BARDA Protocol Review Process Before Patient Enrollment Begins Sample Clauses

BARDA Protocol Review Process Before Patient Enrollment Begins. BARDA has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-supported clinical trials. Therefore, before patient accrual or participant enrollment, the Contractor must ensure the following (as applicable) are in place at each participating institution, prior to patient accrual or enrollment: IRB- or IEC-approved clinical research protocol identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria. Documentation of IRB or IEC approval, including OHRP federal wide number, IRB or IEC registration number, and IRB and IEC name. IRB- or IEC- approved informed consent form/document, identified by version number, date, or both and dates it is valid. Plans for the management of side effects. Procedures for assessing and reporting adverse events. Plans for data and safety monitoring (see above) and monitoring of the clinical study site, pharmacy, and laboratory. Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received training in the protection of human subjects. Documentation to demonstrate that each of the above items are in place shall be submitted to BARDA) for evaluation and comment in conjunction with the protocol. Execution of clinical studies requires written authorization from BARDA in accordance with this section of this contract.
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BARDA Protocol Review Process Before Patient Enrollment Begins. BARDA has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-supported clinical trials. Therefore, before patient accrual or participant enrollment, the Contractor must provide the following (as applicable) for review and approval by the Government: 1. Draft clinical research protocol identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria. 2. Documentation of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number, and IRB or IEC name. 3. Draft informed consent template, identified by version number, date, or both and date it is valid. 4. Plans for the management of side effects. 5. Procedures for assessing and reporting adverse events. 6. Plans for data and safety monitoring, and monitoring of the clinical study site, pharmacy, and laboratory. 7. Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received Good Clinical Practice (GCP) training in the protection of human subjects. XXXXX comments will be forwarded to the Contractor within two weeks (10 business days) of receipt of the above information. The Contractor must address in writing all study design, safety, regulatory, ethical, and conflict of interest concerns raised by the BARDA COR to the satisfaction of the Government before patient accrual or participant enrollment can begin. After the Government receives the corrected documentation, a written Contract Officer Authorization (COA) Letter will be provided to the Contractor. This COA provides authorization to the Contractor to execute the specific clinical study funded in part or in whole by the Government.
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BARDA Protocol Review Process Before Patient Enrollment Begins. The COR has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-supported clinical trials. Therefore, before patient accrual or participant enrollment, the Contractor must ensure the following (as applicable) are in place at each participating institution, prior to patient accrual or enrollment:
Sample 1
BARDA Protocol Review Process Before Patient Enrollment Begins. BARDA has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-supported clinical trials. Therefore, before patient accrual or participant enrollment, the Contractor must provide the following (as applicable) for review and approval by the Government: 1. Clinical research protocol to be submitted for approval by the IRB or IEC, identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria; 2. Informed consent document, identified by version number, date, or both and date it is valid;
Sample 1

Related to BARDA Protocol Review Process Before Patient Enrollment Begins

  • Claims Review Population A description of the Population subject to the Claims Review.

  • Enrollment Process The Department may, at any time, revise the enrollment procedures. The Department will advise the Contractor of the anticipated changes in advance whenever possible. The Contractor shall have the opportunity to make comments and provide input on the changes. The Contractor will be bound by the changes in enrollment procedures.

  • Disenrollment An Enrollee must be disenrolled from the Plan if the Beneficiary: a. No longer resides in the State of Mississippi; b. Is deceased; c. No longer qualifies for medical assistance under one of the Medicaid eligibility categories in the targeted population. The Contractor must notify the Division within three (3) days of their request that an Enrollee is disenrolled for a reason listed above and provide written documentation of disenrollment. Disenrollment shall be effective on the first day of the calendar month for which the disenrollment appears on the Enrollee Listing Report. The Contractor shall not disenroll an Enrollee because of an adverse change in the Enrollee’s health status, or because of the Enrollee’s utilization of medical services, diminished mental capacity, or uncooperative or disruptive behavior resulting from Enrollee’s special needs (except when Enrollee’s continued enrollment in the CCO seriously impairs the Contractor’s ability to furnish services to either this particular Enrollee or other Enrollees.) The Contractor must file a request to disenroll an Enrollee with the Division in writing stating specifically the reasons for the request if the reasons are for other than those specified above. An Enrollee may request disenrollment without cause during the ninety (90) days following the date the Division sends the Enrollee notice of enrollment or the date of the Enrollee’s initial enrollment, whichever is later, during the annual open enrollment period, upon automatic reenrollment if the temporary loss of Medicaid eligibility has caused the Enrollee to miss the annual disenrollment opportunity, or when the Division imposes an intermediate sanction on the Contractor as specified in this Contract. An Enrollee may request disenrollment from the CCO for cause if the CCO does not, because of moral or religious objections, cover the service the Enrollee seeks, the Enrollee needs related services to be performed at the same time, not all related services are available within the network, the Enrollee’s primary care provider or another provider determines receiving the services separately would subject Enrollee to unnecessary risk, poor quality of care, lack of access to services covered under the Plan, or lack of access to providers experienced in dealing with the Enrollee’s health care needs. Enrollee requests for disenrollment must be directed to the Division either orally or in writing. The effective date of any approved disenrollment will be no later than the first day of the second month following the month in which the Enrollee or the Plan files the request with the Division.

  • Enrollment The Competitive Supplier shall be responsible for enrolling all Eligible Consumers through EDI transactions submitted to the LDC for all enrollments of Eligible Consumers during the term of this Agreement.

  • Drug Testing (A) The state and the PBA agree to drug testing of employees in accordance with section 112.0455, F.S., the Drug-Free Workplace Act. (B) All classes covered by this Agreement are designated special risk classes for drug testing purposes. Special risk means employees who are required as a condition of employment to be certified under Chapter 633 or Chapter 943, F.S. (C) An employee shall have the right to grieve any disciplinary action taken under section 112.0455, the Drug-Free Workplace Act, subject to the limitations on the grievability of disciplinary actions in Article 10. If an employee is not disciplined but is denied a demotion, reassignment, or promotion as a result of a positive confirmed drug test, the employee shall have the right to grieve such action in accordance with Article 6.

  • Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.

  • Medicaid Enrollment Treatment Grantees shall enroll as a provider with Texas Medicaid and Healthcare Partnership (TMHP) and all Medicaid Managed Care organizations in Grantee’s service region within the first quarter of this procurement term and maintain through the procurement term.

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • Open Enrollment KFHPWA will allow enrollment of Subscribers and Dependents who did not enroll when newly eligible as described above during a limited period of time specified by the Group and KFHPWA.

  • Claims Review Methodology ‌‌ a. C laims Review Population. A description of the Population subject‌‌ to the Quarterly Claims Review.

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