Standard operating procedures (SOPs)

The CTU has developed and are 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 - 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 #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 Arhive 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