Standard Operating procedure
a) Informed consent documents
b) Obtaining informed consent
c) Storage of informed consent documents
d) Verification of informed consent
1.1 The purpose of this Standard Operating Procedure is to describe the process to be followed when obtaining written obtained consent from trial subjects. It also describes the distribution and storage of the consent forms.
1.2 These processes form the minimum standards to be followed in order to comply with ICH-GCP guidelines.
††††† It is the responsibility of the investigator to obtain written informed consent††††
††††† from all trial subjects before the conduct† any trial related procedure.
3.1 Informed consent documents.
The informed consent documents include any written information to be provided to the trial subject i.e. the informed consent form, patient information sheet, additional advice leaflets etc.
The investigator must ensure that the appropriate ethics committee approves the documents prior to use and that the approval documentation contains reference to the correct version of the informed consent documents.
If during the course of a study any new information becomes available that may be relevant to the subjects consent the documents should be revised. The revised version requires approval by the Ethics Committee and trial patients made aware of new information and reconsented using the new documentation.
3.2 Obtaining Informed Consent
In obtaining and documenting informed consent, the investigator should comply with any applicable regulatory requirements, and should adhere to GCP and the Declaration of Helsinki.
Informed consent must be obtained from the trial subject (or legally acceptable representative) before any trial related procedures are carried out.
Before informed consent is obtained the subject should be allowed ample time and opportunity to read the patient information sheet, to enquire about details of the trial and to decide whether or not to participate.
If the subject wishes to participate the written informed consent form should be completed as appropriate and then signed and personally dated by the subject and the investigator who conducted the informed consent discussions. Witness signature is only required under ICH-GCP if the subject (or legally acceptable representative) is unable to read. However it is still required by some ethic committees and sponsor companies, in which case the investigator must comply with their requirements. A copy of the signed and dated written informed consent and any other written information must be provided to the subject prior to participation in the trial. Similarily the subject should also receive copies of any consent form updates or new information during the trial.
When atrial involves subjects who can only be enrolled with the consent of their legally acceptable representative (e.g. children), the subject should still be informed about the trial to the extent compatible with their understanding and if capable should also sign and date the consent form.
3.3 Storage of informed consent documents
A clean (blank) copy of the informed consent form and information provided to the subjects that have been approved by the ethics committee should be filed in the investigator site file.
All original signed and dated consent forms should be filed at site. During the trial these can be maintained appropriate Case record Forms. After the trial they can be filed the patientís notes, CRF or in the investigator site file as appropriate.
It is the responsibility of the sponsor company to inform the investigator when they can destroy these documents.
3.4† Verification of informed consent
The signed and dated written informed consent forms must be available for review by the sponsor company representatives for data verification purposes or audit. They must also be made available to any regulatory body during regulatory inspection/audit visits.