New Clinical Trial Request

New Clinical Trial Request

During the novation period, we are using this form to receive requests for new clinical trial studies. The research leadership will be reviewing and prioritizing the new requests based on risk until the new and updated agreements between the newly integrated entities and affiliate partners, Sentara and CKHD, are in place, allowing all studies to move forward more routinely.

Study Name*

CRO Name, if applicable

CRO POC (name, email, telephone)

Sponsor Name

Sponsor POC (name, email, telephone#)

Upload the MS Word Version of the clinical trial agreement (CTA).*

Drag and drop files here or

Protocol Number (if available)*

PI Name*

PI Email Address*

Names of study team members*

Number of Expected Patient Enrollment*

Timing of Enrollment*

FDA Oversight*

Select

Study Budget*

On-site CHKD or Sentara Facilities Required*

Select

FDA Device Risk Determination (if applicable)

Select

Requires Research Foundation Employee Hire(s)*

Select

If not directed by the sponsor, provide the name of the outside IRB.*

Will the study use the VHS Medical Campus IRB or ODU Main Campus IRB directed by the sponsor?*

Select

Are fees included in the sponsor budget?*

Select

Requestor Additional Comments

Send me a copy of my responses

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