Human Studies
Human Studies Development
InfoEd’s Human Subjects Development module provides researchers with an online portal for preparing, submitting and tracking their clinical studies and socio-behavioral surveys. The easy to use software streamlines the administrative effort involved in protocol submissions and offers useful new functionality for organizing research projects.
- Organizations can flexibly design and maintain their own protocol application templates using InfoEd’s eForm technology. Data collection requirements can vary by submission type (e.g. initial applications; amendments; modifications; adverse events; etc.).
- InfoEd’s Auto-Fill utility can conveniently load standard personnel and organizational details into new eForms upon creation, reducing effort and improving data quality.
- eForm protocols can be designed to respond interactively to researcher inputs. Study attributes that have regulatory or institutional implications can prompt questions or additional forms (e.g. Socio-behavioral study or clinical study? Conflict of interest? Populations include children? Radioisotope? etc.).
- The system includes a dynamic informed consent builder that generates customized templates on-the-fly based on the nature of each study.
- An intuitive trial design tool enables investigators to quickly build out the arms, visits and procedures that define a study, which once approved becomes an interactive roadmap for the study within InfoEd’s Clinical Trials module.
- User-friendly interface with field level help, links to product manuals, and integrated email support.
- Upload supporting materials (e.g. science documents; investigator brochures; informed consents; etc.).
- Application documents are watermarked with protocol status, board name, and date.
- Upon submission records are automatically checked for completeness. Incomplete records are disallowed with missing items highlighted.
- The module features an electronic routing and approval mechanism for departmental reviews, which then feeds the Human Subjects Management module.
- InfoEd’s compliance workflow supports multiple board reviews of an individual submission, streamlining the submission and tracking process.
- When used in conjunction with InfoEd’s other compliance modules for animal protocols and environmental safety plans, the system supports an interwoven cross-office workflow (e.g. a human study with a radioisotope can be routed to both the human studies board and the radiation safety committee simultaneously).
- Human Subjects captures the complete submission history of a protocol. The InfoEd protocol is in effect a file folder that contains an initial application and all subsequent submissions, with a complete communications history for each.
- Protocol amendments and modifications can be conveniently cloned from the last submission so the researcher can focus solely on necessary changes, minimizing administrative burden.
- eForms can track changes so reviewers can readily compare and contrast a new submission against the currently approved version of the protocol.
- New protocols can be copied from existing records so researchers that focus on a narrow band of activity can leverage forms from previous efforts.