NIAMS POLICY:  REQUEST FOR A PLANNING PHASE IN CLINICAL TRIAL APPLICATIONS

Release Date:  November 8, 2000

NOTICE:  AR-01-002

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Complex or large-scale clinical research requires extensive planning.  A 
clinical trial requires detailed information on the study design, protocols 
and procedures, analytical techniques, identification of facilities, and 
organization of an effective group of investigators with an effective 
administrative plan.  The clinical trial research plan is best presented in an 
organized and detailed Manual of Operations and Procedures (MOOP) that is 
submitted prior to initiation of the clinical trial.  NIAMS is cognizant of 
the time and expense required for preparation of these documents. 

The design and implementation of successful clinical trials can be hampered by 
the lack of refined outcome measures, difficulties with recruitment of 
patients with rare diseases, and lack of information about standardization of 
procedures among participating clinics.  The NIAMS planning period will also 
provide an opportunity to support these activities.

All NIAMS grantees who intend to conduct a clinical trial are encouraged to 
budget a planning phase (up to 9 months) in their application, or be aware 
that NIAMS may restrict/withhold funds and require re-budgeting for pre-
enrollment activities required to help ensure the quality of trial conduct.  
NIAMS will provide appropriate financial support to its grantees during the 
planning period in order to facilitate the development of documents containing 
detailed procedures and approvals for conducting clinical research, including 
the following: 

o Develop a detailed safety and monitoring plan
o Develop a Manual of Operations and Procedures (MOOP), including the clinical 
  protocol, a recruitment plan, case report forms, a data management system, etc.
o Seek IRB approval of consent form(s) and protocol
o Obtain project assurances via the Office of Human Research Protections
o Resolve any IND issues with the FDA  
o Develop a database for study data storage
o Train clinical site staff, develop study management tools 
o Organize an independent data and safety monitoring board (DSMB)

The remaining funds will be released/awarded to the grantee upon approval of 
the procedures and documents listed above.  The designated NIAMS Program 
Director will approve commencement of the clinical trial once all requirements 
have been met.

Inquiries regarding clinical issues should be directed to:

Christine L. Densmore 
Clinical Coordinator, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Disease
45 Center Drive, Rm 5AS-19B
Bethesda, MD 20892-6500
(301) 594-5052 (voice)
(301) 480-4543 (fax)
densmorc@mail.nih.gov

or

Joanne Odenkirchen
Clinical Coordinator, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Disease
45 Center Drive, Rm 5AS-37C
Bethesda, MD 20892-6500
(301) 594-5055 (voice)
(301) 480-4543 (fax)
jo21x@nih.gov

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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