New Projects

For new projects with an industry partner, CTU incorporates the fees for Veeva SiteVault Enterprise in the study budget. This allows for remote monitoring of regulatory documents and source data verification from participants.

The fee for using SiteVault can be viewed in the Sponsor fees section of the CTU website.

Interactions via SiteVault can be implemented immediately after document loading and Sponsor access setup. Access can be gained within 48 hours in most cases.

For access to SiteVault, no individual user agreement needs to be signed by the CRA/monitor. The Regulatory Specialist assigned to the project arranges access for CRAs with the SiteVault Administrators at UofL.

Training for the system is done via power point slides. The Regulatory Specialist sends these materials out to the CRA at the time that access is requested. The CRA will receive a welcome email from Veeva when the account is activated. The CRA is able to click on the email link to access the system and create a permanent password.

UofL contracting covers remote source data review within Veeva SiteVault. The sponsor will not need a separate agreement. Consents of subjects will not need to be altered for this to take place.

Projects Open Prior to October 2019

There are no restrictions on remote source data verification implementation once a review has been done to ensure that the contract has language covering the activity and SiteVault is utilized.

The fee for using SiteVault can be viewed in the Sponsor fees section of the CTU website.

For access to SiteVault, no individual user agreement needs to be signed by the CRA/monitor. The Regulatory Specialist assigned to the project arranges access for CRAs with the SiteVault Administrators at UofL.

Training for the system is done via power point slides. The Regulatory Specialist sends these materials out to the CRA at the time that access is requested. The CRA will receive a welcome email from Veeva when the account is activated. The CRA is able to click on the email link to access the system and create a permanent password.

 If the sponsor wishes to use another platform for remote monitoring, the new platform will be subject to Director approval for waiver, IT security review and fee assessment.

Other considerations

Standard Operating Procedure

UofL CTU has an SOP governing remote and on-site monitoring available upon request.

Meeting Platforms

Remote monitoring meetings can be held with site staff in the following UofL approved platforms:

• Microsoft Teams
• BlueJeans

 If another platform is preferred by the sponsor, it must be approved by UofL IT security and include no recording. It must have end to end encryption.

Clinical Facility EMR

We are able to assist sponsors with gaining access to Medical Records for source review at many of our clinical sites. These requests must be routed to the site at least 4 weeks prior to a planned visit to ensure access. If access is not able to be gained within a reasonable time period, the CRC will make other arrangements for review of the records.

Most clinical facilities require an EMR agreement to be signed by the CRA.

Each facility may have different safeguards for the data access. Please check with your CRC for the specific facility in which you will access records.