This section of the OCCAM website is designed to assist applicants throughout the application process. Please contact program staff in the area in which in your interested for further assistance: http://cancer.gov/research_funding/scientific_programs/

FOR NEW APPLICANTS:

The following resources are available to researchers interested in applying for grants:

• Application for a Public Health Service Grant (PHS 398)

  • Update of the PHS 398 Instructions and Forms (01/10/02)

• Countway Library of Medicine: Grants, Writing, and Publishing Resources

NCI Grant Application and Review Process

This link to NCI’s Cancer.gov page focuses on many resources that are helpful in the grant application process. Information such as basic funding information; forms/instructions; specific grant mechanisms; review process; examples of currently funded research; and NCI Research Resources may be found at this link.
http://cancer.gov/research_funding/grants/

Important Information about Research Policies

This link provides information about NIH human and animal subject protection policies.
http://cancer.gov/research_funding/policies/

Data Safety Monitoring

The applicant must specify plans for monitoring to insure the safety of participants in clinical trials. The type of monitoring depends on the size and complexity of the trial and on the degree of risk to participants.

Phase I and Phase II studies require a Data and Safety Monitoring Plan (DSMP), which may be administered by the investigator, by a project manager, by a member of the NCI program staff, or by an individual designated by the investigator or NCI staff. Or, some combination of these individuals may work together to administer the plan.

A Data and Safety Monitoring Board (DSMB) is required for all Phase III clinical trials. Phase III trials are tests of interventions which, if found to be successful, would likely influence clinical or public health practice.

For more information about the topics to be included in the discussion of data and safety monitoring, see the NCI Data and Safety Monitoring Guidelines: Summary.

Investigational New Drug (IND) Application

Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.

During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.

Please review the FDA website for further information:
http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm

FOR NEW GRANTEES OF NIH FUNDING:

NIH "WELCOME WAGON" LETTER: Information for New Grantee Organizations

Information provided is primarily for officials of organizations planning to submit a grant or cooperative agreement (hereinafter referred to as grant) application or receiving an award from the National Institutes of Health (NIH) for the first time. The intent is to highlight key requirements, provide referrals to important sources of information, and identify NIH, Public Health Service (PHS) and Department of Health and Human Services (HHS) offices that have responsibility for certain administrative functions. Information available through these resources is important to those having responsibility for the administrative and fiscal management of NIH grant awards.
http://grants.nih.gov/grants/funding/welcomewagon.htm

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