Identity
Enter full legal name, institutional affiliation, email, and phone. Use the name matching government-issued ID to prevent delays in identity verification and access provisioning process.
Using a Researcher Information Document centralizes critical project and signer details, reduces administrative errors, and provides an auditable record for institutional review boards and compliance officers. It clarifies responsibilities and supports consistent data governance across study activities.
Common users include principal investigators, study coordinators, IRB administrators, and data managers who need accurate participant and project metadata.
Completed documents are retained by the institution and made available to auditors and sponsors as required by policy.
Enter full legal name, institutional affiliation, email, and phone. Use the name matching government-issued ID to prevent delays in identity verification and access provisioning process.
Describe the research role (PI, co-investigator, technician) and responsibilities. Include start and end dates and supervisory relationships for clear accountability and data access scope details.
Summarize objectives, methodology, funding source, and expected outputs. State whether human subjects, identifiable data, or controlled datasets are involved and any IRB protocol numbers or approvals.
Specify consent obtained, data sharing permissions, data retention limits, and restrictions on secondary use. Attach consent forms or data use agreements where applicable for audit readiness.
Disclose financial interests, consulting relationships, or equity positions that could present conflicts. Describe management plans, recusal obligations, and disclosure filings made to the institution office.
Record IRB approvals, sponsor sign-offs, data access committee decisions, and any required institutional review numbers. Include dates and scanned approval letters uploaded to the repository.
| Form Field or Workflow Setting | Recommended configuration and example values |
|---|---|
| Preferred authentication method for signer | Email link, SMS code, or KBA as configured |
| Conditional visibility and field logic rules | Show consent details only if human subjects involved |
| Approver routing sequence and escalation rules | Route to PI then IRB administrator for final sign-off |
| Document repository and retention folder path | Save signed forms to secure institutional repository with versioning |
Electronic submission requires a compliant eSignature platform supporting multi-factor authentication, tamper-evident documents, and detailed audit trails for regulatory review.
Submit prior to participant enrollment and IRB review.
Allow four to eight weeks for full board review.
Notify IRB and update document when researcher roles change.
Confirm contact, access, and approvals annually or per institutional policy.
Retention period begins at study close-out or final report date.