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Table 2 Summary of key site-activation steps for new comparisons

From: This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols

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
  1. CF consent form, RN research nurse, PIC Patient Identification Centre, PIS Patient Information Sheet, SOP Standard Operating Procedure, TMT Trial Management Team