and accuracy of information and communications received by DST Associates from Authorized Persons, or Proper Instructions from the Fund in connection with the performance of the Services and DST’s duties and obligations hereunder, without further enquiry or liability.
Scope of Responsibilities The Management Committee shall have the following responsibilities: (a) Supervision and review of the work of the other ISO Committees; (b) Review and determination of appeals from actions of the other Committees, and the ability to suspend an action by another Committee pending appeal if the Management Committee determines that such suspension is warranted; (c) Development of procedures for the consideration and determination of requests for the stay of an action by another Committee; (d) Development of positions on ISO operations, policies, rules and procedures and provision of recommendations to the other Committees and the Board; (e) Preparation of the ISO capital and operating budgets for review and approval by the ISO Board; and (f) Subject to Article 19, proposing changes to the ISO OATT, the ISO Services Tariff and this Agreement, reviewing and making recommendations with respect to tariff changes proposed by the ISO Board; (g) Adoption of by-laws for the Management Committee and the review and approval of the by-laws of the other ISO Committees and amendments thereto; (h) Development of procedures and policies for all ISO Committees for the handling of confidential information; and (i) Such other responsibilities and powers conferred on it by the ISO Board. Decisions by the Management Committee may be appealed to the ISO Board by any Party.
Delegation of Responsibilities The Advisor is authorized to delegate any or all of its rights, duties and obligations under this Agreement to one or more sub-advisors, and may enter into agreements with sub-advisors, and may replace any such sub-advisors from time to time in its discretion, in accordance with the 1940 Act, the Advisers Act, and rules and regulations thereunder, as such statutes, rules and regulations are amended from time to time or are interpreted from time to time by the staff of the Securities and Exchange Commission ("SEC"), and if applicable, exemptive orders or similar relief granted by the SEC and upon receipt of approval of such sub-advisors by the Board of Trustees and by shareholders (unless any such approval is not required by such statutes, rules, regulations, interpretations, orders or similar relief).
Provider Responsibilities The Private Child-Caring Facility (PCC) (a.k.a., Provider) must comply with the following requirements:
Company Responsibilities In the case of a piggyback registration of Warrant Shares, the Company shall use its best efforts to keep the Holder advised in writing as to the initiation, effectiveness and completion of such registration. At its expense the Company shall: (a) prepare and file a registration statement (and such amendments and supplements thereto) with respect to such Registrable Securities and use its best efforts to cause such registration statement to become and remain effective for a period of 180 days or until the Holder or Holders have completed the distribution described in the registration statement relating thereto, whichever first occurs; (b) furnish such number of copies of a Prospectus in conformity with the requirements of applicable law, and such other documents incident thereto as a Holder from time to time may reasonably request; and (c) use every reasonable effort to register or qualify the Registrable Securities covered by such registration statement under the state Blue Sky laws of such jurisdictions as the Company's Board of Directors may reasonably determine, and do any and all other acts and things which may be necessary under said Blue Sky laws to enable the sellers of the Registrable Securities to consummate the public sale or other disposition of the Registrable Securities owned by them in such jurisdictions, except that the Company shall not for any purpose be required to qualify to do business as a foreign corporation in any jurisdiction wherein the Registrable Securities are so qualified.
Employee Responsibilities The Employer's policy with respect to employee responsibilities provides for employees: