Study Closure Report:
Canadian SHIELD has an ongoing obligation to ensure study participant safety until the site(s) approved are officially closed. CSERB considers a site closed when the investigator has received a report from the study sponsor that the database has been “locked.” At this point, no further actions from the sponsor ought to occur, and all information from the site ought to have been processed. This may occur after the study sponsor has completed their “Close-Out” visit. It is possible that a site could be closed while the study continues at other sites. If significant new information becomes available, it is the obligation of the sponsor and the investigator to inform the CSERB and potentially the study participants.
All research must be reviewed “at least annually.” The Board may request a frequent review, depending on the conditions of the study. Submission of continuing review is a collaborative submission by the study sponsor and the investigator.
Research ethics boards are obliged to ensure participant safety on an ongoing basis once a study has been approved ICH E.6 (Section 3.1.4) [21 CFR §56.109(f) and 45 CFR §46.109(e)]. A report must be filed with Canadian SHIELD at least annually, but may be required more frequently, based on the degree of risk for the trial participant. Included in the continuing review update are a summary of enrolled participants, a summary of adverse events, any changes to study staff, a summary of protocol deviations, and any other significant issues that may impact the original REB approval.
Changes to the Approved Research:
Study Sponsors or Investigators must submit all amendments to approved protocols and clearly indicate if the amendment impacts the Informed Consent Form (ICF). The Board will also review every amendment and determine if a change is required to the ICF. If the ICF must be changed, a new ICF must be prepared, indicating the new date. In some cases, where new important information about the study drug is added to the ICF, previously enrolled study participants may require “re-consenting.” Canadian SHIELD will advise the investigators regarding this issue. In addition, all significant changes to the study site personal or location must be reported. Investigators are obliged to report all significant protocol deviations. Protocol deviations/violations are reviewed and assessed for their impact on study participant safety and whether any study documentation must be amended.
Adverse Event Reporting:
All serious, life-threatening, or unexpected, drug-related adverse events must be reported to the Canadian SHIELD Ethics Review Board. Forms from the study sponsor may be used. Please note that non-serious adverse events, whether drug-related or not, only need to be reported to CSERB on an annual basis. Sponsor reports may be submitted directly, or the attached form can be used. ADR Instructions