We use cookies on our site to analyze traffic, enhance your experience, and provide you with tailored content.

For more information visit our privacy policy.

STUDY ASSESSMENTS AND PROCEDURES Sample Clauses

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 Xxxxxxx immediately upon occurrence or awareness to determine if the participant should continue or discontinue study intervention. • Adherence to the study design requirements, including those specified in the SoA, is essential and required for study conduct. • All screening evaluations must be completed and reviewed to confirm that potential participants meet all eligibility criteria. The Investigator will maintain a screening log to record details of all participants screened and to confirm eligibility or record reasons for screening failure, as applicable.
Sample 1
STUDY ASSESSMENTS AND PROCEDURES. Study procedures and their timing are summarized in the SoA. • Immediate safety concerns should be discussed with the Sponsor’s Medical Monitor immediately upon occurrence or awareness to determine if the patient should continue or discontinue study treatment. • Adherence to the study design requirements, including those specified in the SoA, is essential and required for study conduct. • All screening evaluations must be completed and reviewed to confirm that potential patients meet all eligibility criteria. The Investigator will maintain a screening log to record details of all patients screened and to confirm eligibility or record reasons for screening failure, as applicable. • Procedures conducted as part of the patient’s routine clinical management (e.g., blood count) that were obtained prior to signing of the informed consent form (ICF) may be utilized for screening purposes provided the procedures met the protocol-specified criteria and were performed within the time frame defined in the SoA.
Sample 1
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. 7.1. Baseline Assessments‌‌‌
Sample 1
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.
Sample 1
STUDY ASSESSMENTS AND PROCEDURES. 44 8.4.1. Time Period and Frequency for Collecting Adverse Event and Serious Adverse Event Information 49 8.4.2. Method of Detecting Adverse Events and Serious Adverse Events 49 8.4.3. Follow-up of Adverse Events and Serious Adverse Events 49 8.4.4. Regulatory Reporting Requirements for Serious Adverse Events 50 8.4.5. Pregnancy 50 8.4.6. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as Adverse Events or Serious Adverse Events 51 8.4.7. Adverse Events of Special Interest 51 8.4.8. Medication Errors 54 8.5. Treatment of Overdose 54 9.1. Statistical Hypotheses 55 9.2. Sample Size Determination 55 9.3. Populations for Analyses 56 9.4. Statistical Analyses 56 9.4.1. Demographic and Other Baseline Characteristics 57 9.4.2. Efficacy Analyses 57 9.4.3. Safety Analyses 58 9.5. Interim Analyses 59 9.6. Data Safety Monitoring Board 60 10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations 61 10.1.1. Regulatory and Ethical Considerations 61 10.1.2. Financial Disclosure 61 10.1.3. Informed Consent Process 62 10.1.4. Data Protection 62 10.1.5. Committees Structure 62
Sample 1
STUDY ASSESSMENTS AND PROCEDURES. ‌ The required study assessments procedures are described in this section. The timeline for all procedures may be found in Section 1.3. 8.1. Screening Visit‌‌‌
Sample 1
STUDY ASSESSMENTS AND PROCEDURES 
Sample 1

Related to STUDY ASSESSMENTS AND PROCEDURES

  • Environmental Review From the date of this Agreement through the Notification Date Buyer may conduct an environmental assessment of the Assets, subject to the following: (a) Buyer shall have the right to conduct on-site inspections, including, but not limited to, Phase I testing (but not Phase II testing) (as those terms are defined by the American Society for Testing and Materials) environmental assessments of the Assets, including, but not limited to, sampling and analysis of soil, air, surface water, groundwater and waste materials, prior to the end of the Notification Date (“Buyer’s Environmental Review”) and Seller shall provide to Buyer a copy of any environmental review Seller has in its possession subject to the same terms of confidentiality subsequently set forth herein; (i) The cost and expense of Buyer’s Environmental Review shall be borne solely by Buyer; (ii) All inspections must be coordinated through a designated representative of Seller who may accompany Buyer during the course of Buyer’s inspection of the Assets; (iii) Buyer shall give Seller notice not less than 48 hours before any visits by Buyer and/or its consultant to the Assets, and Buyer shall seek and obtain Seller’s prior consent (which shall not be unreasonably withheld) before either Buyer or Buyer’s consultant enters the Assets; (iv) Buyer shall provide Seller a copy of any Phase I reports affecting the Assets promptly after Buyer’s receipt of the same; (v) Buyer and/or its consultant shall perform all such work in a safe and workmanlike manner, shall not unreasonably interfere with Seller’s operations, and shall comply with all Laws of applicable Governmental Authorities; (vi) Seller shall use commercially reasonable efforts to obtain any third party consents that are required in order to perform any work comprising Buyer’s Environmental Review; and (vii) Buyer hereby agrees to release and defend, indemnify, and hold harmless Seller and Seller’s Representatives from and against all Claims made by (or attributable to the acts or omissions of) Buyer or Buyer’s Representatives (INCLUDING THOSE RESULTING FROM THE SOLE, JOINT, OR CONCURRENT NEGLIGENCE (BUT NOT WILLFUL MISCONDUCT), STRICT LIABILITY OR OTHER LEGAL FAULT OF SELLER OR ANY OF SELLER’S REPRESENTATIVES) arising out of or relating to Buyer’s Environmental Review. The release and indemnity provisions of this Section 4.09 shall survive termination or Closing of this Agreement notwithstanding anything to the contrary provided for in this Agreement. (b) Unless otherwise required by applicable Laws, Buyer shall treat any matters revealed by Buyer’s Environmental Review and any environmental review provided by Seller to Buyer, including any analyses, compilations, studies, documents, reports, or data prepared or generated from such review, but excluding any public information (the “Environmental Information”), as confidential, and, except as provided below, Buyer shall not disclose any Environmental Information to any Governmental Authority, or, prior to Closing to any other third party without the prior written consent of Seller. Buyer may use the Environmental Information prior to Closing only in connection with the transactions contemplated by this Agreement. The Environmental Information shall be disclosed by Buyer to only those persons who need to know the Environmental Information for purposes of evaluating the transaction contemplated by this Agreement, and who agree to be bound by the terms of this Section 4.09. If Buyer or any third party to whom Buyer has provided any Environmental Information is requested, compelled, or required to disclose any of the Environmental Information prior to Closing, Buyer shall provide Seller with prompt notice sufficiently prior to any such disclosure so as to allow Seller to file for any protective order, or seek any other remedy, as it deems appropriate under the circumstances. If this Agreement is terminated prior to the Closing, upon Seller’s request Buyer shall deliver the Environmental Information, and all copies thereof and works based thereon, to Seller, which Environmental Information shall become the sole property of Seller. Upon request Buyer shall provide copies of the Environmental Information to Seller without charge. The terms and provisions of this Section 4.09(b) shall survive any termination of this Agreement, notwithstanding anything to the contrary.

  • Policies and Procedures i) The policies and procedures of the designated employer apply to the employee while working at both sites. ii) Only the designated employer shall have exclusive authority over the employee in regard to discipline, reporting to the College of Nurses of Ontario and/or investigations of family/resident complaints. iii) The designated employer will ensure that the employee is covered by WSIB at all times, regardless of worksite, while in the employ of either home. iv) The designated employer will ensure that the employee is covered by liability insurance at all times, regardless of worksite, while in the employ of either home. v) The designated employer shall have exclusive authority over the employee’s personnel files and health records. These files will be maintained on the site of the designated employer.

  • 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: (a) ensure that all Eligible Checks transmitted through the Service are made payable to you; (b) endorse the back of all Eligible Checks that you transmit to us through this Service with your signature and the words “For Mobile Deposit Only”; (c) securely store the Original Check until you receive confirmation that your check funds have been posted to your account; and (d) securely and thoroughly destroy the Original Check after you receive confirmation that your check funds have been posted to your account. You agree to follow all other instructions provided by us for capturing and transmitting Check Images via the Service. Check Images we receive that are not endorsed in accordance with this provision may be rejected.

  • 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.

  • Administrative Claims Requirements and Procedures No suit or arbitration shall be brought arising out of this Agreement against City unless a claim has first been presented in writing and filed with City and acted upon by City in accordance with the procedures set forth in Chapter 1.34 of the Chula Vista Municipal Code, as same may be amended, the provisions of which, including such policies and procedures used by City in the implementation of same, are incorporated herein by this reference. Upon request by City, Consultant shall meet and confer in good faith with City for the purpose of resolving any dispute over the terms of this Agreement.

Most Referenced Clauses

Most Referenced Definitions