Adverse Events NCI CRF Standards: Round 2
The Adverse Events module was one of the group of variables included in the second round of the CRF Harmonization and Standardization Initiative. The Adverse Events module includes harmonized variables related to adverse events (AE) and serious adverse events (SAE) recommended for collection on all NCI sponsored clinical trials. Two modules are in the final deliverables based on the use of either CTCAE (Common Terminology Criteria for Adverse Events) version 3.0 or CTCAE version 4.0
Downloads
Adverse Event NCI CRF Standards created on June 11, 2018
Adverse Event NCI CRF Standards created on September 5th, 2014
- Adverse Event and Serious Adverse Event CTCAE v3 NCI CRF Standards in Excel
- Adverse Event and Serious Adverse Event CTCAE v4 NCI CRF Standards in Excel
Adverse Event NCI CRF Standards created on August 15th, 2012
- Adverse Event and Serious Adverse Event CTCAE v3 NCI CRF Standards in Excel
- Adverse Event and Serious Adverse Event CTCAE v4 NCI CRF Standards in Excel
Changes made from August 15th, 2012 to September 5th, 2014
| Module | CDE | CDE Public ID | Change |
|---|---|---|---|
| Adverse Event and Serious Adverse Event CTCAE v3 | Adverse Event Stop Date | 2189843 | Changed from version 2.0 to 3.0 CDE 2189843 v1.0 was replaced with 4396436 v1.0 |
| Adverse Event and Serious Adverse Event CTCAE v4 | Adverse Event Stop Date | 2189843 | Changed from version 2.0 to 3.0 CDE 2189843 v1.0 was replaced with 4396436 v1.0 |
Status
Metrics
CRF Stars: Working Group Membership
* Represents working group leads
No. | First Name | Last Name | Affiliation |
|---|---|---|---|
1 | Pankaj | Agarwal | Duke |
2 | Mary | Cooper | SAIC |
3 | Stephen | Dorian | RTOG |
4 | Sharon | Elcombe | Mayo |
5 | Rhonda | Facile | CDISC |
6 | Shanda | Finnigan | NCI CTEP |
7 | Lara | Fournier | OHSU |
8 | David | Hillman | Mayo - NCCTG |
9 | David | Joyce | Private |
10 | Elizabeth | Langevin | Millennium Pharmaceuticals |
11 | Mary | Lenzen | Octagon Research Solutions |
12 | Elsa | Lin | Georgetown |
13 | Kim | Livengood | Wake Forest University |
14 | Adina | Londrc | City of Hope |
15 | Brenda | Maeske | SAIC |
16 | Linda | Messett | ACRIN |
17 | Lily | Meyer | Ohio State University |
18 | Bob | Morrell | Wake Forest University |
19 | Sal | Mungal | Duke |
20 | Jon | Neville | The Critical Path Institute |
21 | Joyce | *Niland | City of Hope |
22 | Riki | Ohira | Booz Allen Hamilton |
23 | Susan | Pannoni | City of Hope |
24 | Tim | Peters | COG |
25 | Holly | Peterson | Forest Laboratories |
26 | Dianne | Reeves | NCI CBIIT |
27 | Aaron | Seib | OmniComm |
28 | Judi | Seldomridge | Fox Chase |
29 | Ann | Setser | NCI CTEP |
30 | Ranjeeta | Sinvhal | Sanofi-Aventis |
31 | Anne | Tompkins | NCI DCP |
32 | Sean | Whitaker | Northwestern Univ |
33 | Heather | Wolff | Millennium Pharmaceuticals |
