Table 1 Signature of informed consent form checklist

1. Informed Consent Form (ICF): A written document signed and dated by a participant who voluntarily confirms their willingness to participate in a particular trial after having been informed and having understood all aspects of the trial that are relevant to the participant’s decision to participate.

3*

2. The investigator should obtain the ICF willingly submitted by the participant prior to the beginning of the trial.

The investigator or a person designated by the investigator should fully inform the participant of all pertinent aspects of the trial, including the contents of the ICF and documents approved by the Ethics Committee. The investigator or designated person should ensure that the content of the ICF and other trial-related documents is well understood and that the ICF has been signed and dated by the participant.

5 − 1*

5 − 2*

3. All trial staff should be qualified and have the training and work experience necessary to assume their responsibilities in the trial.

14*

4. Prior to the beginning of the trial, the investigator must obtain approval from the Ethics Committee for the ICF and any other written information to be provided to participants. The approval referred to in the preceding paragraph should be made in writing.

16*

5. Any revised ICF and written information shall be approved by the Ethics Committee prior to use; for clinical trials that are approved by a competent authority, the revised documents shall be resubmitted for approval.

17 − 2*

6. Prior to a participant’s participation in the trial, the ICF must be signed and personally dated by the participant, their legal representative, or a legally acceptable representative.

Before informed consent may be obtained, the investigator, or a person designated by the investigator, should give the participant or their legally acceptable representative ample time and opportunity to inquire about the details of the trial.

20 − 1*

20 − 2*

7. The sponsor should appoint appropriately qualified individuals for the following tasks:

a. to supervise the overall conduct of the trial,

b. to handle and verify data,

c. to conduct statistical analyses and prepare trial reports,

d. to perform operations related to conducting the trial.

54*

8. The investigator should be informed of any CRF (case report form) entry error, omission, or illegibility. The monitor should ensure that appropriate corrections, additions, or deletions are made, dated, explained, and marked with initials by the investigator or by a member of the investigator’s trial staff who is authorized to approve CRF changes for the investigator. This authorization should be documented and filed.

77 − 15*

9. The Ethics Committee should approve studies on the basis of the degree of risk to human participants and continually review ongoing trials at appropriate intervals.

These continual reviews should be conducted at least once a year.

87 − 1*

87 − 2*

10. ICF signature order

a. Qualified researchers interpreting the participant’s consent form.

b. Participant

c. Primary investigator/coinvestigator

IRBSOP**