BARDA Protocol Review Process Before Patient Enrollment Begins Clause Samples
The BARDA Protocol Review Process Before Patient Enrollment Begins clause establishes that the Biomedical Advanced Research and Development Authority (BARDA) must review and approve the study protocol prior to the start of patient enrollment in a clinical trial. In practice, this means that the sponsor must submit the full protocol to BARDA for evaluation, and cannot begin enrolling participants until BARDA has provided written approval or feedback. This process ensures that the study design meets regulatory, ethical, and scientific standards before any subjects are exposed to potential risks, thereby safeguarding participant safety and ensuring compliance with funding requirements.
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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. ▇▇▇▇▇ 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.
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.
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:
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;