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Trial Planning Phase R&D Consultation follows the Pharmacovigilance station and occurs in parallel to Protocol Development. The station precedes the Funding Proposal station. R&D Consultation is good practice and is relevant to all trials. This station is …

… Trial Planning Phase The Funding Proposal station follows the … process which is relevant to all trials. This station is part of the 'trial planning phase' group of stations. … … financial investment, and as a result securing funding can be a lengthy process. Major Funders will need to be assured …

… Trial Planning Phase The Peer Review station follows the … practice and is relevant to all trials. This station is part of the 'trial planning phase' group of stations. … Peer review is where a number of 'experts' examine the proposed trial to consider …

Trial Planning Phase The Funding Secured station follows the Peer Review station and precedes the Trial Master File station. This process occurs in parallel with the Trial Registration, Confirm Sponsor, Feasibility & Investigator Selection, and Contracts …

Trial Planning Phase The Trial Master File station follows the Funding Secured station and precedes the Trial Registration station. This process occurs in parallel with Funding Secured, Confirm Sponsor, Feasibility & Investigator Selection, and Contracts …

… Trial Planning Phase The Trial Registration station follows the … Selection, and Contracts & Agreements. The Unique Trial Number is good practice and is relevant to all trials. This station is part of the 'trial planning phase' group of stations. … …

Trial Planning Phase The Confirm Sponsor station follows the Trial Registration station and precedes the Feasibility & Investigator Selection station. This process occurs in parallel with Funding Secured, Trial Master File, Trial Registration, and …

Trial Planning Phase Feasibility & Investigator Selection follows the Confirm Sponsor station and precedes the Contracts & Agreements station. This process occurs in parallel with Funding Secured, Trial Master File, and Trial Registration. Feasibility & …

… Trial Planning Phase Contracts & Agreements follows the … practice and is relevant to all trials. This station is part of the 'trial planning phase' group of stations. … Many parties may be involved in the conduct and management of a clinical …

Trial Planning Phase The Final Protocol station follows the Contracts & Agreements station and precedes the CI Checklist Before Seeking Approval and the IRAS station. This process occurs after the parallel processes of Funding Secured, Trial Master File, …

Trial Planning Phase The following checklist for Chief Investigators has been designed as a means of checking that the necessary documentation required for the permissions and approvals process are in place. This occurs after the Final Protocol and …

… Trial Approvals Phase The IRAS station follows the Final Protocol station and CI Checklist Before Seeking Approval, and precedes the CTA Submission … practice and is relevant to all trials. This station is part of the 'trial approvals phase' group of stations. … The …

Trial Approvals Phase CTA Submission follows the IRAS station and precedes the Ethics Submission station. The process occurs in parallel with Ethics Submission and R&D Submission. CTA Submission is a legal requirement for trials within the Clinical Trial …

… Trial Approvals Phase Ethics Submission follows the CTA … which is relevant to all trials. This station is part of the 'trial approvals phase' group of stations. … … (HRA) facilitates ethical research that is of potential benefit to participants. The Research Ethics Service (RES) …

… Trial Approvals Phase R&D Submission follows the Ethics … which is relevant to all trials. This station is part of the 'trial approvals phase' group of stations. … … guidance on the application process for HRA approval can be found here . In Scotland, the Permissions Coordinating …

Trial Approvals Phase Permissions & Approvals Obtained follows the R&D Submission station and precedes the Final Trial Management Documentation station. Ensuring that permissions and approvals are obtained is a legal requirement which is relevant to all …

Trial Approvals Phase Final Trial Management Documentation follows the Permissions & Approvals Obtained station and precedes either the Trial is Abandoned or Trial Begins stations. The Final Trial Management Documentation is a legal requirement which is …

Trial Approvals Phase The Trial is Abandoned station follows the Final Trial Management Documentation station. Abandoning the trial is a good practice process which can be relevant to all trials. This station is part of the 'trial approvals phase' group …

Trial Recruitment Phase The Trial Begins station follows the Final Trial Management Documentation process. It occurs in the routemap after the Trial is Abandoned station to show that this step is considered before the trial commences. The Trial Begins …

Trial Recruitment Phase Informed Consent follows the Trial Begins station and precedes the Ongoing Management & Monitoring station. Obtaining informed consent is a legal requirement which is relevant to all trials. This station is part of the 'recruitment …

Recruitment Phase Safety Reporting follows the GCP & Serious Breach Reporting Station and precedes the Progress Reporting station. This process occurs in parallel with Progress Reporting , Ongoing Management & Monitoring, and GCP & Serious Breach …

… Recruitment Phase Progress Reporting follows the Safety Reporting station … practice and is relevant to all trials. This station is part of the 'recruitment phase' group of stations. … There is a requirement to send progress reports to a number of interested parties throughout a trial. For example, …

Recruitment Phase Ongoing Management & Monitoring follows the Informed Consent station and precedes the GCP & Serious Breach Reporting station. This process occurs in parallel with Safety Reporting, Progress Reporting, and GCP & Serious Breach Reporting. …

Recruitment Phase The MHRA Inspection station follows the Progress Reporting station and precedes the Audit station. This process occurs in parallel with Safety Reporting, Progress Reporting , Ongoing Management & Monitoring, and GCP & Serious Breach …