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Study Agent Administration NCI CRF Standards:  Round 3

An agent is a distinct substance or ingredient (as defined by FDA's prEN ISO/CD 11238) or compound/product/mixture thereof, contained in drugs, biologics, foods, and devices that act to produce a specific effect (commonly health related). This can include radiopharmaceutical, nutritional, complimentary and alternative medicine (CAM), molecular components of devices (that is, silicon in implants) and nano-technologic agents but does not include whole devices, or procedures (that is, surgeries). Individual agents included in a treatment regimen or therapy (that is, Taxotere, Adriamycin and Cytoxan) are included in this definition, however, whole regimen names or other broad classification of therapies (that is, "CHOP", "chemotherapy", etc), are not.

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Study Agent Administration NCI CRF Standards created on October 19th, 2018

Study Agent Administration NCI CRF Standards created on June 21st, 2016

Study Agent Administration NCI CRF Standards created on September 5th, 2014


Changes made from September 5th, 2014 to October 19th, 2018

ModuleCDECDE Public IDChange
Study Agent AdministrationFrequency2003322

Added PV - every month for 3 months

Study Agent Administration

Frequency

Therapy Type

Units of Measure

2003322

64208

3028750

CDE 2003322 - Added additional value

  1. q6wk

CDE 64208 - Added additional values

  1. Radiopharmaceutical Therapy
  2. Systemic Therapy
  3. Targeted Therapy
  4. Vitamin

CDE 3028750 - Added additional values

  1. 10^6 {TCID50}
  2. 10^7 {TCID50}
  3. 10^8 {TCID50}

Status

status diagram showing pilot status

Metrics

CRF Stars: Working Group Membership

* Represents Working Group Leads

No.

First Name

Last Name

Affiliation

1

Bill

Hess

FDA

2

Chris

Barkley

St. Jude

3

Wendy

Bergantz

RTOG

4

Amy

Biggi

Westat

5

Yancey

Bodenstein

NCI NCCAM

6

Dan

Boring

NCI DCP

7

Linda

Bressler

CALGB

8

Larry

Callahan

FDA

9

Stephen

Dorian

RTOG

10

Nancy

Emenaker

NCI DCP

11

Rhonda

Facile

CDISC

12

Lara

Fournier (L)

OHSU

13

Deb

Grant

RTOG

14

Pamela

Harvey

RTOG-ACRIN

15

Beth

Hasenauer

COG

16

David

Hillman

Mayo - NCCTG

17

Rebecca

Hills

University of Washington

18

Rodney

Howells

NCI CTEP

19

Lisa

Krueger

NIH

20

Angela

Kuras

Gynecologic Oncology Group (GOG)

21

Betty

Lee

SAIC 

22

Eric

Lickerman

Daedalus Software

23

Brenda

Maeske

SAIC 

24

Bev

Meadows

NCI DCP

25

Riki

Ohira

Booz Allen Hamilton

26

Betty

O'Meara

RTOG

27

Susan

Pannoni

City of Hope

28

Diane

Paul

Patient Advocate

29

John

Postiglione

CALGB

30

Vikram

Purohit

Booz Allen Hamilton

31

George

Redmond

NCI CTEP

32

Dianne

Reeves

NCI CBIIT

33

Anne

Ryan

NCI DCP

34

Harold

Seifried

NCI DCP

35

Azita

Sharif

Daedalus Software

36

Frank

Switzer

FDA

37

Tina

Taylor

ACRIN

38

Anne

Tompkins (L)

NCI DCP

39

Joseph

Uhimov

NCI CBIIT - TerpSys

40

Teresa

Watkins

FDA

41

Larry

Wright

NCI CBIIT

42

Dan

Xi

NCI OCCAM

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