This is a ready-to-use register for the life of an IND after it takes effect. An IND stays open through development, and the sponsor keeps feeding it: protocol amendments, information amendments, safety reports, and annual reports. This log keeps the submission history, the reporting clocks, and the acknowledgements in one controlled place. Replace every <<FILL: ...>> placeholder. Field definitions, a blank row, and a filled specimen follow.
Register control
| Field | Entry |
|---|---|
| Register number | <<FILL: LOG-ID>> |
| IND number | <<FILL: IND nnnnnn>> |
| Product / candidate | <<FILL>> |
| Sponsor | <<FILL: COMPANY NAME>> |
| Regulatory owner | <<FILL>> |
Submission-type reference
| Type | Regulation | What it covers | Clock to remember |
|---|---|---|---|
| Protocol amendment | 312.30 | New protocol, change to a protocol, new investigator | Submit before implementing (new protocol may proceed on submission plus IRB approval) |
| Information amendment | 312.31 | New CMC, toxicology, or other technical information | As needed, not otherwise reportable |
| IND safety report | 312.32 | Serious and unexpected suspected adverse reaction; findings affecting safety | 7 calendar days (fatal/life-threatening, initial, by phone or in writing) and 15 calendar days (written) |
| Annual report | 312.33 | Yearly summary of progress | Within 60 days of the IND anniversary of effect |
| Response to clinical hold | 312.42 | Complete response to hold issues | Filed to resolve the hold; agency responds within 30 days of a complete response |
Field definitions
| Field | Format | Required | Who enters |
|---|---|---|---|
| Serial number | 0000 (eCTD serial) | Yes | Regulatory ops |
| Submission type | 312.30 / 312.31 / 312.32 / 312.33 / hold response | Yes | Regulatory |
| Title / description | text | Yes | Regulatory |
| Trigger date | date (event date or protocol finalization) | Yes | Regulatory / safety |
| Regulatory due date | date (per the applicable clock) | If clock applies | Regulatory / safety |
| Date submitted | date | Yes | Regulatory ops |
| On time? | Yes / No / N/A | Yes | Regulatory |
| FDA acknowledgement / response | text | Yes | Regulatory |
| Linked records | protocol / CAPA / deviation refs | If applicable | Owner |
Register table (blank)
| Serial | Type | Description | Trigger date | Due date | Submitted | On time? | FDA response | Linked |
|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Filled specimen
Illustrative rows for one IND across a year. Numbers and dates are examples.
| Serial | Type | Description | Trigger date | Due date | Submitted | On time? | FDA response | Linked |
|---|---|---|---|---|---|---|---|---|
| 0000 | Initial IND | Original submission | 12 Jun 2026 | N/A | 12 Jun 2026 | N/A | Study may proceed (no hold by 12 Jul) | Protocol P-01 |
| 0002 | 312.31 | Updated 6-month stability data | 03 Aug 2026 | N/A | 05 Aug 2026 | N/A | Acknowledged | CMC file |
| 0003 | 312.32 | SUSAR, grade 4 hepatic event, initial | 18 Aug 2026 | 25 Aug 2026 (7 cal days) | 20 Aug 2026 | Yes | Acknowledged | DEV-2026-051, PV case 00219 |
| 0004 | 312.32 | Same SUSAR, written follow-up | 18 Aug 2026 | 02 Sep 2026 (15 cal days) | 29 Aug 2026 | Yes | Acknowledged | PV case 00219 |
| 0005 | 312.30 | Protocol amendment, add dose cohort | 10 Sep 2026 | Before implementation | 10 Sep 2026 | Yes | Acknowledged; IRB approved 22 Sep | Protocol P-01 v2 |
| 0008 | 312.33 | Annual report, year 1 | 12 Jun 2027 | 11 Aug 2027 (60 days) | 24 Jul 2027 | Yes | Acknowledged | Annual report AR-2027-01 |
The two safety-report rows (0003 and 0004) show the pattern every safety group lives by: the 7-calendar-day initial report for a fatal or life-threatening SUSAR, then the 15-calendar-day written follow-up, each tied to the pharmacovigilance case and any related deviation.
Common findings this register prevents
- A safety report filed late because the reporting clock was not tracked from the event date.
- A protocol change implemented before the amendment was submitted.
- An annual report missed because no one tracked the IND anniversary of effect.
- Submission history scattered across inboxes, so no one can reconstruct what was filed when during an inspection.
How to adapt this register
- Set the IND number and regulatory owner in the control block.
- Automate the due-date calculation from the trigger date and the applicable clock.
- Wire the linked-records fields to your pharmacovigilance, deviation, and protocol systems.
- Confirm the current reporting timelines against 21 CFR Part 312 before you rely on them; this is educational guidance, not regulatory advice.