Inventory
Itemize each CRF, associated source files, database exports, and any redactions; include unique IDs and page counts for traceability and reconciliation.
A consistent Transfer of CRF Document establishes chain of custody, clarifies responsibilities, and records data provenance for regulatory review and audits. It reduces disputes about missing records and helps demonstrate compliance with HIPAA and electronic records rules.
Clinical trial teams and records officers typically prepare and receive CRF transfer documents; roles vary by sponsor, site, and vendor.
Cross‑functional review—clinical operations, regulatory affairs, and IT/security—ensures privacy, access controls, and record integrity are maintained.
Itemize each CRF, associated source files, database exports, and any redactions; include unique IDs and page counts for traceability and reconciliation.
Identify the transferring and receiving authorized persons, provide printed names, titles, organization affiliations, and signature blocks with signing dates and contact details.
Specify how records are transmitted — secure SFTP, encrypted archive, courier with chain‑of‑custody seals, or remote electronic transfer with audit trail and access controls.
Record timestamps, handler names, shipment tracking numbers, checksum/hash values, and any custody handoffs to preserve integrity for audits.
List who may access files, any redaction requirements for PHI, export controls, and whether files are subject to clinical data access committees or legal holds.
State required retention periods, the final archival location, and version control conventions so recipients know which version is authoritative.
| Field | Configuration |
|---|---|
| Signers | Sponsor representative | Site PI or designee |
| Authentication | Email link + SMS OTP or stronger KBA when available |
| Storage | Encrypted at rest with access logging |
| Notifications | Automated receipt and completion emails to all parties |
Use a platform that captures audit trails, supports secure file formats, and integrates with CTMS, EHR, or archival storage solutions.
| signNow | DocuSign | Adobe Sign | PandaDoc | HelloSign | |
|---|---|---|---|---|---|
| Starting Price | $8/user/mo | $15/user/mo | $14/user/mo | $19/user/mo | $15/user/mo |
| Free Trial | 7-day free trial | Varies by plan | Varies by plan | Varies by plan | Varies by plan |
| Bulk Send | Yes | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |
| Envelope Cap | No envelope cap | 100 envelopes/user/year | Varies by plan | Varies by plan | Varies by plan |
Transfer finalized upon database lock and site closeout activities.
Allow 30–90 days for reconciliation of queries and missing pages before archiving.
Plan 3–7 business days for in‑person notary or mobile notary scheduling.
Expect availability windows; reserve sessions early for high volume transfers.
Retention typically begins on the effective transfer date recorded in the document.