Standard Operating Procedures (SOPs)
The CTU has developed and is working by a set of standard operating procedures (SOPs). The list of procedures can be seen below:
Researchers collaborating with the CTU can gain access to the SOPs upon request.
SOP #1.1 - Developing, approving, and updating SOPs
Appendix A - SOP template
Appendix B - SOP template instruction
Appendix C - SOP training of CTU staff
SOP #1.2 - Maintaining the CTU’s Master Index and files/folders for development plan and clinical trial files
SOP #1.3 - Contracts
Appendix A - Contract template (in English)
SOP #2.1 - Clinical trial development plan and protocol template
Appendix A - Protocol template
Appendix B - Request for protocol evaluation
Appendix C - Protocol evaluation form
SOP #2.2 - Intervention related documents
Appendix A - Content of the investigator's brochure in a trial on a medicinal product
Appendix B - Content of the investigational medicinal product dossier
Appendix C - Content of the investigator's brochure in a trial on a medical device
Appendix D - Content of the investigator's brochure in a trial on in vitro diagnostic medical device
SOP #2.3 - Participant information and informed consent
Appendix A - Content of participant information and informed consent form (in English)
Appendix B - Indhold af patientinformationsmateriale og samtykkeerklæring (in Danish)
Appendix C - Participant information and informed consent form template (in Danish)
SOP #2.4 - Participant insurance
SOP #2.5 - Clinical trial authorisation
Appendix A - Schematic of Danish clinical research authorisation procedures
Appendix B - Documents required for application for the authorisation of clinical trials to the Regional Ethics Committee
Appendix C - Documents required for application for the authorisation of clinical trials to the Danish Medicines Agency
Appendix D - Documents required for application for the authorisation of clinical investigations of medical devices to the Danish Medicines Agency
SOP #3.1 - Data management
Appendix A - Data management plan
Appendix B - Case Report Form (CRF) guidelines
SOP #3.2 - Randomisation and unblinding in clinical trials
Appendix A - Randomisation check list
Appendix B - Randomisation specification
Appendix C - Paper-based randomisation / emergency randomisation
Appendix D - Staff training in telephone-based randomisation and/or emergency randomisation
SOP #3.3 - Paper case report forms
SOP #3.4 - Electronic case report forms
Appendix A - eCRF validation
SOP #3.5 - Data Safety
SOP #4.1 - Data Monitoring Committee
SOP #4.2 - Adjudication Committees
SOP #5.1 - Filing and archiving of essential documents
Appendix A - Checklist of essential documents
Appendix B - Submitting data to the Danish Data Archive Health
SOP #5.2 - Monitoring of clinical trials
Appendix A - Checklist for pre-trial monitoring visits
Appendix B - Chekclist for initiation monitoring visits
Appendix C - Checklist for periodic monitoring visits
Appendix D - Checklist for closure monitoring/close-out visits
SOP #5.3 - Clinical trial amendments
Appendix A - Schematic overview of submission of amendments
Appendix B - Amendments to clinical trials on medicinal products
SOP #5.4 - Adverse events reporting
SOP #6.1 - Notification of end of trial
SOP #6.2 - Statistical analysis of clinical trials data
SOP #6.3 - Clinical trial reports
Appendix A – Structure and content of the clinical trial report (outside text)
SOP #7.1 - Escalation of problems and handling of scientific misconduct and/or dishonesty
SOP #7.2 - Qualification of trial staff
SOP #7.3 - Audits and inspection
Appendix A - What can be a subject to an audit?
SOP #8.1 - IT