Domain 1-Question Responses 8 10 11.doc

SHEPheRD IDIQ – Domain 1: HAI Research Implementation

Responses to Vendor Questions

1. Will offerors who are selected to participate in the SHEPheRD Program IDIQ have the opportunity to compete for future RFTOPs?

Yes. CDC plans to issue multiple additional RFTOPs through the SHEPheRD Program IDIQ over the course of the five year program. Responses to the RFTOP and sample RFTOPs included with this solicitation for domain 1 of the program will be used to identify offerors who have the capacity to implement HAI prevention research either through networks of healthcare facilities or through access to data from large populations of insured patients. Those offered participation in the contract will be eligible to compete for future RFTOPs issued under domain 1 over the course of the five year contract. Those who are not selected to participate will be ineligible to compete for future RFTOPs issued under this contract. Offerors having limited experience with performing research on a contractual basis are encouraged to seek assistance from their organization’s contract office in developing their proposals.

2. We are interested in applying for this RFP however, I do not see an application. Do I need to add our institution to the "interested vendors" list in order to get an application?

All interested vendors must apply via response to the RFP. Please refer to the instructions for submitting a response in section L of the RFP.

3. Will offerors be allowed to participate in study development (e.g. have input into study design and analysis plans) and participate in authorship of publications that result from the work?

We anticipate that many task order proposals made available through this IDIQ will allow for full scientific participation by the vendor. For example, the RFTOPs accompanying this RFP entitled “Cohort study of patients at risk for C.difficile infection” and “Environmental Interventions to Prevent Healthcare Associated Infections” state that “the vendor may participate in manuscript preparation and authorship as appropriate if desired.” In many cases, it may be necessary to make changes to study protocols based on input from the vendor. It is anticipated that in many cases it may be appropriate for the vendor to provide lead authorship on manuscripts that result from the work performed.

4. Does the sample RFTOP response require both a technical and business proposal? If yes, what are the page limits for each?

Yes please refer to section L of the RFP. To submit a complete response for this IDIQ contract you will need to submit a technical proposal that includes a response to 1 of the 3 RFTOPs and a business proposal. The page limit for each is as follows:

1. Technical proposal: (excluding the RFTOP subvolume) must not exceed 50 single-spaced pages

2. RFTOP: 25 single- spaced pages

3. Business proposal: Please refer to section L. 10 Business Proposal Instructions of the RFP . There is no page limit

5. Section LN5(page 50) of the solicitation states 15 pages as the page limit for the sample task orders yet the first page on each sample RFTOP indicates 25 pages. Which one is correct?

The page limit for the sample task orders is 25 pages.

6. Is it required that we respond to all the three sample RFTOPs?

No. As described in section L, offerors must respond to at least one RFTOP. The Government will utilize the Sample Request for Task Order Proposals (RFTOP) as a means of evaluating the business capabilities factor as it reveals the offeror’s understanding of the requirement, innovativeness in approach to accomplishing the task, identification of risks and management philosophy. Sample Request for Task Order Proposals will be evaluated in accordance with the criteria as described in the individual task order. Offerors may respond to more than one RFTOP if desired, but responding to only one will meet requirements.

7. Page 49 of 56 section L9(C) last line states: “The offeror shall provide a detailed plan of their approach to respond to the workload, including the ability to respond to RFTOs within XX day response time”. What will the response time be?

A completed response to this RFP will include a technical proposal with a response to 1 or more of the 3 RFTOPs and a business proposal. The completed RFP response is due at 11:59 pm August 22, 2011.

8. Is it required that we provide Letters of Support from each participating hospital in responding to this solicitation?

While not required, letters of participation from each hospital would enhance the offeror’s ability to demonstrate that they are capable of performing the task as described. The purpose of the sample RFTOPs is to give offeror an opportunity to demonstrate the capacity to perform the required tasks. Providing letters of participation from participating hospitals helps demonstrate that the offeror’s capacity to recruit and organize multiple healthcare institutions for participation in multi-center HAI prevention studies. Therefore, whether or not letters of support for participation in HAI prevention research are included in the application will be considered in evaluating the proposal.

9. The subject RFP refers to 4 Domain Areas for IDIQ task awards, yet only specifies requirements and qualifications for Domain 1. Will there be additional RFPs for the other three domains? Alternatively, will there be an amendment describing the capabilities and requirements for the other three domains?

Yes, we plan to issue a new solicitation in FY 2012 that will request proposal for domains 2-4. There will not be an amendment to the current solicitation describing the capabilities and requirements for the other three domains. A separate solicitation will be issued in FY 2012.

10. When we submit our proposal, we will be submitting 4 separate excel budgets, one for each of the 3 RFTP's, and then one overall budget including all 3 of these, but with a base year and 4 options? Is this correct?

This is a 5-year contract with no option years. You should include a budget for each RFTOP and the base.

11. With regard to the sample RFTOP entitled “Environmental Interventions to Prevent Healthcare Associated Infections”, is the intended offeror a chain of hospitals?

While the offeror is not required to be a “chain” of hospitals, CDC is seeking offerors who can perform multicenter HAI prevention research in the most efficient manner possible. Competitive vendors should demonstrate access to research populations through multicenter networks healthcare facilities that they own, operate, or with whom they otherwise share existing relationships, and that have a common information technology infrastructure that is currently being used to extract clinical and administrative data in a standardized format common to the facilities in the network, and that can submit such data to a central location for storage and analysis.

12. As a registered “interested vendor” for the above program, we were notified about the recently published task orders. In this format and in the task order announcements, we were unable to find information about anticipated award amounts for each task order? Or suggested budget for each task order?

The current opportunity is funded through a contract mechanism. Unlike competition for grants, contract offerors are not provided budgets in advance. In preparing a proposal for a contract, the offeror is required to demonstrate the ability to perform the work. In reviewing the proposal, CDC will evaluate the proposed approach, staffing and budgeting. Refer to the contracts specialist within your organization to help with this process.

13. For the domain 1 application, the document SHEPERDSOLICITATION.DOC really doesn't have any instructions in it relative to domain 1 or how the contract proposal should be written. Section J is blank. In short, I think something is missing from that document. Is this a different contract application from the contracts related to a) novel cleaning agent cluster trial b) C. diff cohort study i.e. is it 25 pages in response to domain 1, 25 pages in response to the novel cleaning agent cluster trial etc...

Section J is only the list of RFTOPs, which are attachments to the RFP in the solicitation (i.e, RFTOP JX, JY, JZ). A completed response to this RFP will include a technical proposal with a response to 1 or more of the 3 RFTOPs and a business proposal. The page limit is 25 and respective for each RFTOP you intend to respond to.

14. Relative to document rftop.jz i.e. the cluster randomized trial for novel cleaning agent, the document and instructions are clearer. My questions are: a) What is the budget for this contract? b) Is the contract open for application for anyone or is it targeted for a particular person/group? How does this fit into the overall SHEPERD solicitation?

Refer to section B – Supplies Or Services And Prices/Costs, B.4 Minimum Guarantee and B.5 Maximum contract amount for information on contract minimum and max amounts. A specific budget for the RFTOPs should be proposed by the vendor and included in the RFP response. Domain 1 is a full and open competitive requirement, however those who will be considered competitive are vendors who can perform the requirements of this domain. Refer to section C.4 Specific Contact Requirements. Responses to the RFTOP and sample RFTOPs included with this l solicitation for domain 1 of the program will be used to identify offerors who have the capacity to implement HAI prevention research either through networks of healthcare facilities or through access to data from large populations of insured patients.

15. I have a broad question. Are contractors being asked to submit novel research projects or are they to submit to the RFTOP's?

As described in section L, offerors must respond to at least one RFTOP. The Government will utilize the Sample Request for Task Order Proposals (RFTOP) as a means of evaluating the business capabilities factor as it reveals the offeror’s understanding of the requirement, innovativeness in approach to accomplishing the task, identification of risks and management philosophy. Sample Request for Task Order Proposals will be evaluated in accordance with the criteria as described in the individual task order. Offerors may respond to more than one RFTOP if desired, but responding to only one will meet requirements

16. Are the RFPs for the other 3 domains are coming out this fiscal year?

No, we plan to issue a new solicitation in FY 2012 that will request proposal for domains 2-4. There will not be an amendment to the current solicitation describing the capabilities and requirements for the other three domains. A separate solicitation will be issued in FY 2012

17. If one submits as a prime on this RFP, can one go in as a subcontractor on the other domains and vice versa?

Yes. Refer to FAR Clause 52.244-5. Please be advised that as a general rule: No privity of contract exists between the government and any subcontractor.

18. What is meant by the term network? Can one have access to large numbers of facilities even if they are not all part of a common network? Must all participants share a common IT infrastructure for all task order projects or will this need vary by project? The offeror is not required to have access only to facilities that are all part of a common network or that have common IT infrastructure. CDC is seeking offerors who can perform multicenter HAI prevention research in the most efficient manner possible. CDC believes that multicenter HAI prevention projects can be done with great efficiency when working with vendors that do have access to research populations through multicenter networks healthcare facilities that they own, operate, or with whom they otherwise share existing relationships, and that have a common information technology infrastructure that is currently being used to extract clinical and administrative data in a standardized format common to the facilities in the network, and that can submit such data to a central location for storage and analysis. However, CDC will consider proposals from other vendors who have access to networks that do not have these characteristics.

19. On Pages 50-51 under Sample Task Orders, the RFP includes a format for the Technical Proposal. Can the government please clarify if this format should be used as the outline for the entire Technical Proposal or only for the Sample Task Order sub-volume?

Yes the format outlined in section L should be used to prepare the technical response portion of the RFP. The RFTOP should be prepared based on the specific SOW and technical evaluation criteria.

20. Should the offeror follow the Technical Evaluation Criteria listed in each RFTOP to establish the proposal format for the Sample Task Orders listed under L.9.5, page 50? If not, is there another preferred format?

Yes please refer to section L.10 Business Proposal Instructions of the RFP. To submit a complete response for this IDIQ contract you will need to submit a technical proposal that includes a response to 1 of the 3 RFTOPs and a business proposal. The page limit for each is as follows:

4. Technical proposal: (excluding the RFTOP subvolume) must not exceed 50 single-spaced pages

5. RFTOP: 25 single- spaced pages

6. Business proposal: Please refer to section L. 10 Business Proposal Instructions of the RFP . There is no page limit

21. Can the government please clarify what is to be addressed in the Sample Task Order bullet point on page 51 of the RFP under #3 - Special Topics?

Special Topics is #3 of the Submit the Technical Proposal Format. This section simply provides an outline of the sections required in the technical proposal of the in the following format: Format for the technical

22. In section L.9.5, page 50 of the RFP, the government states that responses shall not exceed 15 pages for each Sample Task Order proposal. However, in Part 1, item 6 of the Request for Task Order Proposals, the government states that the contractor shall limit the proposal to 25 pages. Can the government please clarify the page count for the Task Order Proposals?

Yes please refer to section L. 10 Business Proposal Instructions of the RFP. To submit a complete response for this IDIQ contract you will need to submit a technical proposal that includes a response to 1 of the 3 RFTOPs and a business proposal. The page limit for each is as follows:

1. Technical proposal: (excluding the RFTOP subvolume) must not exceed 50 single-spaced pages

2. RFTOP: 25 single- spaced pages

3. Business proposal: Please refer to section L. 10 Business Proposal Instructions of the RFP . There is no page limit

23. Can the government please clarify which role(s) are considered as key personnel for this program? Contractor personnel that the contractor deems necessary for the performance of the contract.

24. Can the government please clarify the number of past performance contracts requested in Section L.11? Three (3) contracts. Relevant information to past performance is the offeror determination The government will update Section L.11. Look for amended solicitation by close of business Friday, August 12, 2011.

25. Can the government please specify the desired location for the L.11 past performance information for the proposal (business, technical, or a separate proposal)? Please attach to the business volume.

26. For the current contracts requested in section L.11, can the contactor assume that the government is only interested in those contracts that are relevant to this procurement? Is there a maximum number of current contracts the government would like included in the proposal? Three (3) contracts. Relevant information to past performance is the offeror determination The government will update Section L.11. Look for amended solicitation by close of business Friday, August 12, 2011.

27. I am writing to ask you a question about the recently published request for task order proposals 2011-N-113526 RFTOP JZ. Regarding the novel and comparator cleaning agents, is it possible to find out more about them? We would be particularly interested in knowing the method(s) of product delivery as we think this may have a substantial impact on facilities' willingness and ability to participate if it will require retraining of housekeeping personnel. Specifically, (1) will the products come in a concentrated form or are they provided in ready-to-use concentrations and (2) what method(s) of delivery will be available (e.g., liquid for spray, pre-saturated disposible cloths, etc.). See responses to questions 1 and 2 above. The purpose of the sample RFTOP is to determine the capacity to perform this type of research. For the purposes of preparing the proposal, the offeror can make their own assumptions about the theoretical cleaning agent to be studied with regard to concentrations and forms of delivery. In reviewing the proposal, CDC will take these assumptions into consideration.

28. For the TOP: Harnessing Electronic Health Records to Enhance Reporting to the Vaccine Adverse Events Reporting System (VAERS), what support or resources will CDC/FDA be able to provide to ensure successful receipt of messaging?

It is not clear what is meant with this question. If it is meant how CDC/FDA will ensure the study sites have submitted VAERS reports then the response is that to ensure VAERS reports before and after implementation of the software system come from the study sites designated to be part of the study, CDC/FDA will analyze data on the reporter who submitted the VAERS form.

29. Key personnel - please clarify - is this just one person? Contractor personnel that the contractor deems necessary for the performance of this contract.

30. Is a 'principal investigator' required for SHEPheRD? Contractor personnel that the contractor deems necessary for the performance of this contract. What are the leadership requirements? In additional to collaborating with CDC staff, it is also expected that key personnel will provide oversight of the work, budget and staffing.

31. Is it acceptable for task-order leads to be somebody other than the PI for the overall contract?

Each offeror should designate appropriate staff to perform the outlined scope of work.

32. How many SHEPheRD contracts will be awarded?

It is anticipated that 2-5 vendors will be awarded under each domain.

33. Submission - does CDC only want a paper copy of the proposal?Yes, paper copies only. No electronic copies? Electronic copies will NOT be accepted

34. Section K - is this needed for subcontractors?

Refer to FAR Clause 52.244-5. Please be advised that as a general rule: No privity of contract exists between the government and any subcontractor.

35. Forms for submission - is a PHS 398 face page acceptable?

The PHS 398 is for the grant application process. The SHEPheRD Program IDIQ is a contract and requires a response to the posted RFP. Please refer to section L of the RFP. To submit a complete response for this IDIQ contract you will need to submit a technical proposal that includes a response to 1 of the 3 RFTOPs and a business proposal.

36. Please clarify page limit for the overall response and the sample task orders? On page 49 of the RFP, its states the response shall not exceed 50 pages, excluding the TO subvolume). On page 50 of the RFP, it states responses shall not exceed 15 pages for each sample TO. In Harnessing Electronic Health Records to Enhance Reporting to the Vaccine Adverse Events Reporting System (VAERS) TO, section 1 #6, it states the response may be up to 25 pages.

To submit a complete response for this IDIQ contract you will need to submit a technical proposal that includes a response to 1 of the 3 RFTOPs and a business proposal. The page limit for each is as follows:

1. Technical proposal: (excluding the RFTOP subvolume) must not exceed 50 single-spaced pages

2. RFTOP: 25 single- spaced pages

3. Business proposal: Please refer to section L. 10 Business Proposal Instructions of the RFP There is no page limit

37. Is there a page limit for the business proposal?

Please refer to section L. 10 Business Proposal Instructions of the RFP. There is no page limit for the business proposal

38. Is there a format/ template for the person loading chart? No Please clarify what this is.

It’s a chart listing for each proposed labor position, the number of man-hours for accomplishment of the task order.

39. Please provide instructions for conducting the required subcontractor price analysis. How should that be documented? Is it actually required? Refer to FAR Clause 52.244-5. Please be advised that as a general rule: No privity of contract exists between the government and any subcontractor.

40. For past performance, please clarify what is meant by b9. type of personal? That is type of personnel used on past performance contracts Can categories be provided? No, these are categories in your past performance contracts Also, what if past performance evaluations are not provided by the contract funders, and therefore not available? Please adhere to L.11 Past Performance Information. An amended solicitation will be posted by close of business Friday, August 12, 2011, to update Section L.11. Past Performance Information. Are they necessary? Yes

41. What is the expected period of performance? 60 months beginning when?

60 months from the time of award. It is anticipated that awards will be made by September 30, 2011.

42. May we propose alternate timelines in the task order responses?

Yes timelines can be adjusted as appropriate within the specified period of performance.

43. Does the Master Task Order need a separate cost schedule outside of the Sample Task Orders or should those costs be included in the three Sample Task Orders costs schedules?

There is no master task order. A business proposal should be included with each Sample Task Order response.

44. Will there be a ‘Frequently Asked Questions’ section to the solicitation website?

There is no FAQ. However, responses to questions received during the inquiry period as noted in section L.5 will be posted to FBO.

45. Will additional RFP’s be forthcoming for the other 3 domains cited in this RFP?

Yes, we plan to issue a new solicitation in FY 2012 that will request proposal for domains 2-4. There will not be an amendment to the current solicitation describing the capabilities and requirements for the other three domains. A separate solicitation will be issued in FY 2012.

46. Should offerors cite capabilities in the domains other than domain one in response to this RFP?

Offerors may provide information on other capabilities that may be complementary to performing the work under domain 1.

47. RFP requires that the contractor have an internal IRB process? Does the prime contractor need to have its own in-house IRB or can the process use contract IRB’s and/or the IRB of one or more sub-contractors?

Competitive offerors should have their own in-house IRB process.

48. Does the government intend to award the sample tasks as a result of this submission?

Responses to the sample task orders will be an important part of the evaluation process. However, sample task orders may also be awarded as funding is available.

49. The instructions do not specify the number of past performances that the government would like to see included in the submission. At least three (3).

50. The RFP references the needs to provide data from large populations of insured patients and to have access to large networks of healthcare facilities. Can the government provide quantitative information or more specific guidance on how large populations and large networks are defined. As stated in the sample request for task order proposal, for those providing data from populations of insured patients, offerors that cover at least 900,000 lives or more are preferred. For offerors providing access to large networks of facilities, 20 acute care hospitals, long term care facilities, or ambulatory settings are preferred; respondents who have larger systems may be more competitive. Nonetheless, smaller networks in this range may be attractive because of their other unique attributes. For example, a networks that include a more complete spectrum of care settings, specialized care settings, or highly sophisticated information systems may be very competitive despite somewhat fewer facilities.

51. We are interested in applying for this RFP but have no experience in completing these applications. There are 3 projects listed. Are we to select one of the projects and submit a proposal specifying how we would do just one of these? Or do we need to submit separate proposals for conducting all three of these.

Please refer to section L of the RFP. A completed response to this RFP will include a technical proposal with a response to 1 or more of the 3 RFTOPs and a business proposal. If possible, you should refer to the contracts specialist within your organization.

52. The technical evaluation criteria within sample Task Order c indicates that letters of commitment from hospitals are required for full points. Is this correct given that this is only a sample task order, without a specified cleaning agent?

While not required, letters of participation from each hospital would enhance the offeror’s ability to demonstrate that they are capable of performing the task as described. The purpose of the sample RFTOPs is to give offeror an opportunity to demonstrate the capacity to perform the required tasks. Providing letters of participation from participating hospitals helps demonstrate that the offeror’s capacity to recruit and organize multiple healthcare institutions for participation in multi-center HAI prevention studies. Therefore, whether or not letters of support for participation in HAI prevention research are included in the application will be considered in evaluating the proposal.

53. Can you tell me if this IDIQ contract 2011-N-13526 is a multiple award or single award? Also is there an incumbent or not?

Yes this is a multiple award contract and there is no incumbent.

54. Please clarify if CDC is interested in respondents proposals including multiple partners in order to cover as many clinical and data sources as possible to be able to respond to task orders.

CDC is seeking to contract with the best qualified offerors perform the work under domain 1. Offerors may have broad infrastructures to support this work.

55. Regarding Past Performance, how many contracts completed during the past three years should be submitted? At least three (3) Are subcontractors required to submit past performance? Refer to FAR Clause 52.244-5. Please be advised that as a general rule: No privity of contract exists between the government and any subcontractor.

56. The page “suggestion” on the individual RFTPs indicates a limit of 25 pages, while p. 50 of the main document indicates each should be limited to 15 pages. Which is correct?

To submit a complete response for this IDIQ contract you will need to submit a technical proposal that includes a response to 1 of the 3 RFTOPs and a business proposal. The page limit for each is as follows:

1. Technical proposal: (excluding the RFTOP subvolume) must not exceed 50 single-spaced pages

2. RFTOP: 25 single- spaced pages

3. Business proposal: There is no page limit

57. Under Price proposal format: “The budget shall be included as an appendix.” Are you expecting one volume for each TO with a pricing appendix or 2 volumes for each TO? One volume fro each TO.

58. What is the advantage to bidding on one, two, or three task orders?

The advantage to bidding on one or more task orders is a business decision to be determined by your organization. Offerors should existing capacity to perform the work for one or more task orders.

59. Will the sample tasks be awarded or are they strictly for evaluation purposes?

Responses to the sample task orders will be an important part of the evaluation process. Sample task orders may also be awarded as funding is available.

60. Who developed the prototype and pilot tested the system for reporting VAER through EHR?

The prototype system was supported in part by the Vaccine Safety Datalink Project of the Centers for Disease Control and Prevention. More information about this prototype can be found at: Hinrichsen VL, Kruskal B, O’Brien MO, et al. Using Electronic Medical Records to Enhance Detection and Reporting of Vaccine Adverse Events. J Am Med Inform Assoc. 2007;14:731–735.

61. Can CDC provide the intervention protocol? Absent the protocol, realistic pricing is not possible. The purpose of the sample task order is to allow the offeror to demonstrate their capacity to perform multicenter HAI prevention research, using the general example of an environmental intervention. CDC understands that precise pricing estimates are not possible without viewing a final protocol. We realize that several assumptions must be made in developing the cost estimates and this could result in significant variation cost estimates across offerors. However, the offerors proposal will be evaluated primarily on their demonstrated capacity to perform multicenter HAI prevention research, based upon the suggested approach to addressing this particular research question. Offerors are encouraged to make clear in their proposal what assumptions they make that could impact the pricing of the work. In reviewing the proposal, CDC will take these assumptions into consideration.

62. For sample Task Order c, Environmental Intervention to Prevention HAIs, does the government have a specific agent in mind that they can identify? No. The purpose of the sample task order is to allow the offeror to demonstrate their capacity to perform multicenter HAI prevention research, using the general example of an environmental intervention. The offeror should assume that the specific agent has the same cost and method of application as the agents currently being used in the facilities participating in the study.

63. I am writing to ask you a question about the recently published request for task order proposals 2011-N-113526 RFTOP JZ. Regarding the novel and comparator cleaning agents, is it possible to find out more about them? We would be particularly interested in knowing the method(s) of product delivery as we think this may have a substantial impact on facilities' willingness and ability to participate if it will require retraining of housekeeping personnel. Specifically, (1) will the products come in a concentrated form or are they provided in ready-to-use concentrations and (2) what method(s) of delivery will be available (e.g., liquid for spray, pre-saturated disposible cloths, etc.). See responses to questions 61 and 62 above. The purpose of the sample RFTOP is to determine the capacity to perform this type of research. For the purposes of preparing the proposal, the offeror can make their own assumptions about the theoretical cleaning agent to be studied with regard to concentrations and forms of delivery. In reviewing the proposal, CDC will take these assumptions into consideration.

64. The SOW states “At the time of award, offerors will be provided with a detailed protocol for a descriptive epidemiologic study which will follow patient cohorts over time longitudinally to determine the background rate of CDI as well as seek to identify any particular factors or trends related to CDI.” Even if the study is premised entirely on existing data files, the details of the study protocol are essential for developing cost proposals. Will the government provide details or bench marks for design purposes? If not, what assumptions should offerors make for purposes of developing credible cost estimates?

The purpose of the sample task order is to allow the offeror to demonstrate their capacity to perform epidemiologic research relevant to HAI prevention research on existing data files , using the general example given in the sample proposal. CDC understands that precise pricing estimates are not possible without viewing a final protocol. We realize that several assumptions must be made in developing the cost estimates and this could result in significant variation cost estimates across offerors. However, the offerors proposal will be evaluated primarily on their demonstrated capacity to perform multicenter HAI prevention research, based upon the suggested approach to addressing this particular research question. Offerors are encouraged to make clear in their proposal what assumptions they make that could impact the pricing of the work. In reviewing the proposal, CDC will take these assumptions into consideration.

65. Task 5 indicates that the contractor “should include plans for a formal mechanism to conduct the proposed intervention.” No intervention is specified or described in the SOW, and offerors are not requested to propose an intervention. Please clarify the intent of this element of Task 5.

The intent of this element is for the respondent to demonstrate, using the example given in the sample RFTOP, their capacity to plan and execute implementation of a multicenter intervention or comparative effectiveness study. This might include steps such as assuring protection of human subjects, training and key aspects of implementation, and overall quality assessment of the implementation.