NIHAO2008017 Responses Questions2.pdf

Responses to Questions Request for Proposal# NIHAO2008017

1. Question: The VRC has a number of completed and on-going trials. Would the government please clarify what legacy data from completed trials will need to be migrated into the DW by the awardee and the desired schedule to complete these migrations?

Response: The legacy data from about 24 clinical trials would be migrated into the data warehouse. This represents data from about 2700 study enrollments. There would be approximately a 4 month transition period over which this data migration would need to be completed.

2. Question: Regarding the capacity to create and utilize automated scripts that would pick up and upload datasets by a secure file transfer process from the incumbent contractor for on-going trials, what is the time line that the government would like to have this process implemented on and approximately how many of the on-going trials would this mechanism need to be deployed?

Response: This process is used for automatic upload of clinical laboratory data and would need to be deployed within the approximate 4 month transition period from the old to the new contract.

3. Question: Is it the government’s intention to migrate all on-going trials to the new EDC software prior to trial closure? That is to say, how long is the anticipated overlap and what portion of the on-going trials will still be active? Active to follow-up only? Does the government foresee changing over all 9 on-going trials to the new solution or will some of the trials be completing with the incumbent?

Response: The anticipated transition (overlap) period is estimated to be 4 months. The government intends to migrate all legacy and ongoing trial data during this transition.

4. Question: Regarding the loading of non-EDC data, including data from the VRC’s LIMS, is the offeror to assume that this data has been cleansed and is ready for loading to the DW or should cost be included regarding anticipated cleansing efforts?

Response: Data moved into the data warehouse from an external source will be final data, but may need to be converted to a standardized format or sorted by specific criteria for integration into the warehouse. An offeror should anticipate some additional effort to ensure a reliable incorporation of externally generated data into the data warehouse.

5. Question: With regards to the coding of verbatim values, will there be a need for adverse events and concomitant medications coding services from the awardee for any of the existing data captured for legacy trials to be loaded to the data warehouse? Is an assumption that the to-be deployed forms under the proposed solution will enable CRC submitters to encode values appropriate for new trials going forward, or will there be a need to encode in-coming data from new trials as well?

Response: The legacy data are already MedDRA coded and will not need to be recoded when transferred. The contractor will be expected to provide MedDRA coding services for new adverse events under the contract.

6. Question: In addition to setting up automated edit checks, which significantly reduces errors, is the contractor expected to conduct manual data validation tasks (i.e. correct reporting of conmeds doses, correct description of adverse events, etc.) or is this an exclusive responsibility of the Government’s monitoring contractors? CRAs?

Response: The contractor is not expected to send Study Monitors to manually verify data entered into the database. Study Monitors are provided by the IND Sponsor. The awardee will be expected to provide reports and database functions that facilitate the activities of the Study Monitors.

7a. Question: Will the incumbent contractor transfer to the new contractor any existing software asset (e.g. websites, reports, data warehouse software, etc.)?

Response: The clinical trial data and data reports are the property of the government and will be transferred from the incumbent contractor. The currently used database software is proprietary to the current contractor and the current website is hosted by the current contractor. Therefore, the new contractor will be expected to provide a website through which the users will interface with the database and to provide the software on which the database operates.

7b. Question: Will the incumbent contractor transfer to the new contractor the current users, roles, and privileges specification?

Response: The tables of user privileges and roles will be provided to the new contractor.

7c. Question: Will the incumbent contractor transfer to the new contractor the current list of users and their roles?

Response: See response to 7b.

8. Question: In regards to ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR

SERVICES - “The Vaccine Research Center (VRC) of the National Institutes of Health requires the Contractor to facilitate management of the current comprehensive data management plan developed for the VRC Clinical Trials Core…,” may we have a copy of the current comprehensive data management plan?

Response: A comprehensive data management plan includes having a data collection plan appropriate for each protocol, but also encompasses a variety of measures that ensure data quality and security, such as queries for missing values, methods for identifying data discrepancies, measures to ensure system security and integrity, capacity for electronic transfer of datasets, and user training and selective privileging of access to the database.

The offeror’s proposal should present information that addresses the features of the system being offered in which a systematic approach to data management is being utilized. The offeror’s plan for data management should demonstrate current or prior experience in providing similar services for clinical trials data management to other clients.

9. Question: In regards to Section A.1, Pg 4 of the SOW …”Work with the VRC Principal

Investigator, protocol operations manager, study coordinators, study statisticians and other VRC personnel, as needed, and at the direction of the Project Officer, to provide continual monitoring and updates of the data collection plan,” does the VRC currently have a contractor that provides trial monitoring services, and will it be in the scope of this contract to train the monitors on the operation of the selected EDC system?

Response: “Monitoring” as used in the Statement of Work is used in a generic sense with regard to the need for any site conducting a clinical trial to continually pay attention to the quality and timeliness of data being collected as the clinical trial is in progress (i.e., the software used should have built-in features that alert study staff to data discrepancies or delinquencies). The contractor will be expected to train users of the system offered.

10. Question: Please clarify if the file formats, names, key fields, data dictionaries, etc.

mentioned in item III.B.3 of the SOW are related to files to be imported to the warehouse, to the objects of the warehouse itself, or to export files.

Response: This section refers to received, maintained and exported files.

11a. Question: Section C.1 pg 6 of SOW requires that the contractor provide downloadable study-specific data reports that are updated daily and posted on the website through automated processes, and made available for use by authorized users. Is this website an asset of the program that will transfer to the awardee, or is it proprietary to the incumbent and an offeror is requested to propose how their proposed solution will support this function going forward? How will the existing user account information be transferred to the awardee in the event that it is not the incumbent?

Response: The current website is hosted by the incumbent contractor. The clinical trial data and the posted reports are the property of the Government. This information will be transferred to the awardee. The offeror should include information or examples on how the offeror typically makes available clinical trial information to clients who use their web-based clinical trial data management system.

11b. Please clarify if the reports mentioned in item III.C.1 of the SOW will include data from ongoing studies, as well as concluded studies?

Response: Yes, the reports will include data from ongoing studies, as well as concluded studies. The majority of reports from concluded studies will be provided in a format already appropriate for posting and use by the study teams. However, the system offered should have the capacity to use the data from concluded studies to meet new report requests as need arises.