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 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 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) the the CO and the COR for evaluation and comment in conjunction with the protocol. Execution of clinical studies requires written authorization from BARDA the CO and the COR in accordance with this section of this contract.

BARDA Protocol Review Process Before Patient Enrollment Begins. BARDA 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: • 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 BARDAthe COR) for evaluation and comment in conjunction with the protocol. Execution of clinical studies requires written authorization from BARDA the COR in accordance with this section Section of this contract.

BARDA Protocol Review Process Before Patient Enrollment Begins. BARDA 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: • 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- 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) the COR for evaluation and comment in conjunction with the protocol. Execution of clinical studies requires written authorization from BARDA the COR in accordance with this section Section of this contract.