reports, as well as retention of source documents, files, and records. Describe coding dictionaries to be used and reconciliation processes (if applicable). At the end of the study, a copy of all datasets will be provided to DMID. If data are to be generated in one location and transferred to another group, describe the responsibilities of each party. Optional Example text: protocol-specific text, customize with as applicable Data collection is the responsibility of the personnel at the participating clinical study site under the supervision of the site principal investigator. During the study, the site principal investigator must maintain complete and accurate documentation for the study. The data coordinating center for this study will be responsible for data management, quality review, analysis, and reporting of the study data. Data Capture Methods Provide details regarding the type of data capture that will be used for the study. Specify whether it will be paper or electronic, distributed or central, batched or ongoing processing, and any related requirements. Indicate expectations for time of submission of CRFs. Reference for electronic data capture: 21 CFR Part 11: Electronic Records; Electronic Signatures Optional Example text: customize with protocol-specific text, as applicable Clinical (including, but not limited to, AE/SAEs, concomitant medications, medical history, physical assessments, and clinical laboratory values) and reactogenicity will be collected on data collection forms by study personnel then entered into eCRFs via a 21 CFR Part 11-compliant internet data entry system provided by the study data coordinating center. The data system includes password protection and internal quality checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. of Data Indicate the of data that will be collected, such as safety, laboratory (clinical, immunology, pharmacokinetic, other study specific), and outcome measure data (e.g., reactogenicity). Specify if safety data are collected in a separate database. Optional Example text: protocol-specific text, customize with as applicable
reports, as well as retention of source documents, files, and records. Describe coding dictionaries to be used and reconciliation processes (if applicable). At the end of the study, a copy of all datasets will be provided to DMID. If data are to be generated in one location and transferred to another group, describe the responsibilities of each party. Optional Example text: customize with protocol-specific text, as applicable Data collection is the responsibility of the personnel at the participating clinical study site under the supervision of the site principal investigator. During the study, the site principal investigator must maintain complete and accurate documentation for the study. The data coordinating center for this study will be responsible for data management, quality review, analysis, and reporting of the study data. Data Capture Methods Provide details regarding the type of data capture that will be used for the study. Specify whether it will be paper or electronic, distributed or central, batched or ongoing processing, and any related requirements. Indicate expectations for time of submission of CRFs. Reference for electronic data capture: 21 CFR Part 11: Electronic Records; Electronic Signatures Optional Example text: customize with protocol-specific text, as applicable Clinical (including, but not limited to, AE/SAEs, concomitant medications, medical history, physical assessments, and clinical laboratory values) and reactogenicity will be collected on data collection forms by study personnel then entered into eCRFs via a 21 CFR Part 11-compliant internet data entry system provided by the study data coordinating center. The data system includes password protection and internal quality checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. of Data Indicate the of data that will be collected, such as safety, laboratory (clinical, immunology, pharmacokinetic, other study specific), and outcome measure data (e.g., reactogenicity). Specify if safety data are collected in a separate database. Optional Example text: customize with protocol-specific text, as applicable
DMID%20eCTD%20Compliant%20Interventional%20Protocol%20Template%20and%20Instructions.docx