Norway CTIS Part II Document Checklist

Core participant and recruitment documents

Recruitment and informed consent procedure

Mandatory. Submit a description of how participants will be identified, approached, informed and consented. Norway recommends the European Commission Recruitment and Informed Consent Procedure template. Submit it in English under the CTIS category for recruitment and informed consent procedures. It does not need a submission signature.

Identify who gives the trial information and who obtains consent. The information-giver should be qualified and part of the research group. REK KULMU considers the treating physician to have a dependent relationship with the patient, including where that physician is expected to treat the patient later. Another person should therefore obtain consent. If electronic consent will be used, state this and describe a secure solution such as BankID or other two-factor authentication.

Recruitment materials

Conditional. Submit advertisements, invitation text, videos and other material used to identify or recruit participants. Submit final Norwegian versions in the CTIS recruitment-material category. These materials are not signed at submission. Patient cards, thank-you cards and staff interview guides that do not identify or recruit participants should not be submitted to REK KULMU.

Patient Information Sheet and Informed Consent Form

Mandatory. Submit the blank Norwegian participant information and consent documents under the CTIS subject information and informed consent category. REK KULMU recommends its national CTR consent template. The participant and the person conducting the consent interview sign and date the approved form when consent is obtained, not at CTIS submission. The Norway patient information and consent guide covers the national content and signature rules.

Conditional. Prepare adapted Norwegian information and consent documents for guardians, legally designated representatives, emergency enrollment, children, adolescents, pregnancy follow-up or optional future research when those pathways apply. Use the relevant population guide in this series rather than forcing every consent pathway into one form.

Investigator and site documents

Principal investigator curriculum vitae

Mandatory for each Norwegian trial site. Submit a curriculum vitae for every principal investigator in the CTIS investigator-suitability category. English is accepted. REK KULMU recommends the European Commission CV template. The CV must show clinical competence, previous clinical-trial experience, patient-care experience and Good Clinical Practice training. For new CTR applications, document current ICH GCP E6(R3) competence or confirm training will be completed before participant recruitment. No signature is required by the Norwegian Part II overview at submission.

Declaration of interests

Mandatory for each Norwegian principal investigator. Describe financial interests, institutional affiliations and other circumstances that could affect impartiality. Use the European Commission Declaration of Interest template or another separate document. Submit it in English with investigator-suitability documentation. REK KULMU does not list a submission signature requirement.

Site suitability form

Mandatory for each Norwegian trial site. Submit a site-specific description in English under the CTIS site-suitability category. The European Commission Site Suitability Form is recommended. In Norway, the form must be issued by the head of department, head of clinic or an equivalent institutional representative who is not the study principal investigator. A handwritten or electronic signature is not required at submission, but the issuer and authority must be clear.

The form or another submitted document must also present the project organization and planned enrollment by site. An enrollment plan may be attached if site-level participant numbers are not stated elsewhere.

Insurance, compensation and financial arrangements

Insurance certificate

Mandatory. Submit a valid certificate issued by the Norwegian Medicines Liability Association under proof of insurance or indemnification. State whether the sponsor has additional trial-specific insurance. The certificate is an issued record and does not need an added sponsor or investigator signature.

Compensation and expense reimbursement

Mandatory. Describe any participant payment and reimbursement of expenses in English under compensation for trial participants. The European Commission compensation template is recommended. Distinguish reimbursement and compensation for lost earnings from any incentive, especially for vulnerable participants. No submission signature is required.

Financing and site arrangements

Mandatory. Provide a short English description of the funding sources, what the funding covers and confirmation that the intervention period is financially secured. Also provide an overview of agreements between the sponsor and sites and any payment arrangements for sites or investigators. Do not upload the underlying agreements. Place the material in the CTIS financial and other arrangements category. Proof of payment belongs in Part I in Norway, including for substantial modifications.

Data protection and biological samples

GDPR compliance statement

Mandatory. Attach an English statement from the sponsor or sponsor's representative confirming that data collection and handling comply with Regulation (EU) 2016/679, the General Data Protection Regulation. State who issues the declaration and on whose behalf. Use the European Commission statement template under the CTIS data-protection category. REK KULMU does not list a submission signature requirement.

Compliance with rules for biological samples

Conditional. Submit this English document when human biological material is collected, stored, analysed, imported or exported. The European Commission biological-samples template is recommended. State the material, analysis, relationship to protocol endpoints, storage locations and periods, biobank details, cross-border movement and destruction or return plan. The document does not require a submission signature.

If samples remain in Norway for more than two months after collection, they must be stored in a study-specific biobank linked to the trial. Samples collected for optional future research need separate treatment. The Norway secondary-use consent guide explains the broad-consent and biobank pathway.

Language, document control and CTIS checks

• Mandatory. Use English for Part II attachments other than consent forms and recruitment materials.
• Mandatory. Use Norwegian for the consent forms assessed by REK KULMU and for recruitment material used in Norway.
• Mandatory. Make version numbers and dates in CTIS structured fields match the uploaded documents.
• Mandatory. Upload searchable, copyable files, preferably PDF rather than scanned images.
• Conditional. Where CTIS publication rules apply, upload both a complete version marked not for publication and a properly redacted version marked for publication.
• Mandatory when responding to an RFI. Upload revised documents to the dossier as clean and tracked-change versions. An attachment only to the response is not enough.

The European Commission's Recruitment and Informed Consent Procedure template v2.0 is intended for new Part II submissions. On the review date of this guide, a transition period runs until full implementation on 1 September 2026. Use the current v2.0 template for a new dossier.

For a final participant-document review, use the Norway patient-facing document QC checklist. Return to the Norway CTIS guide hub for all population-specific pathways.