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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 NCI CRF Standards created on August 15th, 2012

Changes made from August 15th, 2012 to September 5th, 2014

ModuleCDECDE Public IDChange
Adverse Event and Serious Adverse Event CTCAE v3Adverse Event Stop Date2189843

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 v4Adverse Event Stop Date2189843

Changed from version 2.0 to 3.0

CDE 2189843 v1.0 was replaced with 4396436 v1.0

 

Status

      status diagram showing pilot 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

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