Accessibility Information

Users of assistive technologies such as screen readers should use the following link to activate Accessibility Mode before continuing: Learn more and Activate accessibility mode.

Development of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Solicitation Number: N02-PC-85002-29
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Cancer Institute, Office of Acquisitions
  • Print
September 30, 2008
$1,830,006 (Base + Option)
Sloan-Kettering Institute for Cancer Research
1275 York Ave.
New York, New York 10065
United States
Added: Apr 03, 2008 11:44 am


NOTE – this synopsis follows a
Sources Sought notice that was released on December 21, 2007 under RFP

The National Cancer Institute,
Division of Cancer Control and Population Sciences (DCCPS) is planning to award
a contract for a program entitled, 'Development of the Patient-Reported
Outcomes version of the Common Terminology Criteria for Adverse Events
(PRO-CTCAE)'.   The required service is defined as code 541720
under the North American Industry Classification System

The Contractor will work with NCI
program staff and with NCI-sponsored clinical trial networks to develop the
Patient-Reported Outcomes version of symptom elements that are contained within
the Common Terminology Criteria for Adverse Events
(PRO-CTCAE).     The Contractor must be able to support the
development of an electronic-based and psychometrically-robust patient-reported
outcome version of the symptomatic adverse events (AE) to complement the NCI
Common Terminology Criteria for Adverse Events (CTCAE).    

The resulting PRO-CTCAE will: 1) be comprehensive to capture a range of
symptoms and functioning that enhances monitoring of adverse events; 2) have
minimal burden on the patient in terms of survey length and comprehension; 3)
be adaptable for translation into multiple languages to accommodate the
diversity of patients who participate in NCI-sponsored clinical trials; 4)
include both paper and electronic administration; 5) be fully integrated and
complement the revised CTCAE (version 4.0); 6) meet the standards of
compatibility within the CaBIG specifications; and 7) have minimal
administrative burden for health care providers who will collect and interpret
data for reporting adverse events and for informing patient care.    
The contract will also validate the PRO-CTCAE and demonstrate the feasibility
of integrating the system within NCI-sponsored trials.    

It is anticipated that a resulting contract will utilize a phasing approach.

Phase I
Identify Barriers and Ideal Conditions to Develop, Implement, and Validate the
PRO-CTCAE in Cancer Clinical Trials
Develop the PRO-CTCAE assessment system fully integrated with the CTCAE
reporting system

Phase II (Option)
Evaluate the validity, reliability, and feasibility and clinical utility of the
new PRO-CTCAE within the NCI clinical trials network.
Create Training Materials to Support the PRO-CTCAE

The NCI intends to award a cost-reimbursement contract for a one-year base
period of performance on or about 9/30/2008. The contract will also contain the
FAR provisions for the consideration of the optional Phase II
The Government intends to have a full & open competition for this
requirement in the form of a Request for Proposal (RFP).  This synopsis is not an RFP; an RFP is
anticipated for release on or about April 21, 2008 through Federal Business

Questions regarding this requirement must be submitted in writing and directed
to Elizabeth Dean at  The reference number to be used for this
announcement is RFP N02-PC-85002-29.  All
correspondence must cite the reference number as provided.


Added: Sep 29, 2008 12:26 pm
Please consult the list of document viewers if you cannot open a file.

Solicitation 1

Posted Date:
April 25, 2008 (631.71 Kb)
Description: Development of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Amendment 1

Posted Date:
May 21, 2008
amendment1.pdf (13.34 Kb)
Description: Amendment 1

Amendment 2

Posted Date:
May 23, 2008
amendment2.pdf (7.74 Kb)
Description: Amendment 2

Amendment 3

Posted Date:
May 27, 2008
amendment3.pdf (6.46 Kb)
Description: Amendment 3

Amendment 4

Posted Date:
June 13, 2008
amendment4.pdf (8.27 Kb)
Description: Amendment 4
6120 Executive Blvd.
EPS Suite 600
Rockville, Maryland 20852
Elizabeth Dean,
Contract Specialist
Phone: 301-435-3793
Virginia DeSeau,
Contracting Officer
Phone: 301-435-3798