STUDY ASSESSMENTS AND PROCEDURES Sample Clauses

STUDY ASSESSMENTS AND PROCEDURES. ‌ • Study procedures and their timing are summarized in the SOA. • Immediate safety concerns should be discussed with the Sponsor immediately upon occurrence or awareness to determine if the patient should continue or discontinue study treatment. • Procedures conducted as part of the patient’s routine clinical management (e.g., blood count) and obtained prior to signing of the informed consent form (ICF) may be utilized for screening or baseline purposes provided the procedures met the protocol- specified criteria and were performed within the time frame defined in the SOA. • Please reference the Karyopharm Risk Management Plan for Conduct of Clinical Trials During the COVID-19 Pandemic as the document may address procedures being performed as a part of this clinical trial.
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STUDY ASSESSMENTS AND PROCEDURES. Study procedures and their timing are summarized in the SoA (Section 1.3). Protocol waivers or exemptions are not allowed. • Immediate safety concerns should be discussed with the Sponsor immediately upon occurrence or awareness of occurrence to determine if the subject should continue or discontinue study treatment. • Adherence to the study design requirements, including those specified in the SoA (Section 1.3), is essential and required for study conduct. • All screening evaluations must be completed and reviewed to confirm that potential subjects meet all eligibility criteria. The investigator will maintain a log to record details of all subjects screened (including demographic data) and to confirm eligibility or record reasons for screening failure, as applicable. • Procedures conducted as part of the subject’s routine clinical management and obtained before signing the ICF may be utilized for screening or baseline purposes provided the procedures met the protocol-specified criteria and were performed within the time frame defined in the SoA (Section 1.3). • Clinical evaluations of HS will be performed by an experienced and qualified dermatologist (board certified or eligible) or other suitably qualified and experienced designee. To assure consistency and reduce variability, the same assessor should perform all assessments on a given subject whenever possible.
STUDY ASSESSMENTS AND PROCEDURES. 44 8.1. Baseline Procedures 44 8.1.1. Informed Consent 44 8.1.2. Assignment of Subject Number 44 8.1.3. Screening 44 8.1.4. Medical History 45 8.1.5. Demographics 45 8.1.6. Prior and Concomitant Medications 45 8.2. Efficacy Assessments 45 8.2.1. Symptom Diaries 46 8.2.2. Patient-reported Outcomes 47 8.3. Safety Assessments 47 8.3.1. Physical Examinations 47 8.3.2. Xxxxx Xxxxx 47 8.3.3. Electrocardiograms 48 8.3.4. Clinical Safety Laboratory Assessments 48 8.4. Adverse Events and Serious Adverse Events 48

Related to STUDY ASSESSMENTS AND PROCEDURES

  • Risk Assessments a. Risk Assessment - Transfer Agent shall, at least annually, perform risk assessments that are designed to identify material threats (both internal and external) against Fund Data, the likelihood of those threats occurring and the impact of those threats upon the Transfer Agent organization to evaluate and analyze the appropriate level of information security safeguards (“Risk Assessments”).

  • Safeguarding requirements and procedures (1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

  • Environmental Review (a) Buyer shall have the right to conduct or cause a consultant (“Buyer’s Environmental Consultant”) to conduct an environmental review of the Assets and Seller’s records pertaining to the Assets (as set forth in Section 3.01) prior to the expiration of the Examination Period (“Buyer’s Environmental Review”). The cost and expense of Buyer’s Environmental Review, if any, shall be borne solely by Buyer. The scope of work comprising Buyer’s Environmental Review shall not include any intrusive test or procedure without the prior written consent of Seller. Buyer shall (and shall cause Buyer’s Environmental Consultant to): (i) consult with Seller before conducting any work comprising Buyer’s Environmental Review, (ii) perform all such work in a safe and workmanlike manner and so as to not unreasonably interfere with Seller’s operations and (iii) comply with all applicable laws, rules, and regulations. Seller shall use commercially reasonable efforts to obtain any Third Party consents and otherwise cooperate with Buyer in conducting Buyer’s Environmental Review and any activities related thereto. Seller shall have the right to have a representative or representatives accompany Buyer and Buyer’s Environmental Consultant at all times during Buyer’s Environmental Review. With respect to any samples taken in connection with Buyer’s Environmental Review, Buyer shall take split samples, providing one of each such sample, properly labeled and identified, to Seller. The Parties shall execute a “common undertaking” letter regarding the confidentiality for the Environmental Review where appropriate. Buyer hereby agrees to release, defend, indemnify and hold harmless Seller from and against all claims, losses, damages, costs, expenses, causes of action and judgments of any kind or character (INCLUDING THOSE RESULTING FROM SELLER’S SOLE, JOINT, COMPARATIVE OR CONCURRENT NEGLIGENCE OR STRICT LIABILITY) to the extent arising out of Buyer’s Environmental Review. Buyer hereby covenants and agrees that it will have at least $2,000,000 of general liability insurance to cover its indemnification hereunder prior to the commencement of the Environmental Review.

  • Environmental Audits and Reports As soon as practicable following receipt thereof, copies of all material environmental audits, investigations, analyses and reports of any kind or character, whether prepared by personnel of Company or any of its Subsidiaries or by independent consultants, Government Authorities or any other Persons, with respect to significant environmental matters at any Facility that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect or with respect to any Environmental Claims that, individually or in the aggregate, could reasonably be expected to result in a Material Adverse Effect;

  • Policies and Procedures i) The policies and procedures of the designated employer apply to the employee while working at both sites.

  • Notice and Procedures If any suit, action, proceeding (including any governmental or regulatory investigation), claim or demand shall be brought or asserted against any person in respect of which indemnification may be sought pursuant to either paragraph (a) or (b) above, such person (the “Indemnified Person”) shall promptly notify the person against whom such indemnification may be sought (the “Indemnifying Person”) in writing; provided that the failure to notify the Indemnifying Person shall not relieve it from any liability that it may have under paragraph (a) or (b) above except to the extent that it has been materially prejudiced (through the forfeiture of substantive rights or defenses) by such failure; and provided, further, that the failure to notify the Indemnifying Person shall not relieve it from any liability that it may have to an Indemnified Person otherwise than under paragraph (a) or (b) above. If any such proceeding shall be brought or asserted against an Indemnified Person and it shall have notified the Indemnifying Person thereof, the Indemnifying Person shall retain counsel reasonably satisfactory to the Indemnified Person (who shall not, without the consent of the Indemnified Person, be counsel to the Indemnifying Person) to represent the Indemnified Person in such proceeding and shall pay the fees and expenses of such counsel related to such proceeding, as incurred. In any such proceeding, any Indemnified Person shall have the right to retain its own counsel, but the fees and expenses of such counsel shall be at the expense of such Indemnified Person unless (i) the Indemnifying Person and the Indemnified Person shall have mutually agreed to the contrary; (ii) the Indemnifying Person has failed within a reasonable time to retain counsel reasonably satisfactory to the Indemnified Person; (iii) the Indemnified Person shall have reasonably concluded that there may be legal defenses available to it that are different from or in addition to those available to the Indemnifying Person; or (iv) the named parties in any such proceeding (including any impleaded parties) include both the Indemnifying Person and the Indemnified Person and representation of both parties by the same counsel would be inappropriate due to actual or potential differing interest between them. It is understood and agreed that the Indemnifying Person shall not, in connection with any proceeding or related proceedings in the same jurisdiction, be liable for the fees and expenses of more than one separate firm (in addition to any local counsel) for all Indemnified Persons, and that all such fees and expenses shall be paid or reimbursed as they are incurred. Any such separate firm for any Underwriter, its affiliates, directors and officers and any control persons of such Underwriter shall be designated in writing by the Representatives and any such separate firm for the Company, its directors, its officers who signed the Registration Statement and any control persons of the Company shall be designated in writing by the Company. The Indemnifying Person shall not be liable for any settlement of any proceeding effected without its written consent, but if settled with such consent or if there be a final judgment for the plaintiff, the Indemnifying Person agrees to indemnify each Indemnified Person from and against any loss or liability by reason of such settlement or judgment. Notwithstanding the foregoing sentence, if at any time an Indemnified Person shall have requested that an Indemnifying Person reimburse the Indemnified Person for fees and expenses of counsel as contemplated by this paragraph, the Indemnifying Person shall be liable for any settlement of any proceeding effected without its written consent if (i) such settlement is entered into more than 30 days after receipt by the Indemnifying Person of such request and (ii) the Indemnifying Person shall not have reimbursed the Indemnified Person in accordance with such request prior to the date of such settlement. No Indemnifying Person shall, without the written consent of the Indemnified Person, effect any settlement of any pending or threatened proceeding in respect of which any Indemnified Person is or could have been a party and indemnification could have been sought hereunder by such Indemnified Person, unless such settlement (x) includes an unconditional release of such Indemnified Person, in form and substance reasonably satisfactory to such Indemnified Person, from all liability on claims that are the subject matter of such proceeding and (y) does not include any statement as to or any admission of fault, culpability or a failure to act by or on behalf of any Indemnified Person.

  • Endorsements and Procedures You agree to restrictively endorse any item transmitted through the Service as “For Mobile Deposit Only at Allied Federal Credit Union” with your Allied Federal Credit Union account number and signature, signed as the name is formatted on the front of the check. In accordance with Federal Reserve specifications, “For Mobile Deposit Only at Allied Federal Credit Union” must be handwritten and cannot be signified by checking printed boxes on the back of the check designated by the check printer. You agree to follow any and all other procedures and instructions for use of this Service as Allied Federal Credit Union may establish in the future. Any loss we incur from delay or processing error resulting from an improper endorsement or other markings by you will be your responsibility. IMAGE QUALITY: The image being transmitted through Mobile Deposit to Allied Federal Credit Union must be an accurate and legible image of the front and back copy of the check, including but not limited to, information about the drawer, the paying bank that is preprinted on the original check, MICR information, signature(s), any required identification written on the front of the check and any endorsements applied to the back of the original check. The image quality must comply with and meet the standards established by the American National Standards Institute, the Board of Governors of the Federal Reserve, and any other regulatory agency, clearing house or association. RECEIPT OF DEPOSIT: All images processed will be treated as “deposits” under your Allied Federal Credit Union Account Agreement and we reserve the right to reject any item transmitted through the Service, at our discretion, without liability to you. We are not responsible for items that We do not receive or for images that are dropped during transmission. When an image is received by Us, we will confirm receipt via email or text to You. Confirmation does not mean that the image contains no errors and will be accepted as a deposit. FUNDS AVAILABILITY: You agree that items transmitted using this Service are not subject to the funds availability requirements of Federal Reserve Board Regulation CC. Items transmitted by You and received by Us by 6:00 p.m. CST Monday through Friday, not including holidays, shall be credited to the Member’s deposit account on the next Business Day. Items received by the Credit Union after 6:00 p.m. CST on any Business Day shall be credited to the Member’s deposit account on the second Business Day after the deposit. Business Days are Monday through Friday, not including Federal and Credit Union posted holidays. RETURNED DEPOSITS: Any credit to your account for checks deposited using Mobile Deposit is provisional. If any item is not honored for any reason you will receive a Substitute Check, which is a paper reproduction of a check that contains an image of the front and back of the check and meets the other technical requirements for a substitute check under Check 21, as the charged-back item. You may not use this Service to deposit a Substitute Check and you may not deposit the original check, whether by physical deposit or by using Mobile Deposit. You agree to be held liable for funds used before the deposit is accepted and shown as a deposit in Your account. You agree to abide by any additional 2 instructions We may provide to You in connection with return checks. RETENTION OF ORIGINAL CHECKS: After you receive confirmation that We have received a check image, and the check image has been credited to Your account, You must xxxx the front of the check with “VOID” and securely store the original check for 90 days after transmission to Us and make the original check accessible to Us at Our request. Upon this request you will deliver, at your expense, the requested original check within 5 Business Days. If not provided in a timely manner by You, such amount will be deducted from Your deposit account regardless of whether such action may cause your account to not have sufficient funds and You agree to pay any associated fee. You may not present the original check or any image or Substitute Check created from the original check for payment at any other financial institution. Member shall be responsible for safekeeping and destruction of original items which are scanned, transmitted electronically and deposited using the Service. After the 90 days you must destroy the original check by cross-cut shredding or other acceptable means of permanent destruction. After destruction of an original check, the image will be the sole evidence of the original check. DEPOSIT LIMITS: We reserve the right to impose limits on the amount(s) and/or number of deposits that You transmit using the Service and to modify such limits from time to time. Mobile deposit limits are $2,000.00 per check and $4,000.00 per day.

  • COMPLIANCE WITH POLICIES AND PROCEDURES During the period that Executive is employed with the Company hereunder, Executive shall adhere to the policies and standards of professionalism set forth in the policies and procedures of the Company and IAC as they may exist from time to time.

  • Violence Policies and Procedures The Employer agrees to have in place explicit policies and procedures to deal with violence. The policy will address the prevention of violence, the management of violent situations, provision of legal counsel and support to employees who have faced violence. The policies and procedures shall be part of the employee's health and safety policy and written copies shall be provided to each employee. Prior to implementing any changes to these policies, the employer agrees to consult with the Association.

  • No Joint Assessment Borrower shall not suffer, permit or initiate the joint assessment of any Individual Property with (a) any other real property constituting a tax lot separate from such Individual Property, or (b) any portion of such Individual Property which may be deemed to constitute personal property, or any other procedure whereby the Lien of any taxes which may be levied against such personal property shall be assessed or levied or charged to such Individual Property.

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