NCI Response to Questions.pdf

CIRB: Response to Solicitation Questions From Industry NCI Response

Question Number

Solicitation Reference Question

NCI Response

1 The information in the documents stated there were 16 registries with more than one site; and then also that there was an expectation of 25 studies (with a possibility of an increase in subsequent years).

How many PI/site would you like to include per registry study – or an average number i.e.

one study will have 10 sites/PIs?

The 16 registries are the SEER Program contractors which represent a subset of all state central cancer registries. A study investigator wishing to identify cancer outcomes will generally seek to link their study data with data from multiple registries, and these linkages represent the multi-site part of the study. Of the six multi-site studies which have gone through the VPR pilot to date, each of them has sought, based on study objectives, to link with all VPR participating registries as these studies are national in nature. This, however, is not meant to be a predictor of all future studies which come through the VPR system.

2 Would you be able to provide the average duration of your registry studies [i.e. 5 years / 10 years etc.] so we can have an idea on how long the IRB Review/Approval will last? Our IRB requires Continuing Reviews (annually) of all active studies even if minimal risk (Expedited Review projects) to ensure study compliance and ample oversight.

As stated above, these are not considered ‘registry’ studies but rather studies initiated by an investigator seeking to link with data collected by state central cancer registries to meet a study objective. The VPR does not eliminate the requirement for an investigator to obtain institutional IRB approval. Once institutional IRB approval is granted, then the investigator would submit their protocol and application to the VPR which would then utilize the CIRB in place of local IRB review (where the local IRB delegates such authority to the CIRB). If continuing review is required of this study at the local IRB level, then the CIRB, when delegated that authority, would conduct the continuing review. If the institutional IRB requires continuing review, that would occur outside the VPR process but if it results in modifications to the study protocol or early termination of the study, that would be reflected within the VPR workflow including CIRB review. All of the six studies that are part of the VPR pilot are long-term studies (longer than 10 years) but again, this is not a predictor of the duration for future VPR studies. As this contract is a base year plus two option years, offerors should provide budget estimates for that period of performance.

While it may be true of the institutional IRB review, which the investigator must secure prior to submitting their study and application to the VPR which triggers the CIRB review (in lieu of local IRB), the revised Common Rule does NOT require that minimal risk studies which have gone through expedited review have an annual continuing review. Therefore, the offeror should clarify why continuing review would be necessary for these reviews conducted by the CIRB. Further, the offeror should provide a cost estimate which does not include continuing review effort.

3 Do any of the studies require translated documents/informed consents?

a) If so, what documents typically require translation?

b) Will the PI/sites provide a certified translation? Or will the [contractor] utilize their translation vendor?

For any informed consents required on a study, those informed consents are addressed by the institutional IRB prior to the study seeking linking with state central cancer registries through the VPR. As a result, it is not expected that any documents will come to the VPR requiring translation nor would an offeror, at this time, be expected to provide translation services.

4 On average, does each study have one informed consent only or multiple informed consents (ICs)?

Please see the prior response #3 for how we anticipate informed consents to be addressed. While informed consent forms do get uploaded into the VPR system to enable registries (and local IRBs) to see the informed consent forms, it is not expected that the CIRB would need to provide a review of the informed consent forms for any feedback.

5 Historically, do these projects have on average one protocol/one informed consent revision per year?

a. If not, approx. how many modifications occur after initial review – and what type of modifications?

Please refer to the prior responses on informed consent forms. If a protocol is modified, regardless of it resulting in a modified informed consent, it would first go for re-review by the institutional IRB. The CIRB would then re-review the modified protocol but as the informed consent is not a part of the initial CIRB review, a modified informed consent would also not be a part of a protocol’s re-review by the CIRB. We anticipate that the modified informed consent could be submitted to the CIRB for information purposes. As the VPR is in pilot stage, we do not have the historical data to provide an average number of protocol/IC revisions over the duration of the participating studies.

6 Is each PI/site invoiced individually or is there a main NCI invoice contact for project management?

The NCI anticipates that the awardee of this contract, serving as the CIRB, will submit a single monthly invoice to the NCI inclusive of labor performed under SOW 4.1 to “Develop, Implement, Maintain CIRB Review Processes” and fixed costs for each “CIRB Review” conducted under SOW 4.2.

The NCI is establishing the CIRB as a service to the cancer surveillance research community, individual investigators/sites should not be invoiced.

7 SOW 4.1,

#4 Training

We typically do not charge our clients for normal business operations/ correspondence for project management. However, I see in the Scope of Work Section 4.1 / # 4 Training.

Are these training sessions typically less than an hour? Or usually >2 hours in total?

As part of the onboarding efforts of the CIRB to negotiate the delegation of local IRB to the CIRB, discussion around handling local context issues, or other related CIRB policies and procedures, we expect that the CIRB will set up teleconferences/WebEx to cover these topics. As educational needs of local IRBs, researchers and registries are identified, additional trainings may need to occur. The amount of time required for the training sessions is dependent on the content. However, we anticipate that training sessions will be recorded and replayed to avoid additional training sessions on the same topics. It is also anticipated that each training session would average one hour in duration.

SOW ,

Attachment

Per Attachment 1, Statement of Work: NCI anticipates 25 studies in the first year. Can you please provide an estimate (based on the past year of data or experience) an approximate number of individual performance sites anticipated to be participating on each of the studies? For instance, on average each study typically involves X number of collaborating institutions.

Please refer to the earlier responses #1 and #2. Of the six studies currently in the VPR pilot, each study sought to link with all VPR participating registries. This, however, is not an indicator of the number of registries with which future VPR studies would seek to link.

9 SOW ,

Attachment

In Attachment 1, Statement of Work: NCI states the contractor will, “Work with the COR, the DCCPS IT contractor and NAACCR as needed to understand the VPR-CLS workflow and any associated tools (ex. Match*Pro database) used in the VPR-CLS process.”

a. Can you please clarify the expected tasks or effort requested by Contractor related to the VPR-CLS process?

b. Is it anticipated that this task is primarily related to Contractor’s use of the system?

Study investigators seeking to receive CIRB approval through the VPR will submit their application and supporting documents into the VPR-CLS through electronic upload which would then trigger an automated notification to the CIRB. The CIRB shall assess the application and supporting documents for completeness as well as applicability for expedited review against the revised Common Rule criteria. If the criteria are met, the CIRB would conduct its review and provide its adjudication and supporting correspondence into the VPR-CLS. The CIRB shall be responsible for notifying those local IRBs which have delegated authority regarding the adjudication of an application. The CIRB shall utilize their local review and tracking systems for the purposes of managing study applications and supporting documents. As the VPR scales up from pilot project to production, the CIRB shall provide feedback on modifications to the VPR workflow that may enhance the CIRB review, adjudication, and notification regarding studies submitted to the CIRB.

10 SOW ,

Attachment

Per Attachment 1, Statement of Work: NCI requests the Contractor “promote or otherwise post information regarding minimal risk registry linkage study activity on the CIRB’s organizational web site.”

a. Can you please clarify the scope of this request?

b. Is NCI requesting maintenance of a separate website, or is the intention for this task solely around joint publicity statements?

The Government anticipates that the CIRB shall provide a link or button to the VPR-CLS website on the CIRB homepage. It is not anticipated that the CIRB will need to generate any content or maintain any additional websites as a part of this requirement.

This task is not based solely on joint publicity.

11 Please advise if NCI prefers to have proposal pricing submitted in the same or separate document as the technical approach.

NCI does not have a preference.

12 Is there a SOLICITATION/CONTRACT/ORDER for this RFP that needs to be completed?

A Standard Form 18 (SF-18) has been added to beta.SAM.gov. Please complete and return with the quote. Additional Instructions:

1. Lines 101, 201, and 301 should state the total estimated hours and estimated amount for Statement of Work Task 4.1 for each period. The “unit price” on the form will need to be provided for the formula only. The Government understands that actual Labor Rates may vary by Labor Category pursuant to 52.216-31 “Time-and-Materials/Labor-Hour Proposal Requirements- Commercial Item Acquisition”.

2. Lines 103, 203, and 303 provide pricing information for “Optional Quantities”. For the purposes of the SF-18 please state the unit price of an additional CIRB Review conducted under Statement of Work Task 4.2. In the quote, if possible, please provide any assumptions or limitations on the quantity of additional reviews the NCI may order in each period.

13 The provision at FAR 52.204–24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment, and the clause at FAR 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment is revised for all awards effective on or after August 13, 2020. Accordingly, Attachment 4 “FAR 52.204-24 Representation.pdf” has been replaced in its entirety. Please submit the revised representation with the quote.