Table 2 Summary of key site-activation steps for new comparisons
Activation steps | Participating centres | Trial team to consider |
|---|---|---|
Acceptance of substantial amendment | NHS Trust R&D to review and approve amendment; this may include: • R&D approval/Letter of no objections • signed confirmation from Principle investigator, Research Nurse, Pharmacy | • National requirements for NHS Management approval • CTU SOPs on Site Activation • Requirement for mNCA variation |
Site training | Attendance to trial training may be required by: • Site Principle Investigator • Clinical Research team (research nurse, local coordinators, data managers) • Pharmacist | • Site-specific requirements based on level of participation (Patient Identification Centres, Randomising centre, follow-up only) • Development of comparison specific training material • Risk-based consideration for training documentation (self-declared, certificates) • Type of training (in person, teleconference) |
Localise patient-related documents | Comparison specific PIS, CF and GP letters to be localised by each site | • Risk-adapted approach for verification of localised material (site confirmation of documents on headed paper vs emailing copies of documents on local headed paper for verification by trial team) |
Update local investigator, pharmacy site file and site manuals | Sites to confirm (by signing and returning trial-specific confirmation to CTU trial team): • site file updated • updated trial manuals read and understood | • Updated indexes for files sent to sites to include comparison specific documents • trial manuals (i.e. Sample Handling and pharmacy manuals) to be updated and circulated before site activation |