GCP Checklist for PET Centres

The following section is designed to provide a guide for PET centres involved in clinical trials to help comply with GCP.

Documentation

PET centres should ensure they have copies of all the following documentation before accepting referrals for imaging as part of a clinical trial:

• An up-to-date copy of the trial protocol, patient information sheet and any associated documentation pertaining to PET scanning e.g. imaging manual, data forms etc
• A copy of the ethics approval letter
• A copy of the local Research and Development (R&D) approval letter
• If required, a copy of the Research ARSAC Certificate (see ARSAC FAQs to decide if an ARSAC certificate is required)
• If required, a copy of the Clinical Trial Authorisation from the MHRA (only applies to CTIMPS)
• Details of funding arrangements
• Records of up-to-date GCP training for all delegates responsible for aspects of the trial related to PET and records of any trial related training
• Copies of signed and dated CVs and, if relevant, honorary contracts for staff members from the PET department involved in the clinical trial (staff should only be delegated tasks that they are competent to perform, therefore records of qualifications should be kept in the form of a curriculum vitae)
• A copy of the trial delegation log and training log. The process for patient recruitment, consent, allocation of trial ID and referral should be identified and responsibilities assigned by the CI/PI. This should be recorded in the trial delegation log
• Subject screening and ID log, to be kept up to date throughout the trial

In addition sites should ensure the following standard operating procedures (SOPs) are in place before starting clinical trials. All SOPs should have version control and be maintained in a document management system.

• All items of equipment in the PET centre required for acquisition of PET-CT data must be covered by a documented quality assurance (QA) program. Standard operating procedures (SOPs) should be in place covering all calibrations and quality control (QC) tests on the PET system and associated equipment required for quantitative PET. As a minimum this includes the radionuclide calibrator, blood glucose monitor, patient weighing scales and clocks. Further details on the QC tests can be found in IPEM Report 108. Routine measurements should be recorded in a log including dates and signatures to show when the tests were performed and by whom
• Any pre-trial questionnaires and site accreditation procedures should have been completed and documented
• SOPs should be in place to ensure all aspects of patient preparation, acquisition and reconstruction parameters comply with the clinical trial protocol
• A new scan protocol should be entered on the scanner and if an unusual or complex procedure a run through should be performed with a phantom
• SOPs should be in place to ensure the anonymisation and secure transfer of PET-CT data and dataforms to the trial team are consistent with the clinical trial protocol
• SOPs covering data archiving procedures should be in place to ensure that the source data can be retrieved in its original form and should include how long the data must be stored in line with the clinical trial protocol. The source data includes image data which must be stored in original DICOM format and any paper or electronic forms used to record the PET procedures