SOP for Site Initiation

Purpose

To describe the procedures related to site initiation of a clinical trial at all sites.

Scope

This SOP applies to all relevant employees including, but not limited to, visiting health professionals, contractors, consultants and volunteers who propose to undertake, administrate, review and/or govern human research involving patients/participants and staff. All study personnel involved in the clinical study must operate within their scope of practice.

Procedure

1. Site Initiation

Prior to initiation of the study, the Investigator must:

• Mutually agree with the Sponsor a scheduled date, time and location for the Study Initiation Visit at the participating site to ensure the site is prepared to commence the study. In the case of a teletrial, this may be at the Primary Site only, or could include (remotely) the Satellite Site/s as determined by the study complexity by the Sponsor/PI.
• Review all study related documentation and be familiar with the Investigational Product and Protocol.
• Ensure that all relevant staff involved with the study, (Associate Investigator, Pharmacist, Clinical Research Coordinator and others as appropriate including trial related staff at a Satellite Site), have been advised of the meeting and are able to attend either in person or via videoconference.
• Be in possession of all required approvals and authorisations to conduct the research project.
• For teletrials, ensure a Supervision Plan is in place, that documents the manner and frequency of supervision to be undertaken with other trial staff, especially those new to the role, and, where relevant, trial related staff at a Satellite Site. A Supervision Plan is to be created by the Primary Site for each Satellite Site.
• Do not initiate a Satellite Site under the Teletrials Model until such time as a potentially eligible participant population is identified.

During the initiation Visit the Investigator must ensure the following are available and/or addressed:

• Study Master File (SMF) containing all required Essential Documents and review arrangements for organising and maintaining study files (Satellite Site Study File in the case of the PI initiating a Satellite Site).
• A list of all study personnel attending the initiation meeting on an attendance log/Training Log with full name, signature, date and the method attended i.e. in person or via videoconference.
• Original, signed and dated curriculum vitae of all study personnel involved in the study at the site and any Satellite Sites for which the Investigator has responsibility.
• Other documents such as, financial disclosures, Training Logs, medical licenses and other Essential Documents as per Sponsor requirements.
• A contact list with names and contact details of all study personnel from all sites including Satellite Sites, Sponsor and independent third-party service providers is available.
• Timeline for shipment, delivery and receipt of Investigational Product and other study related supplies to site.
• A laboratory manual, where applicable, clearly defining sample handling instructions and processes, shipping procedures, documentation handling, contact list of all laboratories involved and any other laboratory activity to be undertaken during the course of the trial.
• A pharmacy manual clearly defining any activity linked to the handling or the Investigational Medicinal Product (IMP)/Investigational Medicinal Device (IMD).
• Any specialised equipment required will be available throughout the period of the trial, e.g. centrifuge, freezer, etc.
• The Case Report Form (CRF), completion guidelines and that they are accessible by all sites.
• Training in all aspects required by the Protocol is recorded on the Training Log.
• Archiving of study records at the end of the study.
• Subsequent training for staff not in attendance at the Initiation Visit. Such initiation training can be conducted remotely where feasible. It is critical however, that this training is undertaken and documented before they commence activities in the study.
• Supervision Plan for teletrials.
• For each teletrial, the above steps must be repeated for each Satellite Site to be established under the Primary Site.

At the conclusion of the initiation the Investigator must:

• File the Sponsor’s initiation visit report/letter in the SMF.
• Ensure that the staff at the Satellite Site files all communication and documentation in the SSSF.

Annexure

Annexure-1: Initiation Checklist 

Revision History

Nil

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