Common use of BARDA Protocol Review Process Before Patient Enrollment Begins Clause in Contracts

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.

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 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.; 2. Documentation of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number, and IRB or IEC name.; 3. Draft IRB or IEC approved informed consent templatedocument, 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, monitoring (see B above) 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 Contracting Officer Authorization (COA) Letter will letter may 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 provide the following (as applicable) for review and approval by the Government: 1. Draft b. 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.; 2. c. Documentation of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number, and IRB or IEC name.; 3. Draft d. IRB or IEC approved informed consent templatedocument, identified by version number, date, or both and date it is valid.; 4. e. Plans for the management of side effects.; 5. f. Procedures for assessing and reporting adverse events.; 6. g. Plans for data and safety monitoring, monitoring (see B above) and monitoring of the clinical study site, pharmacy, and laboratory.; 7. h. 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 ten (10 10) business days) 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 Contracting Officer Authorization (COA) Letter will letter may 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 provide the following (as applicable) for review and approval by the Government: 1. Draft 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.; 2. Documentation of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number, and IRB or IEC name.; 3. Draft IRB or IEC approved informed consent templatedocument, 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, monitoring (see B above) 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 BARDA 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 protocol approval will be provided by the COR to the Contractor. This COA written approval provides authorization to the Contractor to execute the specific clinical study funded in part or in whole by the Government. Documentation of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number, and IRB and IEC name, must be provided to the BARA COR within 24 hours of receipt by the Contractor.