Study Summary
Concise project overview including objectives, hypotheses, funder, lead institution, contact information, and effective dates; used by reviewers to quickly determine scope and required approvals and documentation expectations.
Used early in project planning, the Research Nexus Study clarifies responsibilities, documents consent and data lineage, and reduces rework during ethical review. It helps organizations meet regulatory standards and creates a consistent record for audit, publication, and institutional oversight.
Concise project overview including objectives, hypotheses, funder, lead institution, contact information, and effective dates; used by reviewers to quickly determine scope and required approvals and documentation expectations.
Detailed methodological description including study design, sampling plan, measurement instruments, preprocessing steps, statistical analysis plan, and any protocol deviations documented with dates and rationales and data transformations.
Eligibility criteria, recruitment sources, enrollment numbers, informed consent status per participant, demographic summaries, and any exclusion or withdrawal reasons tracked with timestamps and consent document identifiers.
Origins of each dataset, acquisition methods, processing pipelines, sample identifiers, versioning, checksum or hash values, storage locations, and access permissions for reproducibility and license terms.
Signed consent forms, scope of consent, data use limitations, IRB approvals, applicable BAAs, data sharing agreements, and governance contact points for subject questions or withdrawal requests.
Comprehensive record of edits, signatures, signers' identities, timestamps, IP addresses, document versions, and any authentication methods used during signing or access events stored in tamper-evident format.
| Field | Configuration |
|---|---|
| Signature field and type setting | Require initials and full signature; audit trail enabled |
| Authentication method and strength | Email link, SMS code, or KBA; document consent required |
| Routing order and signer roles | Sequential or parallel signing; define signer roles explicitly |
| Retention, export, and storage | Set retention period, export format, and secure storage location |
| signNow | DocuSign | Adobe Sign | PandaDoc | HelloSign | |
|---|---|---|---|---|---|
| Starting Price | $8/user/mo | $15/user/mo | $14/user/mo | $19/user/mo | $15/user/mo |
| Bulk Send | Yes | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |
| Envelope Cap | No cap | 100 envelopes/user/year | Varies by plan | Varies by plan | Varies by plan |
Submit complete Study materials per IRB schedule before participant recruitment.
Ensure signed consent before any study procedures or data collection.
Report serious adverse events to IRB and sponsor within required timeframe.
Retention begins at creation or final approval per applicable regulation.
Complete annual continuing review when required by IRB to maintain approvals.
Prepare documents, verify consent language, and assemble attachments.
Obtain written approval and document conditions or modifications.
Collect signatures, dates, and authenticate signers as configured.
Finalize datasets, preserve audit trail, and store records securely.
Optica Ventures used the Study framework to centralize protocol, consent, and data provenance across multiple investors and sites.
Fertility Centers of Illinois integrated signed consent forms and data lineage into a single Study record to support clinical governance and patient inquiries.
Technical requirements and integrations to distribute, sign, and archive the Research Nexus Study across common enterprise platforms.