Standard Operating Procedures
Standard Operating Procedures (SOP)
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
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