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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