Please list all IMP(s) including placebo and supplier details: Please list all known non-IMPs (Non-Investigational Medicinal Products, such as rescue medication, background treatment): Does the IMP have a Marketing Authorisation in UK or EEA: If yes please provide the Marketing Authorisation number: Is the IMP used within its licensed indication/dose/route of administration? If the IMP is used outside the terms of its MA, you might need to write a simplified IMP Dossier (IMPD). If the IMP does not have a MA, you will need to provide the and Full IMPD. Investigator’s Brochure Trial and Data Management The JRCO advises early engagement with the InForm team for a timeline delivery of the project. To discuss project requirements and costs contact Amanda Bravery, Will the study use InForm Other if yes please specify PLEASE NOTE: It is a sponsorship requirement for all CTIMPs that the InForm database is used and hence you must ensure costs are taken into account. Who will manage/coordinate the trial if not the CI/PI : Please note that the involvement of any of the parties below will have a cost element associate to it CRF ICTU CCTS Other if yes specify Have you identified a personnel/systems to undertake randomisation/unmasking (during working hours & out of hours)? (applicable to controlled trials) Will you be transferring data/samples outside AHSC? If this is the case please ensure the PIS/consent form reflects any transfer of data/samples outside the AHSC/EEA. Monitoring arrangements: Please note that the JRCO can make arrangements to monitor the sites under the AHSC umbrella. The CI/PI will need to make further arrangements for sites external to AHSC and should consider costs, for instance with the use of an external monitor. Are any of these Committees in place for the trial: Trial Management Group (TMG) Independent Data Monitoring Committee (IDMC) Trial Steering Committee (TSC) Conflict of Interest Will the IMP (s) be provided free of charge by a company specifically for use in this trial? If yes please state company name Are you (CI) being paid directly by the company to participate in the trial?
Please list all IMP(s) including placebo and supplier details: Please list all known non-IMPs (Non-Investigational Medicinal Products, such as rescue medication, background treatment): Does the IMP have a Marketing Authorisation in UK or EEA: If yes please provide the Marketing Authorisation number: Is the IMP used within its licensed indication/dose/route of administration? If the IMP is used outside the terms of its MA, you might need to write a simplified IMP Dossier (IMPD). If the IMP does not have a MA, you will need to provide the Investigator’s Brochure and Full IMPD. Trial and Data Management The JRCO advises early engagement with the InForm team for a timeline delivery of the project. To discuss project requirements and costs contact Amanda Bravery, Will the study use InForm Other if yes please specify PLEASE NOTE: It is a sponsorship requirement for all CTIMPs that the InForm database is used and hence you must ensure costs are taken into account. Who will manage/coordinate the trial if not the CI/PI : Please note that the involvement of any of the parties below will have a cost element associate to it CRF ICTU CCTS Other if yes specify Have you identified a personnel/systems to undertake randomisation/unmasking (during working hours & out of hours)? (applicable to controlled trials) Will you be transferring data/samples outside AHSC? If this is the case please ensure the PIS/consent form reflects any transfer of data/samples outside the AHSC/EEA. Monitoring arrangements: Please note that the JRCO can make arrangements to monitor the sites under the AHSC umbrella. The CI/PI will need to make further arrangements for sites external to AHSC and should consider costs, for instance with the use of an external monitor. Are any of these Committees in place for the trial: Trial Management Group (TMG) Independent Data Monitoring Committee (IDMC) Trial Steering Committee (TSC) Conflict of Interest Will the IMP (s) be provided free of charge by a company specifically for use in this trial? If yes please state company name Are you (CI) being paid directly by the company to participate in the trial?