Log: IRB/IEC Submission and Continuing Review Tracking

This is a ready-to-use log for tracking what a study has submitted to its Institutional Review Board or Independent Ethics Committee, what came back, and when the next continuing review is due. E6 requires ongoing review at intervals appropriate to risk and not less than once a year, and a lapsed continuing review is one of the more common IRB/IEC findings an inspector raises, usually because nobody was watching the calendar rather than because the study did anything else wrong. This log exists so someone is always watching the calendar. Replace every <<FILL: ...>> placeholder with your specifics and route it through your normal document control. A filled specimen follows. Verify cited regulations against the current source before you rely on them. This is general guidance to adapt, not legal or regulatory advice.

Field	Entry
Study / protocol	`<<FILL>>`
Sponsor	`<<FILL>>`
Governing IRB/IEC name and registration number	`<<FILL>>`
Sites covered by this IRB/IEC	`<<FILL: single site, or list, or "central IRB, all sites">>`
Log owner	`<<FILL: role, e.g. Clinical Trial Manager>>`
Log version / page	`<<FILL>>`

Submission-type legend

Define the submission codes used below so a reviewer can read the log without guessing. Adapt to your study.

Code	Submission type
IP	Initial protocol and informed consent form submission
AM	Protocol amendment
IC	Informed consent form revision not tied to a protocol amendment
IB	Investigator’s Brochure update
CR	Continuing / annual review
SR	Expedited safety report (individual SUSAR or aggregate safety update)
DV	Protocol deviation report
RM	Recruitment or advertising material
`<<FILL>>`	`<<FILL: add study-specific submission types>>`

Submission and review log

Submission ID	Type (code)	Item submitted	Date submitted	Meeting / review date	Decision	Approval / favourable opinion date	Document reference	Next continuing review due	Notes
`<<FILL>>`	`<<FILL>>`	`<<FILL: e.g. Protocol v2.0, ICF v2.0>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL: Approved / Approved with modifications / Deferred / Disapproved>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`
`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`	`<<FILL>>`

Field definitions

Field	Format	Required	Who	When
Submission ID	sequential ID	Yes	Log owner	On submission
Type	code from legend	Yes	Log owner	On submission
Item submitted	text, with version number	Yes	Log owner	On submission
Date submitted	date	Yes	Log owner	Day of submission
Meeting / review date	date	Yes, once known	Log owner	After the IRB/IEC schedules it
Decision	one of the defined outcomes	Yes	Log owner	On receipt of the decision
Approval / favourable opinion date	date	Yes, if approved	Log owner	On receipt of the written decision
Document reference	file/record ID	Yes	Log owner	On filing to the TMF/ISF
Next continuing review due	date	Yes, for CR-type rows	Log owner	Calculated on approval, not later
Notes	text	No	Log owner	As needed

Rules

Every row that grants an approval or favourable opinion carries forward a “next continuing review due” date, calculated at the point of approval, never left blank to be worked out later.
Continuing review is submitted with enough lead time before the due date, <<FILL: e.g. 60 days>>, that a normal review cycle completes before the current approval expires.
No enrolment, consent, or protocol-required procedure continues under an approval that has lapsed. If a due date passes without a documented renewed favourable opinion, escalate the same day and pause the affected activities per <<FILL: SOP for protocol deviation / non-compliance>>.
An approval is checked against the exact protocol and ICF version it names before that version is used; a superseded version being treated as still-approved is a finding, not a technicality.
A protocol amendment is implemented only after IRB/IEC approval, except where implementing it immediately is necessary to eliminate an immediate hazard to subjects; that circumstance itself gets logged here and reported per <<FILL: SOP for protocol deviation>>, never just noted informally.
The log itself is reviewed at a defined cadence, <<FILL: e.g. monthly>>, by someone other than the person who files the submissions, specifically scanning the “next continuing review due” column for anything inside the lead-time window.

Common findings this log catches

Continuing review approval expired and nobody submitted a renewal, so the study ran for a period with no valid IRB/IEC oversight.
An amendment was implemented at sites before the IRB/IEC’s favourable opinion was received or documented.
The version named in the current approval letter does not match the version actually in use at the site.
A safety report was sent to the regulator on time but never separately submitted to the IRB/IEC, or was submitted late.
The IRB/IEC’s decision letter documents “approved with modifications,” but the log (and the TMF) shows no record that the modifications were made or resubmitted.

Filled specimen

Illustrative, values invented. Study ABC-301, a 12-site oncology trial governed by a central IRB.

Submission ID	Type	Item submitted	Date submitted	Meeting / review date	Decision	Approval date	Document reference	Next CR due	Notes
SUB-001	IP	Protocol v1.0, ICF v1.0	2025-11-03	2025-11-18	Approved	2025-11-20	IRB-APP-001	2026-11-20	Initial approval, all 12 sites
SUB-002	AM	Protocol v1.1 (dose-adjustment criteria), ICF v1.1	2026-02-10	2026-02-24	Approved with modifications	2026-03-02	IRB-APP-002	2026-11-20	Modification: added a washout-period clarification before resubmission; confirmed incorporated in v1.1 filed
SUB-003	SR	Aggregate SUSAR summary, grade 4 neutropenia cluster (3 events)	2026-06-15	2026-06-29	Acknowledged, no action required	2026-06-30	IRB-APP-003	2026-11-20	Sponsor safety review also opened, see pharmacovigilance file PV-2026-014
SUB-004	CR	Continuing review package (enrollment, safety, deviation summary)	2026-09-22	2026-10-06	Approved	2026-10-08	IRB-APP-004	2027-10-08	Submitted 59 days ahead of the 2026-11-20 expiry, inside the 60-day lead-time rule
SUB-005	DV	Protocol deviation, Site 07, dosing visit conducted 4 days outside window	2026-09-30	N/A (report-only)	Received, no IRB action required	N/A	IRB-APP-005	2027-10-08	Logged here and on the protocol-deviation log; classified minor per deviation SOP

Reading it: SUB-004 shows the continuing review submitted 59 days before the original 2026-11-20 expiry and approved on 2026-10-08, well inside the window, so the study never operated on a lapsed approval. Had SUB-004 not appeared until, say, 2026-11-10, the monthly log review would have caught it inside the escalation window and forced an expedited submission rather than letting the 2026-11-20 date pass unwatched, which is the exact failure this log is built to prevent.

How to adapt this log

Set your header fields and confirm which IRB/IEC (or IRBs/IECs, for a multi-board study) this log tracks; run one log per governing board if a study uses more than one.
Replace the submission-type legend with the categories your IRB/IEC actually uses on its own forms, so the two systems speak the same language.
Set the lead-time rule in Rules to match your IRB/IEC’s typical cycle time plus a margin, not the bare minimum.
Point the escalation and deviation cross-references at your real SOPs.
Confirm the continuing-review interval (E6 calls for at least annual review, scaled to risk) against what your IRB/IEC and applicable regional rule actually require before relying on a 12-month default.

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