Site Qualification Visits and Site Initiation Visits

Site Qualification Visit Checklist

The purpose of a Site Qualification Visit (SQV) is to assess whether it is feasible for a site to run a study from the sponsor perspective. You will still need an internal feasibility assessment to discuss the study in much more detail, in particular recruitment strategies and targets. 

Consider making a video tour of your facilities since this reduces staff burden and provides an overview of site. It also showcases your research department and can be used during the EOI process. 

Logistics

• Book a room and establish if in person or virtual.

• Be prepared to give a tour of your facility including relevant departments e.g. pharmacy.

• Ensure you have display screen equipment for SQV slides. If your organisation does not allow encrypted or external devices, request that the slides are sent in advance.

• Ensure that your PI is available for some, if not all of the visit. 

• Invite appropriate people from support departments e.g. pharmacy or radiology,  or consider if they will have a separate meeting with the sponsor.

• Make sure you can accommodate the number of attendees, internally and from the sponsor and/or the CRO and allow for additional guests. 

Preparation needed

• Ensure your department is clean and tidy and be aware of confidentiality with departmental documents.

• Review material provided e.g. protocol synopsis, training slides and compile questions, and ensure that the team know the potential time resource required to deliver the study. 

• Check you have equipment required e.g. fridge, freezer, centrifuge, and space resource. If not, make a list of what is required.

• Collate any information about previous sponsor audits or site inspection outcomes.

During the meeting

• Ensure by the end of the meeting you know the answers to the following:

  1.  What is the status of the study?

  2.  What are the study timelines?

  3.  What is the expected target?

  4.  What is the recruitment period?

  5.  Number of UK sites?

  6.  Is the protocol finalised? Can amendments be suggested by PI and site staff?

  7.  If the study is already open what have the challenges been?

  8.  What is the screen failure rate?

  9.  Is recruitment competitive? If so, then see if they will disclose how well the study is recruiting at other sites. 

• Identify any equipment that the sponsor will need to provide or fund and who will order them. Ensure this is discussed and clear at an early stage. Do not wait until SIV when the contract will likely have been finalised.

• Review recruitment strategy.

  1.  Will they allow PIC sites?

  2.  What support do you need from the sponsor e.g. what advertising materials are provided? Is there the opportunity to suggest alterations?

• Ask when the sponsor will inform the site if they have been selected or not.

After the meeting

• Follow up with any actions.

• Be prepared to provide documentation such as GCP certificates, CV’s, calibration certificates, FDF and a contact list of staff.

• If you are not selected as a site, remember to ask for feedback.

Site Initiation Visit checklist

The sponsor run the SIV, however the lead site staff can utilise this opportunity to ask any remaining queries regarding the protocol and identify any outstanding requirements.

Logistics

• Book a room and establish if in person or virtual.

• Ensure you have display screen equipment for SIV slides. If your organisation does not allow encrypted or external devices, request that the slides are sent in advance.

• Invite all staff who will be working on the study. If they are not available they can review the slides after the event. Best practice would be to book SIV when all key site staff are available. The PI may only be needed for part of the meeting.

• Ensure that the PI is available for some, if not all of the visit.

• Invite appropriate people from support departments e.g. pharmacy or radiology and consider if they will have a separate meeting with the sponsor.

• Make sure you can accommodate the number of attendees internally and from the sponsor/CRO. Be prepared for additional external staff to attend.

• Some SIVs can last the full working day. Ensure you are clear on how long the meeting is meant to be and ensure you are aware of lunch arrangements i.e. is the sponsor providing or funding.

Preparation needed

• Prepare any questions you have about the study beforehand.

• Review whether everything is in place for starting the study - IMP,  lab kits, system accesses, all documents including site files, equipment e.g. ECG, medical devices. This may not be the case for some studies with expedited set up.

• Ensure you know the protocol.

• Ensure someone is in attendance that knows the contract, in case any activities are discussed that are not included in the contract.

During the meeting

• Complete the SIV attendance log or send a list of attendees to the CRA.

• Circulate the delegation log if not already completed.

• Raise any queries about missing equipment, documents etc.

• Review inclusion and exclusion criteria.

• Source document review  - Agree what documents are source and what electronic systems the monitors will need access to.

• Ensure that the relevant team members have access to the safety reporting database.

After the meeting

• Record the SIV training on the finance tracker so it can be invoiced.

• Ensure that all of the documents have been received from the sponsor - ask for a checklist. 

• Put a plan in place for screening the first participant.

• Review the participant recruitment pathway.

• Consider a dummy run especially if numerous support departments are involved.

• Request any amendments to the contract that are identified.

• Make worksheets if not already prepared at this point.

Additional top tip

There are some studies that will come with multiple online platforms that need to be used (one for data collection, one for safety reporting, one for randomising etc). It is therefore always a good idea to check with your sponsor about the number of platforms needed and to ensure these are not blocked by IT firewalls before you start recruiting to the study. As a team, it is helpful to have a centralised sheet with the names of the platforms listed, what they are for and who has access to it. It is also helpful to ensure the PI has access to the platforms they need, and that they have been activated before the study commences.