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