1. 1 ETCTN phase 2 accrual goal vs minimum requirement in UM1 parent grant supplements  Total budget is $7.2M for supplements and maximum direct costs per award set at $560,000 in RFA.  The program intends to release funds based on a minimum requirement per site of 72 patients per year.  However, because the application due date is less than 60 days away, the RFA cannot be amended.  Therefore, the RFA accrual goal of 100 patients annually per site may be a basis of review by the SEP panel.  Because of the wording of the RFA, it would be prudent for applicants to describe plans to achieve the accrual goal of up to 100 patients per year.

2. 2 ETCTN phase 2 program direct costs for UM1 supplements  The $560,000 direct cost cap includes the following:  1 biopsy per patient  Protocol development and implementation expenses  Data monitoring and reporting per patient per trial  Indirect costs of affiliates should be included in the direct costs of the applicant, but these indirect costs do not count toward the direct cost cap. Therefore, applicants can apply for a maximum of $560,000 plus the indirect costs of their affiliates in their total direct budget request.

3. 3 Applying metrics to supplemental awards  Performance evaluation will be based on actual number of accruals as documented in OPEN.  Accrual is recognized to be only a partial component of the overall research contribution of a grantee to the ETCTN phase 2 program; however, it is a critical component to program success and can be easily documented and quantified in real time.  Program flexibility can be applied if a global issue affects all grantees

4. 4 Release of funds in UM1 Phase 2 supplement  30% of awarded funds are not dependent on accrual  At the beginning of year 1, the 30% of awarded funds that is not dependent on accrual will be released.  70% of awarded funds are dependent on accrual  At the beginning of the first year, an additional 35% of awarded funds (half of the funds dependent on accrual) will be released to cover costs for accrual over first six months.  Amount of funds released after first 6 months will depend on performance- e.g. achievement of 100% of previous 6 months minimum requirement (36 patients) will result in release of all of next 6 month funds. Released funds after the first 6 months will be prorated if accrual minimums are not met.

5. 5 Biopsies and biomarker development  An additional $1.8M will be used for biopsies, biomarker development and other high priority projects annually  Up to $1M may be used to support ETCTN supplement awardees for second and later biopsies  Anticipated support: Approximately $2000-$3000 per research biopsy  Other sources of funding may also be used to support biopsy costs