Safety Evaluation Clause Samples

Safety Evaluation. Each Party shall provide the following information with respect to its Compound to be used in a Combined Therapy Study: (i) the latest investigator’s brochure and annual updates (with such updates to be provided within five (5) Business Days after being finalized), (ii) list of ongoing clinical studies, (iii) Aggregate Safety Information that emerge from all other clinical trials of the Party’s Compound within five (5) Business Days after general distribution within such Party, (iv) prompt notice of any material safety interactions with any Regulatory Authority and the substance thereof regarding any clinical trials of the Party’s Compound during the term of this Agreement; (v) a summary of all new clinically relevant toxicology study data on the Party’s Compound within five (5) Business Days after generation of such summary within such Party, (vi) safety analyses for the Combined Therapy Study in accordance with the applicable Statistical Analysis Plan, and (vii) such other safety data as set forth in the Pharmacovigilance Agreement. Except as permitted under Section 8.3(g) and Section 8.4, each Party shall use any such information provided by the other Party pursuant to this Section 2.1(g) solely to evaluate the safety of the Combined Therapy and the Compounds for use in the Combined Therapy Study.

Safety Evaluation. In accordance with design procedure 331-86 and KAA-709 for safety screening / evaluation / justification is required. Where there is a possible interface with / impact on safety related equipment, the Contractor’s design complies with the applicable design codes as described in the KNPS Safety Analysis Report (ASME, IEEE etc). The Contractor’s design is such that it does not introduce any additional risk to the safety and / or operation of the plant and / or its people and / or the environment. Activity description Project Manager Contractor Requirements Planning Additional notes Authorisation of individuals in accordance with KTA-001. X All safety screenings, evaluations and justifications are performed by authorised individuals in accordance with KTA-001 Error! Reference source not found.. After tender phase Compilation of an Scheme Design document / Installation Design document and independent reviews X Process in accordance with KAA-709 Error! Reference source not found.. In accordance with Accepted Programme Although not obligatory, it is encouraged that the compiler of the design may not be the compiler of the Safety Evaluation documentation. Probabilistic Safety Assessments (PSA) evaluation. X The Employer performs the PSA. The Contractor to supply all relevant input information when requested to furnish information Incorporate PSA results into safety evaluation and confirm applicability of PSA to detailed design X The Contractor notifies the Project Manager of any discrepancies in the PSA study. The Contractor corrects any safety concerns highlighted by the Safety Evaluation / Safety Justification / PSA in its design. In accordance with Accepted Programme Presentation of safety evaluations, justifications and cases to Koeberg Operations Review Committee (KORC) for approval. X The Project Manager arranges with KORC for an opportunity to present information at KORC. Both the Project Manager and the Contractor technical representatives attend the meeting. The Project Manager or technical delegate performs the presentation. In accordance with Accepted Programme Regular meetings are scheduled every Monday but arrangement of special KORC meetings is possible for urgent issues. Approval of safety evaluation documents. X Project Manager acceptance is subject to the requirements of the safety evaluation process being met. In accordance with Accepted Programme Employer’s KORC Chairman approves the documents. Originals in Scheme Design and copies to TD & RM, ...

Safety Evaluation. Using the ODOT-calibrated crash prediction models, Kittelson will develop a safety evaluation of the recommended concept for the Greenwood West corridor, and summarize the findings of this evaluation in the Operations Analysis memorandum, above.

Safety Evaluation. Per NFAS 15.304(d), solicitations utilizing source selection procedures for procurements within the 50 United States, the District of Columbia, and outlying areas shall contain a standard “Safety” technical evaluation factor. This factor shall be included as a stand-alone evaluation factor and not as a sub-factor or an element of the Past Performance evaluation factor. This action will result in the selection of contractors that have consistently demonstrated a commitment to safety and the ability to properly manage and implement safety procedures for themselves and all tiers of subcontractors under their purview.

Safety Evaluation. All safety data will be included in the subject data listings. Analyses and summary tables will be based upon the safety population. All AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) (current version at the time of database lock), and will be classified by MedDRA preferred term and system organ class. AE listings will be presented by subject, system organ class and preferred term. Incidence of all reported AEs/treatment emergent AEs, AESIs, and SAEs will be tabulated by treatment group (600 U, 800 U, placebo for Treatment 1 and 600 U, 800 U for subsequent treatment(s)) and overall. In addition, summary tables will be presented by maximum intensity, drug relationship and AEs associated with premature withdrawal of IMP. A treatment emergent AE is defined as any AE that occurs during the active phase of the study if: • It was not present prior to receiving the first dose of IMP; or • It was present prior to receiving the first dose of IMP but the intensity increased at any point in the study following the first dose of IMP. Concomitant medication will be coded by using World Health Organisation Drug Dictionary (WHODRUG; current version at the time of database lock) and will be summarised by treatment group (600 U, 800 U, placebo for Treatment 1 and 600 U, 800 U for subsequent treatment(s)) and overall, with the number and percentage of subjects receiving concomitant medication by drug class and preferred drug name. Summary statistics (mean, median, standard deviation, standard error mean, and range as appropriate) by treatment group and overall will be presented for ▇▇▇▇▇ ▇▇▇▇▇, laboratory safety tests, laboratory urinalysis/microscopy etc. at each assessment with change from Baseline. For laboratory safety data, abnormal values will be flagged in the data listings and a list of clinically significant abnormal values will be presented. Shift tables from Baseline of the number and percentage of subjects with low, normal or high values and normal or abnormal examinations will be presented by treatment group (600 U, 800 U, placebo for Treatment 1 and 600 U, 800 U for subsequent treatment(s)).