Updated: Jul 2, 2021
This post continues with Investigator responsibilities in GCP 4.2.3:
The Investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely
How can this be demonstrated at a site level and what do CROs/Sponsors expect to see to fulfil this?
Protocol review and feasibility assessment is critical to ensure that an Investigator can assure they have appropriate staff and facilities to conduct a trial. Review fully the protocol and particularly the schedule of assessments - what tests are needed and when? Are all the tests/procedures required able to be performed at site by appropriately qualified staff? Do you need to outsource pathology or radiology if tests are not provided at our own site? If possible, review the lab/radiology/pharmacy manuals and if they are not available at feasibility assessment stage, ask the Sponsor/CRO if any tests or procedures are more than standard of care so you do not over commit before all aspects of the trial have been reviewed. Key questions to consider at site:
1. What pathology test are required and who will perform them? Can they be done in the time frames required?
2. What radiology tests are required and who will perform them? Can they be done in the time frames required? Is there additional reporting needed (ie RECIST?)
3. How will the investigational product be stored and managed and can the pharmacy department support the requirements?
4. Are there any requirements for samples for central labs and how do they need to be taken/prepared/stored? Do you need a -20 or -80 freezer?
5. Do the participants require an overnight stay, weekend stay or additional tests outside of normal hours? If yes, who will manage this?
6. Are there any tests not performed in your own department such as ECG/ECHO that will require support from other departments you do not routinely use?
This is just a sample of some of the questions that should be considered as part of a robust protocol feasibility. A good process to follow is to complete the TransCelerate Site Profile Form. This document asks for a thorough assessment of your site capability and can be provided to Sponsors/ CROs of new trials who can then also assess if your site is able to support the trial under review. This form can be kept up to date and supplied whenever needed, also reducing work at site. This form is available for download in the fileshare area of the Sophie Mepham GCP website or directly from the TransCelerate website.
Finally, consider using a trial management system where all the critical site start up documents can be stored and access given to Sponsor/CRO reps so they can access and download SOPs, CV's, GCP certificates, lab reference ranges etc.