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 Q&A About Letter of Intent Part 1

Who should submit the Letter of Intent?

It is understood that a budget for the proposed work should not be submitted at this time. Is that correct?

When will the budget be discussed?

Can you provide a sample size estimate per Study location for this activity?

How long will the enrollment period last? Is there a set length, or will recruitment end when the targeted enrollment number is reached?

Regarding the High Intensity/Low Intensity option: will there be incentives for the Low Intensity group, or only the High Intensity?

 

Who should submit the Letter of Intent?

The Principal Investigator from the Study Center should submit the letter of intent via e-mail to ncs@mail.nih.gov.

 

It is understood that a budget for the proposed work should not be submitted at this time. Is that correct?

Yes.

 

When will the budget be discussed?

After the Program Office receives and reviews the Letters of Intent, those who are selected will be asked to prepare a budget. We estimate that this will occur on or around February 1, 2010.

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Can you provide a sample size estimate per Study location for this activity?

Sample size will be determined empirically based in part on recruitment rates utilizing each strategy. For planning purposes, for each strategy, Centers should assume a sample of 100 newborns per location. The factors to consider are number of pregnant women enrolled and percent of pregnant women likely to enroll a child in the Study. Women who are contacted at preconception and enroll when pregnant are of great interest, but women at any stage of pregnancy can be enrolled in the pilot.

 

How long will the enrollment period last? Is there a set length, or will recruitment end when the targeted enrollment number is reached?

The enrollment period will end when either the enrollment rate of pregnant women per week is stable for about 8 to 10 weeks or a target enrollment number to be empirically determined by ongoing data analysis is reached. The dates below represent current best estimates of key milestones.


Recruitment Strategy Initiation of Startup Activities Initiation of Participant Recruitment Completion of Pilot Data Collection

Provider-based

March 2010

June 2010

December 2010–March 2011

Enhanced Household

July 2010

October 2010

April 2011–July 2011

High Intensity/Low Intensity

November 2010

February 2011

August 2011–November 2011

 

Regarding the High Intensity/Low Intensity option: will there be incentives for the Low Intensity group, or only the High Intensity?

Offerors are encouraged to address this issue in their letter of intent proposing strategies that they believe to be effective and cost efficient.

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  1/7/2010
  1/7/2010