CONTROL AND QUALITY ASSURANCE Sample Clauses

CONTROL AND QUALITY ASSURANCE. La Jolla or its designee will instruct the study site regarding the conduct of the study and data capture procedures on eCRFs. Logic and consistency checks will be performed on all data entered into the CRF or ultimately transferred into a database to ensure accuracy and completeness. Training sessions, regular monitoring of the study at the study site by the La Jolla or designated personnel (eg, CRA), instruction manuals, data verification, cross checking, and data audits will be performed to ensure quality of all study data. Investigators’ meetings and/or onsite study initiations will be performed to prepare Investigators and other study site personnel for appropriate conduct of the study and collection of study data. It is the Investigator’s responsibility to ensure the accuracy, completeness, and timeliness of the data reported for each patient. Source documentation supporting the data should indicate the patient’s participation in the study and should document the dates and details of study procedures, AEs, and patient status. The Investigator, or designated representative, should complete data entry as soon as possible after information is collected, preferably on the same day that a study patient is seen for an examination, treatment, or any other study procedure. Any outstanding entries should be completed immediately after the final examination. An explanation should be given for all missing data. The Investigator must sign and date the Investigator’s Statement that will be supplied to endorse the recorded data. To ensure compliance with GCP and all applicable regulatory requirements, La Jolla may conduct a quality assurance audit.

CONTROL AND QUALITY ASSURANCE. 5.1 Each lot of Finished Products manufactured by Noven in accordance with Article 2 herein shall meet the applicable release standards as set forth in the Specifications to assure the Finished Products meet regulatory specifications at all times through the expiration date of that lot as defined in the applicable Product Application. Noven shall employ appropriate change control procedures to ensure that the applicable release standards remain congruent with the applicable Product Application. Control procedures and analytical test methods referenced in a given Product Application may not be modified or superseded without the express written or verbal consent of Novartis and only, if necessary, after approval by the appropriate GRB. 5.2 Noven shall be responsible for procuring all Materials and shall ensure, through applicable GMP testing, that at all times all Materials used in the manufacture of the Finished Products are in compliance with their specifications and, as appropriate, are within the expiration dates printed on their labels or packaging. Noven shall ensure that all Materials are stored according to the precise storage conditions provided by their manufacturer or supplier. Noven shall carry out all Materials testing in accordance with GMP and all laboratory testing failures shall be promptly investigated and documented in reasonable detail. Noven may release Materials for processing only upon receipt of satisfactory test results. Noven shall employ appropriate change control procedures to ensure the control procedures remain congruent with the applicable Product Application and shall notify Novartis promptly of any changes to control procedures. 5.3 Noven shall ensure that all Materials released for processing are tested in accordance with agreed specifications and the filed Product Application. Noven will confirm that all batches of Materials correspond to the applicable specifications and GMP and are approved by Noven for incorporation into the Finished Product. Noven shall retain samples of all Materials used to prepare a lot of a Finished Product (except for water and volatile solvents) for a period of at least one year beyond the expiration date of the last lot of Finished Product containing said component. Packaging components are represented by Noven's retention of samples of finished dosage forms. The amount of retained sample shall be sufficient for at least three complete and full testing analyses in accordance with the control proc...

CONTROL AND QUALITY ASSURANCE. To ensure compliance with Good Clinical Practice and all applicable regulatory requirements, Sage Therapeutics may conduct a quality assurance audit(s) at the clinical site. Please see Section 14.2 for more details regarding the audit process. The investigator must have adequate quality control practices to ensure that the study is performed in a manner consistent with the protocol, GCP/ICH GCP guidelines, and applicable regulatory requirements. The investigator is responsible for reviewing all identified protocol deviations. Significant protocol deviations should be reported to the IRB/IEC per the IRB/IEC’s written procedures. The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site. When the investigator retains the services of any individual or party to perform trial-related duties and functions, the investigator must ensure the individual or party is qualified to perform trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed, and any data generated. The investigator must maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the site’s trial participants. Source data must be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data should be traceable, should not obscure the original entry, and should be explained, if necessary to provide clarification.

CONTROL AND QUALITY ASSURANCE. To ensure compliance with Good Clinical Practice and all applicable regulatory requirements, Hepion (or representative) may conduct a quality assurance audit. Please see Section 13.2 for more details regarding the audit process.

CONTROL AND QUALITY ASSURANCE. Quality control and quality assurance is described in the master protocol.

CONTROL AND QUALITY ASSURANCE. To ensure that we produce a well-engineered PS&E package with a minimal number of construction contract change orders, KOA implements a robust QA/QC process that is followed from the beginning to the end of the project. The QA/ QC plan includes a number of steps, including: (1) Holding design meetings with the City’s PM, senior civil engineers and public services/transportation management staff at key phases in the project design/approval; (2) Obtaining comments and input from the City; and (3) Conducting internal plancheck and QA/QC with KOA’s engineering and construction management staff. This includes tracked color-coded review comments coordinated in Revu Bluebeam® sessions, completion of review checklists, and independent peer review from senior staff to ensure the feasibility and constructability of the project design. KOA’s constructability reviews also allow us to: (1) amplify the odds of being able to identify and anticipate any potential construction problems or conflicts; (2) develop better design alternatives early on in the design phase, and continually throughout the PS&E delivery stages; and (3) provide the City with adequate estimates, quantity takeoffs, and pavement cross sections if needed beyond the typical pavement structural sections provided to us by the City. ENGINEERING DESIGN SERVICES FOR ▇▇▇▇▇ AVENUE AND PINECREEK DRIVE INTERSECTION PROJECT (“PROJECT A”) AND ▇▇▇▇▇ AVENUE BICYCLE FACILITY PROJECT (“PROJECT B”) Below is KOA’s proposed schedule for the projects, to be performed in tandem. 1 day 4 wks Kickoff Meeting Milestone Summary Task Date: Wed 12/9/20 2 wks Final Submittal - 100% PS&E Package 2 wks 90% City Review 5 wks 90% PS&E 15 2 wks 65% City Review 8 wks 65% PS&E 13 0 wks 14 wks Environmental Clearance ‐ Project B 14 wks Environmental Clearance ‐ Project A 0 wks 2 wks City Review - Concept Design 4 wks Concept Design

CONTROL AND QUALITY ASSURANCE. During trial conduct, VIVUS, Inc. or its agent will conduct periodic monitoring visits to ensure that the protocol and GCPs are being followed. The monitors may review source documents to confirm that the data recorded on CRFs are accurate. The investigator and institution will allow VIVUS, Inc. monitors or its agents and appropriate regulatory authorities direct access to all appropriate source documents to perform this verification. The trial site and trial-related documents may be subject to review by the institutional review board (IRB)/independent ethics committee (IEC), and/or to quality assurance audits performed by VIVUS, Inc. or its agents and/or to inspection appropriate regulatory authorities. Refer to Section 13. It is important that the investigator(s) and their relevant personnel are available during the monitoring visits and possible audits or inspections and that sufficient time is devoted to the process by the investigator and site personnel.

CONTROL AND QUALITY ASSURANCE. In 2021, the FDA released 4 draft guidance documents defining data quality, management, and analyses of real-world data, including guidance specific to claims data and disease registries. Given the extensive documentation requirements, separate supplemental protocols will be submitted, one for the Global PBC registry and one for the Komodo Health dataset.

CONTROL AND QUALITY ASSURANCE. During trial conduct, VIVUS or its agent will conduct periodic monitoring visits to ensure that the protocol and GCPs are being followed. The monitors may review source documents to confirm that the data recorded on CRFs are accurate. The investigator and institution will allow VIVUS monitors or its agents and appropriate regulatory authorities direct access to all appropriate source documents to perform this verification. The trial site and trial-related documents may be subject to review by the institutional review board (IRB)/independent ethics committee (IEC), and/or to quality assurance audits performed by VIVUS or its agents, and/or to inspection by appropriate regulatory authorities. It is important that the investigator(s) and their relevant personnel are available during the monitoring visits and possible audits or inspections and that sufficient time is devoted to the process by the investigator and site personnel.