Data Safety Monitoring Sample Clauses

Data Safety Monitoring. The level of Data Safety Monitoring in a clinical trial varies study to study and depends on risk. Trials deemed to be minimal risk by the overseeing IRB and funding agency may require a Safety Officer (SO) rather than a full Data Safety Monitoring Board (DSMB). Decisions about the level of monitoring needed are determined by the funding agency and project officer, but may also be required by the IRB. It is advisable to check with the specific funding agency for sponsor-specific DSM requirements. For example, the National Institute of Aging provides guidance material and templates for DSM that should be followed when appropriate, NIA Data Safety Monitoring. For Sponsor-Investigators of IND Studies, additional forms and documents are required (e.g., FDA 1571). Additional Links to guidance documents and templates are available in the Appendix.  The purpose of DSM is to ensure the safety of human subjects, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. DSM requires reporting of all anticipated and unanticipated adverse events and protocol deviations. DSM also includes monitoring threats to credibility or the validity of the study related to slow rates of accrual, high rates of ineligibility after randomization, high rates of protocol violations, and high dropout rates.  DSMB members or Safety Officer (SO) will be chosen by Project Officer on NIH funded studies. For industry sponsored studies the Sponsor determines the charter of the DSMB. The PI Investigator may be asked to suggest names. The DSMB is a formally appointed independent group, with at least 3 impartial external voting members, who are expert in the field of study, statistics and study design, and also includes the PI and study statistician. The DSMB typically reviews interim monitoring of the study data in an open, a closed and an executive session.  Prior to study initiation the study team must complete the following in collaboration with the Project Officer: i. establishment of a DSMB or appointment of a SO, ii. Creation and approval of a Data Safety Monitoring Plan, iii. Creation and approval of a Data Safety Monitoring Charter, iv. Creation and approval of a Data Safety Monitoring Report, and v. Creation and approval of a Data Safety Monitoring reporting procedures and meetings. Further information is available in the E-Textbook.
Sample 1
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Data Safety Monitoring. ‌ The Cystic Fibrosis Foundation DSMB will establish a Data Monitoring Committee (DMC) to review data relating to safety and efficacy, to conduct and review interim analyses, and to ensure the continued scientific validity and merit of the study, according to the Cystic Fibrosis Foundation DSMB Operations Manual and a DMC Charter created for this protocol. There will be one formal interim review conducted by the DMC for the purpose of monitoring study conduct, assessing patient safety and assessing pre-specified stopping rules. Additional safety reviews will be conducted by the DMC as specified in the DMC Charter. Further details regarding the timing and content of the interim reviews (both formal and safety) will be fully specified in the DMC charter and approved by the study appointed DMC prior to study initiation.
Sample 1
Data Safety Monitoring. Each clinical trial site will have its own management plans for data safety monitoring. A CRO will provide external oversight of data collection and audit compliance with all aspects of the study. If two sites are used for the clinical trial, an independent Data Safety Monitoring Board will be established to review adverse event (AE) reporting during the conduct of the trial. This independent body will report information to the PI, the AFIRM Clinical Trials Core, and will advise on reporting to the institutional IRBs and the FDA. The AFIRM Clinical Trials Core will coordinate the multi-site clinical data using a web-based CFR Part 11-compliant electronic database for recording and verification of data collection in real time. The Core will monitor IRB and FDA approvals, amendments, and annual reports. Updated consents and clinical protocol will be available for online access. It will maintain records for subject registration, patient demographics, accrual dates, key event dates, including graft placement and timed follow-up assessment results. It will record all clinical data on electronic Case Report Forms (CRFs). Major outcome and study endpoint parameters will be monitored, including overall medical condition and complications referable to the burn, such as skin coverage assessed by the Vancouver Scar Scale, frequency of re-grafting, and evidence of inflammation by histopathology. Adverse and serious adverse event data collected at the study sites will be maintained and monitored. Serious adverse event definitions will be compliant with national reporting standards and will use conventional definitions for burn patients. All organ assessment and adverse events will be recorded during the 28 d observation period after graft placement. The Clinical Trials Core database will be available under secure access for audit, and will be reported to the AFIRM executive committee, individual PIs and the device supplier, Lonza Walkersville, Inc.
Sample 1
Data Safety Monitoring. Sponsor will comply with 21 CFR sections 312.32(c), 312.55(b), 812.40 and 812.150(b) in informing Site of serious adverse effects, new uses, or significant new information that could affect the safety of Subjects, their willingness to continue participation, or the risk-benefit ratio, or which could alter the IRB’s approval to continue the study or require changes to the informed consent form.
Sample 1

Related to Data Safety Monitoring

  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Environmental, Health and Safety Matters (a) The Company has complied and is in compliance with all Environmental, Health, and Safety Requirements.

  • Program Management 1.1.01 Implement and operate an Immunization Program as a Responsible Entity

  • REGULATORY ADMINISTRATION SERVICES BNY Mellon shall provide the following regulatory administration services for each Fund and Series:  Assist the Fund in responding to SEC examination requests by providing requested documents in the possession of BNY Mellon that are on the SEC examination request list and by making employees responsible for providing services available to regulatory authorities having jurisdiction over the performance of such services as may be required or reasonably requested by such regulatory authorities;  Assist with and/or coordinate such other filings, notices and regulatory matters and other due diligence requests or requests for proposal on such terms and conditions as BNY Mellon and the applicable Fund on behalf of itself and its Series may mutually agree upon in writing from time to time; and

  • Assistance and Cooperation After the Closing Date, each of Seller and Purchaser shall:

  • Environment, Health, and Safety 24.4.1. The Supplier and its staff (and/or any sub-supplier and/or subcontractor) shall comply with the laws and regulations in force related to protection of the environment, the health and safety instructions applicable to the Goods and Services performed pursuant to the Contract and especially, if appropriate, to the Goodsand Services performedon any Site by a third company.

  • Quality Assurance The parties endorse the underlying principles of the Company’s Quality Management System, which seeks to ensure that its services are provided in a manner which best conforms to the requirements of the contract with its customer. This requires the Company to establish and maintain, implement, train and continuously improve its procedures and processes, and the employees to follow the procedures, document their compliance and participate in the improvement process. In particular, this will require employees to regularly and reliably fill out documentation and checklists to signify that work has been carried out in accordance with the customer’s specific requirements. Where necessary, training will be provided in these activities.

  • Global Safety Database Licensee shall establish, hold and maintain (at Licensee’s sole cost and expense) the global safety database for Licensed Products.

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