Glasgow Clinical Trials Unit

Forms Guidelines
Title Number Version Release Date
Protocol Development 51.001 6.0 11/02/22
Participant Information Sheet and Consent Forms: Design and Approval 51.002 5.0 11/02/22
Peer Review 51.003 4.0 11/02/22
Risk Assessment 51.004 5.0 18/01/22
R&I - End of Study Procedures 51.005 4.0 10/03/23
Identifying a Sponsor Organisation 51.007 5.0 04/10/21
Handling non-compliance with Good Clinical Practice (GCP) and/or the trial protocol in clinical research sponsored, co-sponsored or hosted by NHS Greater Glasgow and Clyde 51.008 4.0 19/04/22
Notification of Serious Breaches of Good Clinical Practice or the Trial Protocol for Clinical Trials of Investigational Medicinal Products 51.009 4.0 17/12/18
Preparation and Review of Grant Applications and Costs 51.010 4.0 26/10/22
University of Glasgow and NHS Greater Glasgow and Clyde Co-Sponsorship Agreement 51.011 4.0 04/10/21
Preparation and Submission of IRAS Forms 51.014 4.0 11/02/22
Assessment of Vendors 51.015 4.0 18/11/21
Preparation and Maintenance of a Trial Master File 51.016 4.0 04/10/21
Registration of Research Projects on Public Databases 51.017 3.0 17/12/18
Sponsor Oversight Checklist 51.018 3.0 02/03/20
Sponsor – End of Study Procedures 51.019 3.0 11/02/22
Sponsor Regulatory Green Light 51.020 3.0 02/03/20
Sponsor Review and Approval of Amendments 51.021 4.0 02/03/20
Research & Development Data & Administration Tasks 51.022 3.0 11/12/19
Sponsor process for an IDMC 51.023 5.0 25/08/22
Archiving Essential Documents from Clinical Research – Process for a Sponsored Clinical Trial of an Investigational Medicinal Product (CTIMP) 51.024 1.1 24/05/18
Archiving Essential Documents from Clinical Research – Process for a Sponsored Non CTIMP 51.025 1.0 12/04/18
NHS Laboratory Samples for Trials Involving an Investigative Medicinal Compound (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and the University of Glasgow 51.028 3.0 08/01/19
Writing Study Specific Laboratory Manuals for Trials Involving Investigational Medicinal Products Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and the University of Glasgow 51.029 2.0 02/11/18
Writing Sample Handling Manuals for Sites Participating in Clinical Trials of an Investigative Medicinal Product (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and University of Glasgow 51.030 2.0 02/11/18
Corrective and Preventative Action Plan Management 51.031 1.0 17/12/18
Research Imaging for Trials involving an Investigative Medicinal Compound (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and the University of Glasgow (UoG) 51.033 1.0 09/03/20
Writing a Trial Specific Research Imaging Manual for Sites Participating in Clinical Trials of an Investigative Medicinal Product (CTIMP) Sponsored by NHS GG&C or Co-sponsored by NHS GG&C and University of Glasgow (UoG) 51.034 1.0 09/03/20
Design and Development of CRFs/eCRFs in CTIMPs and Clinical Investigations 51.035 1.0 11/02/22
Trial Steering Committee for Trials involving an Investigative Medicinal Compound (CTIMP) sponsored by NHS GG&C or co-sponsored by NHS GG&C and the University of Glasgow 51.036 2.0 25/08/22
Storage and Transfer of Laboratory Data for Clinical Trials and Investigations Sponsored by NHS Greater Glasgow & Clyde (NHS GG&C) or Co-Sponsored by NHS GG&C & University of Glasgow 51.037 1.0 03/03/22