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RETURN TO RESEARCH ROADMAP

STEPS TO STUDY ACTIVATION

Return to Clinical Research Roadmap

Complete a Site Initiation Visit (SIV)

Before receiving study activation, the study team will typically need to complete protocol-training. This formal training is often referred to as a “Site Initiation Visit” or “SIV,” especially in reference to industry-sponsored studies. This training will include a review of the protocol and its requirements along with training focused on other components such data entry, lab processing, study drug administration, etc. This training could come in multiple forms:

    • In Person Training with sponsor representatives
    • Virtual Training with sponsor representatives
    • Self-paced Review of Materials

SIV is often one of the last sponsor-required steps prior to activation. SIV should not take place prior to IRB approval and contract/subaward execution.

Preparing for a Site Initiation Visit

To prepare for the SIV, determine how much time will be needed for its completion. Identify which study team members need to be present and which portions they should attend. 

Determine expectations for the SIV with the sponsor:

    • How much time will be needed for the SIV completion? 
    • Who needs to attend the training? What portions of the SIV will each team member need to attend? 
    • Will the sponsor need to tour the facility?
    • Will the sponsor need to tour IDS-if so please note that IDS requires one-month advanced notice to schedule an Investigational Drug Services visit. 
    • What roles will each team member have and what tasks will each team member be responsible for? 

Training should be documented on a training log either provided by sponsor or if one is not available, on an internal training log. The training log should be retained and filed in a regulatory binder. If in-person, this is a great opportunity to have the study team sign the delegation of authority log and complete any other outstanding items. Ensure all team members have access to any systems (electronic data capture system, randomization system, etc.) that will be needed for the study.

Completing the Site Initiation Visit (SIV) is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.