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What if I wish to add extra sites or studies to my project?

Sites: Adding extra sites to a project may be beneficial for various reasons. Additional sites offer the opportunity to increase enrollment and may provide access to specific, desirable populations. Speak with your Program Official (PO) 

Program Official (PO)
staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer 
Project Officer
the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ).
if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Director.
about how additional sites may be added and the appropriate process for doing this.

Studies: An Ancillary Study 

Ancillary Study
additional study independent of the parent grant 
Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH 
National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage.
Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
or contract.
entails the collection from study participants of data and/or specimens, or the conduct of additional analyses of existing materials or samples that are outside the specific scientific objectives of a parent study. Ancillary studies must undergo review with respect to their effect on additional burden on the participants and the need for an additional Consent form 
Consent form
a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects 
Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction 
Interaction
any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46.
or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
research. Also known as Informed Consent.
. Your Program Director 
Program Director
staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Official.
will work with you to evaluate the proposal 
Proposal
a written offer by an individual or non-federal organization to enter into a contract, consisting of a technical and a business proposal which includes a description of the project and its costs, and the methods, personnel, and facilities to carry it out.
prior to submitting an application for an ancillary study.

Ancillary Study investigators should discuss policies concerning ownership of data with the parent study investigators or Steering Committee ( SC 

Steering Committee (SC)
a group, in a Network or multi-center study, composed of the principal investigators, sponsor representatives, the study statistician(s), and others who oversee the design, execution, analysis, and dissemination of results of a study.
)before initiation of an ancillary study. Study management requirements should be negotiated on a case-by-case basis by the parent study Steering Committee and ancillary study investigators. For contract 
Contract
award instrument establishing a binding legal agreement between NIH and an award recipient for products or services. The Office of Acquisition 
Office of Acquisition (OA)
OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH Office of Acquisition Management and Policy)
Management and Policy (OAMP) web site provides additional information
supported studies, the NHLBI 
National Heart, Lung, Blood Institute (NHLBI)
a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage.
Contracting Officer 
Contracting Officer
government employee authorized to execute contractual agreements and to obligate funds on behalf of the Government. Also known as Project Officer.
may need to be included in the negotiations if contract terms or conditions are likely to be affected.

The DSMB 

Data and Safety Monitoring Board (DSMB)
an independent committee that reviews clinical trial progress and safety, and advises the appointing body whether to continue, modify, or terminate a trial. This is sometimes called a Data Monitoring Committee (DMC). (see Data and Safety Monitoring Policy image of word document icon (120 KB))
/ OSMB 
Observational and Safety Monitoring Boards (OSMB)
independent monitoring group whose principal role is to regularly monitor regularly data from large or complex observational studies and to review and assess the performance of its operations. Whether an OSMB is needed is determined on a case-by-case basis by NHLBI.
of the parent study should:

  • Monitor the progress of all ancillary studies.
  • Determine which, if any, ancillary study data should be monitored and how they will be reviewed.
  • Consider adding ad hoc members if monitoring of an ancillary study requires additional expertise beyond that on the Board.


Page Last Updated: February 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov

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