CT SOP version no 2.0

Main changes from CT SOP version no 1.0: minor changes in wording.

CT SOP version no 1.0.

Main changes from LM SOP no. 2.06. Adapted to the wording of the clinical trial regulation no 536/2014.

The sponsor has overall responsibility for ensuring that written information and consent forms are prepared in compliance with this SOP.

The sponsor’s responsibilities shall be described in the quality system of the sponsor institution. Tasks are delegated according to SOP Roles and Responsibilities in clinical trials implemented in the institution.

The sponsor may transfer any or all of the sponsor's trial-related duties and functions to a service provider such as a Contract Research Organisation (CRO), but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf. Transfer of duties shall be specified in a written agreement.

Principal investigator shall ensure that patient information, consent forms and other written information used in the trial have been approved by the ethics committee before use.

Preparing written information

The Informed Consent Document, information sheet and consent form, is required for  the ethics committee application and must be approved before initiating a trial. It is recommended that the coordinating investigator seeks inputs from interested parties, including patients, where relevant.

Informed Consent Documents shall be developed in accordance with the ethics committee requirements. If the ethics committee provides template(s) for the Informed Consent Document, it is recommended to use them to ensure compliance.

Other written information provided to subjects in a clinical trial usually requiring EC approval including:

• Advertising text/recruitment materials (including what is posted on sites such as the hospital website except for website that delivers data to helsenorge.no).
• Questionnaires/PROMs.
• Any other information provided to trial subjects.
  • exceptions: patient study ID-cards, Behandling av dine personopplysninger etter GDPR (Norway)

In trials with patient-reported outcome measures (PROM), the participants should be informed whether the information recorded on the PROMs are checked on an ongoing basis or not. If not, the participants should be informed about other means to share concerns with the investigator.

For paediatric trials, consent must be obtained from parents/guardians. Both parents/guardians must sign. In addition, a separate information sheet suitable for children 12–16 years must be prepared. Minors aged 16 and above must consent in addition to the parents/guardians' consent. The Regional Committees for Medical and Health Research Ethics (REK) has provided templates. If the minor reaches the age of legal consent during the course of the trial, a process for consent should be considered in accordance with applicable regulatory requirements. In Norway this means that that the minor should consent at the age of 16 years. 

In emergency situations when the trial participant is not able to give consent, this must be clearly stated in the protocol and in the application to the ethics committee. Any deviation from the requirement of written informed consent prior to trial start must be explicitly approved by the ethics committee. The participant or the participant's legally designated representative should be informed about the trial as soon as possible and consent to continue should be requested. If such delayed consent is not obtained, data from the subject cannot be used unless the EC has approved it explicitly (usually on a case-by-case basis).

For more information about trials involving subjects who are incapacitated, minor, pregnant or breastfeeding women or emergency situations, see EU Regulation 536/2024, articles 31–35.

Some hospitals/institutions have their own informed consent templates with their logo that can be used.

The following general requirements are applicable to all information sheets and consent forms:

• All pages will have a header with short title and date, version number.
• The contents of the information sheet shall be in accordance with ICH GCP R3 2.8.10.
• The content will be adapted for the specific trial and intended subjects, especially if this includes vulnerable subjects who have a reduced ability to provide consent.
• The information sheet shall be written in a short, clear and understandable way without the use of unnecessary technical or medical terminology.
• The information sheet and consent form are not legally binding contracts for the participants and should not be designed as such.

Any trial participants compensation, should be approved by the ethics committee. Payments to a participant should be timely, prorated and not wholly contingent on completion of the trial by the participant. Reasonable reimbursement of expenses incurred by participants, such as for travel and lodging, is not coercive. Information regarding payment to participants, including the methods, amounts and schedule of payment to trial participants, should be included in the informed consent materials. 

In cluster trials, the Member States may accept that informed consent is obtained by simplified means, see article 30 of the EU Regulation 536/2014.

Information sheets and consent forms in international studies will be prepared in compliance with the applicable national legislation.

Traveling costs in connection with study visits in Norway are covered in the same way as ordinary treatment, see Pasientreiseforskriften.

Revision of written information

The information sheet and any other written information for the participants will be revised when new information becomes available, that may be relevant for the participant’s willingness to consent.

Sponsor/the coordinating investigator will submit the revised informed consent document to the ethics committee for approval prior to use. The new information should be clearly identified to the investigators who in their turn can inform the participants precisely about the new information. 

It is recommended that the template for Informed Consent Form Version Tracking Log is used to keep record of versions of the informed consent form, their implementation date and which participants need to sign. The latter will depend on the relevance for the different participants. 

• Informed Consent Form Version Tracking Log - Template