Efficacy Assessments Sample Clauses

Efficacy Assessments. No efficacy assessments will be obtained during this study.
Sample 1
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Efficacy Assessments. 8.2.1. Hidradenitis Suppurativa Clinical Response (HiSCR) The HiSCR is used to assess the inflammatory signs and symptoms of HS (Xxxxxxx, 2014). The score is determined by counting the number of inflammatory nodules, abscesses, and draining fistulas before and after an intervention (see below). • HiSCR50 is defined as a 50% or greater reduction in total AN count and no increase in abscesses or draining fistulas compared with baseline. • HiSCR75 is defined as at least a 75% reduction from baseline in the total AN count, with no increase from baseline in abscess or draining fistula count. AN count will be done at timepoints specified in the SoA. AN count is correlated with disease severity and is used in HiSCR to evaluate HS. Abscess (fluctuant, with or without drainage, tender or painful), inflammatory nodules (tender, erythematous, pyogenic granuloma lesion), draining fistulas, sinus tracts with communications to skin surface, draining purulent fluid, and other lesions (noninflammatory nodules, non-draining fistulas) will all be individually counted on the entire body at each visit. The AN count will be calculated based on the sum of the abscesses and inflammatory nodules. Draining fistulas should also be counted.
Sample 1
Efficacy Assessments. All assessments will be conducted according to the Schedule of Assessments (Table 2). Study assessments that involve participant interviews, including the HAM-D and SCID-5-CT, may be audiotaped for independent quality control purposes. All assessments must be conducted by raters that have been trained and certified to conduct assessments in this study.
Sample 1
Efficacy Assessments. Efficacy assessments will be collected as outlined in the Schedule of Assessments (Section 1.3).
Sample 1
Efficacy Assessments. The following efficacy parameters will be evaluated:  0.5 hour post dose cysteamine concentration and WBC cystine level.
Sample 1
Efficacy Assessments. The primary efficacy endpoint and many of the secondary and exploratory efficacy endpoints in this study are derived from clinician-administered assessments which must be administered by qualified and trained individuals at each clinical site. Study specific training will be required before staff is allowed to administer these scales. In an attempt to minimize variability in responses of a given patient over time, it is important that the same rater administer the scales to a given patient throughout the study unless absolutely unavoidable due to the rater’s absence from the clinic. It is also important that the assessments, including those that are patient- completed, be conducted in the specified order, according to specific instructions, and in a setting where the patient has minimal distractions, appropriate privacy and sufficient time to complete them.
Sample 1

Related to Efficacy Assessments

  • Conformity Assessment 1. The Parties recognize that a broad range of mechanisms exists to facilitate the acceptance of conformity assessment procedures and results thereby, including:

  • Risk Assessments a. Risk Assessment - DST 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 Schedule 10.2 p.2 occurring and the impact of those threats upon DST organization to evaluate and analyze the appropriate level of information security safeguards (“Risk Assessments”).

  • Security Assessments Upon advance written notice by the JBE, Contractor agrees that the JBE shall have reasonable access to Contractor’s operational documentation, records, logs, and databases that relate to data security and the Contractor’s Information Security Program. Upon the JBE’s request, Contractor shall, at its expense, perform, or cause to have performed an assessment of Contractor’s compliance with its privacy and data security obligations. Contractor shall provide to the JBE the results, including any findings and recommendations made by Contractor’s assessors, of such assessment, and, at its expense, take any corrective actions.

  • Diagnostic Assessment 6.3.1 Boards shall provide a list of pre-approved assessment tools consistent with their Board improvement plan for student achievement and which is compliant with Ministry of Education PPM (PPM 155: Diagnostic Assessment in Support of Student Learning, date of issue January 7, 2013).

  • Security Assessment If Accenture reasonably determines, or in good faith believes, that Supplier’s security practices or procedures do not meet Supplier’s obligations under the Agreement, then Accenture will notify Supplier of the deficiencies. Supplier will without unreasonable delay: (i) correct such deficiencies at its own expense; (ii) permit Accenture, or its duly authorized representatives, to assess Supplier’s security-related activities that are relevant to the Agreement; and (iii) timely complete a security questionnaire from Accenture on a periodic basis upon Accenture’s request. Security issues identified by Accenture will be assigned risk ratings and an agreed-to timeframe to remediate. Supplier will remediate all the security issues identified within the agreed to timeframes. Upon Supplier’s failure to remediate any high or medium rated security issues within the stated timeframes, Accenture may terminate the Agreement in accordance with Section 8 above.

  • Clinical 1.1. Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

  • Conformity Assessment Procedures 1. Each Party shall give positive consideration to accepting the results of conformity assessment procedures of other Parties, even where those procedures differ from its own, provided it is satisfied that those procedures offer an assurance of conformity with applicable technical regulations or standards equivalent to its own procedures.

  • Needs Assessment 1. The Contractor shall conduct a cultural and linguistic group-needs assessment of the eligible client population in the Contractor’s service area to assess the language needs of the population and determine what reasonable steps are necessary to ensure meaningful access to services and activities to eligible individuals. [22 CCR 98310, 98314] The group-needs assessment shall take into account the following four (4) factors:

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