NIHAO200816responses4.pdf

NIHAO200816 Responses to Questions #4 August 26, 2008

This is the final set of responses to questions. No further responses will be posted.

Question 1:

Will NIAID or the host country investigators develop the research questions for each task order?

Response:

For the purposes of the sample task, please assume NIAID will develop the research questions. Task order requests under the contract will specify whether the research questions are being developed by NIAID or host country investigators for specific requirements.

Question 2:

Please clarify whether NIAID wants the offeror to directly hire in-country investigators, study coordinators, nurses, pharmacists, laboratory technicians, etc., or, if there is a funding arrangement anticipated with the host country research program, will you please specify which staff are supported by that other agreement?

Response:

For the purposes of the sample task, please assume that the offeror is responsible for directly hiring in-country investigators, study coordinators, nurses, pharmacists, laboratory technicians, etc. Task order requests under the contract may involve other arrangements with the host country research program.

Question 3:

Will all task orders be to support research programs in developing countries? Will there be any need to support research programs in the U.S.?

Response:

Support for research programs is not limited to a specific country or developing country. Task orders could be requested for the U.S.

Question 4:

Are offerors expected to be able to provide graduate-level and Ph.D. level training in statistics for site staff?

Response:

No, offerors are not expected to provide graduate-level and Ph.D. level training in statistics for site staff. Offerors are expected hire staff with this level of experience for specified jobs.

Question 5:

Does this contract emphasize building capacity of research programs in developing countries to the point that they can develop and implement research programs completely independently? Or does the contract envision that the contractor will provide some level of on-going support (with study design and analysis, regulatory review, etc.) to research programs?

Response:

The contract intends to establish programs that are essentially complete and can be sustained as much as possible by the host country.

Question 6:

Item 1.3.1.d of the SOW states: "Assist sites in the preparation for clinical monitoring.

Assist sites to establish reliable safety monitoring and reporting plans, in accordance with applicable safety guidelines."

Do these two sentences refer to different activities; i.e., does the first sentence mean that the offeror should assist sites with preparation for clinical site monitoring by an outside third party, such as normally occurs on clinical trials, or does it refer only to helping the site set up internal safety monitoring and reporting procedures?

Response:

The two sentences do refer to two different activities. The first sentence/question does mean that the offeror should assist sites for clinical site monitoring by a third party.

Question 7:

If external site monitoring is needed, is the offeror responsible for performing this, or will another contractor do this?

Response:

The offeror is responsible for external site monitoring if needed.

Question 8:

In the responses to questions, the government has described three studies of 200 patients each. In Appendix C of the RFP, the sample study, on page 6, there is a reference to a study in phase 1 of 120 patients. Is this 120-patient study in addition to the three 200-patient studies?

Response:

Yes, it is in addition to the three 200 patient studies.