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

Recruitment Phase Addition of New Sites & Investigators station follows the Substantial Amendments station and precedes the Urgent Safety Measures station. This process occurs in parallel with Safety Reporting, Progress Reporting, Ongoing Management & …

Recruitment Phase The Substantial Amendment station follows the Audit station and precedes the Addition of New Sites & Investigators station. This process occurs in parallel with Safety Reporting, Progress Reporting, Ongoing Management & Monitoring, and …

Recruitment Phase Urgent Safety Measures follows the Addition of New Sites & Investigators station and precedes the Temporary Halt station. This process occurs in parallel with Safety Reporting, Progress Reporting, Ongoing Management & Monitoring, and GCP …

Trial Close-Out Phase The End of Trial Declaration station follows the Early Termination station and precedes the Statistical Data Analysis station. This station follows the parallel processes of Safety Reporting, Progress Reporting, Ongoing Management & …

Trial Close-Out Phase Statistical Data Analysis follows the End of Trial Declaration station and precedes the Clinical Trial Summary Report station. Statistical Data Analysis is good practice and is relevant to all trials. This station is part of the …

Trial Close-Out Phase The Clinical Trial Summary Report station follows the Statistical Data Analysis station and precedes the Dissemination of Results station. The Clinical Trial Summary Report is good practice and is relevant to all trials. This station …

Trial Close-Out Phase The Dissemination of Results station follows the Clinical Trial Summary Report station and precedes the Archiving station. Dissemination of Results is good practice and is relevant to all trials. This station is part of the 'trial …

Trial Close-Out Phase Archiving is the final station on the routemap and follows the Dissemination of Results station. Archiving is a legal requirement which is relevant to all trials. This station is part of the 'trial close-out phase' group of stations. …

Trial Close-Out Phase Early Termination follows the Temporary Halt station and precedes the End of Trial Declaration station. This process occurs in parallel with Safety Reporting, Progress Reporting, Ongoing Management & Monitoring, and GCP & Serious …

Recruitment Phase Temporary Halt follows the Urgent Safety Measures station and precedes the Early Termination station. This process occurs in parallel with Safety Reporting, Progress Reporting, Ongoing Management & Monitoring, and GCP & Serious Breach …

… Sponsorship Principles (Research and Development Forum) …

Regulation Flowchart …

Archiving …

Trial Scenarios for Monitoring …

Conditions and Principles of Good Clinical Practice …

Planning a Randomised Controlled Trial (RTC) – Points to Consider …

Summary of Trial Management Systems Workstream 4 Document B …

Trial Management and Monitoring: Monitoring Procedures Workstream Document C …

A single application for HRA Approval will replace separate applications for governance and legal compliance, for all study types in the NHS led from England from the end of March 2016. This completes the phased roll out that has been underway since May …

… The Department of Health (DH) and the Health Research Authority (HRA) have been working together to review the standard DH contract for …

… The EQUATOR Network aims to increase the transparency and … reporting and dissemination.  A short online survey has been issued which focuses on how to modify the current … responsibly share their research findings. The Network are particularly interested in the views of the UK-based medical …

A new survey has opened across Ireland and the UK, giving everyone involved in recruiting people to clinical trials the chance to submit their uncertainties about methods of recruitment and vote on the most important ideas for future research around …

… A workshop is being held later this year to encourage research into incontinence.  The workshop is being developed by a group of medical research charities to provide advice and …