APPENDIX 3: STUDY GOVERNANCE. 9.3.1 Data Quality Assurance This study will be conducted using the quality processes described in applicable procedural documents. The quality management approach to be implemented will be documented and will comply with current ICH guidance on quality and risk management. All aspects of the study will be monitored for compliance with applicable government regulatory requirements, current Good Clinical Practice, the protocol, and standard operating procedures (SOPs). The monitor will maintain current personal knowledge of the study through observation, review of study records and source documentation, and discussion of the conduct of the study with the investigator and staff. Electronic CRFs and electronic data capture will be utilized. The electronic data capture system is validated and compliant with US Title 21 CFR Part 11. Each person involved with the study will have an individual identification code and password that allows for record traceability. There may be an internal quality review audit of the data and additional reviews by the clinical monitor. Steps to be taken to ensure the accuracy and reliability of data include, but are not limited to: selection of qualified investigator and appropriate study center, protocol training and review of protocol procedures with the investigator and study site personnel before the start of the study, site initiation and periodic interim monitoring visits by SIGA or PPD, and direct transmission of safety laboratory data into the PPD study database for all clinical safety laboratory tests performed. The eCRF will be reviewed for accuracy and completeness by PPD Clinical research associate (CRA) remotely and during on-site monitoring visits. Discrepancies will be resolved with the investigator or designees, as appropriate. The data will be entered into the clinical study database and validated for accuracy. During on-site monitoring visits, 100% of the data will be verified using source documentation. SIGA or Biomedical Advanced Research and Development Authority representatives may accompany the PPD CRA on any scheduled site visit. The investigator will be informed in advance of any visitors to the study site in addition to the PPD CRA. Representatives of SIGA’s Quality Assurance department (or designee) may visit the site to carry out an audit of the study in compliance with regulatory guidelines and PPD policy. Such audits will require access to all study records, including source documents, for inspection an...
