Immutable action journal and filterable investigation views. This workspace exists to enforce consistent clinical execution with accountable ownership, governed evidence, and inspection-ready traceability across the study lifecycle. It supports business and regulatory requirements by connecting operations, quality, submissions, and financial controls in a single system where handoffs are explicit and auditable. Users can proceed by filtering scope, reviewing linked artifacts and actions, and routing escalations with defined approval gates and signature meaning.
Audit Log
ID
Timestamp
Actor
Action
Object
AUD-00000001
2025-01-01T00:00:00.000Z
system.local
SIGN
Agent Run:OBJ-0000001
AUD-00000002
2025-02-02T01:01:01.000Z
system.local
APPROVE
TMF Artifact:OBJ-0000002
AUD-00000003
2025-03-03T02:02:02.000Z
reg.local
APPROVE
TMF Artifact:OBJ-0000003
AUD-00000004
2025-04-04T03:03:03.000Z
system.local
SIGN
Inspection Bundle:OBJ-0000004
AUD-00000005
2025-05-05T04:04:04.000Z
reg.local
REVIEW
Agent Run:OBJ-0000005
AUD-00000006
2025-06-06T05:05:05.000Z
system.local
REVIEW
Inspection Bundle:OBJ-0000006
AUD-00000007
2025-07-07T06:06:06.000Z
quality.local
APPROVE
Visit:OBJ-0000007
AUD-00000008
2025-08-08T07:07:07.000Z
quality.local
UPDATE
KRI Alert:OBJ-0000008
AUD-00000009
2025-09-09T08:08:08.000Z
quality.local
SIGN
Agent Run:OBJ-0000009
AUD-00000010
2025-10-10T09:09:09.000Z
system.local
EXPORT
Agent Run:OBJ-0000010
AUD-00000011
2025-11-11T10:10:10.000Z
system.local
EXPORT
CTIS RFI:OBJ-0000011
AUD-00000012
2025-12-12T11:11:11.000Z
ctm.local
REVIEW
Inspection Bundle:OBJ-0000012
AUD-00000013
2025-01-13T12:12:12.000Z
system.local
EXPORT
Inspection Bundle:OBJ-0000013
AUD-00000014
2025-02-14T13:13:13.000Z
system.local
APPROVE
KRI Alert:OBJ-0000014
AUD-00000015
2025-03-15T14:14:14.000Z
quality.local
CREATE
Inspection Bundle:OBJ-0000015
AUD-00000016
2025-04-16T15:15:15.000Z
quality.local
UPDATE
Inspection Bundle:OBJ-0000016
AUD-00000017
2025-05-17T16:16:16.000Z
assistant.local
EXPORT
Inspection Bundle:OBJ-0000017
AUD-00000018
2025-06-18T17:17:17.000Z
system.local
SIGN
Inspection Bundle:OBJ-0000018
AUD-00000019
2025-07-19T18:18:18.000Z
system.local
SIGN
CTIS RFI:OBJ-0000019
AUD-00000020
2025-08-20T19:19:19.000Z
quality.local
REVIEW
Inspection Bundle:OBJ-0000020
AUD-00000021
2025-09-21T20:20:20.000Z
assistant.local
SIGN
TMF Artifact:OBJ-0000021
AUD-00000022
2025-10-22T21:21:21.000Z
reg.local
CREATE
CTIS RFI:OBJ-0000022
AUD-00000023
2025-11-23T22:22:22.000Z
assistant.local
CREATE
TMF Artifact:OBJ-0000023
AUD-00000024
2025-12-24T23:23:23.000Z
ctm.local
UPDATE
Inspection Bundle:OBJ-0000024
AUD-00000025
2025-01-25T00:24:24.000Z
system.local
REVIEW
TMF Artifact:OBJ-0000025
AUD-00000026
2025-02-26T01:25:25.000Z
ctm.local
EXPORT
Agent Run:OBJ-0000026
AUD-00000027
2025-03-27T02:26:26.000Z
assistant.local
EXPORT
Visit:OBJ-0000027
AUD-00000028
2025-04-01T03:27:27.000Z
ctm.local
EXPORT
KRI Alert:OBJ-0000028
AUD-00000029
2025-05-02T04:28:28.000Z
system.local
REVIEW
Agent Run:OBJ-0000029
AUD-00000030
2025-06-03T05:29:29.000Z
system.local
REVIEW
Visit:OBJ-0000030
AUD-00000031
2025-07-04T06:30:30.000Z
reg.local
REVIEW
Inspection Bundle:OBJ-0000031
AUD-00000032
2025-08-05T07:31:31.000Z
quality.local
UPDATE
TMF Artifact:OBJ-0000032
AUD-00000033
2025-09-06T08:32:32.000Z
ctm.local
UPDATE
Agent Run:OBJ-0000033
AUD-00000034
2025-10-07T09:33:33.000Z
reg.local
SIGN
Inspection Bundle:OBJ-0000034
AUD-00000035
2025-11-08T10:34:34.000Z
assistant.local
APPROVE
TMF Artifact:OBJ-0000035
AUD-00000036
2025-12-09T11:35:35.000Z
system.local
SIGN
CTIS RFI:OBJ-0000036
AUD-00000037
2025-01-10T12:36:36.000Z
system.local
UPDATE
Visit:OBJ-0000037
AUD-00000038
2025-02-11T13:37:37.000Z
system.local
CREATE
Agent Run:OBJ-0000038
AUD-00000039
2025-03-12T14:38:38.000Z
ctm.local
UPDATE
Agent Run:OBJ-0000039
AUD-00000040
2025-04-13T15:39:39.000Z
reg.local
CREATE
Agent Run:OBJ-0000040
AUD-00000041
2025-05-14T16:40:40.000Z
reg.local
UPDATE
Agent Run:OBJ-0000041
AUD-00000042
2025-06-15T17:41:41.000Z
system.local
SIGN
Inspection Bundle:OBJ-0000042
AUD-00000043
2025-07-16T18:42:42.000Z
ctm.local
SIGN
Agent Run:OBJ-0000043
AUD-00000044
2025-08-17T19:43:43.000Z
system.local
UPDATE
CTIS RFI:OBJ-0000044
AUD-00000045
2025-09-18T20:44:44.000Z
ctm.local
UPDATE
Inspection Bundle:OBJ-0000045
AUD-00000046
2025-10-19T21:45:45.000Z
system.local
REVIEW
CTIS RFI:OBJ-0000046
AUD-00000047
2025-11-20T22:46:46.000Z
quality.local
UPDATE
Visit:OBJ-0000047
AUD-00000048
2025-12-21T23:47:47.000Z
ctm.local
UPDATE
Visit:OBJ-0000048
AUD-00000049
2025-01-22T00:48:48.000Z
ctm.local
APPROVE
CTIS RFI:OBJ-0000049
AUD-00000050
2025-02-23T01:49:49.000Z
reg.local
EXPORT
TMF Artifact:OBJ-0000050
AUD-00000051
2025-03-24T02:50:50.000Z
reg.local
UPDATE
CTIS RFI:OBJ-0000051
AUD-00000052
2025-04-25T03:51:51.000Z
ctm.local
CREATE
Inspection Bundle:OBJ-0000052
AUD-00000053
2025-05-26T04:52:52.000Z
system.local
REVIEW
KRI Alert:OBJ-0000053
AUD-00000054
2025-06-27T05:53:53.000Z
reg.local
EXPORT
Agent Run:OBJ-0000054
AUD-00000055
2025-07-01T06:54:54.000Z
system.local
SIGN
TMF Artifact:OBJ-0000055
AUD-00000056
2025-08-02T07:55:55.000Z
ctm.local
SIGN
Visit:OBJ-0000056
AUD-00000057
2025-09-03T08:56:56.000Z
quality.local
EXPORT
KRI Alert:OBJ-0000057
AUD-00000058
2025-10-04T09:57:57.000Z
assistant.local
UPDATE
Inspection Bundle:OBJ-0000058
AUD-00000059
2025-11-05T10:58:58.000Z
system.local
CREATE
CTIS RFI:OBJ-0000059
AUD-00000060
2025-12-06T11:59:59.000Z
reg.local
REVIEW
TMF Artifact:OBJ-0000060
Access & Governance Controls
RBAC+ABACStudy Firewall ActiveRestricted Zone
Operational Controls
Study firewalling chips highlight boundary, country constraints, and vendor partition rules.
Actions requiring GxP control include a human review checkpoint and e-signature meaning capture.
Every state change writes immutable audit evidence with actor, timestamp, and object reference.