Amendment.pdf

Solicitation Number: HHS-NIH-NIDA-SSSA-CSS-17-001 Site and Study Monitoring for Scale-Up Hubs Agency: Department of Health and Human Services Office: National Institutes of Health Location: National Institute on Drug Abuse

The purpose of this amendment is to

1) Provide answers to questions submitted; and

2) Extend the proposal submission deadline to 5:00 PM EST, February 3, 2017.

ANSWERS TO REQUEST FOR CLARIFICATION

1. Is this a new requirement?

Yes

2. Would you consider extending the proposal submission deadline, given the lost work day associated with the January 20th inaugural events?

The deadline is being extended to 5:00 PM EST February 3, 2017.

3. Have site assessment visits (to determine readiness for clinical trials operations) already taken place at the sites chosen to do the studies?

An initial evaluation of study sites was conducted during the initial grant review. The SIV will include a review of the site’s readiness to initiate recruitment including the review of the required study specific operations.

4. Is there a page limitation for the technical proposal, not including the appendices?

The technical proposal should not exceed 20 pages.

5. Have the study protocols been fully developed for each of the research hubs?

The protocol development phase is staggered across the hubs with some hubs having completed the protocol development phase while other hubs will initiate this phase in the next several months.

6. Will the participating sites be required to use the same templates to report the results of study site monitoring?

Monitoring visit templates are developed by the contractor and the visit reports are completed by the contractor following each site visit. The response to any action items raised in the monitoring report is provided to the contractor and the NIMH by the study team. We recommend the use of a common template both for the monitoring report as well as the response to the report.

Solicitation Number: HHS-NIH-NIDA-SSSA-CSS-17-001 Site and Study Monitoring for Scale-Up Hubs Agency: Department of Health and Human Services Office: National Institutes of Health Location: National Institute on Drug Abuse

7. Appendix C notes that during the Base Period, there is “initial team training.” Please clarify if there is to be a separate visit for training, or if training is to be done during site assessment before the site initiation visit.

The initial team training refers to the training of the monitoring staff. Study monitors will need to be trained in the regulations related to federally funded studies as well as the specific characteristics of mental health research studies including the monitoring behaviorally based intervention and adverse events.

8. The number of visits to be conducted per site is noted differently in sections of the RFP. Several sections of the RFP outline the average number of site visits per contract year and over the total contracting period (base plus all options). Please verify our assumptions as outlined below:

a. Confirm that each individual site will require an initiation, interim and closeout visits, and may, in addition, require an ad hoc/specialty visit.

Correct

b. Confirm that overall the average number of visits should be 10 – 15 per year

(average 12), as sites may initiate at different time points during contract performance.

Correct