CLINICAL TRIALS NETWORK FOR FEMALE PELVIC FLOOR DISORDERS:  ADDENDUM TO 
RFA-HD-00-013

Release Date:  September 21, 2000

NOTICE:  HD-00-009

National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov)

On August 25, 2000, an Information Forum was held to address questions from 
potential applicants to RFA-HD-00-013, Clinical Trials Network for Female 
Pelvic Floor Disorders 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-00-013.html).  
This Notice presents a clarification of several issues raised 
at the Information Forum.  A complete summary of questions and answers 
addressed at the Forum can be found at 
http://www.nichd.nih.gov/RFA/HD-00-013/HD-00-013.htm.  
Potential applicants are encouraged to contact staff 
listed below with any additional questions.

CONCEPT PROTOCOLS FOR DATA COORDINATING CENTER APPLICATION

Applications for the Data Coordinating Center must include a concept 
protocol.  As stated in the RFA, the purpose of the concept protocol is to 
serve as an indicator of the applicant's ability to participate in the 
development and design of protocols for cooperative clinical investigation.  
In addition to the concept protocol, applications for the Data Coordinating 
Center should include description of a plan for data collection from the 
Clinical Sites, data management, quality control, processing, analysis, and 
reporting.  The concept protocol and the overall data management plan should 
be provided in the Research Plan portion of the PHS 398 application and are, 
together, subject to the 25 page limit.  Applicants for the Data Coordinating 
Center should judge how much space to allocate to the concept protocol as 
well as the Network-wide plan for handling data, providing as much detail as 
page limits permit.  

FORMAT OF BUDGET

Specific budget instructions for Clinical Sites and the Data Coordinating 
Center are included in the RFA.  As noted in the RFA, since the project 
proposed in the application may not be adopted by the Network, the 
application budget should be viewed as a reasonable estimate for the purpose 
of review.  Budget requests should be estimated as accurately as possible.

Do not use the modular grant application format for the budget.  Applications 
that use the modular format will be judged non-responsive to the RFA and will 
be returned to the applicant without review.

For the purposes of estimating the budget in applications for Clinical Sites, 
assume that your proposed study will be carried out by the Network and that 
your site will be responsible for enrolling a proportion of subjects in that 
protocol.  Based on anticipated enrollment from the pool of eligible subjects 
at your institution, estimate costs of performing that portion of the 
protocol at your site.

For the purposes of estimating the budget in applications for the Data 
Coordinating Center, assume that three new protocols for randomized clinical 
trials will be initiated during the second phase of the study (the second six 
months of Year 01, and Years 02-05).  Assume that the three studies plan to 
enroll 200 subjects in each study, with the collection of 1000 data points on 
each subject in each study.

For applications for the Data Coordinating Center, the travel budget also 
should include travel for the number of personnel needed to carry out 
training of the Clinical Sites’ study coordinators and data entry clerks.  
Assume centralized training for one to two days to be held in the Washington, 
DC area annually during Years 01-05.

INQUIRIES

Inquiries concerning this RFA are encouraged.  The opportunity to clarify any 
issues or questions from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Anne M. Weber, M.D., M.S.
Center for Population Research
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8B13C, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6972
FAX:  (301) 480-1972
E-mail:  webera@mail.nih.gov 

Direct inquiries regarding fiscal matters to:

Mr. Michael Loewe
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17J, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-7008
FAX:  (301) 402-0915
E-mail:  loewem@exchange.nih.gov 


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