Get Involved

Expression of Interest

The RAMPART team are keen to explore opportunities to get new sites involved in the study. Any investigators interested in opening a new RAMPART site should contact the RAMPART team in the first instance to discuss these plans.

New sites will be provided with a copy of the RAMPART Protocol and asked to complete and return a Site Evaluation Form, which requires the local team to provide key information on the following areas to allow the RAMPART team to accurately assess feasibility:

Key contacts

Patient population

PI experience with trial IMPs 

Pharmacy experience

Provision of CT scans 

Translational research capacity

On receipt of a completed Site Evaluation Form, the RAMPART team will assess the site for feasibility and a decision on whether to proceed with opening the study will be communicated to the investigator and main contact by email. Once the RAMPART team and site have confirmed participation, the site setup process will begin.

Site Setup

The site setup process for RAMPART can be thought of as 3 separate streams of work, all of which must be completed before a site can open to recruitment. 

Local Approval

All RAMPART sites must obtain local approval from their R&D department or equivalent to ensure that the facilities and resources required to run the study are available. The RAMPART team will provide a Local Information Pack containing all of the documents required to support this approval process. The Local Information Pack will be distributed by email to all members of staff recorded on the Site Evaluation Form. If any further information or documentation is required, please contact the RAMPART team in the first instance.

Key Initiation Documents

The RAMPART team will provide an Investigator Site File (ISF) containing hard copies of all of the documents required to run the RAMPART study. The files contain several template documents which require input from the site. The following documents must be completed and returned to the RAMPART team before opening to recruitment:

Signed Agreement

Signed Principal Investigator’s Statement

Principal Investigator’s Curriculum Vitae and GCP certificate

Site Delegation Log with Principal Investigator’s authorisation of each entry

Site Personnel List

Participant Information Sheet, Consent Form and GP Letter on local headed paper

Normal lab ranges

Lab accreditation certificates

Investigator Site File Assessment Form

 In addition to the ISF, each site will be provided with a Pharmacy Site File (PSF) which contains all of the documents relevant to the pharmacy team. The only pharmacy specific documents that need to be completed and returned are as follows:

Pharmacy Delegation Log (if completed separately from the research team)

Pharmacy Declaration
Investigator Site File Assessment Form
Site Initiation Assessment

All RAMPART sites will be required to attend a Site Initiation Assessment (SIA) teleconference, which provides site staff with trial specific training on all aspects of the trial conduct. All members of the local research team are welcome to attend, but we expect at a minimum the principal investigator, lead research nurse/trial coordinator and lead pharmacist to be on the call. Following the completion of the SIA, all attending staff should update the Training Log to document the training process and send a copy to the RAMPART team.