Effective October 15, 2013

Duke as a Site Study(DAAS) with DCRI performing as the Coordinating Center

The following outlines the proposed procedures associated with ORA and OSP-specific processing requirementsfor Governmental Contracts whereby DCRI is the contracting party (Coordinating)

Pre- Award Steps--

  1. For Federal sponsored agreements with DCRI, whereby they have multiple site agreements for the conduct of the clinical research activity, with one site being Duke as a Site (DAAS) work, we agree that the Duke CRU performing the site work, may consider this work as a separate clinical research study. The following steps to establish this study would be as follows:
  2. The CRU would work with DCRI to negotiate the site payments
  3. The CRU would submit the budget within the SPS system and reflect the true costs of performing this work, together with the current negotiatedF & A rate for indirects. The costs should represent actual costs of doing the work and should not include any markup in terms of margins.

The CRU study team would input effort for each faculty member on the project with a zero base salary. If there are other faculty/staff with measurable committed effort on the study this amount of effort should also be entered into the salary spreadsheet in SPS with a zero base salary. This is necessary given it is the only way the effort commitment would flow to SES without creating a budget amount in SPS.

  1. The CRU is responsible for requesting a separate and distinct, fund code for this work using a 383X code.The code for the CRU will no longer need to be setup as a sub-award from the parent code of DCRI. Therefore, DCRI is no longer responsible for requesting the code on behalf of the CRU. Also, the site code will not be required to receive a new code each year, although the DCRI parent code will.

**The WBSE Request made by the CRU must state it is a DCRI-Duke as a Site (DAAS) code, so OSP can identify the connection between the codes for their internal reporting.

  1. The DCRI would establish the budget for the overall federal funding agreement and will show all site based payments for all sites as subcontracted amounts, with the exception of the DAAS site payments. The DAAS payments would be reflected in the budget as a separate expense, which will exclude Indirects in the proposal budget.
  1. DCRI would have a separate and distinct fund code for which they request via ORA office,which will change every year if required by the sponsor.
  1. In regards to the above activity, RAD will add a flag in SPS to indicate DAAS and the OSP office will manually track the DAAS code with the DCRI Parent code, based on the information within the SPS record.

Also, once the CRU activity is reviewed and approved in the SPS system, the ORA office will mark the study as an “In-kind Award” to ensure we are not double counting the federal award dollars of the DCRI contract (which includes the DAAS work with the CRU). This process will not be seen by the CRU, but please know the study will be awarded at $0.

Duke as a Site Study(DAAS) with DCRI performing as the Coordinating Center (page 2)

Post Award Steps

  1. In terms of Post-Award processing, the site based payments to the CRU would flow as they do today as a transfer from DCRI to the site using G/L # 800168. The amount of monies would represent the agreed upon site payment for all sites within the federal contract. The Duke as a Site agreement will not bear a separate and distinct payment as a subcontract payment similar to the other sites. Instead the monies for site payments will flow as a transfer and NOT incur IDCR on the transfer of funds. This represents the payment by DCRI of the site payments to the internal duke site.
  1. The other site payments to external sites will flow as they do today as a subcontract payment and bear F & A on the first $25K of current negotiated F & A rate.
  1. TheCRU- DAAS will record actual costs (on the 383 code)incurred to perform the study and by doing so, will generate current negotiated F & A rate on the MTDC of the study.
  1. SOM Finance will monitor the codes setup by the CRU for this transfer activity to ensure these codes are not posting any other revenue activity from another study and the PI is committing appropriate effort. This will be done on a semi-annual basis.
  1. OSP will continue to report on the federal parent project based on the activity on DCRI’s code(s); the transfers/payments for the DAAS activities are included by default in this reported amount even though they are excluded from the F&A base. The activity on the DAAS 383 codes will not be reported on the DCRI parent project, to avoid double-counting of expenses.

Minimum required standards for SPS entries for Duke CRU’s acting as clinical sites on DCRI projects.

SPS Entry Steps:

  1. The SPS record should always list the prime sponsor(NIH etc.) not DCRI
  1. The F & A rate should be consistent with the prime sponsor ( i.e. 57% for government funded studies) and listed within the SPS record.
  1. IRB Protocol for the Duke site should be utilized in the record
  1. Effort should be reflected for each key person working on the site by listing them in the personnel roster in the salary worksheet
  1. All “Investigators” should be flagged so that RIO can review for FCOI. The site PI should always be an investigator for FCOI purposes
  1. A detailed budget is optional to be included within SPS. However the Internal Cost Assessment for the clinical study should be attached to the SPS Record.
  1. The Duke as a Site (DAAS) fund code must be listed in the SPS Proposal Memo in order for the contract to be executed. The CRU- FPM should be the responsible person to submit the request for the Fund code (a 383X code) using the current instructions for requesting a WBSE.
  1. The SPS record must be routed to PCA for the contract to be signed.