Glasgow Clinical Trials Unit

Forms Guidelines
Title Number Version Release Date
Handling Urgent Safety Measures for Clinical Trials for Investigational Medicinal Products 53.001 3.0 04/01/19
The Handling of Poor Quality and Fraud in Clinical Research 53.002 4.0 05/07/22
Temporary Halt or Early Termination of Clinical Trials of Investigational Medicinal Products 53.003 3.0 04/01/19
Monitoring Clinical Research - Site Monitoring Visit 53.004 6.0 26/11/20
GCP Audit of Research Studies and Systems Supporting Research 53.005 7.0 18/02/22
Monitoring Handover Checklist Process 53.006 2.0 25/08/22
Unblinded Monitoring Process 53.007 2.0 06/12/22
Accompanied and Training Visit Process 53.008 2.0 10/03/23
Preparation and Maintenance of a Clinical Trial Monitoring File 53.009 2.0 25/08/22
Monitoring Clinical Research – Preparation and Management of a Monitoring Plan 53.010 1.0 26/11/20
Sponsor Source Data Requirements and Guidance 53.011 1.0 15/12/21
Monitoring Clinical Research – Site Close Out Monitoring Visit 53.012 1.0 25/08/22
Monitoring Clinical Research – For Cause Monitoring Visit 53.013 1.0 25/08/22