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Medicines

Published: 9 November 2018

Self-Certified Clinical Trial Site Notification scheme

Clinical Trial Sites requiring notification under the Self-Certified Clinical Trial Site Notification scheme

Section 30(3)(g) of the Medicines Act 1981 specifies that a clinical trial application must include information about the site(s) at which the trial is to be conducted, and the facilities available at those sites. This information is taken into consideration in deciding whether to grant approval for the trial.

If study participants are staying overnight or longer for monitoring purposes as a result of receiving a study medication, information about the facilities and procedures in place to deal with possible emergencies (Critical Incidents) arising from the study medication must be provided. A Critical Incident is described as a life-threatening or disabling event arising from the study medication.

Medsafe administers a Clinical Trial Site Notification scheme to facilitate the collection and processing of this information for both the regulator and for applicants.

Operation of the Self-Certified Clinical Trial Site Notification scheme

Under this scheme, the person who manages the site (where study participants stay overnight) completes a Clinical Trial Site Notification form (see CTSN Form), and notifies that the site has adequate emergency procedures in place. In most instances, the site manager will be a site staff member in charge of the site, who has the responsibility for managing the site, its staff and its procedures.

The notification can be made at any time and does not need to coincide with submission of an application for approval of a particular clinical trial.

On receipt of a completed notification, Medsafe will add the site to a list below. Re-notification of a clinical trial site is required if there is a change to any of the information in the original notification form.

Applicant responsibilities relating to trials being conducted at notified Self-Certified Clinical Trial Sites

Applicants requesting approval of a clinical trial where subjects are kept overnight for monitoring purposes as a result of receiving the study medications need to check that the proposed clinical trial site has been notified. This can be done by checking the list below. If the site has not been notified, the applicant should contact the manager of the site to submit a notification.

Applicants should not commence a clinical trial that requires trial subjects to stay at a site overnight (or longer), unless the site has been notified.

The following is a list of sites for which self-certification has been lodged with Medsafe using the updated form dated November 2018. (Sites for which self-certification has been lodged with Medsafe prior to November 2018 can be found here).

Name of Site Address
Christchurch Hospital Riccarton Ave
CHRISTCHURCH

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