Clinical Trials of an Investigational Medicinal Product (CTIMP)
CTIMPs General
EU Legislation -
EU Clinical Trials Directive (2001/20/EC)
GCP Directive (2005/28/EC)
UK Regulations -
The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI No. 1031)
The Medicines for Human Use (Clinical Trials) Amendment (No. 1) Regulations 2006 (SI No. 1928)
The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006 (SI No. 2984)
Guidance -
Good Clinical Practice (GCP)
ICH Topic E6: Guideline for Good Clinical Practice (GCP), EMEA
Guidelines for Clinical Trials
Eudralex – Volume 10
Sponsorship
EUCTD: Sponsorship Responsibilities in Publicly Funded Trials, April 2004, DH
Serious Breaches of GCP or the Trial Protocol
Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol, MHRA
GCP Inspection by the MHRA
How to prepare for an inspection for Good Clinical Practice by the MHRA: A Guide for NHS organisations that Sponsor or host clinical trials of medicinal products
Medicinal Products
Best Practice Guidance on the labelling and packaging of medicines, June 2003, Guidance Note 25
A Guide to Defective Medicinal Products (2004), 1 Jan 2004
Clinical Trial Agreement
Guidance -
Commercial Sponsored Studies
Model Clinical Trial Agreement (mCTA) for Commercial Sponsored Studies
Tripartite Agreement
Contract Research Organisation model Clinical Trial Agreement (CRO mCTA)
Clinical Trial Applications (CTA)
Guidance -
What is a Medicinal Product?
A Guide to What is a Medicinal Product, revised June 2007, Guidance Note 8, MHRA
The European Clinical Trials Database
Detailed guidance on the European clinical trials database (EUDRACT Database), April 2003, EC
Authorisation of a Clinical Trial on a Medicinal Product for Human Use
Detailed Guidance for the Request for Authorisation of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities, Notification of Substantial Amendments and Declaration of the End of the Trial, October 2005, EC
Example of the Contents of an Investigator's Brochure
Contents of an Investigator’s Brochure (IB), Appendix 2
Good Laboratory Practice (GLP)
UK Regulations -
The Good Laboratory Practice Regulations 1999 (SI No. 3106)
The Good Laboratory Practice (Codification Amendments Etc.) regulations 2004 (SI No. 994)
Guidance -
UK GLP Regulations
Guide to UK GLP Regulations 1999 – 1 Feb 2000
Good Practice in Research
Guidance -
MRC: Good Research Practice (2000)
MRC: Guidelines for Good Clinical Practice in Clinical Trials
Pharmacovigilance
Guidance -
Collection, Verification and Presentation of Adverse Research Reports
Detailed Guidance on the Collection, Verification and Presentation of Adverse Reaction Reports arising from Clinical Trials on Medicinal Products for Human Use, April 2006, Revision 2, EC
The European Database of Suspected Unexpected Serious Adverse Reactions
Detailed Guidance on the European Database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance – Clinical Trial Module), April 2004, Revision 1, EC
Clinical Trials Tool Kit Material
Pharmacovigilance Document: MRC/DH Joint Project Workstream 6