STUDY ASSESSMENTS AND PROCEDURES Sample Clauses

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
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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 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 (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. 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. ‌ 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

Related to STUDY ASSESSMENTS AND PROCEDURES

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  • 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.

  • 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.

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