Procedures

These procedures are guidelines for medicinal and health research carried out at UiO. You will also find templates (forms and checklists) ready for use in the documentation of your project.


Procedure 1 - Responsibilities and delegation of tasks at UiO, pursuant to the Health Research Act

The procedure describes the reponsibilities of the University Director, the delegation of tasks to faculties and other levels in the organization that carry out medicinal and health research:

Open Procedure 1 - pdf

Procedure 2 - Responsibilities and tasks of the Principal Investigator (Project Manager), pursuant to the Health Research Act

The procedure describes the responsibilities and tasks of the Principal Investigator when managing medicinal and health research which does not involve any use of medicines or medical equipment on research subjects (research on health information):

Open Procedure 2 - pdf

Appendices/ templates: Checklists and forms for documentation of the project:

Procedure 3 - Sponsor's and Principal Investigator's responsibilities and tasks in connection with clinical trials of medicinal products

The procedures describes the responsibilities of the University Director (sponsor) and principal investigator in connection with clinical trials of medicinal products under the auspices of UiO.

Open Procedure 3 - pdf

Appendices/ templates: Checklists and forms for documentation of the project:

Procedure 4 - Sponsor's and Principal Investigator's responsibilities and tasks in connection with clinical trials of medical devices

The procedure describes the responsibilities of the University Director (sponsor) and principal investigator in connection with clinical trials of medical devices under the auspices of UiO.

Open Procedure 4 - pdf

Appendices/ templates: Checklists and forms for documentation of the project:

Procedure 5 - Use of human biological material for research purposes

The procedure describes responsibilities and tasks associated with research on human biological material:

Open Procedure 5 - pdf

Appendices/ templates: Checklists and forms for documentation of the project:

5.1. Checklist for biobank

5.2. Elements of the contract for supply of biological material from UiO

Procedure 6 - Storage and handling of research data

The procedure describes how research data should be stored and handled in ways that respect the privacy protection rights of the research subject:

Open Procedure 6 - pdf

Appendices/ templates: Checklists and forms for documentation of the project:

6.1. Checklist for processing data

6.2. Key elements in an agreement for transfer of material by UiO

6.3. Form for subject identity list and list of trial subjects

Procedure 7 - Internal control and audit

Open Procedure 7 - pdf

Published Apr. 10, 2013 3:52 PM - Last modified Jan. 1, 2019 2:17 PM